cyrilzakka/clinical-trials huggingface dataset:
Precision of Three Different Scanbodies Used for Direct Digitalization Technique

The goal of this clinical trials to evaluate precision of different scanbodies in same participant group. The main guestion it aim to answer is:

1. Are the precision of the three different scanbodies used in direct digitalization the same for the produce of implant-supported prostheses?

Participants are healty and have short edentulous span in posterior region that will receive implant-supported prostheses.

Twenty-five patients receiving two implant supported restorations in treatment of short-span partial edentulism were enrolled into the study. Three different scanbodies, original, non-original and generic, were employed for direct digitalization technique. Full contour PMMA restorations were CAD/CAM fabricated from each digital record, and were evaluated in terms of implant fit, axial- and occlusal-contact. Additionally, patient's impressions for digitalization and delivery procedures were recorded using a visual analog scale. Scanbody scan recordings were subjected to reverse engineering for analytical evaluation of 3D virtual implant positioning.

Eligibility Criteria:
Inclusion Criteria:

* Be willing to voluntarily participate in the study after reading the informed consent form.
* Adult patient over 18 years of age who has completed growth and development
* Partial edentulism in the functional region for a two-implant-supported restoration with two or three occlusal members
* Having a fixed dentition in the opposing arch
* The occlusal relationship between the jaws does not require vertical and horizontal prosthetic treatment.
* Having bone-level implants placed with "straightforward" surgery according to the SAC classification system \[248\] and without advanced surgical technique

Exclusion Criteria:

* Not voluntarily agreeing to participate in the study after reading the informed consent form
* Having one or more of the conditions for which implant treatment is strictly contraindicated (patients who have received radiation therapy, bone cancer, metabolic disorders)
* Having systemic (steroid therapy, uncontrolled diabetes, immunological disorders, pregnancy) risk factors for implant treatment
* Having local (periodontal discomfort, bruxism, poor oral hygiene) risk factors for implant treatment
Carbon Dioxide Insufflation (CO2) and Warm Water Infusion (WWI) Versus Standard Air Insufflation (AI) for Unsedated Colonoscopy

Due to the increasing demand for colonoscopy in clinical practice, great interest has recently renewed for unsedated colonoscopy. Both Carbon dioxide Insufflation (CO2) and Warm Water Infusion (WWI) have been advocated to improve patient tolerance for colonoscopy as compared to standard Air Insufflation (AI). This study is aimed at evaluating the performance of the above techniques versus AI in unsedated patients.


Eligibility Criteria:
Inclusion Criteria

* adult outpatients willing to undergo colonoscopy without routine initial sedation

Exclusion Criteria:

* refuse to initiate colonoscopy without routine sedation
* inadequate bowel preparation
* incapacity to give informed consent
A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.

This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).


Eligibility Criteria:
Inclusion Criteria:

1. Able and willing to provide written informed consent and to comply with the study protocol;
2. ≥18 years of age;
3. Documented diagnosis of multiple myeloma according to 2014 IMWG diagnostic criteria.
4. Phase Ⅰb/Ⅱ: At least one measurable disease: Serum monoclonal paraprotein (M-protein) ≥5 g/L or Urine M-protein ≥200 mg/24 hours or Serum immunoglobulin free-light chains (FLCs) ≥100 mg/L and abnormal kappa/lambda FLC ratio (\<0.26 or \>1.65)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
6. Life expectancy ≥3 months.
7. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
2. Participants with known active infection within 14 days prior to the first MBS314.
3. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal hepatitis B virus DNA or hepatitis C virus RNA).
4. Previously received anti-myeloma treatment within the specified time frame prior to the first administration.
5. Live, attenuated vaccines within 28 days prior to the first infusion of MBS314, or expected to receive live, attenuated vaccines during the study period.
6. Major surgery within 28 days prior to the first infusion of MBS314, or expected to undergo major surgery during the study treatment.
7. Participants with a history of autoimmune diseases.
8. Known severe allergic reactions to other antibodies, or known allergies or hypersensitivity to any components of MBS314.
Bioavailability of Iron From Savoury Food Product

The study is designed to assess the bioavailability of iron from 4 different iron fortified savoury food products


Eligibility Criteria:
Inclusion Criteria:

* Healthy female subjects;
* Age \> 18 and \< 40 years at screening;
* Body weight \<65 kg;
* Apparently healthy: no medical conditions which might affect study measurements (judged by study physician);
* With iron deficiency (Serum ferritin \<15µg/L);
* Currently not smoking and being a non-smoker for at least six months and no reported use of any nicotine containing products in the six months preceding the study and during the study itself;
* Willing and able to participate in the study; Having given a written informed consent.

