cyrilzakka/clinical-trials huggingface dataset:
A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

Primary Objective:

To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy.

Secondary Objective:

To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy.

Total study duration was up to 62 weeks: Up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.

Eligibility Criteria:
Inclusion criteria:

Diagnosis of rheumatoid arthritis (RA), according to the American College of Rheumatology/The European League Against Rheumatism (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria with \>=3 months disease duration.

Moderately to severely active RA defined as:

* At least 4 of 68 tender joints and 4 of 66 swollen joints at screening visit.
* High sensitivity C-Reactive Protein (hs-CRP) \>=4 mg/L or Erythrocyte Sedimentation Rate (ESR) \>=28 mm/hr at screening visit.

For the combination stratum:

Participants who had continuous treatment with non-biologic DMARDs other than MTX for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening.

For the monotherapy stratum:

Participants who per investigator judgment were any of inappropriate, intolerant or inadequate to MTX treatment.

Exclusion criteria:

Participants \<20 years of age. Prior treatment with tumor necrosis factor (TNF) antagonists or any other RA-directed biologic agents without the appropriate off-drug period prior to screening.

Prior treatment with anti-interleukin-6 (anti-IL-6) or anti-interleukin-6 receptor (IL-6R) antagonist therapies, including but not limited to tocilizumab or sarilumab.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Impact of TECAR Therapy on Pain and Function in Adhesive Capsulitis:

Transfer Energy Capacitive and Resistive (TECAR) therapy is a heat therapy method that increases blood circulation at the microscopic level by generating heat in the upper and lower layers of your tissues, reduces inflammation and supports tissue regeneration. In this study, we aimed to evaluate whether this treatment reduces pain and improves functioning in patients with frozen shoulder disease.

Adhesive capsulitis (AC), commonly known as "frozen shoulder," is a prevalent and painful condition resulting from the contracture of the glenohumeral capsule, which significantly impacts individuals' quality of life. While AC is self-limiting in many cases, some patients may experience long-term functional limitations if not treated promptly. One promising intervention is transfer energy capacitive and resistive (TECAR) therapy, which has gained attention for its potential to enhance tissue regeneration, reduce inflammation, and improve pain management by generating heat in superficial and deep tissues. This study aimed to evaluate the effects of TECAR therapy on pain and functional outcomes in patients with adhesive capsulitis (AC).

This prospective, randomized controlled clinical trial included 60 patients \[TECAR group: 30, (50.37 ± 13.90 years); control group: 30, (55.27 ± 10.44 years)\]. Both groups completed a 2-week tailored therapeutic exercise program, with 30-minute hot pack application and Transcutaneous Electrical Nerve Stimulation. The TECAR group also received three TECAR therapy sessions per week, for a total of six sessions. Pain was measured using the Visual Analog Scale (VAS), functional status with the Shoulder Pain and Disability Index (SPADI), and supraspinatus tendon thickness and bicipital effusion were assessed via ultrasonography. Evaluations were conducted at baseline, 1 and 3 months post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were than 18 years of age
* Patients with unilateral shoulder pain of at least 3 on a 10-point Visual Analog Scale (VAS);
* Patients who experienced a more than 50% loss of passive ROM (abduction or external rotation) in the glenohumeral joint relative to the unaffected side
* Patients who had been experiencing the related symptoms for ≥ 3 months.

Exclusion Criteria:

* Patients who had previous shoulder surgery
* Patients who had shoulder injection within the last 3 months
* Patients with inflammatory rheumatic disease,
* Patients with cervical radiculopathy
* Pregnant patients
* Pateints with thyroid disease
* Patients with malignancy,
* Patients who had history of cardiac pacemakers,
* Patients with epilepsy
* Patients who had neurological disease with or without cognitive impairment
Clinical Evaluation of 3M™ ESPE™ Adper™ Scotchbond™ SE Self-Etch Adhesive in Class I and Class II Restorations in Adults

The purpose of this study is to evaluate the performance of a new dental adhesive system in the restoration of Class I and Class II cavities in adult teeth.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Must have 2 or 4 qualifying Class I or Class II cavities
* Must be willing to sign consent form
* Must be willing to return to University dental clinic for 4 study appointments
* Must be in good medical health and able to tolerate dental procedures

Exclusion Criteria:

* Current participation in other restorative product studies
* Known allergies to dental products
* Unacceptable level of oral hygiene
* Chronic periodontitis (gum disease)
* Rampant caries (cavities)
* Severe salivary gland problems
* Inability or unwillingness to attend study appointments
Influence of Periodontal Treatment During Pregnancy in Adverse Pregnant Outcomes

The aim of this study is to evaluate the effects of treatment of periodontal disease during the second trimester of gestation in adverse pregnancy outcomes.

