cyrilzakka/clinical-trials huggingface dataset:
3D -Printed Single Implant Overdentures

A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of 14 participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Introduction: Mandibular single implant overdenture is a well-established treatment modality that address limited financial resources of patients and simultaneously enabled the management of conventional complete denture problems. CAD/CAM technology helped to mitigate the problems encountered with conventional fabrication techniques, which results in improved dentures fit and retention. Therefore, the aim of the current trial study was to evaluate whether overdentures fabricated using CAD/CAM printed technology exhibited improved patient satisfaction, denture retention, implant survival rate and decreased post-insertion maintenance or not compared to overdentures manufactured using conventional techniques.

Methods: A randomized clinical trial (RCT) was designed. The participants were randomly allocated into either of the two groups intervention or control group each of seven participants. Participants in control group (Group-A) received conventional manufactured implant overdenture while participants in intervention group (Group-B) received CAD-CAM manufactured implant overdenture.

Eligibility Criteria:
inclusion criteria

* the participant should be completely edentulous ranging in age from 35 to 75 years
* Angle's class I skeletal relationship
* normal facial symmetry
* adequate inter-arch space not less than 12mm
* should be a cooperative patient -

Exclusion Criteria:

* temporomandibular disorders
* uncontrolled diabetes
* bleeding disorders or anticoagulant therapy
* flabby tissues or sharp mandibular residual ridge
* neuromuscular disorders
* Angle's class II and III skeletal relationship.
* Patients who were heavy smokers
* chemotherapy or radiotherapy or with severe psychiatric disorders
Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions

The use of board games in classrooms has been increasing in recent years. Education and psychology professionals have found in the board game a way to train some key cognitive processes for good academic development: executive functions. Recent research has obtained promising results using modern board games as a neuroeducational intervention in children and old people (Benzing et al., 2018; Estrada-Plana et al., 2019; Estrada-Plana et al., 2020; Vita-Barrull et al., 2022). However, there is still little evidence of its cognitive and academic benefits in typically developing school-age children. Given that it is a methodology that, due to its dynamism and flexibility, could be adapted to different developmental levels, it has been proposed to study the possible effects on executive functions and academic skills of a classroom intervention based on board games with school children from rural areas of Spain (6-12 years). An experimental group will carry out the game program Conectar Jugando, which will be guided by the teachers themselves, through stable game groups of 3-4 students. On the other hand, a control group will develop the classes in a habitual way without the inclusion of board games and will be compensated at the end of the evaluations. The students of each center will be randomly assigned to the experimental group and the control group.

The hypotheses of the study are:

i) the experimental group will show a significantly higher improvement than the control group in the neuropsychological tasks that assess executive functions after completing the Conectar Jugando program; ii) the experimental group will show a significantly higher improvement than the control group in the academic content tasks after the intervention; iii) the experimental group will show a significantly higher improvement than the control group in the results of the evaluations carried out by their families regarding behaviors related to executive functions.

All hypotheses will be controlled for age, estimated IQ and socioeconomic level, as well as previous experience in board games and other cognitive activities.

Eligibility Criteria:
Inclusion Criteria:

* be enrolled in a rural educational center, whether public, private or subsidized
* provide informed consent from both parents and the participant's agreement to participate in the study

Exclusion Criteria:

* comprehension difficulties due to language reasons
* sensory difficulties that make it impossible to carry out the program activities
Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography

As the effect of statin use before the angiography to prevent contrast induced nephropathy (CIN) is not well-known, the aim of the current study is to assess the effect of atorvastatin on prevention of CIN in patients undergoing coronary angiography.


Eligibility Criteria:
Inclusion Criteria:

* having chronic stable angina who were referred for coronary angiography
* non-pregnant female subjects
* no history of diabetes mellitus
* no history of renal failure
* no history of single kidney
* no history of cardiogenic shock
* no history of unstable angina
* no history of myocardial infarction
* no history of hypersensitivity to statins
* no history of previous intravascular contrast injection during one month before admission

Exclusion Criteria:

* glomerular filtration rate (GFR) \<60
* cardiogenic shock
To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets

To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to Roerig's 10 mg Glucotrol tablets.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
A Study of LY2623091 in Healthy Participants

The first purpose of this study is to evaluate the effect of itraconazole (and possibly diltiazem) on the amount of LY2623091 in the blood stream and how long the body takes to get rid of it.

