cyrilzakka/clinical-trials huggingface dataset:
Mandibular Overdentures Retained by Conventional or Mini Implants

This study aims to compare mandibular overdentures retained either by mini or standard size implants as a treatment for edentulous adults, in terms of patient-reported satisfaction and oral health-related quality of life. We will also evaluate post surgical discomfort, the success rate of prostheses and implants in the long term, denture quality and costs.


Eligibility Criteria:
Inclusion Criteria:

* Complete edentulism;
* Request of implant stabilization of the existing lower conventional denture;
* Clinically acceptable maxillary and mandibular complete dentures;
* Adequate space in the anterior mandible for the placement of four mini implants and two conventional implants (regular diameter);
* Ability to maintain adequate oral hygiene and clean dentures;
* Systemic health status that permits minor surgical procedures;
* Adequate understanding of written and spoken Portuguese;
* Capacity of giving written informed consent.

Exclusion Criteria:

* Lack of minimum vertical mandibular bone height of 11mm in the interforaminal region;
* Acute or chronic symptoms of parafunctional disorders;
* History of radiation therapy to the orofacial region;
* Specific conditions that may jeopardize the treatment, i.e. alcoholism and smoking;
* Severe/serious illness that requires frequent hospitalization;
* Impaired cognitive function;
* Impossibility to return for evaluations/study recalls.
TREAT Child Alcohol Use Disorder (C-AUD) in Eastern Uganda

The investigators will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. The investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. The project is approaching the research topic using quantitative and qualitative methods. The TREAT C-AUD research project will therefore document to which degree alcohol drinking is a problem among children in Mbale, Eastern Uganda.

Uganda has as many other sub-Saharan countries high alcohol consumption per capita and traditions for home brewing. The TREAT C-AUD research project, with partners from Makerere University in Uganda, University of Bergen and Norwegian University of Science and Technology in Norway, will investigate the existence of alcohol drinking among children living under adult supervision and care, living within the communities. The investigators will focus on the age group 6-13 years overlapping with the recommended age for primary school attendance. The project is approaching the research topic from comprehensive perspectives including a large cross-sectional study, interviews with parents and carers, children and stakeholders in the communities, schools and in the health system. The investigators have been including community representatives, expert groups, user groups and stakeholders in the development of screening tools and will do so in interpreting and disseminating the results. The investigators have to take the Covid-19 situation into account both with regard to its effect on the research question at stake and the methods used. The TREAT C-AUD research project will therefore document to which degree alcohol drinking is a problem among children in the communities in Mbale District, Eastern Ugandan. The data collection is capturing cofactors such as other substance use, mental health, parenting, trauma, nutrition and growth. The development of alcohol assessment tools can be used by the health- and school-system for detection and handling of children having problems with alcohol. The investigators will collaborate closely with services in case of identification of children suffering severe harm and adhere to Good Clinical Practice guidelines for ethical conduct, the consent procedure, follow-up and referral.

Eligibility Criteria:
Inclusion Criteria:

Care-giver- child pairs

* Children 6-13 years
* Caregiver of eligible child
* Caregiver adult capable of giving informed consent
* Living in household for minimum 6 months together

Exclusion Criteria:

• Caregiver or child not living in household
Arthroscopic Debridement vs Arthroscopic Hemi-Trapeziectomy on Patients With Thumb Carpometacarpal Joint Osteoarthritis

Patients with thumb carpometacarpal joint osteoarthritis usually suffer from pain, joint enlargement, inflammation, deformity and loss of function. Conservative treatments usually are the first-line interventions, unfortunately some of the patients do not response to such treatments and surgical treatment will then be considered.

Compare to other traditional surgical techniques, arthroscopic techniques has resulted in the potential to treat osteoarthritis in a minimally invasive approach, avoiding the need for a larger incision. Other advantages of arthroscopy include less scarring and joint contracture, less risk of neurovascular injury, improved appearance, limited morbidity and quicker recovery. Although arthroscopic methods have been proved to be effective, there is lack of high-level evidence based studies to conclude one operation is superior to another. Hence, this study is designed to investigate outcomes of the two arthroscopic surgical methods (arthroscopic debridement vs arthroscopic hemi-trapeziectomy with Mini TightRope). The result of this study is expected to provide significant evidence based clinical data for surgeons worldwide on treating the thumb carpometacarpal joint osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Eaton and Glickel stage II and III of thumb carpometacarpal joint osteoarthritis
* Age≥18 years old
* Failed to response to nonsurgical/conservative treatments including orthoses/splinting, activity modification, oral analgesics (e.g. nonsteroidal anti-inflammatory drugs), strengthening/flexibility exercises, and injections of corticosteroid or hyaluronic acid
* Willing to receive surgery

