cyrilzakka/clinical-trials huggingface dataset:
Dietary Acid Load During Pregnancy and Gestational Diabetes Mellitus

Dietary habits resembling Western style, rich in animal protein and poor in fruit and vegetables, increase the body acid load, a predictor of type 2 diabetes risk. Recently, the studies related to relationships between dietary acid load and insulin resistance has become a growing interest but there are only a few study conducted with gestational diabetes mellitus (GDM). Therefore, the aim of this study was to evaluate the potential relationship between dietary acid load in second trimester, blood lipid profiles and GDM.

This cross-sectional study conducted with 40 women with GDM diagnosed with two-step 100g oral glucose tolerance test and 40 healthy women, aged 21-41 years, between weeks of 14-28 of pregnancy, who attended the Department of Obstetrics and Gynecology of Gulhane Training and Research Hospital. Participants with polycystic ovary syndrome, chronic diseases, pre-GDM, or multiple pregnancies were excluded. Sociodemographic information was recorded via questionnaire and anthropometrics of women were measured.

Blood samples were taken after an overnight fasting. Dietary information was obtained by mean intakes of a 3-day food records (2 weekdays and 1 weekend day) and analyzed via nutrition analysis software. According to the data obtained from software analysis, animal protein (g/day) to potassium (g/day) ratio (AP/K), potential renal acid load (PRAL; mEq/day) score and net endogenous acid production (NEAP; mEq/day) were calculated from established algorithms to estimate dietary acid load. All nutrients were age and energy- adjusted before being introduced into the equation and tertiles of the scores were used for statistical analysis. ANOVA, ANCOVA and Logistic regression test were used. The study plan was approved by the Hospital\&#39;s Ethics Committee.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy,
* Aged in 20-40 years,
* Gestational age 24-28 weeks,
* Non-history of acute or chronic diseases.

Exclusion Criteria:

* History of GDM,
* Type 1 and 2 diabetes mellitus,
* Preeclampsia,
* Polycystic ovary syndrome,
* Thyroid disease
* Parathyroid disease,
* Metabolic bone disease,
* Kidney disease,
* Abnormal liver function,
* Multiple pregnancy
* Extreme values of energy intake in their dietary records (\<1500 and \>4000 kkal).
The Effect of Corticotomy in En-mass Retraction

* To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.
* Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.
* Monitor postoperative pain.


Eligibility Criteria:
Inclusion Criteria:

* On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).
* Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.
* Healthy systemic conditions.
* No previous orthodontic treatment.
* Patient needs to be in permanent dentition (hence, we need to define their age range).

Exclusion Criteria:

* Patient with systemic disease.
* Patient having any signs of active periodontal disease.
* Patients on long-term corticosteroid therapy.
* Persons taking medications that slows down bone metabolism.
* Craniofacial anomalies.
A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP

The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 3 months), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for immune thrombocytopenia;
* Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18\~ 80 years;
* To show a platelet count \<30 \* 10\^9/L, or with bleeding manifestations, or both;
* Willing and able to sign written informed consent
* ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified.

Exclusion Criteria:

* secondary thrombocytopenia;
* severe immune-deficiency;
* active or previous malignancy;
* HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);
* pregnancy or lactation;
* diabetes;
* hypertension;
* cardiovascular diseases;
* severe kidney function impairment;
* psychosis;
* osteoporosis;
* inflammatory bowel disease or gastric disease;
* arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment;
* an organ or haematopoietic stem-cell transplantation;
* neutrophil count of less than 1500 cells per mm³;
* glycosylated haemoglobin less than 8%;
* partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes;
* history of primary immunodeficiency;
* neoplastic disease within the past 5 years;
* corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
* substance misuse within the previous 12 months;
* people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease

The aim of the study is to compare in a clinical condition the effect of standardized chokeberry extract in different formulations and a complex preparation containing chokeberry extract and other active ingredients in on the levels of selected markers associated with cardiovascular diseases in people with a predisposition to the development of these diseases.

