cyrilzakka/clinical-trials huggingface dataset:
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Uncomplicated Diverticulitis

The purpose of the trial is to compare the efficacy of Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. placebo in patients with acute uncomplicated diverticulitis.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent,
2. Patient is eligible for out-patient treatment,
3. Men or women between 18 and 80 years of age,
4. Diagnosis of left-sided uncomplicated diverticulitis confirmed by ultrasonography (US) and/or computed tomography (CT) according to modified Hinchey classification (stage 1a) or Hansen/Stock classification (stage I/IIa) or Ambrosetti classification (stage mild),
5. Presence of significant left lower quadrant pain during the last 24 hours before baseline,
6. CRP \> ULN and/or leucocytosis (\> ULN) at screening visit

Exclusion Criteria:

1. Existing complications of diverticulitis (diverticulitis with associated abscess, fistula, obstruction or perforation),
2. Right-sided diverticulitis,
3. Previous colonic surgery (except appendectomy, haemorrhoidectomy, and endoscopic removal of polyps),
4. Chronic inflammatory bowel disease (such as Crohn's disease, ulcerative colitis) or celiac disease,
5. Presence of symptomatic organic disease of the gastrointestinal tract (with the exception of non-bleeding hemorrhoids or hiatal hernia),
6. Hemorrhagic diathesis,
7. Active peptic ulcer disease,
8. Abnormal hepatic function or liver cirrhosis,
9. Abnormal renal function,
10. Colorectal cancer or a history of colorectal cancer,
Effect of FFP2 Masks on Peripheral Oxygen Saturation and Pulse Rate During the COVID-19 Pandemic

aim of this research is to evaluate the effects of FFP2/N95 masks on peripheral oxygen saturation and pulse rate in dental professionals


Eligibility Criteria:
Inclusion Criteria:

* dental professionals

Exclusion Criteria:

* subjects not signing informed consent
* subjects unable to wear facemasks due to underlying conditions
Comparison of PSB and RIFPB Combination With PSB and ESPB Combination in Cardiac Surgery With Sternotomy

The goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy.

This study will consist of two randomized groups: Group RIFPB (n=12), Group ESP (n=12). All patients will receive standard general anesthesia. Group RIFPB patients will receive PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. Group ESPB patients will receive PSB and ESPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. All blocks will be performed after induction of general anesthesia and before surgical incision. All patients in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. Within the first 24 hours after surgery, all patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen. Numerical Rating Scale (NRS) will be used to assess postoperative pain at 1, 6, 12, 18 and 24 hours. All patients will receive morphine via a patient-controlled analgesia (PCA) device within 24 hours of surgery. If pain score is ≥ 4 despite this protocol, 50 mg tramadol iv (maximum dose 300 mg/day) will be administered as rescue analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes I-IIIII according to the American Society of Anesthesiologists (ASA) risk classification.

Exclusion Criteria:

* Patients who did not give consent,
* patients with coagulopathy,
* patients with signs of infection at the block application site,
* patients using anticoagulants,
* patients with local anesthetic drug allergies,
* patients with unstable hemodynamics,
* patients who could not cooperate during postoperative pain assessment
Osseodensification Plus Platelet Rich Fibrin With Simultaneous Implant Installation in Closed Sinus Lift

12 patients with indirect sinus lift will be selected with RBH\&gt;5mm , surgical procedure

=osseodensification + Prf+ implant .

1. versah drilling system (osseodensefication technique )will be used , moreover Prf will be prepared by Blood collected in PRF tubes from patients then centrifuge (1300rpm ,14min ) .
2. primary stability will be measured using Resonance Frequency Analysis by Osstellimmediately and after 6 Mn .
3. CBCT will be taken before surgery , perioapical x-ray immediately after surgery and CBCT at 6m follow up to be apple to see the differences regarding bone quality and volume.


Eligibility Criteria:
Inclusion Criteria:

- medically fit non pregnant no sinus pathology

Exclusion Criteria:

* young patients under 18
* sinus pathology
Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III

The aim of the entire project was to perform a translation and cultural adaptation of the Addenbrooke's Cognitive Examination - III (ACE-III), adhering to the Translation and Cultural Adaptation of Patient Reported Outcomes Measures-Principles of Good Practice, in order to make it available to German clinicians.

Part of the translation process is the cognitive debriefing which will be performed as a survey which rates the applicability of every single item as well as of the entire Addenbrooke's Cognitive Examination - III tool.

The recent demographic developments have drastically increased the importance of developing applicable approaches to the diagnostics of dementia and the general evaluation of cognitive function. Many different tests were developed to thoroughly evaluate neurocognitive function.

