cyrilzakka/clinical-trials huggingface dataset:
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications.

Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).

Eligibility Criteria:
Inclusion Criteria:

* The participant has a diagnosis of migraine or MOH as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit.
* The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has ≥15 headache days per month for each month within the past 3 months prior to the Screening Visit.
* The participant has had an onset of migraine diagnosis at ≤50 years of age.

Exclusion Criteria:

* The participant has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome).
* The participant has a diagnosis of acute or active temporomandibular disorders.
* The participant has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
* The participant has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6 months prior to the Screening Visit.
* The participant has a history of clinically significant cardiovascular disease including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).

Other inclusion and exclusion criteria may apply.
Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents

The purpose is to assess the efficacy, clinical outcomes, and potential Quality Indicator benefits associated with the use of Lubiprostone in nursing home residents with a confirmed diagnosis of chronic idiopathic constipation.

The study is a prospective, observational, open-label, non-placebo, controlled study to measure the effects of Lubiprostone on CIC in nursing home residents. All clinical sites will follow a common protocol using standardizes definitions in which eligible patients will be asked to participate in the proposed study. During the course of the study, various selected parameters will be measured and compared to establish the clinical efficacy of Lubiprostone in the treatment of CIC.

The study sample (N=105) will be comprised of nursing home residents with a confirmed diagnosis of CIC. A power analysis generated a sample size of 97 residents. To protect the validity of the test, 8 residents were added to the final study sample to allow for losses to followup. Therefore, a final sample size of 105 residents was identified for the study.

Patients meeting the inclusion criteria will be recruited for participation in the study. 3 sites in Central Florida with multiple Nursing Homes per site will be recruited to participate in the proposed study.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following criteria to be eligible for the study:

* Adult men and women nursing home residents;
* Confirmed diagnosis of CIC using Rome criteria;
* Prescribed two or more laxatives, at recruitment;
* Taking 9 or more oral medicines (including prescription, OTC and prn)
* Free from conditions likely to be fatal within six months;
* Able to read or understand English; and
* Able and willing to provide informed consent or has a guardian/agent who can provide consent.

Exclusion Criteria:

* Currently pregnant;
* Presence of megacolon;
* Presence of rectal sigmoid cancer;
* Presence of colon cancer;
* Presence of anal incompetence;
* Conditions likely to be fatal within six months;
* Taking 8 or fewer medicines;
* Enrolled in hospice;
* Non-English speaking patients; and
* Unwilling or unable to provide informed consent and has no guardian/agent.
* Expected to be discharged within 3 months.
Maxillary Segment Tipping During Transpalatal Distraction

The investigator proposes a multi-centre study to investigate tipping of teeth, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.

Surgically Assisted Rapid Maxillary Expansion (SARME) is widely accepted for the treatment of maxillary hypoplasia. The differences between SARME with a tooth-borne or a bone-borne distractor have already been extensively investigated, bringing to light that a bone-borne distractor has less negative side effects. One of the major concerns with the tooth-borne distractor is the tipping of the anchor teeth, which is bypassed by the bone-borne distractor which applies its force directly on the bone. One study investigated the tipping of teeth with a bone-borne distractor in 10 patients, showing that there was a minor change in the tooth axis. The investigator proposes a multi-center study to investigate this tipping further, bringing into consideration the height of the osteotomy line and the height and placement of the transpalatal distractor as possible factors. If tipping occurs depending on these factors, the investigator could identify the situations that cannot be straightened by the orthodontist and provide another course of action for these specific patients.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing a surgically assisted rapid maxillary expansion with a bone borne transpalatal distractor.
* Cone beam CT pre op and 3 weeks post op is available

Exclusion Criteria:

* Complication of the process by e.g. surgical site infection
* Asymmetrical expansion of more than 3.0 mm measured at the central incisivae occurred
Faringomoss Effectiveness in Inhibiting Acute Throat Pain and Discomfort

The purpose of the study was to assess the effectiveness of Faringomoss in reducing the throat discomfort and pain in patients with acute throat diseases and postoperative patients after throat surgeries.

Study objectives were:

1. To asses the symptoms of throat pain and discomfort after pharyngeal surgery in early postoperative period.
2. To evaluate those symptoms also in outpatient subjects with acute throat pain and discomfort.
3. To compare the data of different groups of patients who had received the topical throat spray with the placebo group.
4. To estimate the gender, age and surgery impact on the results.
5. To record the side effects of the topical sprays.

