cyrilzakka/clinical-trials huggingface dataset:
Patient Controlled Epidural Analgesia Versus Continuous Epidural Infusion: Obstetrical and Neonatal Outcomes

The investigators intend to perform a large randomized trial using standardized obstetrical and anesthetic practice at a single institution to determine the effects of patient controlled epidural analgesia on obstetrical and neonatal outcomes.

Women in their first pregnancy in spontaneous labor desiring epidural anesthesia will be randomized to one of three groups. Each group will initially be given intrathecal bolus. Before and 30 minutes after the initial bolus, the patient's verbal pain score will be recorded. The continuous epidural infusion group (Group I) will be started immediately on a continuous pump infusion.They will also have the opportunity to give a PCA bolus Finally, the patient controlled epidural group (Group III) will be able to give a bolus every 20 minutes with no continuous infusion. Each group will also be allowed 2 boluses,by the anesthesia staff in the event that their pain is not controlled by the indicated study medication. An hourly evaluation of verbal pain score and maternal mobility will be recorded. After delivery, obstetrical outcomes, neonatal outcomes, anesthesia interventions, and patient satisfaction questionnaires will then be collected.

Eligibility Criteria:
Inclusion Criteria:

* Early labor
* Nulliparous

Exclusion Criteria:

* Inductions
* Breech
* Contraindications to regional anesthesia
Genius Toothbrushes on Periodontal Status of Orthodontic Patients

This study evaluates the effects of genius toothbrushes on periodontal status of patients during fixed orthodontic treatment.Half of the patients received manual orthodontic toothbrushes (Oral B Ortho, Procter \& Gamble, USA) with V-shaped bristles and rounded ends. The others received genius orthodontic toothbrush (Oral B Genius 8900, Procter \& Gamble, USA) with Oral-B CrossAction brush head, Procter \& Gamble, USA).

Powered (genius) toothbrush with position detection technology provides patient to clean all areas of the mouth during the required time. By connecting phone to the Oral-B App, the genius toothbrush uses facial recognition technology to guide patient's brushing, zone to zone. Pressure control and personalization are another characteristics of these toothbrushes. Pressure sensor alerts patient if the brushing is too hard and helps her/him not to put too much pressure by reducing the speed of brush head. Due to the Bluetooth technology, toothbrushing can be performed more efficiently among orthodontic adolescent patients. In addition, the position detection and timer can be used to control which area is brushed in the mouth and how much total brushing time is continued. The application allows patient to see all the days brushing activity and real-time feedback on brushing habits can be received by this way.

Eligibility Criteria:
Inclusion Criteria:

* Permanent dentition with no missing teeth
* No systemic or severe periodontal problems
* Indication of non-extraction fixed orthodontic treatment
* No use of drugs in the past two months
* Absence of physical problems that prevent brushing
* Right handedness for brushing
* Same bracket type (0.022 slot metal, conventional) and ligation technique (wire ligature)
* Finishing of leveling phase (use of rectangular wires)
* Initial total score was between 3 and 10 for the labial surface of each tooth according to the modified Silness and Löe plaque index

Exclusion Criteria:

* Missing teeth
* Systemic or severe periodontal problem
* Indication of extraction treatment
* Use of drugs in the past two months
* Levelling phase of fixed orthodontic treatment
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse

Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out". This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.

To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.

To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed GBM
* Clinical Target Volume between 5 and 60 cc (inclusive)
* 18 to 75 years old (inclusive)
* Karnofsky Performance Status ≥ 70 percent
* If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
* Adequate hematology
* Adequate renal function
* Adequate liver function

Exclusion Criteria:

* Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
* Bilateral non-contiguous gadolinium enhancing tumor
* Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
* Known or suspected allergy to study medication or iodine
* Surgical procedure within four weeks of baseline
* More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline
* Radiation therapy within four weeks of baseline
* Investigational agent within last 30 days
* Previous treatment with any chimeric monoclonal antibody
* HIV positive
* Evidence of active hepatitis
A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed R/R B-cell malignancy: DLBCL (THRLBCL, EBV-positive DLBCL of the elderly, Grade 3b FL, HGBL with MYC and BCL2 and/or BCL6 rearrangements, transformed lymphoma); MCL ((with cyclin D1 overexpression or t(11;14); FL (Grade 1, 2, 3a); MZL (extranodal, nodal, splenic) ; CLL, or SLL
* Willingness to undergo biopsy
* At least 2 prior systemic treatment regimens, including prior treatment with an anti-CD20 antibody (all cohorts) or prior treatment with a BTK inhibitor (CLL/SLL)
* Relapsed, progressive, or refractory NHL or CLL
* For NHL/SLL: Radiographically measurable nodal or extranodal disease (all cohorts except CLL)
* ECOG-PS 0 - 2
* LVEF ≥ 50%
* Adequate renal, hepatic, bone marrow function

Exclusion Criteria:

* Any other histological type of lymphoma
* Primary or secondary CNS lymphoma
* Anticancer and/or investigational therapy within the past 30 days or 5 half-lives
* Allogeneic stem cell transplantation within the past 6 months, or ASCT within 3 months before C1D1
* Previous treatment with CD19-targeted therapy or PI3K inhibitors
* Clinically significant cardiac disease
* Other malignancy within the past 3 years
* Active graft-versus-host disease
* Stroke or intracranial hemorrhage within the past 6 months
* Chronic or current active infectious disease
* Positive virus serology for HCV, HBV, HIV
* Currently pregnant or breastfeeding
DESWT-Pilot Study on the Safety of Myocardial Regeneration by Direct Epicardial Shock Wave Therapy in Combination With Coronary Artery Bypass Grafting

Study purpose: To examine the safety of myocardial regeneration by direct epicardial shock wave therapy in combination with coronary artery bypass grafting.

