cyrilzakka/clinical-trials huggingface dataset:
Hyaluronic Acid and Gingivitis in Pediatrics

The purpose of this observational, non-controlled, single site trial with a retrospective design is to verify, in a large paediatric population affected by gingivitis, the tolerability and safety of 0.1% HA-based film-forming devices (Gengigel Prof® Fluid, Ricerfarma) administered three to five times a day over a 4-week period as an adjunct to domiciliary care and oral hygiene instructions

The efficacy and safety data belonging to clinical trials with Hyaluronic Acid (HA) in oral mucosa pathologies (gingivitis, post-surgical treatment of incisions of the buccal cavity, periodontitis and other pathological periodontal conditions) have been confirmed in about 20 years of clinical practice by dentists. Starting from this experience, several clinical centers, including our institute, have been introducing over the last years HAbased film-forming devices in pediatrics. In particular, we have been using a liquid formulation with 0.1% HA; it has been routinely administered in our clinic during the routine pre-visit by Nurses and Dental Hygienist to children with gingivitis and given to the parents to administered to the children in the post visit period as an adjunct to domiciliary care and oral hygiene instructions. The product we used is featured by the following additional characteristics:

* a high concentration of HA, which explains its efficacy in reducing swelling and secondary pain;
* a liquid formulation, which can easily treat the whole gingival area, including the points of more difficult access;
* and at last, a really acceptable taste, that plays an interesting role to obtain a good compliance from young patients.

The variables collected in this observational trial are the same collected during our current clinical practice: Gingival Index (GI), Plaque Index (PII), Bleeding on probing (BOP), count of edematous gingival sites and AE/SAE for safety.

Eligibility Criteria:
Inclusion Criteria:

* Any gender and age between 6 and 16 years
* healthy condition and with a clinical diagnosis of mild to moderate gingivitis
* Gingival Index (GI) from 1 to 2 (0= Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding)
* Plaque Index (PII) over then 7% (0= no plaque; 1= a film of plaque adhering to the free gingival margin, adjacent to the tooth; 2= moderate accumulation of soft deposits within the gingival pocket or between the tooth and gingival margin; 3= abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin)
* Bleeding on probing (BOP) over then 5%

Exclusion Criteria:

* taking antibiotics or anti-inflammatory drugs during or for 1 month prior to the study.
* any relevant systemic disease which is known to cause gingivitis
* history of any allergic reaction to HA
* to treat the gingivitis with any other medication/mouthwashes in the period of the study.
The preSPG4 Study - Studying the Prodromal and Early Phase of SPG4

Study goals

1. Prospective longitudinal data on progression in the natural course of SPG4 in presymptomatic mutation carriers prior to clinical disease onset and in early stages of disease
2. Biomarkers providing objective measures of disease activity


Eligibility Criteria:
Inclusion Criteria:

* First degree relatives (parents, offspring, and sibs) of SPG4 patients or symptomatic individuals with known SPAST mutation
* Age 18 to 70 years
* Written, informed consent (patient)

Exclusion Criteria:

* No known SPAST-mutation within the family
* Manifest spastic gait (subclinical signs like increased deep tendon reflexes, positive Babinski sign are allowed)
* Participation in interventional trials
A EUropean REgistry and Sample Sharing networK to Promote the Diagnosis and Management of Light Chain Amyloidosis (EUREKA)

A prospective patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers from across Europe and a sample sharing network will be created to study mechanisms of the disease through the use of advanced molecular technologies and big data analysis tools.

In the frame of the EUREKA Consortium, a patients' registry collecting all new cases of AL amyloidosis evaluated at referral Centers across Europe or at their satellite sites will be created, in association with a cross-border biorepository and sample sharing network for the study of both disease-causing light chains and plasma cells with advanced molecular technologies. A dedicated site will support the Consortium with big data analysis and artificial intelligence applied to health. The aims are: 1) Defining the impact of advanced molecular technologies to promote early diagnosis and guide therapeutic choices; 2) describing the natural history of the disease in a representative cohort of AL patients in the contemporary era of effective anti-plasma cell therapies; 3) investigating and refining novel advanced technologies to detect with high sensitivity residual disease-causing plasma cells/light chains in patients achieving a complete hematologic response to therapy (minimal residual disease, MRD).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of systemic AL amyloidosis;
* treatment-naïve;
* age ≥18 years;
* ability to understand and willingness to sign an informed consent;
* planned follow-up at participating center.

