cyrilzakka/clinical-trials huggingface dataset:
Oral Health of Individuals Who Attended a Mother-child Dental Care Program - Longitudinal Study

The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.

The aim of this longitudinal study was to assess the oral health of individuals attending a mother-child dental care program (PPPWB). Letters were sent to the 343 children who were examined in phase 1. One hundred and thirty nine individuals returned for the oral examination - experimental group (40.5%). The control group consisted of 139 individuals who did not receive dental care from the PPPWB. These individuals were paired to the experimental group according to their age and socio-demographic characteristics. Gingival bleeding (GBI) and DMFT indices were used in order to determine the children's oral health status. The mean DMFT and GBI in the second phase and the control group were 0.75 and 6.75, 1.47 and 10.74, respectively. It was concluded that the individuals who attended the PPPWB had better oral health status than the control group. When the two phases of the study were compared, it was noted that the individuals in the second phase had better oral health, although they had a higher score for gingival bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Children who participated to the program

Exclusion Criteria:

* children who did not participate
Corneal Barrier Function With Multi-Purpose Solutions

The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Eligibility Criteria:
Inclusion Criteria:

* Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40

Exclusion Criteria:

* Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications
The Interactive Physical and Cognitive Exercise System (v3) for Mild Cognitive Impairment (MCI)

The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.

A specific aim is to evaluate the potentially unique contribution of combining mental and physical exercise in an interactive way: "pedal-to-play" (iPACES), as compared with non-interactive, but simultaneous: "pedal-while-play" (PACE).

Eligibility Criteria:
Inclusion Criteria:

1. 50 years of age or older
2. co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well
3. self or partner meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018)
4. available for participation for one year (tablet surveys, videoconference evaluations)
5. willing and able to exercise 3-5 times per week for at least 6 months
6. can pedal an under-table elliptical
7. can read off of a small tablet screen
8. proficient in English (speaking and reading for completion of interview, surveys, game)
9. can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech)
10. written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study
11. can provide informed consent

Exclusion Criteria:

1. already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk)
2. significant history of cardiovascular problems
3. significant history of stroke
4. significant history of memory problems (e.g., dementia/Alzheimer's)
5. significant history of other neurological condition (e.g., seizures, Parkinson's, etc.)
6. tremor (idiopathic) such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)
7. not prone to cybersickness (e.g., "car sickness" or problems with "screen time")
8. cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)
Post-Market Evaluation of HEMOBLAST™ Bellows in Laparoscopic Abdominal, Gynecological, and Urological Surgery

A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery.

A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in laparoscopic abdominal, gynecological, and urological surgery. Up to 100 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

Eligibility Criteria:
Pre-operative Inclusion Criteria:

* Patient is undergoing a non-emergent laparoscopic abdominal, gynecological, or urological surgery
* Patient is willing and able to give prior written informed consent for investigation participation;
* Patient is 18 years of age or older.

Intra-operative Inclusion Criteria

* Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.
* The TBS(s) has been treated with HEMOBLAST™ Bellows and the HEMOBLAST™ Bellows Laparoscopic Applicator as per their instructions for use.

Exclusion Criteria:

* Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
* Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
* Patient has religious or other objections to porcine, bovine, or human components;
* Patient has any significant coagulation disorder;
* Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
* Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator
Perceptions of Vaping Products

This clinical trial studies the effects, appeal, and abuse liability of 6-methyl nicotine (metatine) electronic cigarettes among young adults.

PRIMARY OBJECTIVES:

I. Assess the pharmacokinetics of metatine and nicotine electronic (e)-cigarettes.

II. Assess the abuse liability and appeal of commercial e-cigarettes containing metatine versus nicotine.

III. Determine the impact of metatine on e-cigarette puffing behavior (topography).

OUTLINE: Participants attend 3 sessions where they will be randomized to 1 of 3 types of e-cigarette. Participants will use the e-cigarette ad-libitum for 30 minutes and answer survey questions about their perceptions of the e-cigarette. Participants must also undergo 4 blood draws during the vaping session.

Eligibility Criteria:
Inclusion Criteria:

* Aged 21-34 years
* Current nicotine EC user (defined as ≥ weekly use over the past 3 months)
* Willing to provide informed consent and abstain from using any e-cigarette at least 12 hours prior to the three lab sessions
* Read and speak English

Exclusion Criteria:

* Recently coronavirus disease 2019 (COVID-19) positive (defined as a positive test in the past 30 days) or a recent COVID-19 hospitalization (defined as a hospitalization within the past 6 months)
* Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
* History of cardiac event or distress within the past 3 months
* Have suffered from any serious lung disease or infection (e.g., tuberculosis, cystic fibrosis, or lung cancer) in the past 30 days
* Are currently pregnant, planning to become pregnant, or breastfeeding (will be verified with urine pregnancy test)
* Have hemophilia or another type of bleeding disorder
* Are blind, severely visually impaired, deaf, hard of hearing, or have a severe motor disability
Yale Wellness Project