Randomized, double-blind, parallel study conducted under medical supervision on a group of 40 patients with known hypertension and/or hypercholesterolemia. Patients receive one of the investigational products or placebo for 6 weeks. Before and after the study, the following parameters are analyzed: extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B), levels of glucose, insulin, homocysteine, markers of kidney and liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), uric acid). Effects on blood pressure and anthropometric parameters are also being evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Women and men, 18-55 years old
* Patients with known: hypertension or hypercholesterolemia,
* Patients on hypotensive or hypolipemic therapy for at least 6 months prior to study enrollment
* Signed informed consent

Exclusion Criteria:

* Intake of supplements containing plant extracts, polyphenols or anthocyanins,
* Intake of supplements with antioxidant properties,
* Participation in another clinical trial,
* Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
* Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant,
* Patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal anti-inflammatory drugs in exacerbations of chronic disease.
* Patients with signs of inflammation such as increased body temperature, redness, swelling, pain.
* Patients who have not given written consent to participate in the study.
Improving Follow up Care for People After Minor Stroke

The goal of this feasibility study is to ascertain if this follow-up programme of care can feasibly be implemented within a healthcare system with people after minor stroke.

The main feasibility questions are:

i) To establish recruitment uptake ii) To establish treatment adherence iii) To determine participant retention. Participants will be randomly allocated to the intervention and control group. Those in the intervention group will receive a follow-up telephone call at two weeks after discharge and a second follow-up appointment at six weeks after discharge. Outcome measures will be taken at twelve weeks after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18
* Clinical or radiological diagnosis of minor stroke from a stroke consultant.
* Admitted to HASU or seen in rapid assessment/TIA clinic.
* Pre-admission mRS of 0-3 with no formal package of care prior to stroke.
* Discharge mRS of 0-3.
* No onward referral to community therapy team or for package of care.
* Has capacity to consent.

Exclusion Criteria:

* Any serious co-morbidities that would impact a person's ability to participate in the follow-up appointments and outcome measurement.
* Insufficient English to engage in intervention and outcome measures and no family or friends to support with this.
* Not resident in England.
* Pregnant women.
ALA on Glycemic Control in T2DM Participants

With the emerging worldwide epidemic of type 2 diabetes, dietary recommendations to improve diabetes management have been emphasized in the scientific community. Particular attention has been drawn to various benefits of replacing saturated fatty acids with unsaturated fatty acids. Alpha-linolenic acid, the only omega-3 fatty acid that is from plant sources, has been suggested by animal and cell studies to play a beneficial role in regulating blood glucose levels. However, human studies have been more inconsistent with their findings. The focus of this project is to investigate the evidence in the context of ALA and blood glucose parameters in participants with type 2 diabetes by conducting a systematic review and meta-analysis of randomized controlled trials.


Eligibility Criteria:
Inclusion Criteria:

* Controlled, randomized, clinical trials
* Trials greater than one month
* Focusing on ALA and T2DM participants
* Viable endpoint data

Exclusion Criteria:

* Non-human studies
* Non-random treatment allocation
* Less than 1 month
* Lack of suitable control
* Lack of endpoint data
Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.

This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.

Eligibility Criteria:
Inclusion Criteria:

* Prior Myocardial Infarction
* An implantable defibrillator
* One of the following VT events (within the past 3 months):

  * greater than or equal to 3 episodes of symptomatic VT treated with ATP
  * greater than or equal to 1 appropriate ICD shock
  * greater than or equal to 3 VT episodes within 24 hours
  * sustained VT below detection rate of the ICD documented by ECG
* "Failed" first-line antiarrhythmic drug therapy as defined by one of:

  * Appropriate ICD therapy or sustained VT occurred while patient was taking amiodarone (stable dose \>/= 2 weeks)
  * Appropriate ICD therapy or sustained VT occurred on another antiarrhythmic drug (stable dose \>/= 2 weeks)

Exclusion Criteria:

* Active ischemia (acute thrombus, dynamic ST elevation on ECG) or another reversible cause of VT (eg. electrolyte abnormalities, drug induced arrhythmia)
* Are known to be ineligible to take amiodarone (eg. active hepatitis, current hyperthyroidism, pulmonary fibrosis, known allergy)
* Are ineligible for ablation (left ventricular thrombus, implanted mechanical aortic and mitral valves)
* Renal Failure (creatinine clearance \< 15 ml/min)
* Current NYHA functional class IV heart failure or CCS Functional Class IV angina
* Recent ST elevation myocardial infarction (\< 1 month)
* Recent coronary bypass surgery (\< 3 mon) or recent PCI (\< 1 mon)
* Pregnant
* prior ablation for ventricular tachycardia
* A systemic illness likely to limit survival to \< 1 year
* Unable or unwilling to provide informed consent
Comparing Different Suturing Techniques on the Post-operative Morbidity After Removal of Impacted Mandibular Third Molar

This study compares the effect of two types of suturing techniques in the postoperative swelling and mouth opening after surgical removal of impacted mandibular third molar. total wound closure will be performed in one group of participants while partial closure will be performed in the other group.

Third molar surgeries are mostly associated with pain, swelling and limited mouth opening, referred to as post-operative morbidity. Wound closure technique is an operative factor which is associated with reduced post-operative morbidity. In the total wound closure, the mucoperiosteum is hermetically sealed whereas in the partial wound closure, a window or opening is left to allow for secondary healing. This study therefore compares the effect of partial and total wound closure techniques after surgical extraction of impacted mandibular third molar teeth in reducing the swelling and limited mouth opening.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing surgical removal of mesioangular impacted mandibular third molar.
* Healthy patients (ASA I) or patients with mild systemic disease with no functional limitations (ASA II).
* patients who are not allergic to the drugs and local anesthetic agent used in the surgical protocol.

Exclusion Criteria:

* Patients having systemic conditions that might have an effect on the bone growth or periodontal healing.
* patients who are on antibiotics premedication or any drugs that might affect wound healing.
Combination Therapy for the Treatment of Bipolar Disorders

This study will compare triple and double drug regimens in the treatment of patients with depression, hypomania, or mania.

Early studies have shown lithium to produce a high percentage of satisfactory clinical response in patients with bipolar disorders. These studies, however, do not include lithium-refractory subgroups, such as bipolar II disorder patients. When the wide spectrum of bipolar disorders is considered, the lithium response rate decreases significantly. More broadly effective regimens are needed.

Participants in this study will be randomly assigned to receive either lithium plus divalproex or lithium, divalproex, and lamotrigine for 7 months. Symptoms of depression and mania will be assessed with scales and patient questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar I or II Disorder
* Meet criteria for rapid cycling, defined as four or more episodes over the past 12 months
* Meet criteria for a major depressive episode

Exclusion Criteria:

* History of intolerability of lithium, divalproex, or lamotrigine
Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique

Comparing between the failure rates of molar tubes bonded with conventional bonding technique using resin adhesive and the alternative bonding technique using compomer (containing glass ionomer) adhesive by adding a layer of compomer adhesive at the molar/tube interface.


Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring fixed appliance orthodontic treatment (with no previous orthodontic treatment).
2. Patients aged \>12 years with full permanent dentition (excluding third molars).
3. Intact buccal enamel surface of the molars without any of the following:

   * Caries, abrasion, or any other crown defect (like hypoplasia).
   * Pretreatment chemical agents.
   * Restorations or fractures.
   * Morphological modifications or other crown alterations.
4. Patients who have the desire and ability to comply with the trial protocol.

Exclusion Criteria:

1. Treatments with planned extraction of first permanent molars.
2. Occlusal interference that prevents correct position of molar tube.
3. Patients with a craniofacial anomaly (like cleft lip and palate) and/or require orthognathic surgery.
4. Patients that require extra-oral or intra-oral anchorage device (headgear, palatal arch, lingual arch) or expander (quad-helix, hyrax).
5. Lack of consent to participate in the trial.
Improved Automatic CPAP Algorithm to Treat Obstructive Sleep Apnea (OSA)

The purpose of this study is to compare a modified AutoSet algorithm running on research hardware versus the traditional AutoSet algorithm running on an S7 AutoSet Spirit. The study will determine if the modified AutoSet algorithm reacts appropriately to obstructive apnoeas and hypopnoeas and provides suitable levels of positive airway pressure compared to the S7 AutoSet Spirit.