Exclusion Criteria:

* Blood donation or significant blood loss over the past 6 months;
* Reported use of any medically- or self-prescribed diet;
* Use of medication (except oral contraceptives)
* Use of vitamin or mineral supplements and unwillingness to discontinue their use two weeks prior the study and during the study;
* Is pregnant or will be planning pregnancy during the study period;
* Is lactating or has been lactating in the 6 weeks before pre-study investigation and/or during the study period;
* Known gastrointestinal or metabolic disorders;
* Participation in another clinical trial during the last 30 days prior to the beginning of the study.
A Study to Compare Three Doses of T-20 When Given in Combination With Abacavir, Amprenavir, Ritonavir, and Efavirenz to HIV-Infected Adults

The purpose of this study is to see if it is safe and effective to give T-20, a new type of anti-HIV drug, with a combination of other anti-HIV drugs. The other anti-HIV drugs used are abacavir (ABC), amprenavir (APV), ritonavir (RTV), and efavirenz (EFV). Three different doses of T-20 are tested.

Patients are assigned to one of four groups. Three dose groups receive a background antiretroviral regimen (ABC, APV, RTV, and EFV) and T-20, which is given at one of three doses on a twice-daily regimen. The fourth group (control) receives the background antiretroviral regimen alone. For each treatment group, 17 patients are enrolled. Treatment is administered for 16 weeks, followed by a 32-week treatment extension, and a 2-week follow-up period. The following are assessed throughout the trial: safety parameters (as measured by hematology, clinical chemistry, urinalysis, and treatment-emergent adverse events); virologic and immunologic activity; phenotypic and genotypic resistance; T-20 plasma levels; and pharmacokinetics of T-20 and oral antiretrovirals. The total study duration is 1 year.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have an HIV level (viral load) between 400 and 100,000 copies/ml at the screening visit.
* Have taken at least 1 PI (protease inhibitor) for at least 16 weeks, and have had no interruptions in their most recent PI-containing anti-HIV drug regimen.
* Are at least 18 years old.
* Agree to abstinence or use of 2 effective methods of birth control, including a barrier method, during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have ever taken an NNRTI (nonnucleoside reverse transcriptase inhibitor).
* Have an opportunistic (HIV-related) infection.
* Have had an unexplained fever of at least 38.5 C for 7 days in a row within 30 days prior to screening.
* Have had diarrhea lasting at least 15 days within 30 days prior to screening.
* Have ever taken abacavir, amprenavir, or efavirenz (ABC, APV, or EFV).
* Have certain genetic characteristics (drug resistance mutations) that could change the way a drug acts in the body.
* Are allergic to any of the study medications.
* Have a tumor other than certain skin or cervical cancers.
* Are on chemotherapy that cannot be discontinued during the study.
* Are taking an investigational drug within 30 days prior to screening.
* Have ever received an HIV vaccine.
* Are taking certain medications.
* Abuse drugs or alcohol.
* Have hemophilia or another blood clotting disorder.
* Have had an organ transplant.
* Are pregnant or breast-feeding.
Clinical Utility of a Low-Cost Hand-Held Breast Scanner

Early detection of breast cancer improves the survival rate and makes treatment less costly. This study would measure the accuracy a low-cost hand-held commercially viable device, iBE, for the detection of clinically relevant findings in the breast using the results of current mammography as a comparison. This research will have no impact on clinical decision making.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Women and men with symptomatic breast lump (either by palpation or imaging) OR
* Asymptomatic women presenting to the imaging center for a screening mammogram.
* Signed Informed Consent

Exclusion Criteria:

* Patients under 18 years of age
* Patients who previously participated in this study and are returning to the Women's Imaging Center for follow-up diagnostic tests
IOP Fluctuations in Primary Open Angle Glaucoma Patients Before and After Deep Sclerectomy With Collagen Implant

Primary open angle glaucoma (POAG) is associated with inadequate drainage of the aqueous humor via the trabecular meshwork towards the systemic circulation. This may lead to an increase in IOP and may damage the optic nerve. The purpose of glaucoma management is to lower IOP in order to prevent progression of the optic neuropathy and subsequent visual loss. Firstline treatment usually includes IOP-lowering drug therapy. However, if IOP remains uncontrolled and/or the optic nerve damage progresses despite controlled IOP, surgery may be indicated. Deep sclerectomy with a collagen implant (DSCI) is a non-penetrating surgical procedure for the treatment of open angle glaucoma that allows the enhancement of the aqueous outflow. This forms the rationale to conduct this prospective, open label study to assess the 24-hour IOP fluctuation profile recorded with Triggerfish® in patients with POAG before and after DSCI.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of POAG
* Documented glaucomatous VF damage with mean defect (MD) \> 3 dB
* Progressing glaucomatous damage justifying a DSCI
* Aged ≥18 years, of either sex
* Not more than 4 diopters spherical equivalent on the study eye
* Not more than 2 diopters cylinder equivalent on the study eye
* Have given written informed consent, prior to any investigational procedures