The Yale College Emotional Intelligence project aims to highlight the beneficial impact of wellness programs for Yale students. The investigators will examine the benefits of 3 empirically-validated programs (Emotional Intelligence, Mindfulness-Based Stress Reduction (MBSR) \& SKY Yoga Breathing) for Yale students on measures of general well-being (e.g. perceived stress, gratitude etc). The study will also include a no-treatment control group as a comparative measure to the well-being programs. The goal of the study is to show how each program benefits student well-being over time. Pre-intervention and post-intervention data will be collected. The hypothesis is that all 3 workshops will decrease stress and improve well-being and that the manner in which each workshop will do so may be different (e.g. MBSR will benefit student well-being by increasing mindfulness and self-compassion whereas Emotional Intelligence may benefit student well-being by improving cognitive emotion regulation). Given the current state of mental health challenges and stress on college campuses, the goal of this randomized-controlled trial is to strengthen the literature on wellness programs for students and to show that student well-being can significantly increase through effective interventions.


Eligibility Criteria:
Criteria: Inclusion Criteria:

* Yale student.

Exclusion Criteria:

* Under 18 years old.
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment

We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is used as a 'trigger' injection during IVF therapy for infertility.

Participants in the study will have a standard Gonadotrophin Releasing Hormone (GnRH) antagonist IVF cycle, but instead of having a trigger injection of hCG (human chorionic gonadotrophin) they will be randomised to receive one of 4 doses of kisspeptin injection.

Oocytes will be retrieved and graded by an embryologist to see whether or not they have matured.

The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and progesterone will also be measured

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 - 34 years
* Body mass index between 18 and 29 kg/m2
* Stable body weight for at least 3 months
* Normal early menstrual cycle follicular phase serum FSH concentration
* Serum anti-Mullerian hormone (AMH) \> 40pmol/L
* No more than one previous IVF treatment cycle
* Both ovaries intact

Exclusion Criteria:

History of any medical, psychological or other condition, or use of any medications, including over-the-counter products, which, in the opinion of the investigators, would either interfere with the study or potentially cause harm to the volunteer

* Without access at home to a telephone, or other factor likely to interfere with ability to participate reliably in the study
* Treatment with an investigational drug within the preceding 2 months
* Donated blood during the preceding 3 months or intention to do so before the end of the study
* Previous poor response to IVF treatment
Comparison of Hemodynamics Between Dexmedetomidine and Propofol for Sedation in Patients With Abdominal Surgery

This is a single-blind randomized clinical trial. Patients undergoing abdominal tumor surgery were recruited to participate in the study. Apart from routine treatment in the surgical intensive care unit, the subjects were randomly divided into two groups: Propofol group (Group P) and Dexmedetomidine group (Group D) and received continuous intravenous infusion of Propofol (infusion dosage range: 0.3 \~ 1.6 mg/kg/h) or Dexmedetomidine (infusion dosage range: 0.1 \~ 0.7 mcg/kg/h) according to their assigned group. Patients' hemodynamic status was monitored using a chest Bioreactance technique, Continuous Non-Invasive Cardiac Output and Hemodynamic Monitor at preset time points (time of recruitment \[0h\], 2, 4, 6, 12h and 24h). Clinical data such as vital signs, hemodynamic parameters, laboratory results, fluid volume and drugs used were also recorded.


Eligibility Criteria:
Inclusion Criteria:

* non-emergent major abdominal tumor surgery with ICU admission
* the need of sedation during ICU stay

Exclusion Criteria:

* age older than 99 years
* age younger than 20 years
* refractory arrhythmias
* refractory shock status after resuscitation
* new onset of myocardial infarction
* severe heart failure or NYHA 4
* APACHE score \> 30 when recruiting
* severe liver cirrhosis or CHILD B or C
* organ transplantation within one year
* pregnancy
* allergic to propofol or dexmedetomidine
Assessing Interest in Web/App Platforms for Early Phase Clinical Trial Recruitment

Study objective:

To assess whether the different stakeholders (volunteers, patients, doctors and industry) involved in early phase trials would be interested in using a platform to facilitate recruitment and engagement in this type of trials. In addition, we will also evaluate the degree of awareness existing in society about clinical trials.

Study subjects: General population, patient, physicians, pharmaceutical-biotechnological industry.

Keywords: healthy volunteer, patient, pharma industry, patient associaiton, questionnaire, clinical trial, platform, recruitment, engagement.


Eligibility Criteria:
Inclusion Criteria:

* Participant will be over 18 years old.
* Male, female or do not want to specify.
* Participants will be capable to understand spanish language.
* Subjects able to communicate with the investigator and able to read and write and follow all study instructions.