The Addenbrooke's Cognitive Examination, developed in 2000, was one such tests and has served as an open source neurocognitive examination tool ever since. The current version is the Addenbrooke's Cognitive Examination III (ACE-III). The aim was to develop a tool that would be able to identify dementia in its early stages and also to differentiate between the different types of dementia.

In order to achieve reliable results, cognitive tests should be conducted in a familiar language and draw from the cultural background a participant is familiar with. The ACE-III and all its predecessors were developed in English and for an English-speaking cultural background, not directly applicable to the typical German patient. This made it necessary to perform not only a verbatim translation of test contents, but also to appropriately adapt the test content to reflect the cultural background of the typical German patient. The International Society For Pharmacoeconomics and Outcomes Research (ISPOR) - Task Force for Translation and Cultural Adaptation has developed the "Translation and Cultural Adaptation of Patient Reported Outcomes Measures-Principles of Good Practice", to ensure a consistent and rigorous methodology in the process of translating and adapting patient-reported outcomes measures.

The Principles of Good Practice consist of ten steps:

1. Preparation
2. Forward Translation
3. Reconciliation
4. Back Translation
5. Back Translation Review
6. Harmonization
7. Cognitive Debriefing
8. Review of Cognitive Debriefing Results and Finalization
9. Proofreading
10. Final Report

Eligibility Criteria:
Inclusion Criteria:

* Male and female employees of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité Universitätsmedizin Berlin (residents, specialist physician for anesthesiology, senior physicians, medical students engaged in research projects)

  .- ≥ 18 years of age
* Experience in the field of neurocognitive testing

Exclusion Criteria:

* Insufficient knowledge of the German language
The Effect of CBT- Based Weight Loss Program on Obesity

The investigators purpose is to study how CBT (cognitive behavioral therapy)-based weight loss program affects on eating behavior, weight loss and risk factors for CHD (coronary heart diseases)and type 2 diabetes. Moreover, the investigators aim is to recognize subjects suffering from anhedonia (one of the core symptoms of depression, lack of pleasure) and follow how they benefit from the program in order to achieve maintained weight loss. Also, the associations between weight loss, physical activity and musculoskeletal disorders are studied.

Obesity is an increasing problem and effective weight loss methods are needed. The study is randomized follow-up study with 9 months intervention and three (3) years follow-up period. The study is organized in Oulu University Hospital, Department of Internal Medicine. Eighty (80)obese, 20-65 years, study subjects will be randomized into intervention or control group.

The hypothesis of the CognObe study is: CBT (cognitive behavioral therapy)-based weight loss program is successful in sustained and favourable change in eating behavior and weight as well as decreased risk for coronary heart diseases or type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 30

Exclusion Criteria:

* other concurrent weight loss programs
* disease which prevents weight loss
* medication which affects on weight loss
A Study of Danoprevir in Healthy Volunteers And Patients With Hepatic Impairment

This non-randomized, multi-center, open-label study will evaluate the pharmacokinetics and the safety and tolerability of danoprevir (RO5190591) and ritonavir in healthy volunteers and patients with mild, moderate or severe hepatic impairment. Participants will be administered repeated daily doses of danoprevir and ritonavir. The anticipated time on study treatment is 10 days.


Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers:

* Adult healthy volunteers, 18-70 years of age
* Weight \>/=50.0 kg
* Body Mass Index (BMI) 18.0-40.0 kg/m2
* Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
* Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
* Medical history without major recent or ongoing pathology

Patients with hepatic impairment:

* Adult patients, 18-70 years of age
* Weight \>/=50.0 kg
* Body Mass Index (BMI) 18.0-40.0 kg/m2
* Ability and willingness to abstain from alcohol-containing beverages or food from 48 hours prior to entry in the clinical study center until discharge
* Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge
* Stable, mild, moderate, or severe liver disease of cryptogenic, post-hepatic, hepatitis B or alcoholic origin

Exclusion Criteria:

Healthy Volunteers:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Uncontrolled treated/untreated hypertension (systolic blood pressure \>/=160 mmHg and /or diastolic blood pressure \>/=105 mmHg
* Any history of clinically significant cardiovascular or cerebrovascular disease
* Creatinine clearance \</=60 mL/min
* Positive test results for drugs or alcohol
* Donation or loss of blood over 450 ml within 60 days prior to screening

Patients with hepatic impairment:

* Pregnant or lactating women and male partners of women who are pregnant or lactating
* Uncontrolled treated/untreated hypertension (systolic blood pressure \>/=160 mmHg and /or diastolic blood pressure \>/=105 mmHg
* Any history of clinically significant cardiovascular or cerebrovascular disease
* Severe ascites at screening or admission to the clinic
* History of or current severe hepatic encephalopathy (grade 3 or higher)
* Any evidence of progressive liver disease within the last 4 weeks
* History of liver transplantation
* Creatinine clearance \</=60 mL/min
* Positive test results for drugs or alcohol
* Donation or loss of blood over 450 ml within 60 days prior to screening
Virtual Reality Cognitive-Affective Training for Opioid Use Disorder- A Phase 2 RCT