Exclusion Criteria:

* Corneal or conjunctival abnormality precluding contact lens adaptation
* Severe dry eye syndrome
* Patients with allergy to corneal anesthetic
* Patients with contraindications for silicone contact lens wear
* Patients not able to understand the character and individual consequences of the investigation
* Participation in other clinical research within the last 4 weeks
Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers

An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects

1. Screening
2. Enrollment and treatment randomization
3. Confinement to Research Unit from day - 1 to day 2
4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)
5. Drug administration : Overnight Fasting
6. Blood sampling for PK, PD and genotyping

   1. PK: up to 24 hours after dosing
   2. PD: up to 72 hours after dosing

Eligibility Criteria:
Inclusion Criteria:

* male aged 19 to 45 years
* weigh over 60 kg
* body mass index 18 to 30 kg/m2

Exclusion Criteria:

* any history or state of clinically significant disease
* any gastrointestinal disease may interfere absorption of drug
* any history of hypersensitivity to prasugrel or other drug
* any history of taking herbal medication within 30 days before dosing or taking prescription medication within 14 days before dosing or taking over the counter drug within 7 days before dosing
* taking investigational drug within 60 days before dosing
* transfused within 30 days or donated blood within 60 days before dosing
* Positive serology test ( Hepatitis B surface antigen (HBs Ag), HIV, HCV)
* Clinically significant finding in laboratory result or electrocardiogram result
Effects of Intermittent Theta Burst Stimulation in Addition to Constraint-Induced Movement Therapy in Stroke Patients

In recent studies, it has been reported that intermittent theta-burst stimulation (iTBS) provides additional benefits when applied in adjunct to the rehabilitation in all stages of stroke (acute, subacute, or chronic). In our study, it was aimed to evaluate the effectiveness of iTBS applied in addition to modified constraint-induced movement therapy (mCIMT). By doing so, we intend to increase patient adherence to neurorehabilitation and decrease the cost of rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* First time and unilateral stroke
* 1-12 months after the incident
* Getting 24 points or more in Mini Mental Status Examination
* Being able to stand for 2 minutes without any help by using the upper extremity as a support tool when necessary.
* Being a low-functioning patient according to the CIMT criteria: a) At least 10 degrees of active wrist extension starting from the angle of full flexion, b) 10 degrees of extension at the metacarpophalangeal and inter-phalangeal joints of at least 2 fingers

Exclusion Criteria:

* those who score more than 2.5 points on the Motor Activity Log-28 scale,
* who have severe pain in the upper extremity (5 and above on the Visual Analogue Scale) and spasticity (3 and above on the Modified Ashworth Scale), which may affect the treatment, and
* Those who do not have adequate communication skills.
* Patients who have visual problems
Identify the Prosthesis Users' Necessities Concerning Their Devices.

Despite many advances in prosthesis development, there are still some areas that need to be improved. One of them is the weight of the devices which could cause muscular fatigue in long-term use of the prosthesis and even abandonment. This study aims to identify the desired improvements in prosthetic devices from the perspective of the users, therapists, and relatives. That would be done through two kinds of questionnaires about technology acceptance.

The World Health Organization (WHO) estimates that around 1.3 billion people experience significant disability. One of the actual challenges is facilitating and breaking the barriers of persons with disabilities. Assistance technology supports inclusion and participation, principally for people with disabilities.

In Brazil, the DATASUS estimated that around 57802 amputations (one kind of disability) were performed in 2022. Prostheses are assistive devices that aim to mitigate the psychological impact of missing a member and help in activities of daily life (ADL). One kind of prosthesis is electrically powered, which uses electrical components to actuate the device and is commonly controlled by body signals such as surface electromyography (sEMG). Despite many advances in prosthesis development, some areas need to be improved such as weight, size, ergonomic design, etc. of the devices which could cause muscular fatigue in long-term use of the prosthesis and even abandonment.

This study aims to identify the aspects that cause major discomfort in upper limb prosthesis users. Also, recognize in which activities of daily life, the prosthesis is involved. That information will be used to improve the design of an upper limb prosthesis.

