cyrilzakka/clinical-trials huggingface dataset:
Two-Piece Zirconia Dental Implant vs Two-Piece Titanium Dental Implant- Randomized Clinical Control Trial

2 Arms (60 subjects - 30 each arm). Experimental group with two-pice zirconia dental implant and Control group with two-piece titanium dental implant Evaluate Changes in inflammatory and microbiology levels from T0 (baseline) T2 (8 weeks) and T3 (after crown placement) Also evaluate secondary outcomes: marginal bone loss (MBL), gingival height (GH) levels, osseointegration, gender, age, time of surgery, anatomical position and implant stability. p values\<0.05 were considered statistically significant


Eligibility Criteria:
Inclusion Criteria:

Single implants in any area (maxillary and mandibular), extracted teeth for at least 3 months before implant placement, with bone volumes sufficient (at least 2 mm mesial, distal, buccal and palatal) to accommodate dental implant without the need for regeneration. Controlled oral hygiene, absence of any lesions in the oral cavity, at least 2 mm keratinized tissue. In addition, patients must agree to participate in a postoperative control program and signed the informed consent.

Exclusion Criteria:

1 - allergic to local anaesthetics, or any of the other components. 2 - Patients with hepatic or renal dysfunction 3 - Patients with epilepsy, shock, cardiac conduction disorders or myasthenia gravis 4 - Patients with myocardial injury 5 - Hyperthyroidism 6 - Severe Hypertension 7 - Insufficient bone volume 8 - Smoking more than five cigarettes / day 9 - Excessive alcohol consumption 10 - localized anti-tumour radiation therapy of the oral cavity 11 - Chemotherapy 12 - Liver Diseases 13 - immunosuppressed patients 14 - Patients taking corticosteroids 15 - Pregnancy 16 - inflammatory and autoimmune diseases of the oral cavity

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Quick Large Balloon Dilatation for Removal of Large Bile Duct Stones (SHODBADI)

ESGE guidelines suggests 30-60 seconds endoscopic large balloon papillary dilation from the disappearance of the waist of the papilla.

The investigators have good results in stone removal with much quicker dilatations when the cholangiogram is followed and the dilation is finished as soon as the disappearance of the waist of the papilla is seen. This Scandinavian multicenter prospective study is especially interested in stone clearance rate and short and long-term adverse events such as pancreatitis, cholangitis, bleeding, perforations, residual biliary stones, and newly developing biliary stones.

This study is planned as a multicenter Scandinavian prospective study including all the patients \>18 years with \>10mm diameter common bile duct stones visible in cholangiogram. Before ERCP all patient will be informed about this trial, and if they agree to participate this study, they need to give a written informed consent. The endoscopists will decide whether the first step will be large EST and stone extraction or small EST and dilatation. If simple EST does not success, the dilatation will remain as a rescue method. The diameter of dilatation balloon cannot exceed the diameter of common bile duct above the papilla. Cholangiogram is followed when papilla is dilated and the dilatation will be ended when the waist of the papilla disappears. The duration of the dilatation measured, but it does not define the ending of dilatation. All adverse events will be recorded one month and a year after the procedure.

Classification of the patients:

1. EST and stone extraction
2. EPLBD when EST and stone extraction did not succeed
3. Short EST and EPLBD

The investigators will collect the information of adverse events such as bleeding, pancreatitis, cholangitis with patient questionnaire as well as from the patient records one month and a year after the procedure

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Common bile duct stone \>10mm diameter

Exclusion Criteria:

* Altered anatomy after surgery (B II, Roux-en-Y reconstruction)
* Common bile duct cysts
* Acute pancreatitis
* Distal common bile duct stricture or tumor
* Coagulation disorders
* Ongoing coagulation medication
* Pregnancy
* Inability to give an informed consent
Phase I Study of Cisplatin Plus OSI-7904L in Patients With Solid Tumors

This is a Phase I, open-label, dose escalation, study of the combination of cisplatin and OSI-7904L given on Day 1 every 21 days in patient who have advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Advanced and/or metastatic solid tumor for which no effective therapy is available
* ECOG performance status 0-2
* Adequate bone marrow, hepatic and renal function

Exclusion Criteria:

* Patients with active or uncontrolled infections
* Neurotoxicity \>= Grade 2
* Symptomatic brain metastases which are not stable
The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms

Stress-related disorders have over the last decade increased and contributed to a worldwide disease burden. At the same time there is limited treatment access for mental health disorders, which has left many people without necessary care. However, in recent years there has been a rise in digital mindfulness interventions. Specifically, these interventions have focused on smartphone-based applications as an effective format for mindfulness training programs. Thus, the goal of this randomized controlled trial is to test the effects of three types of mindfulness programs in a population with elevated stress. The three formats of mindfulness interventions are identical in total training duration but varies in content and intervention length. Specifically, the first intervention consists of programmatic mindfulness content that progress over the course of 30 sessions with a duration of 10 min per session. The second intervention consists of single succinct breathing exercises with no programmatic content over the course of 30 sessions with a duration of 10 min per session. The third intervention consists of mindfulness-based content specifically targeted to people with elevated stress that progress over the course of 20 sessions with a duration of 15 min per session. An active control group listening to an audiobook over the course of 30 sessions with a duration of 10 min per session will be employed and a passive control group.

The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and physiological effects of stress using HRV.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to high perceived stress based on PSS total scores (14-40)
* Fluent in English

Exclusion Criteria:

* Regular mindfulness practice for more than 1 month within the last year
* Medical diagnosis e.g. psychiatric/neurological conditions
* Low levels of stress (i.e., less than a score of 14 assessed with the PSS)
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).


Eligibility Criteria:
Inclusion Criteria:

* Infants born at \< 30 weeks gestational age who develop clinically significant apnea while on NCPAP \> 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
* Infants on maximum caffeine therapy (10mg/kg/day)

Exclusion Criteria:

- Major congenital anomalies including congenital heart disease
A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics

This is a first-in-human Phase 1 study designed to investigate the safety, tolerability, PK and PD of intravenously administered AL001 in Healthy Volunteers and FTD-GRN mutation carriers.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.0-35.0 kg/m2
* 45-120 kg, inclusive
* At screening, females must be non-pregnant and non-lactating, or of nonchildbearing potential (either surgically sterilized or physiologically incapable of becoming pregnant, or at least 1-year postmenopausal (amenorrhoea duration of 12 consecutive months); nonpregnancy will be confirmed for all females by a pregnancy test conducted at screening, (each) admission, and at follow-up.
* Female participants of child-bearing potential must agree to use adequate contraception from screening until 90 days after the follow-up visit.
* In good physical health on the basis of no clinically significant findings from medical history, physical examination (PE), laboratory tests, 12 lead ECG, and vital signs, as judged by the Investigator.
* Willingness and able to comply with the study protocol, in the investigator's judgement.

Exclusion Criteria:

* Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins.
* Positive drug or alcohol at screening and prior to first dose
* History of alcohol abuse or substance abuse
Longitudinal SV2A and MRI in Premanifest HD

AIM: to compare the sensitivity of SV2A PET and volumetric MRI to detect longitudinal striatal changes in premanifest HD.

DESIGN: The investigators will include late premanifest HD mutations carriers and matched healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 18F-SynVesT-1 PET and volumetric MRI at baseline and after 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years inclusive.
* Capacity to understand the informed consent form.
* HD mutation carriers:

  * HTT (CAG)n ≥ 40
  * HD-ISS \< 2
  * CAP100 score \> 70

Exclusion Criteria:

* neuropsychiatric diseases (other than HD for HD mutation carriers)
* major internal medical diseases
* white matter lesion load on FLAIR Fazekas score 2 or higher or other relevant MRI abnormalities
* history of alcohol abuse or current alcohol abuse (chronic use of more than 15 units per week) or drug abuse
* contraindications for MR
* pregnancy
* previous participation in other research studies involving ionizing radiation with more than 1 mSv in the previous 12 months.
The Impact of School Teachers in Care Navigation and Signposting Dental Caries in Primary School Children

The study aims to investigate the role of school teachers in care navigation and signposting dental caries in primary school children.

Dental caries is a multifactorial disease with high prevalence in children. Dental caries is a global public health problem with detrimental impact in developing countries. Despite advances in caries management and detection poorer countries continue to suffer a high burden of disease. Advances in care navigation and sign-posting concepts are increasingly being utilized in general health care to aid early diagnosis and ease the burden of disease in poorer communities. This study aims to investigate the role of primary school teachers as care navigators with regard to dental caries in children.

