cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Half-guided Implant Placement

The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation.

Implant insertion with half-guided surgical protocol was utilized by surgical motor (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20 implants with a torque wrench. After the healing period, accuracy comparison method between planned and actual implant positions was performed based on digital intraoral scan. Coronal, apical and angular deviation parameters, insertion time and maximum insertion torque was evaluated.

Eligibility Criteria:
Inclusion Criteria:

* at least one edentulous maxillary premolar or molar site treated successfully by sinus floor elevation with a xenogenic bone substitute (cerabone, botiss biomaterials, Zossen, Germany) confirmed by preoperative cone-beam computed tomography
* full- mouth plaque and bleeding scores (FMPS and FMBS) \<20%
* good patient compliance (including willingness to participate in the follow-up procedures)
* signed informed consent

Exclusion Criteria:

* clinically relevant diseases (e.g.: diabetes, rheumatism, cancer)
* systemic steroid or bisphosphonate use
* acute or chronic inflammatory processes
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)

This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.

Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in vitro fertilization (IVF).

Design: Double blinded crossover randomized controlled clinical trial

Setting: Academically affiliated private infertility centers

Subjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment.

Interventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm.

Main Outcome Measures: Implantation rate(IR) and pregnancy rates.

Second Outcome Measures: Live birth rates and miscarriage rates.

Statistical and Power considerations: Analysis will be by regression with IR as dependent and treatment as independent. Results will be adjusted by age and indices of ovarian reserve, such as antiMulerian Hormone (AMH). Presuming an implantation rate of 10% and anticipating a 10% increase to 20% with treatment, 120 women, producing about 200 embryos in each study arm, will have to be recruited for 80% power and alpha of 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Women already enrolled in an IVF cycle at one of the participating institutions

Exclusion Criteria:

* Sickle Cell disease
* Renal insufficiency
* Upper respiratory infection or Pneumonia
* Chronic Neutropenia
* Known Past or present malignancy
Probiotics Effects to Initial Periodontal Treatment

The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.

The aim of this study is to evaluate the clinical and microbiological effects of Bifidobacterium animalis subsp. lactis DN-173010 containing yoghurt as an adjunct to mechanical periodontal treatment.

Thirty chronic periodontitis patients were randomized into 2 groups. As adjunctive to MPT, Group 1 consumed 2×108 CFU/day of Bifidobacterium animalis subsp. lactis DN-173010 containing probiotic yoghurt while Group 2 natural yoghurt once daily for 28 days. Subgingival plaque samples were obtained from 2 periodontal sites with probing pocket depth (PPD) of 4≤PPD\<7 mm via paper-points at baseline, 28th day, 3rd month. Samples were cultured to evaluate total viable count (TVC), the proportions of obligate anaerobes (OA) and Bifidobacterium species (B) (TVC%). The full-mouth recorded clinical parameters were plaque index, gingival index, PPD, bleeding on probing, and clinical attachment level.

Eligibility Criteria:
Inclusion Criteria:

* chronic periodontitis patients with radiographically detected horizontal bone loss
* the presence of at least 2 teeth with one approximal site with a probing pocket depth (PPD) of 4≤SD\<7 mm (5-7 mm) and a GI of ≥2 mm in each quadrant,
* previously untreated periodontitis, systemically healthy

Exclusion Criteria:

* Systemic diseases
* Antibiotics and anti-inflammatory drugs within 3 months before the study
* Untreated caries lesions or local retention factors
* Allergic reactions to lactose or fermented milk products
* Previous probiotic supplements in diet
* Smoking
* Pregnancy
Vitamin-D Receptor Activation (VDRA) in Chronic Kidney Disease

To investigate whether treatment with a vitamin-D receptor activator is able to improve important markers of cardiovascular risk.

Main question:

May 12 weeks of VDRA treatment reduce the pathological sympathetic overactivation associated with moderate kidney disease?

Secondary questions aim to thrown light on how VDRAs can reduce albuminuria and CRP, i.e. does VDRA treatment improve (prespecified statistical analyses):

A) diastolic dysfunction? B) capillary microcirculation, and whether ameliorated disturbances relate to improved diastolic dysfunction? C) endothelial dysfunction and arterial stiffness? D) inflammatory activation? E) platelet function and haemostasis? F) levels of antibacterial peptides? G) levels of IGFBP-1 and adiponectin?

