cyrilzakka/clinical-trials huggingface dataset:
Comparison of Subacromial Ozone (O2-O3) and Corticosteroid Injections in the Treatment of Rotator Cuff Tendinopathy

Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain.

The aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.

Shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. Rotator cuff tendinopathy is the most common cause of shoulder pain.

There are limited studies comparing the efficacy of ozone and corticosteroid injections in rotator cuff tendinopathy. In this context, the aim of this study is to compare the effects of ultrasound-guided subacromial ozone (O2-O3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 70 years
* pain in the shoulder region and increase in pain with overhead-throwing activity
* chronic shoulder pain for more than 3 months
* partial rotator cuff tear or rotator cuff tendinosis diagnosed by US or magnetic resonance imaging (MRI).

Exclusion Criteria:

* a full-thickness rotator cuff tear diagnosed by US or MRI
* allergic reaction betamethasone or lidocaine
* contraindications for ozone (O2-O3) injection, such as uncontrolled hyperthyroidism, glucose-6 phosphate dehydrogenase deficiency (G6PDD), pregnancy and platelet level \<50 103/µL
* history of coagulopathy, diabetes, or hepatitis
* intra-articular/subacromial injections in the last 3 months
* history of shoulder infection, fracture, trauma, bony lesion, tumor or inflammatory rheumatic diseases
* history of brachial plexus lesion/cervical radiculopathy.
Wear of Vita Ambria Only Restoration Compared With IPS Emax Onlay Restoration

The 1ry objective will be to evaluate the amount of wear of onlays restorations made from VITA AMBRIA \& IPS e.max Press and their opposing natural teeth.

2. The 2ry objective of the clinical trial will be to evaluate the fractures, retention, contact points, food impaction and radiographic examination of the VITA AMBRIA onlays compared with IPS e.max press onlays as defined by FDI criteria.

A randomized controlled clinical trial, a double-blind (patient and examiner) is conducted by one trained and calibrated operators who perform all restorative procedures. The restorations are evaluated by a blind and calibrated two examiner using the FDI World Dental Federation criteria. A total of 24 patients will be randomly assigned to each group for a total of 48 patients. The randomization sequence will be generated (www.randomlists.com/team-generator) and to ensure the confidentiality of the allocation, this will be used opaque, sealed and numbered envelopes in series. These will be kept with an independent researcher for the moment of inclusion of the subjects.

Both groups will receive Onlay preparation . Digital impression by intra oral scanner will be taken, wax pattern for the onlay restoration will be designed and milled using CAD/CAM software. After that, the wax pattern will be invested and final onlay restoration will be constructed from VITA AMBRIA and IPS e.max press ingots according to manufacturing instructions. Primary outcome: The amount of wear will be evaluated according to FDI standard.

Eligibility Criteria:
Inclusion Criteria:

* The patient is healthy.
* 18-50 years old.
* Normal occlusion.
* Good oral hygiene.
* Tooth with complete root apex.
* Tooth with moderate coronal decay.

Exclusion Criteria:

• Patient Incapable of self-care, mental illness, undergoing radiotherapy, diabetic patient, allergy to one of the materials used, pregnancy, smoker, parafunctional habits, poor oral hygiene, severe periodontitis, tooth need vital pulp therapy or surgical crown lengthening or marginal elevation, tooth with enamel or dentin hypoplasia or hypocalcification, Mallaligned or malformed teeth and adjacent or opposing teeth are missed.
Ketamine Versus Dexmedetomidine With Local Anesthetic in TAP Block

Comparing the analgesic effects of ketamine and dexmedetomidine when added to local anesthetic in TAP block for postoperative analgesia after lower abdominal cancer surgery.


Eligibility Criteria:
Inclusion Criteria:

* All patients ASA I and II to whom abdominal surgery for cancer will be conducted will be included in the study

Exclusion Criteria:

* Coagulopathies
* ASA III or IV, patient refusal, sensitivity to the used drugs
Preoperative S-1/OHP With Radiation Therapy for Low-lying Rectal Carcinoma in Neo-adjuvant Setting

The purpose of this study is to assess the safety and efficacy of S-1 and oxaliplatin combined with radiation by Phase I/II study.