Exclusion Criteria:

* non-AL amyloidosis;
* previous treatment for AL amyloidosis.
Non-pharmacological Pain Management in Term Neonates

A randomised clinical trial in a single centre. This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.

The study was conducted on 90 babies. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).

Aims and objectives: This study was performed to compare the effect of white noise, facilitated tucking, and their concerted application during heel-stick sampling on pain in term babies.

Design: A randomised clinical trial in a single centre. Methods: The study sample size was determined by the free-software G\* Power. Based on the power analysis performed prior to the study in order to determine the number of babies to be included in the sample group (with β=0.14087 and α=0.05 risk, Power=0.85913), according to the study by Karakoc and Turker (2014), it was found that 27 neonates should be included in each group. The study was conducted on 90 babies, between July 1, 2017 - August 9, 2017. Using stratification and blocking method, 30 babies were included in the white noise group (1st Group), 30 in facilitated tucking group (2nd Group), and 30 in white noise + facilitated tucking group (3rd Group). Pain scores of the babies in all groups before, during, and after the procedure were evaluated by two nurses independent from each other using Neonatal Infant Pain Scale (NIPS).

Eligibility Criteria:
Inclusion Criteria:

* Being term baby
* Being with mother
* Being a healthy baby
* Being able fed orally
* Being fed at least half an hour before the procedure
* Being able to draw blood at the first try (since the pain level will change on the second try)
* Agreed to participate in the study and gave verbal consent were included in the study.

Exclusion Criteria:

* Having received analgesics and/or sedatives within the last 24 hours
* Having any complications that prevent pain evaluation (e.g. intracranial hemorrhage, neuromotor growth retardation, etc.)
* Having undergone any painful procedures within the last hour (e.g. blood drawing, aspiration, ophthalmologic examination, etc.)
* Prior history of surgery
* Being connected to mechanical ventilator
Spinal Cord Stimulation for Multiple System Atrophy

Spinal Cord Stimulation (SCS) is a newly emerged neuromodulation technique in recent years. It is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. Combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for multiple system atrophy with SCS. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in multiple system atrophy (MSA) patients before and after SCS treatment, and shed new light on the treatment for MSA.


Eligibility Criteria:
Inclusion Criteria:

* Meeting possible or probable multiple system atrophy (MSA) criteria according to the 2008 second consensus statement on the diagnosis of MSA.
* Citizens of the People's Republic of China, aged \>18 years and \<80 years.
* The presence of significant symptoms of dysarthria, dysphagia, orthostatic hypotension or urinary retension in patients with MSA.
* Maintaining medication during the study period.
* Good compliance, signed written informed consent, and consent to surgical treatment of spinal cord stimulation (SCS).

Exclusion Criteria:

* Patients with severe neuropsychiatric disorders or a history of severe neuropsychiatric disorders.
* Patients with significant cognitive impairment (Mini-Mental State Exam \< 24) or inability to complete the questionnaire independently.
* Presence of anatomical abnormalities or other lesions of the spine that interfere with electrode implantation
* Dysarthria, swallowing difficulties, orthostatic hypotension from other causes not related to MSA.
* Critically ill or unstable vital signs.
* Other conditions that in the opinion of the investigator make them unsuitable for participation in this study.
Efficacy and Safety of Aripiprazole in First Episode Psychosis

The aim of the study is to investigate the efficacy and safety of aripiprazole in patients with first episode psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.

Exclusion Criteria:

* Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
* Needing another nonantipsychotic psychotropic medication at enrollment
* Having a serious or unstable medical illness.
* Pregnant or lactating women or women without adequate contraception will be also excluded.
Safety and Efficacy of Natalizumab in Combination With Remicade in the Treatment of Crohn's Disease

The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn's Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.


Eligibility Criteria:
* Male and female patients at least 18 years of age with at least a six-month history of Crohn's disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)
* Women must not be breastfeeding or pregnant, and must not become pregnant during the study.
Opioid Analgesic Use and Disposal Following Outpatient Dental Surgery

Background: Overdose deaths from prescription opioid analgesics quadrupled from 4,000 cases to nearly 17,000 cases annually during 1999-2011. Most people who misuse or abuse prescription opioids obtain these pills from friends or family members who have surplus medication left over from prior prescriptions. There is little published data on surplus opioid analgesics remaining after patients recover from painful procedures. Even less is known about patients' willingness to dispose of these leftover pills.