Overall design The study is designed as a double-blind, randomised, placebo-controlled trial involving two groups (n=72) of patients: 1) chronic kidney failure (CKD, eGFR 15-59 mL/m2) and 2) chronic kidney failure and concomitant diabetes mellitus (CKD+DM).

It will start with a two-week placebo run-in, followed by randomisation to:

1. Zemplar 1 μg (taken as 1 x 1 μg capsule and one placebo capsule),
2. Zemplar 2 μg (taken as 2 x 1 μg capsules) and
3. placebo (taken as two placebo capsules).

Eligibility Criteria:
Inclusion Criteria:

eGFR 15-59 ml/m2

Exclusion Criteria:

Current vitamin D treatment
Alfentanil Versus Remifentanil in Patient-controlled Sedation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Self-administration of propofol and opioid mixture by the patient him- or herself (patient-controlled sedation, PCS) could be successful alternative to the anesthesiologists-managed deep sedation during endoscopic retrograde cholangiopancreatography (ERCP). However, it is not known which opioid would be the most suitable for PCS. The aim of this double-blind study was to compare remifentanil and alfentanil in PCS during ERCP.

Deep sedation with propofol has been suggested necessary for successful performance of endoscopic retrograde cholangiopancreatography (ERCP).Airway obstruction, hypoventilation and hypoxemia occurs in deeply sedated patients with a high incidence of 12-30%.As a result of frequent hypoxemia events, deep sedation is associated with increased morbidity and mortality.Careful monitoring of vital signs and involving of anesthesia-trained personal are recommended for deeply sedated patients.Self-administration of propofol by the patient him- or herself (patient-controlled sedation, PCS)could be a safer way to use propofol without the presence of an anesthesiologist. In comparison to the anesthesiologists managed deep sedation the main advantages of PCS are reduced consumption of anesthetics and faster recovery.A combination of propofol and different opioids is widely used for PCS however, it is not known which opioid would be the most suitable one. Remifentanil is a potent opioid with ultra short duration of action and usually administered as a constant infusion. The elimination half-life of alfentanil is 8-32 minutes being about 3 times longer, than that of remifentanil. Both opioids have been evaluated previously in PCS but comparative studies are lacking. This study was carried out in order to compare remifentanil and alfentanil in PCS during ERCP in terms of propofol consumption, sedation levels, endoscopist´s and patient's satisfaction. The investigators also sought information about frequency of sedation related complications associated with the different opioids.

Eligibility Criteria:
Inclusion Criteria:

* elective ERCP patients

Exclusion Criteria:

* allergy to propofol or opioid analgesics, drug addiction, inability to co-operate, ASA class greater than 3, or patient's refusal.
Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

The hypothesis of this study is that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. Patients were randomised in the operating room to receive either a periarticular infiltration, or a placebo consisting of Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.

The efficacy of periarticular injections during total knee arthroplasty is well established but there is little published data on their effect in primary hip arthroplasty. We hypothesized that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. A double blinded, randomised, placebo-controlled trial on patients undergoing primary hip arthroplasty was performed. Patients were randomised in theatre to receive either a periarticular infiltration of 150mg levobupivicaine in 60mls of 0.9% Saline, or a placebo consisting of 60mls 0.9% Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent.

Exclusion Criteria:

* Patients with cognitive impairment, neurological disorders, advanced liver or renal impairment, known ischemic heart disease, a previous diagnosis of a pain syndrome or any post-operative surgical or medical complications were excluded.
NOMAC : New Tools for Managing the Fate of Cereal Nutrients in the Gut : Effects of Amylose Content on Glycemic Index.

The consumption of cereals-based foods with low glycemic indexes, high micronutrients and fibers contents are highly recommended. The target of this work is to provide new solutions for cereal based foods: the knowledge and understanding on the in vivo fate will be used to define structural features to gain in foods.