Eligibility Criteria:
Inclusion Criteria:

Healthy school children between the ages of 5-8 years Regular school attender Lives in the local village Co-operative

Exclusion Criteria:

* known medical history or disability
* irregular school attenders
Motivation and Adherence to Psychotherapy Assignments

The aims of this study are to experimentally investigate and compare whether motivation variables can predict adherence to a prescribed assignment in face-to-face and online interventions using a psychotherapy analogue model.

A total of 100 participants are included in this study and randomized to either a face-to-face or online intervention. Participants in both groups receive a psychoeducation session and are given an assignment for the subsequent week.

The aims of this study are to investigate (1) participants' different forms of motivations to complete a typical psychotherapy assignment, (2) participants' subsequent adherence to the prescribed assignment and the associations between motivations and adherence and (3) any differences regarding motivations, adherence and their associations between the face-to-face and online conditions.

The hypotheses are that participants in the face-to-face condition will report higher motivation as well as higher adherence to the assignments compared to participants in the online condition, that adherence to the assignment will be positively associated with both autonomous motivation and externally regulated motivation and that adherence to the assignment will be more weakly associated with autonomous motivation in the face-to-face compared to the online condition.

To investigate the association between motivation and adherence to assignments in face-to-face and online settings, this study have a longitudinal randomized design with two conditions. The two conditions are face-to-face psychoeducation with a therapist and online psychoeducation with therapist support. A psychotherapy analogue model with a one-session intervention for a non-clinical population is used. Data is collected at baseline and at seven to nine days follow-up.

Eligibility Criteria:
Inclusion Criteria:

* having at least one problematic behavior one wished to understand or change

Exclusion Criteria:

* being below 18 years of age, having no access to a mobile phone and the Internet, reporting elevated levels of depressive symptoms or currently attending psychotherapy.
Safety and Efficacy Maintenance Study of Quetiapine SR to Treat GAD Patients.

The primary objective of this study is to evaluate the efficacy of quetiapine SR compared to placebo in increasing time from randomisation to an anxiety event in patients with generalised anxiety disorder (GAD).

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be male or female, 18 to 65 years of age (inclusive), with a diagnosis of GAD according to DSM-IV criteria 300.02 as assessed by the MINI.

Exclusion Criteria:

* Patients suffering from depressive symptoms, defined as having a Montgomery-Åsberg Depression Rating Scale (MADRS) total score of 17 or more at the enrolment visit, will be excluded from participation in this study.
Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan Study of Pulmonary Parenchyma

Main objective: to demonstrate that the diagnostic quality associated with the acquisition mode with tin filter, evaluated in a subjective way, is not inferior to that associated with the acquisition mode without filter.

The chest x-ray is the first-line exam for the study of pulmonary parenchyma. Nevertheless, it does not make it possible to reveal all pulmonary pathologies, and in particular those of very small sizes. Thanks to its very high spatial resolution and contrast resolution, the scanner is able to detect all infra-millimetric pathologies of the pulmonary parenchyma but also mediastinal pathologies that could not have been seen on the standard x-ray.

This study fits into the context of pleural pathology screening for patients exposed to asbestos in their professional environment.

Today, the chest CT scan in millimetric sections isth e standardised method used in the context of this screening.Tin filtration is an additional filtration at the output of the X-ray tube made available on premium Siemens scanners. In diagnostic medical imaging, the photon beam has an energetic spectrum ranging from 0 to 150 keV. However the weak energies do not participate in the formation of the image but, on the other hand, to the overall radiation of the patient. The purpose of the addition of the tin filter is to be able to suppress, at the output of the tube, all low and medium energy levels, only allowing high energy levels to pass through. A previous study comparing the same group of patients on two different machines (one with tin filtration, one without tin filtration) showed a significant decrease in the radiation dose; nevertheless, a certain number of parameters differed between the two scanners used. In order to get rid of the different biases encountered on previous published studies, we propose to carry out this study on the same machine, by activating and deactivating tin filtration, all other parameters of acquisition and reconstruction of the image being equal in all respects.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 and over.
* Patient referred for chest CT scan in the context of screening or monitoring of occupational exposure to asbestos.
* Patient with health insurance or beneficiary of a social security scheme.
* Patient having given their express consent.

Exclusion Criteria:

* Woman who is pregnant or likely to be pregnant.
* Lactating or parturient women
* Minors.
* Protected patients: Adults under trusteeship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision; hospitalised without consent.
High Cut-off Hemodialysis in Patients With Advanced Cardiac AL Amyloidosis and End Stage Renal Disease

The aim of the study is to assess survival of patients with advanced cardiac AL amyloidosis treated with high cut-off hemodialysis (HCO-HD) combined with chemotherapy.