The purpose of this study is as follows,

* In phase I, to determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD).
* In phase II, to evaluate the antitumor effect (pCR rate) and the safety .


Eligibility Criteria:
Inclusion Criteria:

1. Patients with confirmed locally advanced and non-metastatic rectal adenocarcinoma (clinical stage T3, anyN or T4, anyN)
2. Possible to R0 resection
3. Received no prior therapy
4. Performance status (ECOG) 0-1
5. Normal organ and marrow function.
6. Sufficient oral intake

Exclusion Criteria:

1. History of serious allergic reaction
2. Patients without serious complications such as sensory neurotoxicity or serious diarrhea (with watery stool).
3. Female with pregnancy or lactation
4. Have another malignancy in the past 5 years except early stage other cancer that cure by local treatment
Establishing a Database of People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Data Project [C-Data])

Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to gather medical information from children and adults with SCD and establish a database so that researchers can contact people to participate in future SCD research studies.

SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. This study, the Collaborative Data Project (C-Data), will establish a comprehensive database of children and adults receiving medical care at participating CSCC research centers who are potentially eligible for inclusion in SCD clinical trials. The main purposes of this study are the following: 1) to gather medical information about a large number of people with SCD over a long period of time; 2) to identify potential participants for future SCD clinical trials; 3) to collect information about how SCD affects quality of life; and 4) to evaluate the relationship between SCD patients' characteristics and medical events.

In this study, research staff will review participants' medical records twice a year for at least 5 years. Information will be collected regarding participants' medical history, physical exams, blood tests, and demographics. Once a year, participants will take part in a short interview about their health and lifestyle. Participants will also complete quality-of-life and patient satisfaction questionnaires during the first year of the study and may complete additional questionnaires in the future. During an interview, participants will be asked general questions about their experience with SCD and more specific questions on headaches and any possible relation they may have to SCD pain. Participants may also be asked to provide a blood sample at some point during the study. CSCC researchers will analyze the information in the database and may contact participants in the future to see if they are interested in enrolling in SCD clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SCD
* Evaluated within the 24 months prior to study entry in the hospital or clinical setting
* Expected to return episodically or regularly for care at one of the CSCCs

Exclusion Criteria:

* Deceased CSCC patient
* Inactive CSCC patient
Movicol in Childhood Constipation (ProMotion Study)

This was a single centre study comprised of two stages (Parts I and II). Part II was a 12 week randomised double blind comparison of Movicol and Lactulose Dry as maintenance therapy on an out-patient basis. The aim was to evaluate the safety and efficacy of Movicol in the treatment of faecal impaction in children

Two days following disimpaction (Part I of the clinical trial) patients were assigned (based on their randomisation number) to receive either Movicol or Lactulose as maintenance therapy for the remainder of the study. At discharge all patients received the appropriate supply of study medication. This includes 1 week's overage should they miss their next visit to the ProMotion clinic. They did not know whether they have been randomised to receive Movicol or Lactulose Dry.

Following discharge patients were contacted after 3-5 days by telephone or home visit (whichever was appropriate) to encourage treatment and to ensure compliance. Parents were instructed to contact the Pro-Motion team who would advise appropriately if patients had any difficulty i.e. none, irregular and/ or uncomfortable or very loose bowel movements.

The daily use of Movicol or Lactulose Dry during Part II was recorded in the diary. If the dose of Movicol or Lactulose was changed by the Pro-Motion team at any time then it was documented appropriately in the patient notes and the case report form.