Aims: 1) Measure the impact of a risk education intervention and a financial incentive intervention on patients' willingness to dispose of surplus opioids left over after outpatient dental surgery. 2) Measure the number and proportion of opioid pills left unused after outpatient dental surgery.

Methods: The study will be a pilot randomized controlled trial. Adult patients at the Penn Dental Care Center will be enrolled prior to elective outpatient dental surgery. Patients will be randomized to a control group, an educational intervention, or a financial incentive intervention. The primary outcome of the trial is the proportion of patients in each arm that express willingness to return their unused opioids. Secondary outcomes include patient use of prescribed opioids and their number of unused pills. These outcomes will be measured using novel text-message based data collection software that patients will interact with using a web-enabled cellular telephone or tablet.


Eligibility Criteria:
Inclusion Criteria:

* Non-institutionalized

Exclusion Criteria:

* pregnancy
* a history of opioid analgesic misuse/abuse
* ongoing participation in other clinical research
* or daily use of opioid analgesics in the week prior to surgery
Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.

To evaluate the effect of tolterodine ER in conjunction with behavioral intervention on subject satisfaction in OAB subjects who were dissatisfied with their most recent antimuscarinic OAB medication therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects greater than or equal to 18 years of age
* Overactive bladder symptoms for at least 3 months
* Previously treated with antimuscarinic OAB medications

Exclusion Criteria:

* Participation in any professionally coached sessions (RN, NP, PA or PT) teaching behavioral interventions
A Study in Healthy Adult Male Participants to Assess Absorption, Distribution, Metabolism and Excretion (ADME) of Radiolabeled PF-06865571.

This study is a Phase 1, open-label, non-randomized, 2-period, fixed-sequence, single-dose study of PF-06865571 in healthy male participants to characterize the ADME properties of \[14C\]PF-06865571 following oral administration; and to evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of PF-06865571 following oral administration of unlabeled PF-06865571 and IV administration of \[14C\]PF-06865571.


Eligibility Criteria:
Inclusion Criteria:

* Male participants, 18 to 60 years of age, inclusive, at the time of signing the informed consent document.
* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac tests.
* Participants who are nonsmoking for at least 3 months at the time of signing the informed consent document.
* BMI of 17.5 to 30.4 kg/m2, inclusive; and a total body weight \>50 kg (110 lb).

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of irregular bowel movements including irritable bowel syndrome or frequent episodes of diarrhea or constipation, defined by less than 1 bowel movement on average per 2 days, or lactose intolerance.
* History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg,or HCVAb. Hepatitis B vaccination is allowed.
* History of SARS-CoV-2 PCR or antibody (eg, IgG, IgM, etc) positive result would necessitate accompanying history of asymptomatic state for at least 6 months prior to screening.
* Use of prescription or nonprescription drugs.
* Previous administration with an unapproved drug within 60 days preceding the first dose of study intervention used in this study.
* A positive urine drug test.
* A positive urine cotinine test.
* A positive COVID-19 (SARS-CoV-2) PCR test.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
Misoprostol in the Prevention of Postpartum Haemorrhage

Postpartum haemorrhage is a major contributor to maternal mortality in the developing world. The incidence is between 5 and 12% in Jamaica and varies depending on the route of delivery. Misoprostol is a uterotonic agent which has the potential to augment the effects of the standard parenteral oxytocic agents used as best practice in the active management of the third stage of labour, thereby reducing the risk of postpartum haemorrhage and its attendant complications.

The Aim of the study is twofold: to show that this additive effect translates to a reduced postpartum haemorrhage rate and secondly to demonstrate reduced side effects of misoprostol resulting from the lower dose and the powdered sublingual administration.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women admitted to the labour wards at University Hospital of the West Indies (UHWI) and Victoria Jubilee Hospital (VJH) undergoing a vaginal delivery
* Consent given to participate in the study

Exclusion Criteria:

* Women undergoing caesarean section
* Gestational age less than 28 weeks
* Any severe allergic conditions
* Severe asthmatics
* Age \<16 years
* Temperature \>38 degrees Celsius
* Women not wishing to consent to join the study
Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

The primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.

Patients in a group with medical intervention receive nicotine patch within 24 hours after surgery. The nicotine patch is replaced every day. Delirium is evaluated every day by the Confusion Assessment Method (CAM) - ICU test. The maximum length of intervention is 7 days.

