cyrilzakka/clinical-trials huggingface dataset:
Journey™ UNI Post Market Clinical Follow-Up

This is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the Journey UNI UKS was previously implanted.

The purpose of the current investigation is to assess the safety and effectiveness of the JOURNEY UNI Unicompartmental Knee System (UKS) in patients with non-inflammatory degenerative joint disease (NIDJD) of the knee who previously had the Journey UNI UKS implanted. This clinical study will prospectively evaluate the 36 and 60-month safety and performance of the JOURNEY UNI UKS in patients with NIDJD of the knee who required lateral or medial knee compartment replacement.

Eligibility Criteria:
Inclusion Criteria:

1. Between 12 and 48 months previously, subject had unicompartmental knee replacement implanted for unicompartmental, NIDJD including OA, traumatic arthritis, avascular necrosis, for correction of functional deformity, or to repair a fracture that was unmanageable using other techniques.
2. Subject received a Journey UKS implant (consisting of a femoral component, tibial baseplate, and a tibial insert).
3. Subject was considered skeletally mature at the time of surgery and was at least 18 years of age.
4. Subject is willing to have retrospective data collected and to participate in required prospective follow-up visit(s) at the investigational site and to complete study procedures and questionnaires.
5. Subject has consented to participate in the study by signing the Institutional Review Board (IRB)/Ethics Committee (EC)-approved informed consent form (ICF).

Exclusion Criteria:

1. Subject has Body Mass Index (BMI) \> 40 within 1 month of surgery.
2. Subjects who have received the Journey UNI UKS as part of a revision surgery.
3. Subject has a condition that may interfere with the unicompartmental knee arthroplasty (UKA) survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
4. Subject has a known allergy to study device or one or more of its components.
5. Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would preempt his/her ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
6. Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
7. Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers

This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum species). The review of patients' records and blood samples will be performed for patients treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to December 2013.

The objective of this study is to evaluate the Day 42 PCR adjusted cure rate of mefloquine-artesunate (MAS3) in patients with P. falciparum

Study procedure

Clinic and patient records and log books will be reviewed and the following clinical information will be extracted: vital signs especially the temperature, clinical signs and symptoms, blood slide and haematocrit result and findings of physical examination (anaemia, jaundice, liver, spleen etc). As a routine, these data were recorded on the clinic patient record and malaria smear microscopy logbook accordingly (which will be regarded as the source documents in this analysis). These source documents will be reviewed and stored specimen will be analysed after getting the permission from the Director of Shoklo Malaria Research Unit, the University of Oxford Tropical Research Ethical Committee (OxTREC)and the Faculty of Tropical Medicine Ethics Committee (FTMEC). These data will be extracted and transcribed into the case record forms and entered into Microsoft access. During the data extraction, the unique ID will be assigned to each patient whereas the patients' name will neither be entered into database nor disclosed in the analysis process (ie: the data will be anonymised).

Eligibility Criteria:
Inclusion Criteria:

* Patients of any age and sex who received treatment for uncomplicated malaria and followed up between January 2003 to December 2013
* Symptomatic of malaria infection, i.e. history of fever or tympanic temperature ≥37.5°c
* Microscopically confirmed asexual stages of P. falciparum ≥ 5/500 WBC (alone or mixed with non- P. falciparum species)
* Received fully supervised treatment of mefloquine-artesunate

Exclusion Criteria:

* Pregnant woman
* P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells Signs or symptoms indicative of severe malaria29
* Mefloquine treatment within the 60 days preceding the current episode of malaria
* Splenectomy

Patients will be excluded from the efficacy analysis if they didn't finish the 3 days treatment of mefloquine artesunate but still kept in intention-to-treat population.
OCS-01: a Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
* Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]).

Exclusion Criteria:

* Have any intraocular inflammation (e.g. white blood cells or flare)present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit lamp examination;
* Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye.
Erector Spinae Block in Segmental Mastectomy.

Erector spinae plane block (ESPB) is a recently described block. Although there is still no consensus of its mechanism, the published case series seems to promise a new regional anesthesia technique for both chronic and acute pain. In this clinical trial, the postoperative analgesic effect of ESPB will be studied in patients underwent unilateral breast cancer surgery.