Patients were selected from Lithuanian University of Health Sciences Ear-Nose-Throat department and Vita Longa Clinic outpatients.

In random order research participants got a topical spray to use for 7 days after the surgery or from the start of acute throat infection. Neither the patient nor the investigator did not know if it was the medical device (Faringomoss) or the placebo. All the participants got a standard care and treatment with non-steroidal anti-inflammatory drugs.

The intent was to investigate about 70 - 80 subjects.

All the research subjects were tested using objective methods.

The confidentiality of the participation was guaranteed. The names were anonymous. The results were summarized.

Faringomoss is a topical spray, approved as a medical device. It is not harmful because it is made of vegetable oils.

Eligibility Criteria:
Inclusion Criteria:

* Patients after throat surgeries: tonsillectomy, adenotonsillectomy, uvulopalatoplasty, uvulopalatopharyngoplasty
* Patients with acute throat diseases: pharyngitis, tonsillitis, pharyngotonsillitis

Exclusion Criteria:

* Purulent infection
* Refusal to participate
* Allergy to tested material
Azento IIS 3 Year Outcomes Implant Study

The revised purpose of this study is to compare and evaluate the stability of the implant body, survival rate, bone-level changes, and the implant's soft-tissue outcomes over a period of 1 year. Only 1 tooth is studied per participant.

In July of 2024, the revised protocol and revised Statistical Analysis plan were amended post-hoc, and the revised protocol and statistical analysis plan were approved by the IRB review committee in July of 2024.

As a result, the study has been terminated due to a change in the study's data analysis, and so the study will only analyze data up to and including the 1-year point.


Eligibility Criteria:
Inclusion Criteria:

* Subjects may identify as either male, female, or intersex
* Age: 18 years or older
* Subjects with a healed, single-rooted tooth (except mandibular incisors) that has previously undergone ARP-SG with particulate allograft material within the past 2 months.
* Subjects must have stable occlusion, with absence of caries or other known acute pathology (i.e., untreated endodontic lesion, periodontal abscess, external/internal resorption, etc.) on teeth proximal to the implant site that would negatively influence implant outcomes
* Must be in adequate physical and mental health to undergo routine dental treatment including the surgical procedures associated tooth extraction and implant placement
* Subjects' treatment plan must include replacement of the tooth to be extracted with dental implant supported fixed restoration
* Subjects must have read, understood and signed an informed consent form
* Subjects must be willing to return for the required number of visits
* Subjects' tooth must be a permanent tooth, not a primary tooth (also known as baby tooth).

Exclusion Criteria:

* Mandibular incisors
* Acute infection associated with the tooth to be extracted or with adjacent teeth
* Unstable occlusion, presence of caries or other acute pathology on teeth adjacent to the implant site
* History of significant heart, stomach, liver, kidney, blood, immune system disease, or other organ impairment or systemic diseases that would prevent undergoing the proposed treatment or may result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use \[\>10 cigs/day\]), history of head/neck radiation, history of chemotherapy within the last 5 years
* Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
* Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
* Pregnant women or nursing mothers
* Subjects that are unwilling or unable to sign the informed consent
* History of lack of compliance with dental visits
* Subjects unwilling to return for the required number of visits
* Subject currently undergoing orthodontic treatment
Assessment of Pulmonary Artery Pressure and Right Sided Hemodynamics in Patients With OSA Before and After CPAP TTT

Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an incidence of 5-20% in the middle-aged population in Europe and Northern America . plumonary hypertension is present in 12%-34% of patients with osa.continous positive air way pressureis the main standard treatment ofOSA.Echocardiograghy is the most common non invasive imaging method for assessment the effect on right ventricular function.

Obstructive sleep apnea (OSA) is a frequent sleep-related breathing disorder with an incidence of 5-20% in the middle-aged population in Europe and Northern America . Pathophysiologic consequences of OSA are increased sympathetic activity, hypoxia, hypercapnia, increased left ventricular after-load , acute arterial hypertension, increased diastolic and systolic pressure of the right ventricle, atrial dilation. Recent studies have shown that OSA is an independent risk factor for cardiovascular mortality and morbidity. OSA has a social impact because of fragmentation of sleep leads to increased daytime sleepiness, decreased intellect, behavioral and personality changes, enuresis and sexual dysfunction.