Eligibility Criteria:
Inclusion Criteria:

* Healthy individual,
* Age between 19-65 years
* With normal food habits with at least 2 main meals per day
* Non smoking
* Having filled the consent form

Exclusion Criteria:

* BMI \> 25 kg/m2,
* Diabetes or any illness susceptible to alter
* Coeliac disease
* Past history of intestinal diseases.
* Treatment susceptible of modifying glycemia.
* Allergy
Recording of Intraoperative Spinal Cord Stimulation and Monitoring

Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.


Eligibility Criteria:
Inclusion Criteria:

* Any patients undergoing brain or spinal cord surgery where spinal neuromonitoring is utilized.

Exclusion Criteria:

* none
Turkish Version of Ottawa Sitting Scale in Patients With Stroke

The aim of the study is to describe the cultural adaptation of the Ottawa Sitting Scale and to examine the factor structure, reliability and validity of the scale in patients with stroke.

The scale will be translated into Turkish language by following the procedure. 80 patients will be recruited in the study. Berg Balance Scale and Trunk Impairment Scale will be included with Turkish Ottawa Sitting Scale to test the validity. Outcome measures will be repeated by a second physiotherapist the day after the first assessment for interrater reliability and conducted twice within 2 weeks (test-retest) for reliability.

The interrater and intrarater reliability of the Ottawa sitting scale will be determined using intraclass correlation coefficients and internal consistency will be assessed using Cronbach's alpha.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with acute stroke
* aged above 18 years

Exclusion Criteria:

* Patients who do not cooperate enough to read or approve the consent
Transcutaneous Electrical Nerve Stimulation for Tissues Perfusion

The aim of this study is to determine the effect of transcutaneous electrical nerve stimulation in mechanically ventilated patients on the lower limb and renal tissue perfusion.


Eligibility Criteria:
Inclusion Criteria:

* Recently intubated patient.
* Adult and both gender.
* Hemodynamic stability

Exclusion Criteria:

* Vascular diseases
* Diabetic patients
* Patients who receive vasoactive drugs
* Patients with varicose vein
* Systemic scoliosis
RTMS for Treatment of Pain and Craving

The purpose of this study is to develop repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for pain in individuals on prescription opioid medication. Repetitive TMS is a non-invasive technique that uses magnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthetic, or other invasive procedures). This study will test whether 10 days of rTMS over the prefrontal cortex can produce a reduction in perception of pain and the desire to use opiates. TMS has been approved by the FDA as an investigational tool as well a therapy for depression.

Individuals between the ages of 18 and 65 with current (past 3 months) prescription opioid use and chronic pain are being recruited. Participants will be screened on the telephone for major inclusion/exclusion criteria. Individuals meeting inclusion criteria based on the screening assessment will be set up for an appointment in the clinic. Participants will be instructed not to use alcohol, prescription opioids, or any other drugs on the day of their appointment. All study procedures will take place at the 30 Bee Street location of the Brain Stimulation Lab (BSL). The protocol contains 1 screening visit, 10 TMS visit, and 2 follow up visits. Individuals that are eligible following the screening visit will be randomized to receive real or sham TMS.

On each TMS visit participants will undergo a single 20-minute session of 10Hz real or sham rTMS (on-time=5 secs, off-time=10 secs) at up to 110% of resting motor threshold using a MagVenture MagPro TMS machine.

Primary outcomes will be:

1. change in pain sensitivity levels in the pain assessment task and
2. change in levels of opiate craving.

The investigators will use analysis of variance models with group (real rTMS vs. sham) as the between-subjects factor and time (pre- to post-TMS) as a within-subject factor. The investigators will test the hypothesis that rTMS will result in significantly lower levels of reported pain sensitivity and craving, as compared to sham. Blind interim analyses of the data will be conducted when 50% of the sample has been accrued.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* currently prescribed prescription opiates for pain

Exclusion Criteria:

* documented history of seizures
* unstable chronic medical illness
* currently using any medications known to lower seizure risk
* metal above the waist
* pregnancy
* history of a negative reaction to TMS
Exploring Advanced Clinical Practitioner's Experience Developing Clinical Competence and Opinions on Role Identity

In the United Kingdom, there is an urgent need to reshape the National Health Service (NHS) workforce to equip it to meet the changing demands of the population it serves and deliver the vision set out in the Next Steps on the NHS Five Year Forward View (2017) and recently published NHS Plan (2019). One of the key elements to this is the continuing development, support and utilisation of Advanced Clinical Practice (ACP) roles.