In this study 30 patients will be enrolled to study between March 2018-August 2018. All patient will be randomly selected who will be operated for breast cancer surgery between determined dates. Age, weight, ASA score, body mass index , additional dissease ststus will be recorded. The patients will be divided in two groups. One group will have ESPB at the end of the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 4/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be apllied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Being volunteer
2. Over 18 years old
3. Unilateral segmental mastectomy patients

Exclusion Criteria:

1. Emergency operations
2. Younger than 18 years old,
3. Non Volunteers
4. ASA 3 and 4 patients
5. Non-cooperative patients
Cognitive Performance After a Night Shift in Internal Medicine Residents

A quasi-experimental design where internal medicine residents in a high complexity hospital were assessed after a 24-hour shift for cognitive impairment by a trained neurologist.

The investigators conducted a cross sectional study during the 2014-2016 period in a high complexity school hospital in Buenos Aires. Second and third year Internal Medicine residents who consented to participate were included.

A neurologist conducted a cognitive evaluation to the residents who had done 24 hours shifts (with sleep deprivation) within 6 hours of its end.

Auditory memory deficit was evaluated (PASAT - Paced Auditory Serial Addition Test), verbal fluency (FAS), direct and indirect Digit-Span, Rey auditory verbal learning test (RAVLT) and Continuous Performance Test 2 (CPT2).

Results were presented as means of standardized scores (z score) with their interquartile range (IQR).

Eligibility Criteria:
Inclusion Criteria:

* Internal Medicine residents on the second or third year of formation.

Exclusion Criteria:

* Denial to participate in the study or to the informed consent.
Artificial Intelligence-assissted Glaucoma Evaluation

Glaucoma is currently the second leading cause of irreversible blindness in the world. Our study intends to combine clinical data of glaucoma patients in Zhongshan Ophthalmic Center with Artificial Intelligence techniques to create programs that can screen and diagnose glaucoma.

Glaucoma is currently the second leading cause of irreversible blindness in the world, which brings heavy burden to human society. Compared to other ocular diseases, diagnostic process of glaucoma is complicated depends on multiple test results, including visual field test, OCT, etc. How to diagnose glaucoma correctly and fast has always been a hot topic in glaucoma researches. Artificial intelligence is used to study and develop theories and methods that can help simulate and extend human intelligence, which has been utilized in a lot of research fields such as automatic drive and medicine. The study intends to combine clinical data of glaucoma patients in Zhongshan Ophthalmic Center with Artificial Intelligence techniques to create programs that can screen and diagnose glaucoma.

Eligibility Criteria:
Inclusion Criteria:

1. BCVA\>0.1
2. able to complete reliable visual field test
3. no history of intraocular surgery or fundus laser

Exclusion Criteria:

1. unable to complete visual field test
Contrast Nephropathy and Nitrates

Contrast-induced nephropathy (CIN) is a complication of percutaneous coronary angiography that occurs in about 10 to 20% of patients exposed to contrast media. Iodinated contrast is used during coronary angiography to see the coronary arteries. It has been shown that exposure to this agent may cause kidney injury. CIN usually goes away on its own but in some high risk patients it progresses into renal failure.

This research study offers a new possible option to prevent CIN. We propose that if intravenous nitroglycerin is given before the procedure it may lower the chances of developing contrast-induced nephropathy.

The Contrast Nephropathy and Nitrates trial (CoNaN) is a single center, randomized, 1 x 1 factorial clinical trial designed to test the effects of intravenous nitroglycerin infusion in renal function given prior to PCI.

Specific aims for this trial include:

* To determine whether the intravenous nitrates have any effect on the glomerular filtration rate (GFR) after the exposure to contrast media.
* To determine if intravenous nitroglycerin will decrease the incidence of contrast induced Nephropathy.

  400 patients with a Mehran score of \> 6 and a pre-procedural creatinine measurement will be enrolled. Following baseline assessments, patients will be randomly assigned to receive intravenous infusion nitroglycerine plus intravenous normal saline or normal saline only. Subjects will participate in this study from the time they sign consent (prior to angiographic procedure), until 48-72 hours post procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be scheduled for percutaneous coronary angiography.
2. Patients must have a Mehran score more or equal to 6 before the procedure.
3. Patients must have baseline creatinine and hemoblogin drawn before the procedure.
4. Signed informed consent.