Pregnant patients during the 1st and 2nd trimesters at antenatal care in a Public Health Center will be divided into two groups: NIG- 'no intervention' or IG- 'intervention,' according to agreement in receive periodontal treatment during pregnancy. Treatment will be performed by a single periodontist consisting of scaling and root planning (SRP), professional prophylaxis (PROPH) and oral hygiene instruction (OHI). Patients at NIG will receive PROPH and OHI during pregnancy and will be referred for treatment after delivery. Periodontal evaluation will be performed by a single trained examiner, blinded to periodontal treatment, according to probing depth (PD), clinical attachment level (CAL), plaque index (PI) and sulcular bleeding index (SBI) at baseline and 35 gestational weeks-28 days post-partum. Primary adverse pregnancy outcomes to be addressed are: preterm birth (\< 37 weeks), low birth weight (\< 2.500 Kg), late abortion (14-24 weeks) or abortion (\< 14 weeks). The results obtained will be statistically evaluated according to OR, unpaired t test and paired t test.

It is expected that periodontal treatment during the second trimester of gestation will result in decreased rates of adverse pregnancy outcomes.

All patients entering the study at the 1st and 2nd trimesters will be invited to participate in an oral health program, including oral hygiene instruction, caries diagnosis and treatment, and evaluation and treatment of periodontal conditions during the second trimester. Those who refuse to receive periodontal treatment during pregnancy will constitute the 'no intervention' control group (NIG), while those who agree in receiving dental and periodontal treatment during the second trimester of gestation will constitute the 'intervention' group (IG).

Patients are going to be evaluated by a single calibrated periodontist blinded in relation to periodontal treatment, which will be performed by another periodontist. Treatment consists of scaling and root planning, professional prophylaxis and oral hygiene instruction. Obstetrical data, birth weight and gestation duration will be recorded after examination and recording by the responsible obstetrician and nursery staff.

Eligibility Criteria:
Inclusion Criteria:

* confirmed singleton gestations
* pregnancy of 9-24
* systemically healthy women
* age range: 16-39 years old

Exclusion Criteria:

* non confirmed pregnancy
* age inferior to 16 years or superior to 39 years
* multiple gestations
* smoking
* alcohol or drugs abuse
* history of congenital heart disease
* current use of corticosteroids or antibiotics
* presence of systemic conditions (eg: diabetes, hypertension, or genitor-urinary infections)
Promoting Community Mobility for Wellness in Older Adults in Urban Environments

This study evaluates the program outcomes of the Let's Go program. The standardized community mobility program employs multi-modal group and individual sessions to facilitate wellness in older adults.

This study examines the outcomes of Let's Go, a standardized community mobility program which employs group and individual sessions of education, peer interaction, engagement in meaningful occupations, and self-reflections to help individuals understand the importance of community participation and its relationship to well-being. Program outcomes explored include increased confidence in community mobility, increased autonomy outdoors, social life and relationships, frequency of community trips, and decreased social isolation.

Eligibility Criteria:
Inclusion Criteria:

1. Community dwelling individual
2. Report desire to learn about community mobility options
3. Able to participate in group education sessions (
4. Able to attend during a 45 minute session
5. Independent mobility in community with or without an assistive device.

Exclusion Criteria:

1. Individual lives in Long Term Care facility
2. Aphasia
3. Individual has impaired cognition demonstrated by MoCA exam score ≤ 17
4. Individual is unable to stay awake for entire group session
5. Individual acts out (yelling, monopolizes, motor restlessness or agitation) in group setting.
Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 60 years;
2. having a PHQ-9 score or a GAD-7 score upon enrollment;
3. being able to operate a smartphone fluently;
4. having normal vision after correction

Exclusion Criteria:

1. clinical diagnoses of severe psychiatric conditions such as schizophrenia or bipolar disorder;
2. at high risk of suicide or self-harm;
3. having significant cognitive impairments;
4. active substance abuse or dependence;
5. currently undergoing other psychological or pharmacological treatments for depression or anxiety;
6. pregnant individuals or those with postpartum depression, and those with serious physical health conditions that could impact mental health.
Effect of Mulligan on Sub-acromial Space in Patients With Shoulder Impingement Syndrome

the aim of this study is to investigate the Effect of mulligan technique on sub-acromial space in patients with shoulder impingement syndrome

Shoulder Impingement Syndrome (SIS) is defined as the mechanical entrapment of the rotator cuff (mainly the supraspinatus tendon) or the sub-acromial bursa in the sub-acromial space between the humeral head and the acromion or coracohumeral ligament .It is typically exacerbate when the arm is elevated or when overhead throwing activities are performed . Mulligan technique is a type of manual therapy with hypoalgesic effects, increases joint ROM, enhances muscle function and treats specific pathologies. Mobilization with movement (MWM) can be defined as the application of a sustained passive accessory force / glide to a joint while the patient actively performs a task that was previously identified as being problem.