The goal of this clinical trial is to examine the usefulness of a virtual reality-delivered intervention for individuals with opioid use disorder who are taking medication. The main question it aims to answer is will people with opioid use disorder who receive the study intervention, Mindfulness-Oriented Recovery Enhancement in Virtual Reality (MORE-VR), have fewer days in which they use opioids than will people who just receive their usual treatment. Participants will be randomly assigned to either receive 8 weekly sessions of MORE-VR in addition to their usual treatment, or treatment as usual only. Researchers will compare these groups at the end of treatment and three months after treatment is over on number of days of opioid use and time until first opioid use lapse, as well as drug craving and mood.

This project is a Phase II, two-arm, parallel randomized controlled trial (RCT) of a virtual reality form of Mindfulness-Oriented Recovery Enhancement (MORE-VR) versus treatment as usual (TAU) for patients receiving medications for opioid use disorder (MOUD) to assess the efficacy of the MORE-VR system. Participants will be randomized (1:1) to either 8 weekly sessions of MORE-VR or TAU. Participants will be assessed at intake, post-treatment, and a 3 month post-treatment follow-up. The primary outcome assessed will be days of opioid use.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* current DSM-5 OUD diagnosis
* prescribed medications for opioid use disorder (e.g., buprenorphine, methadone)

Exclusion Criteria:

* completion of a standardized mindfulness intervention (e.g., MORE, MBRP, MBSR)
* active psychosis or suicidality
* reports, or is noted by clinical or study staff as showing cognitive impairment
* condition which might be contraindicated for VR use including seizure disorder, vertigo, severe motion sickness, recent concussion
Heart Failure and Aortic Stenosis Transcriptome

This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.

The investigators will collect plasma and cardiac tissue specimens from consenting subjects. The investigators will evaluate the expression of mRNAs, miRNAs and lncRNAs in patients affected by both end-stage and not end-stage HF as well as in patients affected by aortic stenosis and undergoing valve replacement and requiring cardiac myectomy. The tissue dysregulated RNAs will be next measured in plasma samples in order to clarify their potential as biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Non end-stage heart failure

   * left ventricle restoration surgery (SVR)
   * End Systolic Volume Index (ESVI) \>35 ml/m2
   * Ejection Fraction (EF)\<40%
   * previous transmural anterior myocardial infarction (MI)
   * age: 40-75
2. End-stage heart failure

   * left ventricle assisted device (LVAD) surgery
   * age: 40-75
   * Ejection Fraction (EF) \<25%
   * End Systolic Volume Index (ESVI)≥60 ml/m2
3. Aortic Stenosis

   * aortic valve replacement
   * intracardial pressure difference \>40 mmHg
   * septal diameter ≥1.3 cm

Exclusion Criteria:

1. Non end-stage heart failure

   * End Systolic Volume Index (ESVI)\<35 ml/m2
   * Ejection Fraction (EF)\>40%
   * Time from MI unknown
   * Pregnancy
   * Other genetic diseases
   * Neoplasms
   * Collagenopathies
   * Chemo/radiotherapy
   * Prolonged use of corticosteroids
   * Infections
   * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
2. End-stage heart failure

   * EF\>25%
   * Time from MI unknown
   * Pregnancy
   * Other genetic diseases
   * Neoplasms
   * Collagenopathies
   * Chemo/radiotherapy
   * Prolonged use of corticosteroids
   * Infections
   * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
3. Aortic Stenosis

   * coronaropathies
   * Pregnancy
   * Other genetic diseases
   * Neoplasms
   * Collagenopathies
   * Chemo/radiotherapy
   * Prolonged use of corticosteroids
   * Infections
   * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive
Cortical Effects of Peripheral Nerve Injury At Birth

Cortical activity during rest and with stimulation by functional magnetic resonance imaging will be investigated in patients with OBPI.

Peripheral nerve injury results in a number of cortical changes due to the lack of sensory and motor stimuli. Although functional magnetic resonance imaging (fMRI) studies that revealed the changes in the cortical activation exist, the cortical activation changes in obstetrical brachial plexus injury is poorly known. For this reason, the aim of this study is to investigate the cortical activity during rest and with stimulation by fMRI in patients with OBPI.

