cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance Evaluation of a Glass-ionomer Restorative System Evaluation

The aim of this clinical trial was to compare the clinical performances of a glass ionomer restorative system with a micro hybrid resin based composite in class I and class II cavities. A total of 140 (80 class I and 60 class II) lesions in 59 patients were restored with a glass ionomer restorative system (Equia) or a micro hybrid composite(Gradia Direct). Restorations were evaluated at baseline and yearly during 9 years according to the modified-USPHS criteria. Data were analyzed with Cohcran's Q and McNemar's tests (p\<0.05).

Since the introduction of glass ionomers many modifications of these materials have been performed over the years. Compared to other permanent filling materials like resin-based composites, glass ionomers show several advantages, such as the ability to adhere to moist enamel and dentin and anti- cariogenic properties such as the long-term fluoride release. So, it was doubtful that glass ionomers represent a capable counterpart of amalgam or resin-based composites in posterior teeth.

Eligibility Criteria:
Inclusion Criteria:

1. a need for at least two but not more than four posterior toothcolored restorations;
2. the presence of teeth to be restored in occlusion;
3. teeth that were symptomless and vital;
4. a normal periodontal status;
5. a good likelihood of recall availability.

Exclusion Criteria:

1. partly erupted teeth;
2. absence of adjacent and antagonist teeth
3. poor periodontal status;
4. adverse medical history;
5. potential behavioral problems.
Outcomes in a Comparison of Manual Penetrating Keratoplasty and the IntraLase® Enabled Keratoplasty

To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old, with keratoconus and corneal transplant indication

Exclusion Criteria:

* Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP

This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.


Eligibility Criteria:
Inclusion criteria

* RA patients who participated in the previous studies
* Patients who completed the last observation in the previous studies
* Patients who were confirmed to have no problems with safety in the previous studies.

Exclusion criteria

* Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
* Patients who were not enrolled by 3 months after the last observation day of the previous study
Autologous Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes

This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 6 months. The study is evaluating whether stem cell transplantation is safe when chemotherapy and immunotherapy are used in combination and if it has immune resetting effect that may halt the immune attack to pancreas islets and thus preserve the body's own insulin production.

Type 1 diabetes is an autoimmune disease in which the immune system mistakenly attacks the insulin-producing beta cells in the pancreas. Generally, at the time someone is diagnosed with type 1 diabetes, not all of a person's beta cells have been destroyed. It's important to preserving the remaining precious beta cells so as to stop the diabetes progression.

The exact mechanism of action of Autologous Hematopoietic Stem Cell Transplantation(AHST) in autoimmune disorders is not fully understood. Preliminary data supported post-AHST immune resetting included an increase in thymus-derived naive T cells, decreased central-memory T cells, increased output of recent thymic emigrants, and recovery of a diverse but distinct T-cell receptor repertoire following AHST. In the patients of type 1 diabetes, decreasing titer of anti-GAD antibody may bring improvement of beta-cell function after intensive immunosuppression. Furthermore, there may exit the possibility of regeneration of beta cells from surviving beta cells or from pancreatic or bone marrow stem cells.

Patients recently diagnosed (less than 6 months) with type 1 diabetes mellitus proved by positive antibody against glutamic acid decarboxylase will be included in this study. Hematopoietic stem cells will be mobilized with cyclophosphamide (2.0 g/m2) and granulocyte colonystimulating factor (10 μg/kg per day) and then collected from peripheral blood by leukapheresis and cryopreserved. The cells were injected intravenously after conditioning with cyclophosphamide (200 mg/kg) and rabbit antithymocyte globulin (4.5 mg/kg). This procedure is performed in isolated rooms at the Bone Marrow Transplantation Unit of Shanghai Ruijin Hospital affiliated to Shanghai Jiao-Tong University School of Medicine. Patients will be discharged from the hospital 1 month after transplantation and continue the follow-ups for 3 years. Patients fitting the inclusion criteria but not agreeing to perform the transplantation are the control group and they will be followed in parallel with transplanted patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibody
* Less than 6 months from diagnosis

Exclusion Criteria:

* Previous diabetic ketoacidosis
* Pregnancy
* Severe psychiatric disorder
* Severe organic impairment (renal, hepatic, cardiac, pulmonary)
* Active infectious disease
* Previous or present neoplastic disease
Exercise Training in ICD Recipients; Effect on Therapy Delivered, Depression and Anxiety

Interventional study in patients with ICD. Controlled, open intervention with exercise training. Assessment of changes in physiological and psychological parameters.