Patients in a group with placebo receive a placebo patch within 24 hours after surgery. This patch is replaced every day. Delirium is evaluated in the same way - CAM - ICU test. The maximum length of the placebo intervention is 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical procedure - urological, surgical, trauma surgery, orthopedic surgery, dental surgery)
* Age 18 years and above
* Patient with an assumption of nicotine abstinence (smoking a minimum 10 cigarettes/day).
* Ex-smokers (if they stopped smoking less than 30 days prior to surgery)
* An assumption of hospitalization at the intensive care unit (ICU) after surgery
* Signed Informed consent

Exclusion Criteria:

* Age ˂ 18 years
* Non-signing of the informed consent
* Patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke
* Patients with psychiatric diseases
* Nicotine, Curapor or Hydrocoll allergy
* Patient with a heart attack, unstable angina pectoris or patients with a serious heart arrhythmia
* Pregnant and breastfeeding patients
* Patients with nicotine treatment
Exploration of Fatigue, Uncertainty, Depression and Quality of Life in Heart Transplantation Recipients

The purpose of this study is to explore the fatigue, uncertainty, depression and quality of life in heart transplant recipients, and associated factors of quality of life .

The purpose of this study is to explore the symptom distress, fatigue, depression, uncertainty, and quality of life in heart transplant recipients, and associated factors of quality of life (QOL). The eligible patients are (1)who undergone heart transplantation were recruited from the Department of Cardiac Surgery, Nation Taiwan University Hospital,(2)18 year old or older. A set of questionnaire with the Transplant Symptom Frequency and Symptom Distress Scale, Hospital Anxiety and Depression Scale (HADS) , Fatigue Symptom Inventory (FSI), Mishel's Uncertainty Scale, and 12-item Short-Form Health Survey (SF-12) were used to collected symptom distress, fatigue, depression, uncertainty, and QOL .

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of heart transplantation
* Adults 18 years of age

Exclusion Criteria:

* The woman who are pregnant
The Moment Study: Mixed Method Ecigarette Study

The universe of tobacco products is expanding, with new noncombustible products gaining popularity even as the reduction in prevalence of cigarette smoking slows or stalls. E-cigarettes, or Electronic Nicotine Delivery Systems (ENDS), are the most prevalent of these emerging noncombustible products. With sales increasing rapidly and more efficient pulmonary delivery devices under development, ENDS are likely to play an increasing role in the future tobacco market. Little is known about the cognitions and behaviors leading to or sustaining ENDS use. Smokers may use ENDS to subvert smoking restrictions, to reduce perceived smoking harms, or for smoking cessation. Evidence about ENDS use is emerging from national surveillance and laboratory research, but the majority of information on ENDS is limited to retrospective surveys and convenience samples of White male ENDS users. The investigators research suggests Black smokers are less likely than White smokers to try and be current ENDS users, perhaps due to a greater degree of perceived harm associated with ENDS, a preference for menthol, or cultural norms. Thus, it is timely and critical to study how all smokers, including Blacks and menthol smokers, experience and initiate ENDS use employing valid, innovative research methods.


Eligibility Criteria:
Inclusion Criteria:

Participants must:

1. be aged 18 years or older
2. reside in Washington, D.C. metro area (including VA and MD suburbs)
3. be proficient in English
4. be daily smoker with at least 5 years of established daily smoking

   * A person will be categorized as a daily smoker if he reports daily smoking of at least 8 cigarettes a day for the past 5 years, and records an exhaled air carbon monoxide (CO) level \> 8 parts-per-million (ppm) at the baseline in-person meeting.
   * Daily smokers will be eligible for the main study if they do not intend to quit in the next 30 days.
   * If they do intend to quit in the next 30 days, eligible daily smokers will be enrolled in the second arm of the study.
5. not taking smoking cessation medications;
6. smoked LCC/cigars/hookah less than 5 times in last 30 days
7. have not used other tobacco products in last 30 days
8. have not used an ENDS product (electronic cigarette) in the last 30 days
9. be interested in trying an ENDS
10. have an iPhone or Android that allows installation of applications and use it daily
11. have a phone plan that allows unlimited text messages
12. be willing to travel to the data collection cite four times in three weeks
13. not be breastfeeding or planning to become pregnant
14. not have heart disease/uncontrolled blood pressure
15. not have psychosis/suicidal thoughts
16. not be currently enrolled in an alcohol treatment program
17. not be out of town for more than 5 nights in the next 6 weeks

Exclusion Criteria:

* Individuals who do not satisfy the criteria above will not be eligible for this study.
* There will be no involvement of vulnerable populations.