Exclusion Criteria:

* Individuals not willing to complete the eraly phase clinical trial platform Study survey
* Individuals who do not meet eligibility criteria
A QT/QTc Evaluation Study of TS-172 in Healthy Adult Subjects

A clinical study to evaluate the effects on QT/QTc interval of TS-172 in healthy adults subjects


Eligibility Criteria:
Inclusion criteria

1. Japanese healthy subjects aged =\>18 and \<40 years at the time of obtaining informed consent
2. Subjects whose body weight is \>=40 kg at the screening test, and body mass index is \>=18.5 and \<25.0
3. Subjects with both heart rates are =\>45 and =\<100 beats/min on a standard 12-lead electrocardiogram at the screening test and before drug administration in Period 1

Exclusion criteria

1. Subjects with a history of hypersensitivity to moxifloxacin or other quinolone antibiotics
2. Subjects with a family history or risk factors for aortic aneurysm or aortic dissection (e.g., Marfan syndrome)
3. Subjects with a family history of sudden death
4. Subjects with congenital diseases, heart diseases, or medical history of such conditions
5. Subjects with risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, or a family history of long QT syndrome) or medical history of such conditions
6. Subjects with medical history of syncope suspected to be related to TdP, unexplained syncope, or seizures
7. Subjects with standard 12-lead electrocardiogram waveforms that make it difficult to evaluate QTc prolongation (e.g., drift, EMG interference, T wave morphology, significant sinus arrhythmia, or frequent ectopic beats) at the screening and before the administration of the study drug in Period 1
8. Subjects with a QTcF (QT interval corrected using Fridericia's formula) of =\>450 msec in the standard 12-lead ECG test at the screening and before the administration of the study drug in Period 1
A Study of MabThera/Rituxan (Rituximab) in Patients With Follicular Non-Hodgkin's Lymphoma

This single-arm, open-label, multi-centre study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in patients with follicular non-Hodgkin's lymphoma with minimal residual disease after autologous haematopoietic stem cell transplantation (bone marrow or peripheral blood). Two groups of patients will be considered for treatment. Group A: Patients with evaluable minimal tumor mass, Group B: Patients with complete response and abnormal B-cell lymphoma 2 (bcl2) status. Patients will receive MabThera/Rituxan 375 mg/m2 intravenously once every week. The anticipated time on study treatment is 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-75 years of age
* Diagnosis of follicular non-Hodgkin's lymphoma (FNHL)
* Previously treated with chemotherapy with autologous haemotopoietic stem cell transplantation (bone marrow or peripheral blood cells)

Exclusion Criteria:

* Active viral hepatitis
* Eastern Cooperative Oncology Group (ECOG) performance status \>2
* Patients not willing to sign informed consent form
Delayed Cerebral Ischaemia and Coagulation Alterations After Aneurysmal Subarachnoid Haemorrhage

Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI).

In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.

Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from a secondary injury during the first 2-3 weeks from the insult.

Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only a limited understanding of the mechanisms of secondary insults causing brain injury after SAH, also called delayed cerebral ischemia (DCI).

In this study, the investigators are exploring the use of quantifiable biomarkers from blood and continuous EEG monitoring as tools for the diagnostics of DCI. Additionally, the investigators are looking into other clinical variables (eg. pain, heart function) as factors of DCI.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admitted to the Tampere University Hospital ICU due to aneurysmal SAH
* Acute subarachnoid haemorrhage (confirmed by computed tomography, CT, AND confirmed origin either with computed angiography (CTA) or digital subtraction angiography (DSA)
* Definite or approximated time for the onset of symptoms and delay to ICU admission no more than 24 hours
* Expected treatment time at least 120 hours in the Tampere University Hospital

Exclusion Criteria:

* Known pregnancy
* Any long-term anticoagulant or antithrombotic medication, except for low-dose aspirin (under 150 mg/day)
* Known active cancer or cirrhotic liver disease or end-stage renal disease requiring renal replacement therapy
Effects of Movement Representation Techniques with Sensorimotor Training for Rotator Cuff Related Shoulder Pain

The aim of this study is to evaluate the efficacy of 12 weeks of sensorimotor training with movement representation techniques for reducing pain intensity in people with rotator cuff related shoulder pain, relative to standard care. Besides, the secondary aim of this study is to explore the mechanisms underlying the effects of central mechanism treatment in people with rotator cuff related shoulder pain. A total of 122 older adults aged 50 or above with the presence of shoulder pain for more than three months will be recruited and randomized into 12-weeks of movement representation techniques with sensorimotor training vs. standard care. Shoulder pain and disability Index (SPADI), changes in primary motor cortex (M1) using brain MRI, changes in subacromial space using ultrasound imaging, Widespread Pain Index (WPI), Pain Catastrophising Scale (PCS), and Fear-avoidance Beliefs questionnaires (FABQ) will be assessed at baseline and 12-week post intervention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 or above
* Presence of shoulder pain for more than three months
* Clinical test showed 3/5 positive tests (painful arc, resisted external rotation, Neer test, Kennedy-Hawkins test, and Jobe test), and the intensity of pain being provoked should be ≥ 3/10 on an 11-point numeric pain rating scale (NPRS)
* Structural changes of rotator cuff tendons using MRI or ultrasound imaging

Exclusion Criteria:

* History of trauma
* Shoulder fracture, glenohumeral osteoarthritis, or arthritis in the acromioclavicular joint
* Clinically suspected labrum lesion
* Previous shoulder surgery or dislocation
* Clinical signs of anterior shoulder instability
* Clinical signs of frozen shoulders
* Previous clinical treatment or corticosteroid injection for a shoulder injury within the last 12 months
* Symptoms referred from or related to the spine; and (9) other competing diagnoses (i.e., rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, or psychiatric illness).