Pulmonary hypertension is present in 12%-34% of patients with Obstructive Sleep Apnea syndrome. When PH occurs as a consequence of OSA however symptoms may not be present because of obesity and alack of physical exertion or symptoms of PH may be overlapped by other cardiovascular abnormalities.

Continuous positive air way pressure therapy is the main standard treatment of OSA works the best in the most people as positive pressure ventilation functions as a pneumatic splint for the collapsing upper air way. Echocardiography is the most common non invasive imaging method for assessment the effect of right ventricular function.

Eligibility Criteria:
Inclusion Criteria:

* Moderate and severe OSA and candidates for initiation of CPAP therapy.

Exclusion Criteria:

* Significant lung disease ,lfet sided heart failure,end stage malignancy and advanced organ failure.
YATEP - The Impact of Horse Assisted Therapy (HAT) on Treatment Outcomes

The objective of the study is to assess the impact of horse assisted therapy (HAT) on:

* Addiction treatment outcomes (its effectiveness as an alternative therapy)
* Addiction treatment dropout \& addiction relapse (its efficacy in preventing dropout).

Hypothesis: HAT will correlate with:

* beneficial treatment outcomes of depression, anxiety, aggression
* with improved self esteem \& motivation
* lower treatment dropout \& addiction relapse.

Background Inclusion of horses in therapeutic settings is a scientific issue with significant social and health implications in Norway. Challenges include increasing provision of horse assisted therapy of variable quality to vulnerable population groups with little substantiating evidence of associated benefit(s) due to lack of research, design issues, mainstream clinicians'/scientists' scepticism of "alternative therapy" and associated difficulties in attracting top researchers and funding. Extensive review of literature found a growing volume of studies but as indicated in the most recent systematic review, there are few studies with adequate research design.

Oslo University Hospital's Dept of Addiction Treatment - Youth (AUA) presents a unique research/evaluation potential to study HAT. It will treat approximately 100 patients per year aged 16 to 26 years with a primary diagnosis of addiction. Horse assisted therapy (using AUA's residential herd) is an integral part of the addiction therapeutic program. Furthermore, AUA's strong emphasis on research and its Youth Addiction Treatment Evaluation Project (YATEP) data base will provide an evidence base needed for sound study in an emerging area of science and psychotherapy.

Patient drop out from addiction therapy is high, often exceeding 50% (Stark 1992). Many AUA patients claim that they remain in treatment because of the horses.

The study is a randomised controlled trial of in-patients undergoing treatment. The Participant Group has treatment as usual plus HAT; the Control Group treatment as usual.

Participant and control groups are drawn from AUA patients (aged 16 to 26 years of age with a primary diagnosis of addiction International Classification of Diseases (ICD F10-F19), admitted between 2013 and 2014 to AUA's in-patient unit and who have consented to participate in research.

HAT is a structured program of 12 X 90 minute therapeutic sessions with horses, including horse care, ground and mounted work, conducted by two clinically qualified therapists who are also Level I Riding Instructors.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of addictionInternational Classification of Diseases ICD F10-F19, admitted in 2011-2014 for treatment at AUA's in-patient unit

Exclusion Criteria:

* Ongoing psychoses
Observational Study to Reduce Medication Errors

A medication error is a failure in the treatment process that leads to, or has the potential to lead, to harm to the patient.1 Medication errors are a common unfortunate occurrence in hospital. They can occur in different phases of the therapeutic process (prescribing, distribution, administration and monitoring) and have significant impact on morbidity and mortality. Prescribing faults and prescription errors are major problem among medication errors .Prescription errors account for 70 % of medication errors that could potentially result in adverse drug effects.2 Overall it has been estimated prescription errors affect 7 % of medication orders, 2% of patient days and 50 % of hospital admissions.3,4 When harm arises from a medication error it is potentially preventable. The medication errors project was devised to analyze and limit through educational audit and other tools, as much as possible, damages due to the therapeutic process. The project will include 5 phases. Preliminary phase: organizational meetings. Phase I: Patient monitoring: a monitor in collaboration with health professionals of involved units will review all patient charts and will register all adverse drug reactions(ADRs). All ADRs will be introduced by the monitor in a database. Health professional will be invited to send the reports of observed ADRs. Evaluation of ADRs : a panel of experts will evaluate if the ADRs are due to medication errors or not. Phase II :educational audits directed to health professionals will be organized. Tools to reduce the medication errors will be proposed. Phase III: the same procedure of the first phase. Final phase (IV): analysis of data with publication of a scientific article.