Exclusion Criteria:

1. Patients on renal replacement therapy before randomization, will be excluded.
2. Being exposed to any types of nitrates 48 hours prior to randomization,
3. History of allergic reaction to any of the components of intravenous nitroglycerin.
4. Exposure to contrast media 4 days prior randomization.
5. Planned revascularization in the next 24 to 48 hours of the first PCI procedure.
6. The patient is hypotensive (\<90/60mmHg) at the time of randomization.
Evaluate Capsular Apposition to Intraocular Lens

In this study, the investigators examined the capsule-IOL interaction including anterior and posterior capsule adhesion, contact between posterior capsule and the posterior edge of intraocular lense (IOL), configuration of capsular bend and the incidence of posterior capsular opacity (PCO) between high myopia eyes and emmetropia eyes.

150 eyes of 150 cataract patients scheduled for phacoemulsification surgery were recruited, of which 20 eyes were high myopia (AL \> 26mm) and 40 eyes were emmetropia (22 \< AL \< 25mm) as control group.High myopia eyes and 20 emmetropia eyes were implanted with the single-piece hydrophobic acrylic IOL (Acrysof IQ SN60WF, Alcon laboratories, Inc. IQ group). Another 20 emmetropia eyes were implanted with the other single-piece hydrophilic acrylic IOL (Akreos Adapt, Bausch \&Lomb, AO group).80 eyes implanted with the single-piece hydrophobic acrylic IOL were examined by SSOCT to build the 3-D model of anterior segment.

Methods: 60 eyes were examined by custom-built UL-OCT at 4 hours, 1 day, 7 day, 14 day, 28 day, 3 month, 6 month,12 month after surgery.30 eyes implanted with the single-piece hydrophobic acrylic IOL were recruited for evaluation of the SSOCT reliability.50 eyes were examined by SSOCT at 1 day, 7 day,1 month, 3 months,6 months,12 months after surgery.

Measures: Contact of the anterior and posterior lens capsule with the IOL optic surface was evaluated. Types of capsular bend were described at the last follow-up. The incidence of posterior capsular opacity (PCO) was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Eyes with an AL of 26.00mm or more were recruited to the high myopia group.
* Eyes with an AL of 22.00 to 25.00 mm were recruited to the emmetropia group.

Exclusion Criteria:

* Preoperative exclusion criteria included diabetes, history of ocular surgery or inflammation, pupils could not be dilated over 7mm after mydriasis,
* patients who could not be available for follow-up.
Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes
* Non smoker
* Normal lung function

Exclusion Criteria:

* Significant pulmonary, hepatic, or renal disease
* Severe congestive heart failure
* Active malignancy
* Systemic glucocorticoid therapy
Study Investigating Enbrel Treatment for Ankylosing Spondylitis

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

1. Unknown adverse reactions, especially serious adverse reactions
2. Change of the incidences of adverse reactions under the routine drug uses
3. Factors that may affect the safety of the drug
4. Factors that may affect the effectiveness of the drug


Eligibility Criteria:
Inclusion Criteria:

* Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion Criteria:

* Patients with known hypersensitivity to Enbrel or any component of the product
* Patients with sepsis or risk of sepsis
* Patients with active infections including chronic or localized infections such as tuberculosis.
Efficacy of Intra-articular NSAID Versus Corticosteroid in the Treatment of Shoulder and Knee Conditions: A Randomized, Double-Blind, Prospective Study

The proposed study will compare the efficacy of Triamcinolone versus Ketorolac for intra-articular injection of the knee and shoulder

This study will be a randomized prospective study comparing Triamcinolone to Ketorolac for injections in the knee and shoulder for a variety of orthopedic conditions. The investigators will monitor pain relief, length of pain relief, cost, and patient satisfaction after the injections

Eligibility Criteria:
Inclusion Criteria:

* knee and shoulder arthritis
* shoulder impingement
* rotator cuff tear

Exclusion Criteria:

* chronic pain management
* allergy to NSAIDs or steroids
* prior surgery
* kidney disease that would preclude NSAID administration
Use of Infrared Photomodulation for Hormonal Balance (Joovvin' for Hormonal Health)

8-week pilot study looking at the impact of Joovv's infrared photo modulation product on male and female hormone levels.


Eligibility Criteria:
Inclusion Criteria:

* United States resident

Exclusion Criteria:

* current Joovv or other photomodulation therapy user
* under medical supervision for medically treatable illness
* significant travel during study period
* use of birth control
Neuroendocrine Brake for Type 2 Diabetes Mellitus

Evaluation to determine the safety of two laparoscopic procedures to control T2DM.