Eligibility Criteria:
Inclusion Criteria:

age of patients from 30- 55 years old . Both Male and female.

Shoulder pain and two out of four specified objective signs and symptoms:

Positive Neer impingement test. Positive Hawkins-Kennedy impingement test. Painful or limitation of active shoulder elevation (flexion, abduction, scaption).

Pain or limitation with the functional movement patterns of hand-behind-back or hand-behind-head.

Exclusion Criteria:

Systemic or neurological disorder. Adhesive capsulitis. Cervical radiculopathy. History of shoulder surgery. Corticosteroid injection within the past month Subjects who had received physical therapy treatment for their shoulder within the past three months.
Study on Anti-inflammatory Effects of Topical R115866 Gel

The purpose of this exploratory trial is to assess the anti-inflammatory effect(s) of topical R115866 in a model of UVB-induced inflammation and in a model of cutaneous irritation.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index should be between 18 and 28 kg/m2
* Subjects are healthy as determined by medical history, physical examination and clinical laboratory tests carried out at screening
* Subjects with a phototype III or IV (according to Fitzpatrick classification)

Exclusion Criteria:

* Subjects with history of or active alcohol or substance abuse problems.
* Known hypersensitivity to azoles, adapalene, retinoids or any other ingredient of the gels
* Subjects who have a laboratory value which, in the opinion of the investigator, is clinically-relevant out of the normal range
* Subjects with clinically relevant abnormal ECG-intervals or morphology of the ECG, QTc interval \>450 ms
* Use of vitamin A (\>1000 µg/day) or the use of concomitant medication, except paracetamol; All other medication must have been stopped at least 14 days before the first administration of gel)
* Subjects who have received an investigational product which is not a biological within the month preceding the screening visit; If the investigational product is a biological, a 3-month wash-out period is required.
* Use of ultraviolet light (including artificial UVA and UVB as well as excessive natural sun exposure) unless stopped at Visit 1
* Subjects judged by the investigator to have a high probability of lack of compliance with the provisions of the protocol
* Subjects having any medical condition which, in the opinion of the investigator at the site, is a contraindication to enrollment
Colonization of the Female Urethra With Mycoplasma Hominis, Ureaplasma Urealyticum, Chlamydia Trachomatis, or Neisseria Gonorrhea in Patients With Lower Urinary Tract Symptoms

The purpose of this study is to assess the prevalence of mycoplasma hominis, ureaplasma urealyticum, neisseria gonorrhea, and chlamydia trachomatis in women with overactive bladder symptoms, and to correlate these findings with cystoscopic and urodynamic findings.


Eligibility Criteria:
Inclusion criteria:

* women with urogynecologic and urodynamic examination at our institution between 1.1.2009 and 31.12.2011

Exclusion criteria:

* none
Study of Mitomycin C and Nasal Splint to Treat Nasal Synechiae

This study evaluates whether Mitomycin C is an effective alternative to septal splints in the treatment of nasal synechiae.

Nasal synechiae is an important cause for the failure of many a nasal surgery. Septal splints have been widely used for the treatment of nasal synechiae, but are associated significant morbidity until removal. To the best of our knowledge there are no studies in literature comparing Mitomycin C with septal splints as an atraumatic alternative in the treatment of nasal synechiae. This is a preliminary study taken up to evaluate the therapeutic efficacy of Mitomycin C in the treatment of nasal synechiae.

Eligibility Criteria:
Inclusion Criteria:

* Patients with nasal mucosal synechiae due to surgical or non-surgical trauma

Exclusion Criteria:

* Patients with nasal vestibular stenosis
* Patients with nasal synechiae due to diseases like Hansen's disease, Syphilis, Rhinoscleroma, Atrophic Rhinitis etc.
Long or Very Long-Limb Gastric Bypass in Superobese

The goal of this study is to compare the clinical efficacy (weight loss and metabolic changes) of long (150 cm) versus very long (250cm) Roux alimentary limb gastric bypass in superobese (BMI\>50) patients.

The study is a multicentre trial in which superobese (BMI\>50) patients will be randomly assigned (in a 1:1 ratio) for laparoscopic gastric Roux-en-Y gastric bypass with: a) long (150 cm) or b) very long (250cm) alimentary Roux limb. Patients will be included from three hospitals: Kaunas University of Medicine Hospital (Lithuania), Klaipeda District Hospital (Lithuania), Vaasa Central Hospital (Finland) ) where preoperative investigation, the same technique surgical procedures and follow up will be performed acording approved protocol.