Eligibility Criteria:
Inclusion Criteria:

* all patients hospitalized in the involved units who gave their informed consent. Patients hospitalized during the week-end will be enrolled on the next monday.

Exclusion Criteria:

* all patients with evident mental and physical problems and all patients who did not give their informed consent.
A Trial to Evaluate Natural Orifice Transgastric Endoscopic Cholecystectomy With Laparoscopic Assistance

The study will document being able to successfully perform transgastric cholecystectomy (laparoscopic visualization) using a small collection of study surgical tools.


Eligibility Criteria:
Inclusion Criteria:

Men and women will be enrolled in this study who:

* Are willing to give consent and comply with evaluation and treatment schedule, able to understand and complete study questionnaires;
* At least 18 years of age;
* Have a clinical diagnosis of gallbladder disease indicated for cholecystectomy;
* ASA Classification I or II (Appendix II); and
* Have a negative serum pregnancy test (for women of childbearing potential);
* Have the study procedure attempted.

Exclusion Criteria:

* BMI \> 35;
* Use of immunosuppressive medications (within 6 months of surgery; single burst dosages and inhalable steroids are acceptable);
* Suspicion of gallbladder cancer, tumor, polyps, or mass;
* Acute cholecystitis or acute pancreatitis;
* Presence of common bile duct stones;
* History of open abdominal surgery;
* Evidence of abdominal abscess or mass;
* Diffuse peritonitis;
* Use of anticoagulants or anti-platelet agents (use of daily cardio protective doses of aspirin, up to 81 mg/day, is acceptable and shall not constitute an exclusion criterion) or the presence of coagulopathy;
* Clinical diagnosis of sepsis;
* History of peritoneal trauma;
* Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or that could impact the scientific integrity of the trial;
* Planned concurrent surgical procedure;
* Prior or planned major surgical procedure within 30 days before or after study procedure;
* Previous diagnosis of intra-abdominal adhesions;
* Participation in any other investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints;
* Previously enrolled in the current series of 4 trials investigating the EES NOTES GEN1 Toolbox; or
* Any condition which precludes compliance with the study (Investigator discretion).
Efficacy of a Modified Lip Repositioning Surgery Technique With Tie Levator Labii Superioris and Without Frenectomy and Myotomy for Treatment of Excessive Gingival Display

The objective of this prospective study was to investigate a modified lip repositioning surgery technique with tie labii superioris and without frenectomy and myotomy for the treatment of excessive gingival display

Excessive gingival display (EGD), commonly referred to as a "gummy smile" (GS), is one of the most common deformities and conditions of the gingival mucosa around teeth and can be a significant aesthetic concern for some individuals, leading them to seek treatment. The presence of EGD/GS has a negative impact on the patient's oral health-related quality of life, including aspects of functional limitation, psychological distress, psychological disability, and social disability. Successful treatment of Excessive gingival display with the lip repositioning surgery (LRS) has been reported in the literature. The last few years have seen the introduction of new techniques for altered passive eruption (APE) and hypermobile upper lip (HUL)management, an expansion of the available aesthetic crown lengthening (ACL) and LRS variations, and additional evidence further supporting the effectiveness of these two procedures. Several of the recently introduced approaches offer unique, innovative, and potentially impactful concepts. However, for many of these newly described treatments the available evidence is limited to case reports and the exact indications remain to be adequately defined. The literature lacks adequate clinical trials of LRS with sufficient follow-up time. Nevertheless, in regards to gingival display GD reduction, a recent systematic review found a mean reduction of 3.4 mm with a median follow-up time of 6 months. Some research found significant increase in upper lip length and upper lip vermilion length 6-months post-operative PO. Moreover, some case reports of LRS mentioned fuller upper lip appearance after treatment. Excessive gingival display, or "gummy smile", can be successfully managed through various surgical approaches that must be chosen based on the underlying etiology and clinical characteristics of each case. Therefore, this study aimed to explore the efficacy outcomes of a lip repositioning technique for the treatment of excessive gingival display

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old)
* Systemically healthy
* No medication intake
* Nonsmoker
* Periodontally healthy
* Maxillary anterior teeth of normal dimensions
* Normal upper lip length (females: 20-22 mm; males: 22-24 mm) hyperactive upper lip (lip mobility \>8 mm) and gingival display \> 4mm during smile

Exclusion Criteria:

The patient has trauma and facial deformities