cyrilzakka/clinical-trials huggingface dataset:
Assessment of Esthetics and Patient-reported Outcomes of Single Implant Crowns

The aim of this retrospective study is to perform an assessment of esthetic outcomes of single implants and obtain patient reported outcome measures through the use of a satisfaction questionnaire and the OHIP-14 (Oral Health Impact Profile) questionnaire. Dentists will be performing clinical examination including teeth charting and periodontal charting as well as pink/white esthetic score assessment and these outcomes will be compared to the level of patient satisfaction and patient reported outcomes. The results of this research will add evidence-based data on treatment recommendations for teeth replacement with implants from a patient-centered perspective.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Good oral hygiene
* Single implant crown in the esthetic zone (maxillary 2nd premolar to 2nd premolar)
* Implant crown surrounded by natural teeth
* Implant crown opposed by natural dentition or fixed prostheses
* Implant crown has been installed for at least one year

Exclusion Criteria:

* Presence of active infection around the implant
* Presence of active periodontal disease in the esthetic area.
* Opposing removable prosthesis
Effect of Insulin on Wound Healing-A Randomized Controlled Trial

A randomized controlled trial examining the effect of insulin on wound healing in both diabetics and non diabetic patients in a local health center in Bahrain.

This is a double blinded RCT comparing the effect of insulin on wound healing in both diabetics and non diabetics.

The study will run in primary care setting in Bahrain. The aim of this study is to heal wound in an innovative way. and the Objective: to evaluate the effect of topical insulin administration on wound healing.

All adult patients with skin wounds attending primary health care center will be included in the study. Patients with acute and chronic wounds of the upper and lower extremities will be eligible to participate.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with Texas 1 and 2 wound criteria

Exclusion Criteria: Texas 3 and 4 wound criteria

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Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Acute rehabilitation inpatients with moderate-to-severe brain injury will wear biosensors that track total sleep time and heart-rate variability for up to 1 week. During this time the participants will also complete surveys regarding symptoms of anxiety. The investigators hypothesize that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Eligibility Criteria:
Inclusion Criteria:

* traumatic brain injury
* injury within past 6 months
* medically stable
* able to communicate

Exclusion Criteria:

* on medication: beta-blocker
* adverse skin reaction to biosensor adhesive
* non-English speaking
* pregnant women
* prisoners
Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.

This is a single institution, non-randomized, prospective, phase IV trial of SBRT for unresectable pancreatic cancer.

Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient age \>= 18 years
* Performance status of 0-3
* Unresectable pancreatic cancer
* Maximum tumor diameter \< 7.5 cm
* Signed study-specific consent form

Exclusion Criteria:

* Maximum tumor diameter \> 7.5 cm
* Prior radiotherapy to the upper abdomen
* Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
* Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* BMI of 18.5 to 43.0 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Renal Impaired Subjects (Group 1):

* Considered stable in the judgement of an Investigator
* Presence of severe renal impairment or kidney failure (as defined by eGFR\< 30 mL/ min)

Hepatic Impaired Subjects (Group 2):

* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
* Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).

Subjects with Normal Hepatic and Renal Function (Group 3):

* Medically healthy, in the opinion of an Investigator
* Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus or HIV
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Renal and Hepatic Impaired Subjects (Group 1 and 2):

* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c \> 10%
* Undergoing any method of dialysis
* Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan

Renal Impaired Subjects (Group 1):

* History of renal transplant
* Concurrent use of medications known to affect the elimination of serum creatinine

Hepatic Impaired Subjects (Group 2):

* History of liver transplant
* Evidence of hepatic carcinoma presence at Screening
Magnetic Resonance Imaging Screening in Li Fraumeni Syndrome

This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.


Eligibility Criteria:
Inclusion Criteria:

* Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years
* Please note, TP53 carrier cohort is complete and no longer open to recruitment
* Age between 18 and 60
* Able to give informed consent

Exclusion Criteria:

* Individual with low penetrance TP53 mutation
* Individual with TP53 variant of unknown significance.
* Previous malignancy diagnosed \< 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)
* Current symptoms suggestive of malignancy
* Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist
* Claustrophobia
* ECOG performance status \>2
Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)

The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA
* NYHA Functional Class III or IV
* On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks
* Age 12-75 years, of either gender
* Six minute walk distance 100-425 meters at Baseline

Exclusion Criteria:

* Any new long-term treatment for PAH added within the last 4 weeks
* Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks
* PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877

This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice a week basis. For Part B, an additional 20 patients will be treated at the maximum dose identified in Part A. AZD4877 is an Eg5 or Kinesin Spindle Protein inhibitor that interferes with tumor cell division leading to tumor growth


Eligibility Criteria:
Inclusion Criteria:

* Part A: Advanced solid tumors (including lymphoma without bone marrow involvement) for which standard treatment doesn't exist or is no longer effective.
* Part B: B-cell non-Hodgkin lymphoma that is not eligible for curative therapy or has relapsed.
* Relatively good overall health other than your cancer

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells). Serious heart conditions. Poor liver or kidney function
Ruxolitinib for Chuvash Polycythemia

Chuvash polycythemia (CP) is a rare form of congenital polycythemia caused by mutations in the VHL gene. Currently, there are no therapies that have proven effective for CP. Recent studies have demonstrated that VHL (von Hippel-Lindau tumor suppressor) regulates the activity of JAK2 (Janus kinase 2). In mouse models, inhibition of JAK2 reverses the CP phenotype. Therefore, the investigators hypothesize that JAK2 inhibition may have significant clinical benefits for CP patients.