ICD therapy with DC shock is associated with impaired quality of life and development of anxiety and depression. In a selected group of patients with ICD the intervention with organized high intensity training is evaluated. Peak VO2, inflammatory profile, performed interventions by the ICD and psychological profile is assessed. In addition a qualitative evaluation using interviews is performed.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria: Age 18 years or above, documented coronary heart disease, myocardial scar tissue verified by CMR, implanted ICD

Exclusion Criteria:

* Planned revascularisation by bypass surgery or percutaneous coronary intervention following the ICD implantation, planned arrhythmia ablation, long QT-syndrome, Brugada syndrome, WPW syndrome, Drug-induced torsades, catecholaminergic polymorphic ventricular tachycardia, Hypertrophic cardiomyopathy right ventricular cardiomyopathy, dilated cardiomyopathy, Aortic stenosis, mitral valve prolapse, anomalous origin of coronary arteries, Myocardial bridging, ongoing myocarditis, recent chest trauma,
The Study of Polycystic Ovary Syndrome (PCOS) and Questionnaire

Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous as the syndrome. This first part of study is determine whether genetic polymorphisms influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and controls. Furthermore, women with PCOS were reported with high risk of cardiovascular disease, the investigators planned to calculate the difference of carotid intima-media thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal control to determine the premature atherosclerosis of women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* women at reproductive age
* women with PCOS and women without PCOS

Exclusion Criteria:

* young women who had their menarche less than 3 years
* women older than 45 years old, Amenorrhea of menopause, hyperglycemia, hyperthyroidism, hypothyroidism, heart failure, lung failure, renal failure, anemia, dystrophy, gonitis
Comparison of Caudal Block Versus Dexmedetomidine Infusion in Pediatric Patients Undergoing Hypospadias Repair Surgery

Pain is one of the most misunderstood, underdiagnosed, and untreated medical problems, particularly in children. New Joint Commission on Accreditation of Health Care Organization regards pain as fifth vital sign and requires caregivers to regularly assess pain. Inadequate pain relief during childhood may have long-term negative effects including harmful neuroendocrine responses disrupted eating and sleep cycles and increased pain perception during subsequent painful experiences. Also, postoperative pain can result in an uncooperative and restless child. Hence, it is preferable to prevent the onset of pain rather than to relieve its existence.

Various multimodal techniques have been designed for pediatric pain relief. These include both systemic and regional analgesia. The most commonly used regional technique is caudal epidural block. Advantages of the caudal block are smoother recovery with less distress behavior, early ambulation, decreased the risk of chest infections, decreased postoperative analgesic requirements, and early discharge.

In our culture; considerable number of parents still refuses caudal anesthesia fearing from the rare neurological sequelae may occur. This the motive for searching for parenteral surrogate gives clear headed recovery resembles regional analgesia.

Dexmedetomidine is an alpha 2 agonist which has sedative, analgesic, and opioid-sparing effect. It prolongs the duration of analgesia by its local vasoconstrictive effect and by increasing the potassium conductance in A-delta and C-fibers.

It also exerts its analgesic action centrally via systemic absorption or by diffusion into the cerebrospinal fluid and reaches alpha 2 receptors in the superficial laminae of the spinal cord and brainstem or indirectly activating spinal cholinergic neurons. The sedative effects of dexmedetomidine are mostly due to stimulation of the alpha 2 adrenoceptor in the locus coeruleus


Eligibility Criteria:
Inclusion Criteria:

1. male children
2. american society of aneasthesia physical status grade I \&II
3. patients aged from 2 years to 12 years
4. patients will undergoing hypospadias repair surgery

Exclusion Criteria:

1. history or evidence of infection at the back
2. allergy to the study drugs
3. bleeding/coagulation disorder
4. developmental delay
5. septic patients
6. neurological or spinal diseases.
Myoelectric Game Training and Outcomes

The purpose of this study is to evaluate the effects of myo-electric training tools on prosthesis functional outcomes.

Participants will undergo informed consent and schedule an initial site visit. A logging device will be used to track activity of prosthetic arm usage while in everyday use at home. After a baseline period, participants will schedule a second visit to be introduced to the training technology.

The study will span up to 7 months with participants training at home for 15-60 minutes, 3-5 times a day. Every 3-6 weeks, investigators will schedule a study event and sit visit to conduct functional outcome tasks and measurements.