Eligibility Criteria:
Inclusion Criteria:

1. - Male and female between 18 and 65 years.
2. BMI 25.1 - 34.9.
3. Type 2 diabetic patients on oral anti-diabetic agents and/or insulin treatment for a minimum of 12 months prior the enrollment.
4. Diagnosis of T2DM for at least 3 years.
5. Patient has been under routine care of hte study physician or another physician that can supply a reliable medical record for at least 3 years.
6. HbA1c \>/ 7.5 documented for at least 3 months.
7. Stable weight (nor significant weight change (\>3%) over the 3 months prior to enrollment.
8. Stable medication for at least one month prior to enrollment except for diabetes medications which should be stable for at least 3 months prior to enrollment.
9. Ability and willingness to return for all scheduled visits and participate in recommended parameter setting and physician recommended medical/laboratory assessments.

Exclusion Criteria:

1. Prior abdominal surgery, except laparoscopic cholecystectomy.
2. Taking appetite suppressant.
3. Severe eating disorders.
4. Severe pulmonary, renal or cardiac disease.
5. Obese due to a clinically diagnosed endocrine disorder.
6. Subjects with impaired liver function.
7. History of peptic ulcer disease.
8. History of malignant disease.
9. Use of prescription, over the counter or herbal weight loss products.
10. Pregnant or planning on pregnancy while enrolled in study.
Physical Therapy Intervention for Puerperal Mastitis

Puerperal mastitis is one of the most commonly reported problems during breastfeeding. Women frequently report breast pain, tenderness, redness, engorgement, fever, malaise, chills, lethargy, sweating, headache, nipple damage and a hot spot on the affected breast. These highly distressing symptoms may severely impact on a woman's daily activities and quality of life and might lead to the premature cessation of exclusive breastfeeding, which may have significant impact on infant health and survival. The role of physical therapy in reducing pregnancy/postpartum-related disorders including breast problems is gaining momentum and importance in obstetrics. However, to date, only low-level evidence has shown positive effects of breast massage, a physical technique, on pain, milk supply and symptom relief in women with breastfeeding problems. This is encouraging, however further research is needed to explore whether physical therapy is effective to reduce symptoms of puerperal mastitis. The investigators will conduct a prospective, assessor blinded single-center randomized controlled trial to assess the effectiveness of an individualized physical therapy program with therapeutic ultrasound, education and massage for patients with puerperal mastitis, compared to patients receiving usual obstetric care and sham ultrasound treatment.

The high incidence of mastitis in breastfeeding women places health professionals working with postpartum women in key positions for managing women for symptoms of mastitis. This study aims to investigate the effectiveness of a physical therapy program for mastitis. The data the investigators collect from this study will provide evidence on effective and targeted strategies to achieve the goals of acceptable, effective and low risk physical therapy treatment of mastitis in postpartum women. Once these perspectives are known, recommendations on mastitis management can be made.

Eligibility Criteria:
Inclusion Criteria:

* Have given birth at National Cheng Kung University Hospital (NCKUH)
* Are Breastfeeding
* Are aged 21-35
* Are diagnosed with early stage mastitis
* Have sufficient Chinese/Mandarin language skills to participate

Exclusion Criteria:

* History of breast reduction or augmentation
* An abscess
* Severe physical/psychiatric impairments
* Presence of any malignancies
Differential Expression and Potential Value of c-MYC in Non-Invasive and Invasive Mammary Carcinoma

Retrospective observational study to evaluate c-MYC expression in non invasive and invasive mammry carcinoma

To correlate different levels of c-MYC expressions with variable clinical and pathological parameters of mammary carcinoma (such as patients' ages, tumor grading, staging, laterality, focality and nodal metastasis, co-existing in-situ components). This study will be carried out on archived formalin-fixed and paraffin embedded tissue blocks that were belonged to 70 women with breast lumps.

Eligibility Criteria:
Inclusion Criteria:

Specimens of Modified Radical Mastectomies from breast carcinoma patients

Exclusion Criteria:

* Cases with insufficient clinical data.

  * Tissue blocks of destroyed or insufficient material, unfit for diagnosis.
  * Cases who received pre-operative chemotherapy.