Study involvement will last for 48 weeks. There will be approximately 11 visits through week 48. Visits may take up to 2-3 hours to complete and occur every 4 weeks for the first 24 weeks, then every 12 weeks until week 48.

During each study visit, any or all of the following procedures may occur:

* List current medications and participant general health
* Obtain blood pressure, body weight, body temperature, respiratory rate and heart rate
* Measure Spleen by examination
* Obtain an abdominal MRI to evaluate spleen and any pre-existing or new blood clots
* Obtain blood samples for safety tests and to monitor kidney/liver function.
* Questionnaires for participant to complete regarding symptoms related to disease.
* Ruxolitinib dosing may be increased after 4 weeks if needed. The dose of the ruxolitinib may be reduced related to side effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Chuvash polycythemia

Exclusion Criteria:

* Unable to comprehend or unwilling to sign an informed consent form.
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.

The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups

* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks

Eligibility Criteria:
Inclusion Criteria:

* undergoing cataract surgery

Exclusion Criteria:

* glaucoma patient, pregnancy, allergy to dexamethasone
Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules

Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing validation. the primary aim of the study is to compare ENB to radiologically guided bronchoscopy, considered the standard comparator.


Eligibility Criteria:
Inclusion Criteria:

* Presence on a conventional or low dose chest CT at least one lung nodule 5-20 mm in its largest axis, of indeterminate nature; the nodule must be positive at PET-CT examination (in case of PET-CT negative, only follow-up is proposed)
* The pulmonary nodule(s) must be known for less than 6 months
* The nodule appearance can be solid, presents as a ground glass opacity with solid component or as pure ground glass opacity
* Availability for participating in the detailed follow-up of the protocol
* Signed informed consent.
* Age \> 18 years

Exclusion Criteria:

* Nodules found in the context of an active infection or for whom, the clinical context and/or additional available investigations (serology, microbiological samplings, immune abnormalities) show that cancer diagnosis is unlikely
* Nodules found in the context of an active previously documented disease that can be associated with pulmonary nodules (anthracosilicosis, histoplasmosis, tuberculosis, autoimmune or rheumatoid diseases ...)
* Calcified nodule
* Anticoagulation therapy of any type that cannot be suspended for the duration of the investigation
* Respiratory failure, recent myocardial infarction (less than 3 months prior to the date of lung nodule screening), uncontrolled angina pectoris, congestive cardiac failure, cardiac arrhythmia, uncontrolled infectious disease or any other physical, biological or psychological factor which may prevent adherence to the study protocol or which may impair the patient's tolerance to the endoscopy and/or the general anaesthesia
* Presence of a implanted cardiac device (pace-maker, defibrillator, ...)
* Pregnant women
Hepatitis B Virus (HBV) Viral Suppression by Entecavir in Adefovir Partial Responders

We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. The aim of the study is to describe sequential virologic response to adefovir and entecavir.

Amendment was made, and approved by WIRB in January 2009, to this protocol: We propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 96 weeks of entecavir following adefovir treatment. The aim of the study is to describe sequential virologic response to adefovir and entecavir.

Eligibility Criteria:
KEY INCLUSION CRITERIA:

* Age 18 years or older
* All genders and ethnicity
* Positive HBsAg
* HBeAg positive and negative
* Pretreatment HBV DNA of 10,000 copies/mL or higher (for purposes of this study, both copies and equivalent IU measurements will be recorded and analyzed)
* Patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician.
* Patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total

KEY EXCLUSION CRITERIA:

* Patients who refused to consent to the study
* Patients younger than 18
* Vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits.
* Patients with prior exposure to another nucleoside for more than 2 weeks. Those with prior exposure to lamivudine will be enrolled under conditions detailed above.
* HIV co-infection
* HCV co-infection
* HDV co-infection
* Recipients of solid organ transplantation
* Patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)
Social Media Effects on Mental Health

In the last decade, research on social media and mental health has produced mixed results. Overall, the current findings suggest that the negative effects on mental health are exacerbated by longer and more frequent social media usage, whereas the positive effects are bolstered when social media is used to connect with other people.