For the execution, two kinds of questionnaires about technology acceptance will be used. In the first questionnaire, which is for prosthesis users, there will be 15 questions to identify in what kind of activities the person uses the prosthesis, how much is the use time and what is the main problem with the device. In the second questionnaire, which is for the therapist and relatives, there will be 9 questions to analyze which device characteristics cause major discomfort during the use and could be improved.

Eligibility Criteria:
Inclusion Criteria:

* Prosthesis users with at least 6 months of device use.
* Therapists with experience in working with amputees.
* Relatives of the prosthesis users.

Exclusion Criteria:

-
Immunophenotyping of Blood Cells in the Diagnosis Work-up of Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematological malignancies characterized by cytopenia(s), dysplasia in one or more major myeloid cell lines and progression to acute leukemia. Morphological analysis of peripheral blood (PB) and bone marrow (BM) remains the cornerstone of the diagnosis. Preliminary studies identified Flow Cytometry (FC) markers on red cells, platelets and circulating leukocytes that are expressed differently in MDS and in controls. However, these markers have been evaluated separately. The investigators propose to test in a large cohort of patients these markers, and to combine the most relevant ones in order to define a PB FC-based diagnosis score that would discriminate between MDS and non-clonal hematopoiesis and would avoid useless bone marrow samples in elderly


Eligibility Criteria:
Inclusion Criteria:

1. Patient who have been orally informed, and given a short written information notice about the study
2. Adult patient\>18 years
3. For whom a blood sample analysis is routinely prescribed
4. Presenting cytopenia on at least one lineage according to the 2016 WHO classification (Hemoglobin level\<100 g/L and/or platelets \<150 G/L and/or Neutrophils\<1G/L).
5. For whom a bone marrow analysis for morphology assessment and cytogenetics have to be performed, because of suspicion of MDS.t The results of this bone marrow evaluation will classify the patients in Group 1 (MDS diagnosis) and Group 2 (no MDS according to the 2016 WHO criteria), defining the two populations of this validation cohort for whom the FC score will be calculated.

Exclusion Criteria:

1. Transfused patients (less than 3 months) in RBC or platelets units
Study of Sapacitabine in Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS)

This is a combination study to evaluate sapacitabine administered in alternating cycles with decitabine in previously untreated Acute Myeloid Leukemia (AML) or concomitantly with venetoclax in previously treated AML or MDS

This is an open-label, single arm, study of sapacitabine administered in alternating cycles with decitabine in elderly patients with previously untreated AML (Part 1) or concomitantly with venetoclax in adult patients with relapsed or refractory AML or MDS (Part 2). Treatment will be administered on an outpatient basis. One treatment cycle is 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML based on WHO classification (Part 1) or previously treated AML or MDS (Part 2)
* Age 70 years or older for whom the treatment of choice is low-intensity therapy by investigator assessment or who has refused intensive induction therapy recommended by investigator (Part 1); age 18 years or older (Part 2)
* ECOG performance status 0-2
* Adequate renal function
* Adequate liver function
* Able to swallow capsules
* Ability to understand and willingness to sign the informed consent form

Exclusion Criteria:

* AML is of the sub-type of acute promyelocytic leukemia or extramedullary myeloid tumor without bone marrow involvement
* Known central nervous system (CNS) involvement by leukemia
* Uncontrolled intercurrent illness including
* Known hypersensitivity to decitabine (Part 1) or venetoclax (Part 2)
* Known to be HIV-positive
Patient Reported Outcomes in Friedreich's Ataxia Patients After Withdrawal From Treatment With Idebenone (PROTI)

This is a Phase IIIb Double-Blind, Randomised, Placebo-Controlled Study. The aim is to further investigate the effects of idebenone in patients with Friedreich's ataxia.

The objective of the PROTI study is to establish whether patients can correctly determine which treatment assignment (placebo or idebenone) they received during the randomised phase of the trial, and identify any potential changes on symptoms or activities.


Eligibility Criteria:
Inclusion Criteria:

* Completion of V5 (Month 12), V6 (Month 18), or V7 (Month 24) in the MICONOS extension study
* Patients who in the opinion of the investigator are able to comply with the requirements of the study
* Body weight ≥ 25kg
* Negative urine pregnancy test

Exclusion Criteria:

* AE during the course of the MICONOS extension study which in the opinion of the investigator is attributable to idebenone and precludes further treatment with idebenone
* Clinically significant abnormalities of clinical haematology or biochemistry including, but not limited to, elevations greater than 1.5 times the upper limit of normal SGOT, SGPT or creatinine
* Parallel participation in another clinical drug trial
* Pregnancy or breast-feeding
* Abuse of drugs or alcohol
* Any change of concomitant medication within the last 30 days that in the opinion of the investigator the intake could negatively impact the study