Eligibility Criteria:
Inclusion Criteria:

* User of upper-limb myo-prosthesis or able to wear prosthesis simulator
* The subjects must be able to read, write, and speak English in order to be properly consented and to express their thoughts to the study personnel, and they must be willing and able to complete the activities outlined in the study.

Exclusion Criteria:

* The risks to pregnant people and fetuses are unknown and therefore pregnant individuals should not participate in the study.
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts

In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones

Many researches proposed that rodent deteriorate symptoms in patients with respiratory allergy who sensitized. The test that can identify rodent sensitization will be very useful. The investigators found lots of problems from imported mouse and rat allergen extract, eg. expensive cost and hard to find importing agency in Thailand. Making own local allergen extract will be the good solution for the country. This study aim to compare the results of locally rat and mouse allergen to imported ones.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
* Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.

Exclusion Criteria:

* Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
* Patient with allergic asthma who is still uncontrollable.
* Patient with active severe atopic dermatitis
* Patient who are pregnant or in lactating period
* Patient or parent deny to join in the study
Physiological Responses to a Prolonged Cycling Expedition in Older Men

The aim of this study was to test the physiological response to a 2800 km cycling expedition, from Copenhagen, Denmark to Nordkapp, Norway, in a group of older male recreational cyclists.


Eligibility Criteria:
Inclusion Criteria:

* Participation in the cycling expedition

Exclusion Criteria:

* None
A Pilot Study in Endoscopic Therapy on Quality of Life and Pain in Chronic Pancreatitis

This study is a prospective study designed to assess the effect of pancreatic endotherapy on quality of life, pain levels, pancreatic exocrine function, and endocrine function.

Pancreatic endotherapy represents a potential treatment modality for patients with painful chronic pancreatitis. While pancreatic endotherapy is commonly performed, the effect of chronic pancreatitis on patient-centered outcomes remains poorly studied. Furthermore, the effect of endotherapy on pancreatic endocrine and exocrine are largely unknown. This study therefore aims to prospective observe patients with chronic pancreatitis after endotherapy is performed to better understand how it affects patient-centered outcomes such as pain and quality of life and pancreatic function. In doing so, the study also hopes to be able to predict which patients with chronic pancreatitis will benefit from pancreatic endotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Pancreatitis (as defined by the American Pancreatic Association Guidelines)
* Presence of Pain
* Referred for pancreatic endotherapy

Exclusion Criteria:

* Prior pancreatic endotherapy
* Prior pancreatic surgery
* Pregnant females
* Subjects unable to consent
* Imprisoned individuals
IV Lidocaine on Postoperative Pain and QOR on Morbid Obese Patients Undergoing Bypass Surgery

Can Intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery? The hypotheses:does the use of intraoperative systemic lidocaine decrease postoperative opioid consumption and improve quality of recovery after laparoscopic gastric bypass surgery.

This study has the potential to confirm an opioid sparing strategy for morbid obese patients undergoing laparoscopic gastric bypass surgery. The high incidence of obstructive sleep apnea and the increased risk of postoperative hypoxemia make the development of opioid sparing techniques in this patient population warranted.


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II,III;
* BMI \> 35 kg/m2,
* Age between 18-70,
* Fluent in English,
* Patients undergoing laparoscopic gastric bypass,
* EKG within 3 months.

Exclusion Criteria:

* History of allergy to local anesthetics,
* History of chronic opioid use,
* Pregnant patients,
* History of EKG abnormalities.

Dropout: Conversion to open, patient or surgeon request.
Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma

This research study is collecting and storing samples of bone marrow and blood from patients with relapsed acute lymphoblastic leukemia or relapsed non-Hodgkin lymphoma. Collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about cancer and help predict the recurrence of cancer.

OBJECTIVES:

I. Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) at first and subsequent relapse.

II. Make these specimens available to qualified researchers to study the biology of ALL.

OUTLINE: This is a multicenter study.

Patients undergo collection of bone marrow and peripheral blood at diagnosis of relapse and/or at the end of the first month of treatment.