Exclusion Criteria:

* Patients received previous thumb surgery proximal to the interphalangeal joint (IPJ)
* Patients with prior traumatic thumb injuries (e.g. fracture, dislocation)
* Patients with significant metacarpophalangeal joint (MCPJ) pain
* With concurrent procedures on the thumb, e.g. ganglion removal, trigger thumb release
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients

The same initial and long-term anticoagulation is suggested for unsuspected pulmonary embolism as for patients with symptomatic embolism. Based on these indications, cancer patients with unsuspected pulmonary embolism would be anticoagulated for at least 6 months or until the disease is active, which in most cases would mean indefinite treatment. In fact, dedicated studies on the treatment of unsuspected pulmonary embolism are missing, leaving doubts over the need for (indefinite) anticoagulation which exposes these patients to an increased risk of major bleeding events. Concerns over the need for anticoagulant treatment may especially hold for pulmonary embolism of the distal pulmonary tree since segmental and sub-segmental PE seem to have a more benign course than more proximal embolism.

The scope of this study is to evaluate the current treatment approaches for unsuspected pulmonary embolism and to assess their efficacy and safety in a large prospective cohort of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* cancer patients with a first diagnosis of unsuspected PE

Exclusion Criteria:

1. age \<18 years;
2. ongoing anticoagulant therapy for previous VTE or indications for long-term anticoagulation other than deep vein thrombosis (DVT) or PE;
3. life expectancy less than 3 months.
Polyp Detection With the EndoRings™: A Randomized Tandem Colonoscopy Study

To compare the adenoma miss rate with the EndoRings™ vs. the adenoma miss rate with Standard view colonoscopy.

To compare the polyp miss rate with the EndoRings™ vs. the polyp miss rate with Standard view colonoscopy.In addition, time measurements including time to cecum, time for withdrawal and overall procedure time will be analyzed and reported for each group.

Patients who are scheduled for screening, surveillance or diagnostic colonoscopy will be recruited to the study and randomized to one of two groups. Each enrolled subject will undergo two "back-to-back" procedures.

Subjects in Group A (study group) will undergo a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy. Subjects in Group B (control group) will undergo an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.

Results from the two groups will be analyzed and compared, with primary outcome measures being adenoma miss rate and polyp miss rate. Secondary outcome measures will include withdrawal time, total procedure time and characteristics of polyps detected, including size and histological results.

Subjects will be followed through a 24 hour and a 7-days telephone interview for analysis of unexpected adverse events. Clinical results will be analyzed using various statistical measures of significance.

Multi-center study with up to 126 patients. Up to 126 treated patients (2 groups of 57 patients +6 drop-out patients) will be enrolled into the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject between the ages of 40 and 75
* The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic workup;
* Written informed consent must be available before enrollment in the trial

Exclusion Criteria:

* Patients with a history of colonic resection;
* Patients with known (or newly diagnosed) inflammatory bowel disease;
* Patients with a personal history of polyposis syndrome;
* Patients with suspected chronic stricture potentially precluding complete colonoscopy;
* Patients with diverticulitis or toxic megacolon;
* Patients with a history of radiation therapy to abdomen or pelvis;
* Patients with a hemorrhagic diathesis
* Patients with acute lower GI bleeding
* Pregnant women and women with childbearing potential without adequate contraception
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Social Determinants of Health Screening and Interventions

The primary objective of this study is to connect patients with community resources to improve social determinants of health. Secondary objectives are improving patient satisfaction within the trauma and general surgery service, enhancement of physician-patient communication, betterment of surgery department Hospital Consumer Assessment of Healthcare Providers and Systems scores, and increased understanding of correlations between patient satisfaction and social determinants of health.

The investigators hypothesize that (1) directed screening and intervention can have a positive effect for patients and hospitals, (2) directed patient advocacy will have an effect on patients' perception of care, (2) social determinants of health will have an effect on patients' perception of care, and (4) traumatic injury and acute surgery will have an effect on patients' perception of care.