The second purpose of the study is to evaluate the effect of LY2623091 on the amount of simvastatin (and possibly tadalafil) in the blood stream and how long the body takes to get rid of it.

The safety and tolerability of LY2623091 when given with itraconazole, simvastatin and diltiazem or tadalafil will be evaluated.

There will be three groups of participants in this study. Results from Groups 1 and 2 will be analyzed during the study to determine whether to enroll participants in Group 3 or 4. The study is expected to last up to 40 days from the first dose to follow-up (inclusive). Screening may occur up to 28 days prior to enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participants as determined by medical history, physical examination, clinical laboratory tests, and electrocardiograms (ECGs).
* Have a body mass index (BMI) between 18 and 32.0 kilograms per square meter (kg/m\^2) inclusive, at screening
* Female participants must be of non-childbearing potential

Exclusion Criteria:

* In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study
Way to Safety Cellphone Blocking

Research participants will be recruited to take part in a randomized control trial. Participants' cellphone use will be observed during an initial baseline period. Participants will then be randomly assigned to one of four conditions: education only (control), opt-in blocking, opt-out blocking, and opt-out blocking with parental notification.

Motor vehicle crashes are the leading cause of death in teens in the United State and for drivers aged 15-19 involved in fatal crashes, 21% of distracted drivers were distracted by the use of cellphones. Nearly 90% of teens expect a response to a text message within 5 minutes, and the compulsion to respond is stronger for messages from close social contacts. This suggests that behavioral-economic interventions such as immediate and frequent incentives are needed to offset the disutility caused by not being able to communicate by cellphone while driving. If proven to be effective, incentives could be scaled up via auto insurance discount contributions, school programs, and parental contributions.

Eligibility Criteria:
Inclusion Criteria:

1. High school student
2. 16 or 17 at start of the study
3. Have a valid driver's license
4. Lives in parent's/guardian's home
5. Drives to school
6. Primarily drive one car
7. Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
8. Parent/guardian is willing to assist with installation
9. Admit to texting while driving \>1 time in the last 30 days

Exclusion Criteria:

1. Already uses a smartphone app or hardware device to limit cellphone use while driving
Banana Flower Extract in the Efficacy Verification Program of Hair and Body Health Care

To assess Banana flower extract supplement on hair and body health care


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* The students taught by the PI.
* Subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months
Study of INS365 Ophthalmic Solution in a Controlled Adverse Environment in Patients With Dry Eye

Comparative efficacy trial of INS365 Ophthalmic Solution and placebo in patients with dry eye.


Eligibility Criteria:
Inclusion Criteria:

* have Non-Sjogren's associated dry eye disease with symptoms lasting greater than 6 months
* had intermittent or regular artificial tear use within past 3 months

Exclusion Criteria:

* had LASIK surgery
* had punctal occlusion or cauterization within last 3 months
Korean Post-marketing Surveillance for Kombiglyze XR®

The purpose of this post-marketing surveillance is to investigate and confirm the type and incidence of newly identified adverse events and any other factors affecting safety and efficacy of Kombiglyze Extended release (XR) so that the regulatory authority can manage the marketing approval properly


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* ≥ 18 years of age
* Have diagnosed Type 2 diabetes mellitus (T2DM)
* Are initiating Kombiglyze XR treatment within the approved Korean indications

Exclusion Criteria:

* Being treated for an indication not approved for the use of Kombiglyze XR in Korea
* Is contraindicated for the use of Kombiglyze XR as described in the Korean label
Effectiveness of a Educational Intervention to Improve the Resolution Capacity of Primary Health Care Teams.

There is a great variability in the different primary care teams referral rate. And variability means inappropriateness somewhere in the process of care. The most important determinants of the variability are the attitude and knowledge of the professional, the existence and availability of evidence, the resources available and the professionals practice style. To improve the knowledge of the professionals could be a way to decrease the variability. Because of this, we have the aim to determinate the effectiveness of an educational intervention to improve the primary care teams from the city of Barcelona referral rate.

The aim of our study is to determinate if an active educational intervention (interactive sessions discussing clinical cases plus the minimal intervention) reduces the professionals referral rate compared with the minimal intervention group (written adapted clinical practice guidelines and feedback about their referral rate compared with other primary care teams). It is a cluster-randomized controlled trial stratified by the percentage of reform and the referral rate. The subjects were primary care physicians of the 51 teams of Barcelona city attending 1.160.748 inhabitants.