Eligibility Criteria:
Inclusion Criteria:

* patients that, in the opinion of the investigator, are constipated/faecally impacted as to require hospital stay to treat and/or relieve the impaction
* children aged 2 - 11 years old inclusive
* patients of either sex

Exclusion Criteria:

Patients with

* intestinal perforation or obstruction
* severe inflammatory conditions of the intestinal tract
* uncontrolled renal/hepatic/cardiac diseases
* uncontrolled endocrine disorder(s)
* any neuromuscular condition affecting bowel function
* hypersensitivity to lactulose or PEG or other constituent of Movicol
* patients who have taken any investigational drug in the three months
* patients or patients whose parents would in the opinion of the investigator are unable to comply with requirements of the study
Efficacy of Cyclosporine Ophthalmic Emulsion in the Treatment of Dry Eye Syndrome in Contact Lens Wearers

Cyclosporine Ophthalmic Emulsion is currently used in the treatment of dry eye syndrome. Contact lens wearers frequently suffer from dry eye syndrome. The purpose of this study is to evaluate cyclosporine ophthalmic emulsion verses re-wetting drops in the relief of dry eye symptoms in contact lens wearers


Eligibility Criteria:
Inclusion Criteria:

* contact lens wearer
* clinical diagnosis of dry eye syndrome

Exclusion Criteria:

-
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

This is a randomized, double-blind, placebo-controlled, 2 arm multicentre, global Phase III study to assess the efficacy and safety of selumetinib compared with placebo in adult participants with NF1 who have symptomatic, inoperable PN.

Eligibility Criteria:
Key Inclusion Criteria:

* Adults ≥ 18 years at enrollment with diagnosis of NF1 with symptomatic, inoperable PN
* At least one inoperable target PN measurable by volumetric MRI analysis
* Chronic target PN pain score documented for minimum period during screening period
* Stable chronic PN pain medication use at enrollment
* Adequate organ and marrow function

Key Exclusion Criteria:

* Confirmed or suspected malignant glioma or MPNST (low grade glioma, including optic glioma not requiring systemic therapy or radiation therapy are exempt from this exclusion)
* History of malignancy except for malignancy treated with curative intent with no known active disease ≥ 5 years before the first dose of study intervention and of low potential risk for recurrence
* Clinically significant cardiovascular disease, including inherited coronary disease, acute coronary syndrome within 6 months prior to enrollment, uncontrolled angina, symptomatic heart failure, cardiomyopathy, severe valvular heart disease, abnormal LVEF and uncontrolled hypertension
* Ophthalmological findings/conditions including intraocular pressure \> 21 mmHg, RPED/CSR or RVO
* Prior exposure to MEK inhibitors
Comparison of 12-day Reverse Hybrid Therapy and 12-day Standard Triple Therapy for Helicobacter Pylori Infection

Reverse hybrid therapy is a one-step two-phase treatment for Helicobacter pylori infection with less cost than standard triple therapy. Whether reverse hybrid therapy can replace standard triple therapy as the recommended first-line treatment is unknown. The investigators compared the efficacy of 12-day reverse hybrid therapy and 12-day standard triple therapy in first-line treatment.

For this multicentre, single-blind, and randomized-controlled trial (REHYTRI study), the investigator recruited patients with H pylori infection. Using a computer-generated randomization sequence, the investigator randomly allocated patients to either 12-day reverse hybrid therapy (pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg, amoxicillin 1 g for another 5 days; with all drugs given twice daily) or a 12-day standard triple therapy (pantoprazole 40 mg, clarithromycin 500 mg, amoxicillin 1 g for 12 days; with all drugs given twice daily) at a 1:1 ratio. Our primary outcome was the eradication rate by intention-to-treat and per-protocol analyses.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive H pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria:

* previous H pylori-eradication therapy
* ingestion of antibiotics or bismuth within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
Research of the EML4-ALK Gene Expression in the Pleural Effusion or Tumor Tissue From Lung Cancer Patients

We wants to analyse the EML4-ALK mutation rate in the patients who have non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* 20 or more than 20 years of age
* The pathological diagnosis confirmed lung cancer
* Patients have achieved pleural effusion, or surgical biopsy to obtain tumor tissue specimens
* The patient had signed inform consent

Exclusion Criteria:

* pleural effusion or tumor tissue can not be obtained
* the patient is not suitable to join the research according to the judgement by the investigator
Biomarkers in Cerebrospinal Fluid in Critical Care Patients With Delirium

Critical care patients are at a high risk of developing delirium and impaired cognitive function 3 and 12 months after their ICU stay. In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU and subsequent development of cognitive dysfunction in ICU survivors.