The hypothesis is that the modified AutoSet algorithm will be more efficacious than the traditional AutoSet algorithm

Subjects in the trial will spend 2 nights in a sleep laboratory being monitored with a full montage polysomnograph (PSG) with each of the algorithms providing positive airway pressure therapy. The PSG records EEG, EMG, EOG, patient airflow, respiratory effort, blood oxygen saturation, and body position.

In a randomised order each subject will spend one night being treated by the modified AutoSet algorithm and a second night being treated by the traditional AutoSet algorithm.

The subjects will be blinded to which therapy they are receiving and the scorer of the PSG will also be blinded to which therapy is being used.

Eligibility Criteria:
Inclusion Criteria:

* PSG-confirmed diagnosis of OSA, showing an apnoea-hypopnoea index (AHI) of at least 15 events/hr and an obstructive apnoea index (OAI) of at least 5 events/hr.
* On CPAP therapy (fixed pressure or autoCPAP) for at least 1 month.
* Using a ResMed mask (this requirement applies only to phase 2 of the trial) without significant discomfort for at least 2 weeks.
* Age between 18 and 70 years.
* Written informed consent.

Exclusion Criteria:

* Unstable medical condition, including unstable angina, myocardial infarction within previous 6 months, cardiac failure NYHA grades III and IV, epilepsy, psychiatric disturbance.
* Respiratory insufficiency, defined as arterial CO2 greater than 50 mm Hg during the daytime or arterial oxygen saturation less than 90% when asleep and breathing room air on effective CPAP therapy.
* Recent severe epistaxis.
* History of spontaneous pneumothorax.
* History of regurgitation of gastric contents during sleep.
* Unable to give written informed consent.
Development of a Drill Guidance System to Aid Intra-operative Surgical Drilling

The Investigators have developed a camera based drill guidance system to improve the accuracy of surgical drilling. The aim of the study is to assess:

Accuracy in vivo Safety Acceptability of use amongst surgeons and theatre staff

This project is a collaboration between the Royal United Hospitals Bath and the Department of Mechanical Engineering at the University of Bath in the development of a drill guidance system to aid intra-operative surgical drilling in Orthopaedic and trauma surgery. The types of operation will include drilling into bones to place screws or wires to develop a track for passage of a screw, suture or other material. The project has been funded by an National Institute for Health Invention for Innovation Grant (NIHR i4i) over 3 years.

The Drill Guide System (DGS) has been developed so it can be attached to a surgical drill with the overall aim of improving the accuracy of surgical drilling of holes in bones. The drilling will be performed as standard, i.e. as required for any specific operation. The drill guide will be an adjunct to visual observation by the surgeon and fluoroscopy (peri-operative radiographs - X-rays). The surgeon can decide to not use the drill guide if it is considered to be hampering the operation. A camera and computer based system attached to a surgical drill will be used to improve drilling accuracy in an operating theatre

The Drill Guidance system has undergone rigorous testing and various laboratory trials with surgeons and operating staff as part of development of the design.

The final prototype will be used as part of a wider clinical trial involving Orthopaedic Surgeons at the Royal United Hospitals Bath and the Great Western Hospital, Swindon (within the NHS) to test the efficacy and value of the system during surgery.

The Investigators intend to recruit up to 30 surgical patients as part of the trial from two sites.

Background: It is recognised clinically and in laboratory studies that "freehand" drilling has appreciable inaccuracies. This risks misplacement of screws potentially compromising surgical outcome and increasing the risk of complications.

Furthermore, inaccurate initial drilling can lead to inaccurate subsequent drilling and so suboptimal positioning of the screw/wire with potential adverse outcomes and increased costs. The screw may be placed and then have to be changed. A new different length screw may be required with the first screw discarded with further costs.

Eligibility Criteria:
Inclusion Criteria:

* adults, i.e. 18 years or over;
* awaiting orthopaedic or trauma surgery;
* have capacity to consent to participate in the study
* the proposed operation is deemed to be appropriate by the treating Orthopaedic surgeon for use of the DGS

Exclusion Criteria:

* children, i.e. \< 18 years of age
* the patient is unable to give informed consent;
* the surgeon does not feel able to use the DGS
* the surgeon does not feel use of the DGS is appropriate for the type of surgery required