Eligibility Criteria:
Inclusion Criteria:

* Primary care teams who agree to participate.
* Primary care teams attending adult population (older than 14).

Exclusion Criteria:

* Primary care teams where the intervention would be difficult to take place.
* Primary care teams where the referral rate is not available.
* Primary care teams with a percentage of reform lower than 40%.
Thermoregulatory Reactions of Medical Workers Who Use Personal Protective Equipment From Biological Hazards

This research will provide data on thermal condition, functional status and working conditions of medical workers who use personal protective equipment from biological hazards. Acquired data will be used to define acceptable period of use for these protective costumes.

This research will recruit 14-20 volunteers. During 8 hours each subject will perform their work using protective costume. Heart rate, electrocardiogram, oxygenation, skin and air temperature under costume and hygrometric data will be registered. Also there will be questionnaires for volunteers for subjective assessment of thermal and moisture sensations and assessment of working conditions.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals (based on medical screening)

Exclusion Criteria:

* endocrinological diseases and disorders
* health deviations at the time of the study
Survey of Testosterone Levels in Male Cancer Patients

The purpose of this study is to survey the total serum testosterone levels in male patients with hormone-independent malignancies. The prevalence of hypogonadism is not known, but is thought to be significant. Results will be adjusted for age and stratified for type of cancer, stage, study site,and presence of opiate use for pain management, which is known to reduce testosterone levels.

Fatigue - extreme tiredness - is associated with cancer as well as its treatment. It has many causes, including the direct effects of the cancer itself, nutritional changes, anemia, changes in activity levels, worry, or, perhaps, hormones such as testosterone. This study is a survey of the amount of testosterone in the blood of men being treated for cancers that are not directly influenced by testosterone (not prostate or testicular tumors).

Testosterone is a hormone that is made by the body from teenage years through adulthood, and helps define male characteristics: sexual function, muscle building, ability to grow hair and deepen the voice. It is believed that the amount of fatigue experienced by men with cancer may be at least and in part due to reduced testosterone levels.

Male cancer patients will be recruited for this study at the time of regularly scheduled visits with their oncologists for treatment or for follow-up care. Patients who agree to participate and sign a consent will be asked to answer questions about their health, medications, vitamins \& supplements, and to complete a standardized questionnaire about their quality of life. One tube of blood (8.5 cc) will be drawn at the same time as the other blood tests scheduled for that visit to avoid an additional blood draw. Various elements of the collected information will be compared with the testosterone levels to see if any meaningful patterns exist. The study sample will be drawn from a geographically diverse set of oncology practices in the US. A larger follow-up study is planned if testosterone levels are found to be lower in men with cancer than similar age men without cancer, or if low testosterone levels are associated with more fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Male Cancer patients coming to oncology appointments for treatment or follow-up
* Must be able to answer questionnaire in english, alone or with assistance
* Informed consent

Exclusion Criteria:

* Known HIV infection
* Known hypogonadism
* testosterone or DHEA supplementation within 3 months
* prostate, breast, or testicular cancer
Luteal Phase Support With Progesterone Versus Estrogen and Progesterone on Pregnancy Rates

This is a single center, 3 arms, prospective randomized controlled open study to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.

Patients will be randomized into 3 groups:

1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
2. Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].
3. No luteal support

Study design:

single center, 3 arms, prospective randomized controlled open study

Objective:

to determine the impact of luteal phase support on pregnancy rates in ovarian stimulation and IUI cycles with recombinant FSH in patients with unexplained infertility and mild male factor.

Methods:

All patients in all study groups will undergo a single insemination procedure and then will be randomized into 3 groups:

1. Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel)
2. Luteal support with estrogen + progesterone \[(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg\].
3. No luteal support

Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived. A pregnancy test will be performed 2 weeks after insemination (Serum hCG) an intrauterine pregnancy will be confirmed using a transvaginal ultrasound 2 weeks after a positive pregnancy test. If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.

Eligibility Criteria:
Inclusion Criteria:

1. Couples with diagnosis of unexplained infertility
2. In their treatment cycle with ovarian stimulation and IUI using recombinant FSH in our institution.