The investigators will be conducting this study as a prospective, non-randomized quality improvement study that will look at patients 18 years of age and older who are admitted under the trauma and general surgery specialties. Patients will be identified through admission to the trauma or general surgery service or referred to surgery services.

Eligible patients will be identified and approached by the study team. Once the informed consent is completed, patients will be given a Social Determinants of Health Screening Tool, an Hospital Consumer Assessment of Healthcare Providers and Systems Feedback Tool, and an short form health survey (SF-12) Quality of Life Questionnaire. Feedback from the Hospital Consumer Assessment of Healthcare Providers and Systems results will be given immediately to the relevant teams (nurses, doctors, etc.) to address the patient's concerns. Prior to discharge, the patients will also be given referrals to designated community resources. On day 15 (+/- 7 days) after discharge, the patients will receive a follow up phone call where they will be asked if they have utilized the Social Determinants of Health Referrals. Participants will also be given a second Hospital Consumer Assessment of Healthcare Providers and Systems Feedback Survey at this time. On day 30 (+/- 7 days) after discharge, the patients will receive a follow up phone call where the participants will be asked if they utilized the Social Determinants of Health Referrals. Participants will also be given a second short form health survey (SF-12) Quality of Life Survey at this time.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Admitted to the trauma or general surgery services
* Live within Lucas County (for county referrals)
* Patient or legally authorized representative agrees to participate and is willing to sign informed consent

Exclusion Criteria:

* Anyone less than 18 years old
* Any patient or legally authorized representative unwilling to sign informed consent
* Anyone who lives outside of Lucas County or expresses unwillingness to use referral services
Sleeve Gastrectomy Versus Medical Management for Remission of Diabetes in Mild to Moderately Obese Patients

The investigators plan to randomize mild to moderately obese (BMI 30-34.9) subjects to medical management (diet, exercise, and best medical therapy) versus sleeve gastrectomy with medical management, with a primary endpoint of diabetes remission (normal fasting glucose, off medications and insulin) at one year. Sleeve gastrectomy (also called greater curvature gastrectomy, vertical sleeve gastrectomy, and sleeve gastroplasty) involves stapled resection of the gastric fundus. Secondary endpoints include weight loss, improvement in hypertension, sleep apnea, c-reactive protein, and fasting lipid profile.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, Type 2
* Body Mass Index (BMI) 30-34.9
* Able to understand and comply with study process

Exclusion Criteria:

* Pregnancy
* Prior bariatric surgery
* Diabetes mellitus, Type 1
* Renal impairment
* Cirrhosis or portal hypertension
* Diabetes secondary to a specific condition
* Recent internal malignancy (\<5 years)
* Recent major vascular event
* Drug or alcohol dependence
* Uncontrolled psychiatric disease
* Crippling cardiopulmonary disease
* Prohibitive anatomic features (extensive prior surgery, giant paraesophageal hernia)
Comparison of NovoFine® Needles (4 mm vs. 6 mm)

This trial is conducted in Europe. The aim of this investigation is to explore the safety of a 4 mm needle compared to a 6 mm needle when injected in children and lean adults with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Children
* Type 1 diabetes
* Insulin treatment for more than ½ year
* BMI lesser than or equal to 19 kg/m2
* Last HbA1c taken within the last year lesser than 10.5%
* Girls: only prepubertal
* Boys: both pre pubertal and pubertal. Adults
* Type 1 and 2 diabetes
* Insulin treatment for more than ½ year
* BMI lesser than or equal to 23 kg/m2
* Last HbA1c taken within the last year lesser than 10.5%

Exclusion Criteria:

* Known or suspected allergy to trial product(s) or related products.
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (including country-specific adequate measures, if any).
* Skin disease at abdomen and/or thigh
A Study to Characterize the Effect on the Pharmacokinetics of ASP1941 and Pioglitazone Hydrochloride When Given Together to Healthy Subjects

The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics and safety following the administration of ASP1941 and pioglitazone hydrochloride in multiple and single doses.

All subjects will be enrolled at one center and confined to the unit for up to 23 days. Subjects will be dosed in the fasting state in one of the four groups.