Biomarkers in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium in the ICU. Samples will also be taken 3 and 12 months after the ICU-stay. CSF will also be obtained in healthy age- and sexmatched controls undergoing surgery.

Critical care patients are at a high risk of developing delirium, a form of acute brain dysfunction, and may develop impaired cognitive function 3 and 12 months following their ICU stay.

In this study the aim is to try to elucidate the pathophysiology behind delirium in the ICU comparing patients with and without delirium and possible development of cognitive dysfunction in ICU survivors. Neuroinflammatory markers and markers of structural damage in cerebrospinal fluid (CSF) will be analysed in patients with and without delirium assessed with the CAM-ICU (Confusion Assessment Method) test in the ICU. CSF samples will also be taken in ICU-survivors, 3 and 12 months after the ICU-stay. For comparison CSF will be obtained in healthy age- and sexmatched controls undergoing surgery in spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to ICU for acute respiratory, septic and/or circulatory chock

Exclusion Criteria:

* Abnormal coagulation
* Recent exposure to intensive care
* Patients unable to assess for delirium
* Patients difficult to follow up
* Patients expected to live less than 24 hrs
* Patients with known cognitive dysfunction based on medical records or relatives report
* Abnormal coagulation
Lanugo Hair Loss as a Marker for Peri-ocular Malignancy

Skin cancers around the eye are common, but so are other lid lumps. It is useful to be able to tell which lumps are likely to be cancer.

This study looks at whether the loss of fine hairs (lanugo hairs) on the skin are a good indicator of whether a lump is a skin cancer or not.

The investigators are recruiting patients who have lid lumps who haven't had a biopsy before, who would be having a biopsy as part of their treatment, and seeing whether those who have loss of the fine skin hairs are the same as those who have skin cancer confirmed on their biopsy.

The study doesn't involve any extra examinations or treatments for participants. The investigators look at the patients before the biopsy as part of their usual care, and take a note of whether or not they have lost the fine hairs at this stage.

The main benefit of participating is that the medical community has better evidence about which lid lumps are likely to represent skin cancer, helping future diagnosis.

There are no additional risks to participating. The risks of biopsy are unchanged whether patients participate in the study or not.

The study is run from the Princess Alexandra Eye Pavilion in Edinburgh, in conjunction with Moorfields Eye Hospital, London

The investigators aim to start the study in Spring 2018, and will most likely recruit for 6 months depending on the number of participants recruited.

There is no additional funding from any source at present - the work will be undertaken by doctors in their research time.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing biopsy for peri-ocular lesion

Exclusion Criteria:

* Age under 18; previous biopsy or excision on the same lid
Patient Preference Comparison of AZARGA Versus COSOPT

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
* On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.
* IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.
* IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).
* Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.
* Able to follow instructions and willing and able to attend all study visits.
* Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
* Best corrected visual acuity worse than 20/80 Snellen in either eye.
* Any abnormality preventing reliable applanation tonometry in either eye.
* Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.
* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.
* Progressive retinal or optic nerve disease from any cause.
* History of ocular herpes simplex.
* Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker.
* Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
* Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control.
* Participation in any other investigational study within 30 days prior to the Screening/baseline Visit.
* Other protocol-defined exclusion criteria may apply.
Effect of Transversus Abdominis Plane Block With Compound Lidocaine on Pain After Gynecological Surgery

Purpose:

To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine on postoperative pain after gynecological laparotomy.

Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid-related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal open sugery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection for postoperative analgesia in patients undergoing gynecological laparotomy.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is scheduled to undergo gynecological laparotomy under general anesthesia
2. Subject's American Society of Anesthesiologists physical status is I-II.
3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion Criteria:

1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
2. Subject has a diagnosis of Insulin dependent diabetes.
3. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
4. Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
5. Subject has any contraindication for the use of patient-controlled analgesia (PCA).
6. Subject is pregnant or breast-feeding.
7. Subject is obese (body mass index \>30kg/m\^2).
8. Subject is incapacity to comprehend pain assessment and cognitive assessment.