Exclusion Criteria:

1. female partners with one or more of the following:

   * previous ovarian surgery
   * one ovary
   * polycystic ovaries on ultrasound examination
   * other endocrine abnormalities (i.e., polycystic ovarian syndrome, thyroid disorders,hyperprolactinemia,6.hypogonadotropic hypogonadism)
   * past ovarian hyperstimulation or hyperstimulation during the study period
   * diminished ovarian reserve (basal FSH level \>15 IU/mL)
   * age of \>40 years
2. sever male factor \< 5 million total motile sperm on the day of insemination.
Early Pulmonary Effects of Excursion Deep Diving with Closed-circuit Gas Recycling: SPIDD Study

Scuba diving with closed circuit gas rebreathers is currently booming. Initially developed for professional and military diving, this type of diving has become very successful in recreational activities.

The possibilities offered by this equipment are immense and reduce the constraints of exploration time and depth. More and more divers are seeking to reach depths previously considered unusual or inaccessible in recreational diving, beyond 100 meters. By pushing back these limits, the diver is exposed to new risks which should lead to a reflection on the means of prevention and treatment in case of incident.

The physiological repercussions of these deep dives are not well known. During daily deep excursions in the 90-120 meter zone, there is a significant reduction in vital capacity on leaving the dive, which persists and worsens the following day.

It seems necessary to confirm the importance of this impairment, never documented before, and to explore its mechanisms. A better knowledge of this respiratory impact could allow to improve the prevention and the preliminary evaluation of the medical aptitude of these divers.


Eligibility Criteria:
Inclusion Criteria:

* Diver ≥ 18 years old
* Recreational rebreather diver with a recognised qualification (Mixed Gas CCR training or equivalent) and the necessary experience for this type of diving who has scheduled a dive in the 60 metre depth zone
* Diver using his/her own equipment, i.e. a closed circuit rebreather with back lungs meeting CE standards.
* Having a medical certificate of no contraindication to the practice of underwater activities \< 1 year issued by an authorised doctor
* Having taken out personal insurance covering this type of activity
* Voluntary and having given his/her express, free and informed consent
* Affiliated to the Social Security

Exclusion Criteria:

* Diver refusal
* Known previous respiratory pathology
* Use of medication that may alter pulmonary and/or vascular function as well as inflammatory and haemostasis parameters
* Any temporary contraindication to the practice of scuba diving
* Patient under guardianship or trusteeship
* Immersion beyond 30 metres within 7 days or any scuba diving within the previous 48 hours.
To Evaluate Whether Acetyl Salicylic Acid (Aspirin) and Darexaban (YM150) Interact in Their Effects

The primary objective of this study is to evaluate whether ASA and darexaban which have different effects on blood coagulation influence each other in their effects. Also it will be investigated whether the blood levels of either drug are influenced by the presence of the other drug. In addition, the safety and tolerability of each drug and the combination of the drugs will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5-30.0 kg/m2
* Male subjects must be non-fertile, i.e. surgically sterilized or must practice an adequate contraceptive method to prevent pregnancies

Exclusion Criteria:

* Known or suspected hypersensitivity to darexaban or ASA or any components of the formulation used
* Any of the liver function tests (i.e. ALT, AST and bilirubin) above the upper limit of normal at repeated measures
* Any clinically significant history of any other disease or disorder - gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic as judged by the medical investigator
* Any clinically significant abnormality following the investigator's review of the pre-study physical examination, ECG and clinical laboratory tests
* Use of any prescribed or OTC (over-the-counter) drugs (including vitamins, natural and herbal remedies, e.g. St. John's wort) in the 2 weeks prior to admission to the Clinical Unit, except for occasional use of paracetamol (up to 3 g/day)
* Regular use of any inducer of liver metabolism (e.g. barbiturates, rifampicin) in the 3 months prior to admission to the Clinical Unit
* Donation of blood or blood products within 3 months prior to admission to the Clinical Unit
* Any use of drugs of abuse, or smoking of more than 10 cigarettes (or equivalent) or more than 21 units (210 g) of alcohol per week within the 3 months prior to study
* Participation in any clinical study within 3 months or participation in more than 3 clinical studies within 12 months, prior to the expected date of enrolment into the study, provided that the clinical study did not entail a biological compound with a long terminal half life