Advanced Clinical Practitioners are educated to Masters Level in clinical practice and assessed as competent in practice using their expert clinical knowledge and skills. They have the freedom and authority to act, making their own decisions in the assessment, diagnosis and treatment of patients.

Although the level of education and assessment of competence are common for ACPs working in all areas, training and supervision varies between primary and secondary care, specialties and sites.

The proposed research will explore ACP experiences of how they develop clinical competence and their opinions on role identity, specifically:

* Factors that have influenced their clinical competency achievements.
* Training experience (clinical and external education opportunities)
* Experience of educational/ clinical supervision and its benefits.
* Self-identified knowledge gaps, with a focus on mental health.
* Future ACP role identity


Eligibility Criteria:
Inclusion Criteria:

* Qualified ACP or trainee ACP who has completed at least 1 years (FTE) of ACP clinical training
* Currently working in this role within either Primary or Secondary Care and based in South Yorkshire and Bassetlaw.

Exclusion Criteria:

* Unable to communicate in English
Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses

The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.


Eligibility Criteria:
Inclusion Criteria:

* age 18 to 55
* informed written consent
* multiple sclerosis (Mc Donald criteria, relapsing-remitting
* EDSS before relapse : 0 to 5
* relapse : increase of 1 point or more for 1 or more functional systems of Kurtzke, with SF score most affected \> 1 for all functions except for sensory (\> 2); duration of symptoms \> 24 h

Exclusion Criteria:

* fever
* previous relapse, and/or corticosteroid treatment \< 1 month before present relapse
* first symptoms of the present relapse appeared \> 15 days before inclusion
* under mitoxantrone of cyclophosphamid or natalizumab treatment
* diabetes
* infection not under control
* liver or kidney failure
* psychiatric symptoms not under control
* pregnancy
* hypersensibility to methylprednisolone
A Study of Atezolizumab Compared With Docetaxel in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum-Containing Therapy

This global, multicenter, open-label, randomized, controlled study evaluated the efficacy and safety of atezolizumab (an anti-programmed death-ligand 1 \[anti-PD-L1\] antibody)compared with docetaxel in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy. Participants were randomized 1:1 to receive either docetaxel or atezolizumab. Treatment may continue as long as participants experienced clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic (Stage IIIB, Stage IV, or recurrent) NSCLC
* Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens
* Disease progression during or following treatment with a prior platinum-containing regimen for locally advanced, unresectable/inoperable or metastatic NSCLC or disease recurrence within 6 months of treatment with a platinum-based adjuvant/neoadjuvant regimen or combined modality (e.g., chemoradiation) regimen with curative intent
* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Known active or untreated central nervous system (CNS) metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Active hepatitis B or hepatitis C
* Prior treatment with docetaxel
* Prior treatment with cluster of differentiation 137 (CD137) agonists, anti-cytotoxic-T-lymphocyte-associated antigen 4 (anti-CTLA4), anti-programmed death-1 (anti-PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents
BTT1023 in Psoriasis

Patients with plaque psoriasis will be enrolled. They will be dosed with repeated intravenous doses of BTT-1023 or placebo. During the trial, the safety of the treatments and the pharmacokinetics of BTT-1023 will be assessed. The patient allocation to treatment groups will occur at random, and the actual treatment will not be revealed to the investigator or to the patient during the trial.


Eligibility Criteria:
Inclusion Criteria:

* Plaque psoriasis affecting at least 8% of the body surface area and scoring 8 or higher in the psoriasis area and severity index

Exclusion Criteria:

* Seropositive for infection with human immunodeficiency virus, hepatitis B virus, or hepatitis C virus; Tuberculosis; Acute systemic infection;
* Treatment with a monoclonal antibody therapy within 12 weeks prior to study entry;
* An absolute indication for a known effective treatment