Approximate duration of subject participation

Subjects in the study will participate for approximately 5 years:

* Preoperative investigation and surgery 3- 5 days in the hospital;
* First follow up visit: 6 months after surgery;
* Next follow up visits: 12, 24, 36, 48 months after surgery;
* Last follow up visit: 5 years after surgery.
* The interim results after 12, 24 and 36 months will be calculated and presented before end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male or female subjects 18-65 years of age.
* Obese subjects with body mass index (BMI= kg/m²)\>50
* Patients without mental or nervous disorders interfering with adequate evaluation of one's health condition.
* Patients who read the informed consent form and gave a written consent to participate in the study.

Exclusion Criteria:

* Previous open abdominal surgery, except appendectomy, cholecystectomy and gynaecological procedures.
* Presence of any significance cardiac, hepatic, renal, blood, alimentary tract disease which may lead to system or organ failure in intraoperative or postoperative period.
* Pregnant women.
* Subjects taking immunosuppressive therapy.
* Any concomitant condition that, in the opinion of the investigator, would preclude an operation and postoperative follow up acording to a protocol
Ultrasound-guided Deep and Superficial Serratus Anterior Plane Block

This study evaluates the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Thoracotomy is known as one of the most painful surgery. Thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. Although it has reduced postoperative pain and complications compared with thoracotomy, VATS is still quite painful operation. Serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. Two methods were proposed to target the top and bottom of the serratus anterior muscle. However, the difference of deep and superficial serratus anterior plane block during intraoperative period has not yet been studied.

In this study, therefore, the investigators decided to assess the difference of deep and superficial serratus anterior plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* a) American Society of Anesthesiologists (ASA) physical status 1 or 2
* b) age 20-75 years
* c) elective three port Video-assisted thoracoscopic surgery (VATS) lobectomy.

Exclusion Criteria:

* a) a history of drug allergy for opioids or local anesthetics
* b) local infection at the injection site and systemic infection
* c) coagulopathy
* d) difficulty in understanding the study protocol
* e) refusal to participate
Luteal Phase Supplementation With Recombinant LH After GnRh Agonist Oocytes Triggering in Women at Risk of OHSS

The purpose of this study is to prove that luteal phase supplementation with recombinant LH can solve the luteal phase deficiency after Gnrh agonist oocytes triggering in women at risk of OHSS

The investigators enrolled patients, undergoing controlled ovarian stimulation for an IVF/ICSI cycles, who on the day of oocytes triggering were at risk of OHSS.

These patients had an estradiol \> 4000 pg/ml and more than 24 follicles with a diameter greater than 12 mm.

The investigators used 0,2 mg of triptorelin for the oocytes triggering and supplemented the luteal phase with recombinant LH at a dose of 75 UI twice/day for 10 days and vaginal gel progesterone and oral oestradiol for 14 days The investigators measured bhCG at 14 days from the pick up. In case of positive bhCG we have defined the IVF/ICSI outcome: Pregnancy Rate and Implantation Rate.

Eligibility Criteria:
Inclusion Criteria:

* patients with an oestradiol \> 4000 pg/ml on the oocytes triggering day
* patient with more than 24 follicles of diameter greater than 12 mm on the oocytes triggering day

Exclusion Criteria:

* patients with no risk of OHSS on the oocytes triggering day
* patients with an oestradiol \< 4000 pg/ml on the oocytes triggering day
* patient with less than 24 follicles of diameter greater than 12 mm on the oocytes triggering day
The Effect of rTEM in the Prognosis and Severity of Sepsis Induced ARDS

To observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.

90 patients will be included in this study. Blood samples from these patients in the first day, the third day, were maintained and tested to detect the change of rTEM level. Severity of illness and survival status of every patient were recorded within 28 days. The objective is to observe the changes of plasma rTEM levels in patients with sepsis, sepsis induced ARDS, and to explore its clinical significance.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed as Sepsis 3.0 Patients signing informed consent

Exclusion Criteria:

Pregnant women Patients with tumor、hepatitis、liver cirrhosis、acute myocardial infarction、chronic renal tubular nephritis、interstitial pneumonia、acute pancreatitis、systemic lupus erythenatosus、ulcerative colitis、crohn's disease、HELLP syndrome
Functional and Physiological Changes Induced by Pinhole Glasses in Presbyopia

This study is aimed at presbyopic patients that do not require magnifying glass at close rage. The purpose of this study is to investigate the functional and physiological changes in eye induced by pinhole glass.


Eligibility Criteria:
Inclusion Criteria:

1. age over 45 years
2. spherical equivalents(SE) within ± 3.0 diopters(D)
3. normal ocular alignment

Exclusion Criteria:

1. disturbance of accommodation due to any reasons such as an Adie's pupil, Parkinson's disease, a history of previous ocular surgery or trauma, and a history of systemic or topical medication that might affect accommodation
2. corneal pathologic features
3. glaucoma
4. cataracts of grade II or greater by the Lens Opacities Classification System III (LOCS III)
5. vitreous and retinal abnormalities that might limit the accuracy of testing