With the largest number of global users, Facebook is the most frequently studied social media network. Over the past few years, the increasing concerns about the risks associated with Facebook have even translated to wider pop culture conversations, as exemplified by the 2020 documentary The Social Dilemma. In response, Facebook has rolled out a series of features supposed to mitigate these risks and encourage responsible social media usage. These features include activity trackers and reminders, unfollow and snooze buttons, and data sharing regulators. Currently, there is no research done to address whether (1) these features are used at all, and (2) whether they are successful in moderating the negative mental health consequences of Facebook usage.

This study seeks to address the gap in literature through a survey done on the crowdsourcing platform Amazon Mechanical Turk (MTurk).


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteers, aged 21 and above
* English proficiency
* Facebook users

Exclusion Criteria

* Participants below 21 years old
* Non-Facebook users
Trastuzumab Emtansine(T-DM1) After Trastuzumab Deruxtecan(T-DXd) in HER2-Positive Breast Cancer in Korea

Prospective observational study of trastuzumab emtansine immediately after trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer in Korea


Eligibility Criteria:
Inclusion Criteria:

* HER2-positive, advanced (unresectable locally advanced or metastatic) breast cancer
* Prior treatment with trastuzumab deruxtecan(T-DXd) in the advanced setting
* Intention to treat with Trastuzumab Emtansine (T-DM1) as first therapy upon T-DXd progression

Exclusion Criteria:

* Any systemic treatment, other than T-DM1, for breast cancer after trastuzumab deruxtecan (As an exception, patients treated with endocrine agents, not in combination with cytotoxics or antibody-drug conjugates, will be permitted in the study)
* Has been previously treated with T-DM1 for advanced breast cancer
* Has been previously treated with 4 or more lines of therapy for advanced breast cancer

  * Half (50%) or more patients will be those who were treated with second-line trastuzumab deruxtecan (i.e. patients at the later line will be capped).
Effects of Regular Exercise During Pregnancy

There is a great lack of results from randomized clinical trials with high methodological quality, assessing the effects of exercise during pregnancy. The main aims of this trial is to study the effects of exercise during pregnancy in the prevention and treatment of disease and complications which may arise during pregnancy:

* Does regular exercise during pregnancy aid in preventing gestational diabetes?
* Does regular exercise during pregnancy prevent low back and/or pelvic girdle pain?
* Does regular exercise during pregnancy prevent urine and/or fecal incontinence?
* Does regular exercise during pregnancy have an effect on labour and delivery?
* Does regular exercise during pregnancy prevent maternal excessive weight gain and fetal macrosomatia?

Pregnancy is regarded as a period of high risk when it comes to development of e.g. excessive weight gain, gestational diabetes and musculoskeletal problems such as low back pain and pelvic girdle pain, and urinary and fecal incontinence. While pregnancy and labor imply these and other risks, exercise is regarded as advantageous during pregnancy. Today's knowledge about the importance of exercise during pregnancy is mainly based on observational data from epidemiological studies, and the scientific strength of the clinical recommendations given is open to question. There is a great lack of results from randomized clinical trials with high methodological quality, assessing the effects of exercise during pregnancy. As a result of this, many important questions are still not answered. One of these is the effect exercise during pregnancy has in the prevention and treatment of disease and complications which may arise during pregnancy. Another question is the consequences that exercise during pregnancy has for labor and delivery. This study is designed as a randomized clinical trial using validated measurement tools to find answers to the mentioned questions.

In both national and international literature the importance of physical activity is highlighted. WHO has recently presented a global strategy for nutrition, physical activity and health. In Norway physical activity and exercise have been strongly addressed, and is an issue of high priority also in pregnant and postpartum women (St.meld.nr.16). Nevertheless, few trials evaluating the effects of regular exercise have been published. There is a need for evidence based knowledge to be implemented in education of health professionals, and in the development of health promotion strategies aiming at the general population.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant 18 weeks
* attend the routine ultrasound control at the three hospitals
* healthy
* age 18 years or more
* singleton live foetus at the routine ultrasound scan
* normal pregnancy.

Exclusion Criteria:

* pregnancy complications
* high risk for preterm labour
* pain during pelvic floor muscle contractions
* ongoing urinary tract infection
* diseases that could interfere with participation (following recommendations from SEF 2000, ACOG 2003)
* living too far from the hospitals to be able to attend weekly exercise groups
Safety and Performance of the EndoFast Reliant SCP in Vaginal Wall Reinforcement

A Single arm, single site, retrospective cohort Post Marketing Clinical Follow up Study Evaluating the Safety and Performance of the EndoFast Reliant SCP for apical support.


Eligibility Criteria:
Inclusion Criteria:

1. Female subjects \>18 years old that underwent Pelvic Organ Prolapse repair utilizing the EndoFast Reliant SCP

Exclusion Criteria:

1. Patients without follow-up