Patients with OBPI diagnosis in the cervical 5-6 (C5-6) (upper trunk) who are followed up in Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation Division of Hand Rehabilitation will participate in the study. Patients with a surgery history at least 5 years ago and over 10 years age will be included. Clinical motor and sensory assessments will be performed to help in explaining the analyses of cortical activation. In their first visit, clinical assessments including Active Movement Scale, modified Mallet Classification (MMC) and sensory tests will be performed; while fMRI scanning will be carried out in the second visit. Patients will be scanned for 3 paradigms at one single fMRI session: at rest and during sensory stimulation and watching videos of motor movements. Video images will include the 5 movements used in MMC and will be watched by glasses integrated in the MRI device. Images obtained from MR scanning will be analyzed with analysis programs like Leonardo, Fresurfer, SPM, BrainVoyager and clinical results will be compared to MR images.

Eligibility Criteria:
Inclusion Criteria:

* upper trunk (cervical 5-6) involvement
* cooperated

Exclusion Criteria:

* illiterate
* surgical history for his arm in the previous 5 years
* other than only C5-6 involvement
* any impairment that prevents positioning in MRI machine
The Impact of Tibial Tubercle-trochlear Groove Distance and Patellar Height on the Outcome of Isolated Medial Patellofemoral Ligament Reconstruction

The investigators plan to perform a prospective observational cohort study of patients undergoing MPFL reconstruction for the treatment of episodic patellar instability in the absence of significant degenerative disease. The investigators will follow these study subjects for a minimum of two years to monitor their functional and clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* MPFL Reconstruction

Exclusion Criteria:

* Trochleoplasty Required
* Prior ipsilateral knee surgery
* Iwano grade 2+
* CHondral injury requiring surgical treatment beyond debridement
* Major ligamentous injury to the knee
Visual Outcomes and Patient Satisfaction After Bilateral Implantation of Non-diffractive EDOF IOL Made of a New Hydrophobic Acrylic Material

The objective is to measure the range of vision and patient reported visual disturbances after bilateral implantation for this unique non-diffractive extended depth of focus (EDOF) intraocular lens (IOL) made from the Clareon material.

This study is a single-arm unmasked clinical evaluation study of binocular distance-corrected distance (6m) and intermediate (66cm) visual acuity after successful bilateral cataract surgery. Subjects will be assessed pre-operatively, operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include administration of a visual disturbance questionnaire (QUVID), and a satisfaction questionnaire (IOLSAT), as well as measurement of bilateral visual acuity and manifest refraction.

Eligibility Criteria:
Subjects are eligible for the study if they meet the following criteria:

Note: Ocular criteria must be met in both eyes.

* Visually significant age-related cataracts bilaterally.
* Best monocular Corrected distance Visual Acuity predicted to be (20/25) or better after cataract removal and IOL implantation as determined by surgeon.
* Gender: Males and Females.
* Willing and able to provide written informed consent for participation in the study.
* Willing and able to comply with scheduled visits and other study procedures.
* Clear intraocular media other than cataract.
* Planned Bilateral implantation of the Clareon Vivity and Vivity toric IOLs.
* IOL powers between 6D and 30D, T2-T6.

If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.

* Previous ocular or refractive surgery
* Ocular surface disease/Dry Eye Disease
* Intraoperative complications during procedure
* Glaucoma, including well-controlled
* Any disorders that reduce binocular vision (ie Strabismus)
* Any ocular comorbidity that, in the opinion of the investigator reduce post-op visual acuity (e.g. AMD etc)

The principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial.

Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

TQB3107 is a protein inhibitor that induces apoptosis and inhibits the proliferation of various tumor cells. This clinical study aims to evaluate the safety and tolerability of TQB3107 tablets in subjects with advanced malignancies, to determine the dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) (if any), and the recommended dose for Phase II (RP2D).


Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤ age≤ 75 years (calculated from the date of signing the informed consent); Score 0\~1 point, estimated survival ≥ 3 months；
* Malignant tumors with no standard treatment regimen or disease progression or intolerance after prior standard therapy；
* The major organs are functioning well；
* Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception throughout the study and for 6 months after the study ends;
* Subjects voluntarily participated in this study, signing the informed consent form and demonstrating good compliance.

Exclusion Criteria:

* Hematologic malignancy has or is suspected to involve the central nervous system, or primary central nervous system lymphoma;
* Received any anti-cancer therapy such as major surgery, chemotherapy and/or radiotherapy, immunotherapy, or targeted therapy within 4 weeks prior to the first dose;
* Combined with severe or not well-controlled diseases, which the investigator judges to be at greater risk of entering this study；
* Those with a history of drug addiction or substance abuse；
* Based on the investigator's judgement, subjects with concomitant diseases that pose a significant risk to their safety or compromise the study's completion, or subjects deemed unsuitable for enrollment due to other reasons, will be excluded.