This will be a single-center phase II open label trial. Subjects with advanced cardiac AL amyloidosis and end-stage renal disease will undergo HCO-HD while receiving chemotherapy for their plasma cell dyscrasia according to the current standards of care.

After giving written informed consent, the patients will be evaluated for eligibility. Briefly, the subjects with a biopsy-proven diagnosis of AL amyloidosis who are cardiac stage 3 based on NT-proBNP (\> 332 ng/L) and cTnI (\> 100 ng/L) and whose estimated glomerular filtration rate (eGFR) is \< 15 mL/min per 1.73 m2 will be eligible for the study. Patients with non-AL (e.g. familial and senile) amyloidosis will be excluded, as well as subjects who have less than 100 mg/L circulating amyloidogenic FLC. Sixteen patients will be enrolled.

The study includes 3 periods: screening, treatment followed by the end-of-treatment evaluation and follow-up. During dialysis the patients will undergo the first cycle of chemotherapy according to the current standard of care for subjects with advanced cardiac AL amyloidosis. Measurements of FLC and cardiac biomarkers will be done before and after each dialysis session. High cutoff HD will be continued during the first chemotherapy cycle. After the first cycle the end-of-treatment evaluation will take place. Follow-up evaluations will be performed after the end of each subsequent chemotherapy cycle and every 2 months after chemotherapy discontinuation for 1 year or until disease progression occurs.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AL amyloidosis.
* Age ≥ 18 years.
* Evidence of a monoclonal light chain in serum and/or urine by positive immunofixation and abnormal FLC κ/λ ratio.
* Evidence of cardiac involvement at echocardiography (mean left ventricular wall thickness \> 12 mm in the absence of other causes).
* Cardiac stage III (both NT-proBNP \> 332 ng/L and cTnI \> 100 ng/L).
* Estimated GFR \< 15 mL/min per 1.73 m2 or requiring dialysis.
* NYHA class III or IV.
* Initiation of chemotherapy for AL amyloidosis scheduled between day 3 and day 8 after first HCO-HD session.

Exclusion Criteria:

* Non-AL (e.g. familial, senile) amyloidosis.
* Concomitant non-amyloid related clinically significant cardiac diseases.
* Involved (amyloidogenic) FLC \< 100 mg/L.
* Inability to undergo chemotherapy for AL amyloidosis.
* Uncontrolled infection.
* Inability to give informed consent.
* Previous or ongoing psychiatric illness (excluding reactive depression).
* Pregnant or nursing women.
Quilting Sutures After Mastectomy

The use of wound drains after mastectomy is common practice in Belgium. However, placement of suction drainage has several disadvantages. Skin bacteria can enter via the drain and cause infection, or the drain itself can cause discomfort and a need for daily nursing. After drain removal, seroma is the most common complication following breast cancer surgery. Seromas are collections of serous fluid that frequently develop under the skin or in the axillary space formed after mastectomy and/or axillary lymph node dissection, resulting from surgical trauma to blood/lymphatic vessels and post-traumatic inflammation. Seroma formation can cause discomfort and limitations in shoulder function. Moreover, it is associated with surgical site infections, often requires treatment and increases healthcare consumption. Wound healing problems might be a cause of postponement of adjuvant therapy.

The quilting suture technique, in which the skin is sutured to the pectoralis muscle and drain placement is not needed, may lead to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections.

In this national multicentric study, we will compare mastectomy with placement of suction drains, a standard technique used in the vast majority of Belgian hospitals, with the new quilting suture technique without placement of suction drains. We will focus on 3 distinct primary outcomes:

* Pain of the mastectomy area 6 months after surgery
* Upper limb function 6 months after surgery
* Cosmetic outcome scored by the patient 6 months after surgery.

The goal of this study is to demonstrate the absence of long-term negative effects of the quilting suture technique on shoulder function, cosmetic outcome, and pain management.


Eligibility Criteria:
Inclusion Criteria:

* capable of giving written informed consent
* age ≥ 18 years
* scheduled for unilateral mastectomy without immediate breast reconstruction with or without axillary surgery (sentinel lymph node biopsy or axillary lymph node dissection)

Exclusion Criteria:

* scheduled for mastectomy with immediate breast reconstruction
* scheduled for synchronous bilateral breast and/or axillary surgery