Patients are followed periodically for up to 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute lymphoblastic leukemia (ALL) or prior history of non-Hodgkin lymphoma
* In first or subsequent marrow relapse with ≥ 25% blasts in bone marrow and/or peripheral blood
* Bone marrow and/or peripheral blood samples (≥ 5 mL) required at the time of diagnosis of relapse
* No concurrent systemic antileukemic treatment administered for current relapse

  * Intrathecal chemotherapy allowed
  * On-therapy relapse allowed
NOGO for an Overactive Bladder

This is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids per night and/or less then 2 hours between voids at least half time of the day (question 2 IPSS)

Exclusion Criteria:

* High alcohol consumption (males \> 3 beers/day (36 g alcohol), females \>2 beers/day --
* (24 g alcohol), but we take weekly average.
* Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation.
* Chronic incontinence.
* Recurrent urinary tract infections (3 or more times per year).
* Pregnancy, lactation, last child born at least one year before, uterine prolapse, histerectomy
* Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. Moderate to severe prostate hyperplasia (IPSS questionnaire).
* Medical history or active conditions which, in the opinion of the principal investigator (PI) and physicians participating in the study would prohibit participation in the study. This includes, but is not limited to: diabetes, cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (\<6 months) myocardial infarction or unstable coronary artery disease.
* Psychiatric diseases and medication.
* Use of NoGO or other products containing A. archangelica extract within the previous 2 months prior to randomisation.
* Known allergy to compound or any other ingredients of NoGo.
* Supplements like pumpkin seeds, natural products with diuretic effect. Not exclusion if they have a wash out period.
* Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.
Immune Cells in Patients With Granulomatous Mastitis

Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying etiologies, including infectious and non-infectious causes. Etiological reasons were examined in various studies, but neither etiology nor definite criteria for diagnosis were found. Our aim in this study is to examine the role of immunophenotyping in differentiating the etiology of granulomatous mastitis and using it as a prognostic marker.

Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying aetiology, including infectious and non-infectious causes. This disease can clinically and radiographically mimic breast cancer, which can pose a diagnostic challenge as well as concern during evaluation. A nonspecific inflammatory response, 'granuloma' is defined as necrosis or infiltration of other inflammatory leukocytes, with or without mononuclear phagocyte collection. It is thought to be caused by infectious agents or foreign substances that activate the immune system, leading to granuloma formation. Some of the known inflammatory etiologies of granulomatous mastitis are autoimmune diseases such as tuberculosis (most commonly caused by Mycobacterium tuberculosis), sarcoidosis, fungal infection and granulomatosis with polyangiitis and giant cell arteritis. These diseases cannot be distinguished clinically, pathologically, and radiographically from idiopathic granulomatous mastitis.In this study, we aimed to investigate lymphocyte subtypes in patients with granulomatous mastitis and to evaluate the differences in cell populations and its usability as a predictive marker in diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with granulomatous mastitis

Exclusion Criteria:

* Cancer Patients
* Patients with known immunodeficiency
* Pregnancy
* Patient diagnosed with tuberculosis
Correlation Between Neck Pain and Postural Abnormalities Among Female Office Workers at University of Dammam

This study is a cross sectional study conducted to find out the Correlation between neck pain and postural abnormalities among female office workers at University of Dammam by objective assessments methods.

Eligible participants will sign the consent form followed by filling up demographic data, visual analog scale \& neck disability index.

After that, Forward Head posture and Thoracic Kyphosis posture will take place by valid and reliable methods.

The study population and sampling were calculated by Raosoft sample size calculator using an estimated average of population size 200 and allowing a 5% tolerable error, based on a 95% confidence interval (CI).

About 140 female office workers were targeted from the medical colleges of University of Dammam (UoD); Medicine, Applied Medical Science, Nursing, Dentistry, Clinical Pharmacology and Health Track of preparatory year were recruited into the study (N=140).

The study was approved by the Institutional Review Board (IRB) at the University of Dammam (IRB-PGS-2015-03-194).

Eligible individuals for this study were informed of the risks and benefits and were asked to read and sign a written consent form.

Participants' confidentiality was maintained by using a code (number) instead of the participant's name on the data collection form.

All data collection forms were saved in a file and secured in a locker \& the electronic file saved with password. Only the researcher and the supervisor had an access to them.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with/without non-specific neck pain complaint.
* Age from 28 up to 40 years old.
* At least 25 working hours a week ( at least 2 hours on computer - at least 3 other office working).
* More than 5 years of experience as an office worker.

Exclusion Criteria:

* Subjects who had prolonged absence from work anticipated within the past 12 months.
* Complain of: cervical radiculopathy, migraine, vestibular Dysfunction.
* Had spinal fracture or surgery.
* Pregnancy.
* History of cervical trauma.
* Comorbid medical conditions as cancer, type 1 diabetes, heart disease.