Eligibility Criteria:
Inclusion Criteria:

* The subject weighs at least 50 kg, and has a body mass index (BMI) of 18 to 32 kg/m2 inclusive
* The subject's 12-lead electrocardiogram (ECG) results are normal
* The female subject must be at least two years postmenopausal, surgically sterile or practicing effective birth control and not pregnant or lactating
* The male or female subject agrees to practice highly effective birth control from Screening until 7 days post last dose

Exclusion Criteria:

* The subject has a history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
* The subject has any condition possibly affecting drug absorption (e.g., gastrectomy)
* The subject has history of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/substance abuse within past 2 years prior to screening or the subject tests positive for alcohol or drugs of abuse
* The subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check in
* The subject has a supine mean systolic blood pressure \< 90 or \> 160 mmHg and a mean diastolic blood pressure \< 50 or \> 90 mmHg, or pulse rate higher than 100 beats per min (bpm)
* The subject has a 12-lead ECG demonstrating QTc \>470 msec (female) or \>450 msec (male)
* The subject is known positive for human immunodeficiency virus (HIV) antibody
* The subject has a positive test for tuberculosis (TB), hepatitis C antibody, or positive for hepatitis B antigen (HBsAg)
* The subject has used prescription or non-prescription drugs within 2 weeks or 5 half-lives (whichever is longer) or complementary and alternative medicines (CAM) within 14 days prior to study drug administration (excluding oral contraceptives, hormone replacement therapy \[HRT\], and acetaminophen)
* The subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
Pulmonary Gas Exchange Abnormalities in Patients With Mild COPD

People with mild chronic obstructive pulmonary disease (COPD) can have significant physiological abnormalities and breathing inefficiency which become more pronounced during the stress of exercise, leading to intolerable breathing discomfort (dyspnea). To better understand the mechanisms of respiratory symptoms and exercise limitation in mild COPD, we will examine detailed lung function tests and other important measurements during rest and exercise in people with mild COPD compared with healthy non-smokers. This will be the first study to uncover the fundamental causes of breathing inefficiency and the related shortness of breath during physical exertion in patients with mild COPD. We hope to demonstrate that one simple measurement during exercise \[the relation (ratio) between the total amount of air breathed (ventilation) and the amount of carbon dioxide breathed out\] gives meaningful information about the extent of damage to the small airways and blood vessels in mild COPD and the overall gas exchanging function of the lungs, without the need for an arterial blood sample.

This is a case-controlled observational study not involving an intervention. Participants will complete 2 visits approximately 1 week apart, each conducted at the same time of day. Visit 1 will consiste of screening for iligibility, symptom and activity assessments, pulmonary function tests and an incremental cycle cardiopulmonary exercise test (CPET) for familiarization purposes. Visit 2 will include spirometry followed by an incremental cycle CPET with detailed measures of ventilatory, gas exchange, sensory-perceptual and arterial blood gas responses.


Eligibility Criteria:
Inclusion Criteria:

* Stable symptomatic patients with GOLD grade 1B mild COPD;
* at least 50 years of age;
* a cigarette smoking history ≥20 pack-years;
* a Baseline Dyspnea Index focal score ≤9;
* post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥80 %predicted and an FEV1/forced vital capacity (FVC) ratio \<0.7 and \< lower limit of normal.

Exclusion Criteria:

* clinically significant comorbidities;
* contraindications to exercise testing;
* history/clinical evidence of asthma;
* body mass index \<18.5 or \>30 kg/m2;
* use of supplemental oxygen.
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

Goal of the study is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable CREDO® heal Stent.


Eligibility Criteria:
Inclusion Criteria:

* Patients, treated with CREDO® heal according to IFU
* Over 18 years old
* With acute persistent vascular occlusion due to high grade intracranial artery stenosis in the anterior or posterior circulation for which alternative therapy concepts are not considered or fail
* With suspected underlying stenosis of the occluded artery, which is suitable for PTA and stenting according to the treating physician's assessment and/or persistent occlusion after failed recanalization by mechanical thrombectomy of the target region
* With small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion \< 70 ml)
* With symptoms onset less than 24 hours before start of the procedure
* Treated with study device following at least one futile mechanical recanalization attempt with a stent retriever, direct aspiration or combination of both
* With pre-stroke disability mRS 0-2

Exclusion Criteria:

* Any contraindication according to IFU and patients:
* With atherosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses \> 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and signs of restricted collaterals) and recurrent symptoms in spite of medical therapy
* With contraindication against treatment with anti-platelet medication
* Participating in another trial