Direct epicardial shock wave therapy: DESWT will be performed in adjunct to a standard CABG procedure. Prior to aortic cross clamping, DESWT will be performed using a CardioGold® CG050 (CRT Cardiac Regeneration Technologies, Woodstock, USA / manufactured by MTS-Europe GmbH, Konstanz, Germany) shock wave therapy device and a specially designed handheld applicator under sterile conditions. Depending on the localisation of the myocardial infarct scar, 290-310 impulses will be applied to the anterior, lateral, or posterior wall. Shock waves will be generated at 1 or 2 Hz in a non ECG triggered fashion, should DESWT result in significant ventricular arrhythmias, ECG gating will be initiated. After completion of DESWT, CABG will be continued in a regular fashion.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients above 18 years of age undergoing primary coronary artery bypass grafting.
* Patients have to present with reduced left ventricular function defined as LVEF \< 50%.
* Patients have to present with regional left ventricular wall motion abnormalities.
* Patients have to give written informed consent to participate in the study.

Exclusion Criteria:

* Significant concomitant valve disease(except significant valve disease not detected in preoperative cardiac ultrasound that is detected intra-operatively).
* HIV positive patients.
* Hepatitis C positive patients.
* Patients in cardiogenic shock.
* Patients with a contraindication for cardiac MRI.
* Present contraindication for transoesophageal echocardiography (TEE).
* History of significant ventricular arrhythmias, except arrhythmias associated with MI.
* Highly reduced left ventricular function defined as LVEF \<30%.
* Present co-morbidity which reduces life expectancy to less than 6 months.
* Presence of ventricular thrombus.
* Presence of a cardiac tumor.
* Pregnancy.
Russian Registry of Patients With nAMD

A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.

The registry is a structured system which uses observational study methods for systematic collection of data on health condition in the specific patient population.

Real world clinical practice data will be collected. Patients will not undergo any additional examinations or procedures that are outside of the standard clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Age \> to 18 years
* Male or female patients diagnosed with nAMD (with or without previous treatment for nAMD including but not limited to PDT, laser coagulation, vitamins, retinolamine, emoxipine, anti-VEGF therapy or any surgery for nAMD).
* Willing and able to provide informed written consent personally or by legal proxy

Exclusion Criteria:

* The patient does not meet the inclusion criteria;
* The patient is simultaneously participating in a different nAMD therapy study.
Virtual Reality Headset And/or Aromatherapy for Patients Undergoing a Transperineal Prostate Biopsy

The purpose of this study is to evaluate if a VR headset and/or aromatherapy can be used to reduce patient pain, anxiety, and embarrassment during a transperineal biopsy (TPBx) compared to standard of care (SOC). The primary objective is to evaluate differences in self-reported pain, fear, or embarrassment during and after the procedure between the VR Group, Aromatherapy Group, VR+Aromatherapy Group, and the Control group.

This is a single-center, randomized controlled trial comparing the use of a virtual reality (VR) device vs. an aromatherapy patch vs. VR+aromatherapy vs. standard of care as a non-anesthetic pain management tool during a transperineal prostate biopsy (TPBx).

208 patients who express interest in participating in the trial will be consented via Redcap. Patients will be centrally, dynamically randomized in a 1:1:1:1 ratio to one of the treatment groups or control group. There will be no subgroup stratification. The randomization will be predetermined by participant ID number. There will be a sealed envelope prepared and labeled with the participant ID that will contain the information for which treatment group a participant is assigned to. Once a participant is consented and assigned an ID, the envelope will be reopened to reveal which intervention the patient will be assigned to.

All participants will take a survey immediately following the procedure and that will conclude their participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years or older
* Patient is male
* Patient is due for a transperineal prostate biopsy
* Patient signed and dated informed consent form on Redcap agreeing to participate in the study

Exclusion Criteria:

* Patient has a known psychiatric or mental illness that would impede use of the VR device or aromatherapy patch
* Patient has severe hearing or vision problems that would impair use of the VR headset (under the physician's discretion)
* Patient has a history of seizures or epilepsy or is on a medication that would lower the threshold for a seizure
* Patient has a history of reactions to noxious odors
eLearning for Suicide Prevention

Project WISE (Workplace Integrated Support \& Education) includes developmental and pilot research to create an e-learning training in suicide safety planning enhanced with novel skill-building technologies that can be integrated into the routine workflow of nurses serving patients hospitalized for medical, surgical, or traumatic injury reasons. This study pilots an initial version of this eLearning training and collects data on the acceptability of the training and its components as well as engagement of nurses in the training. The evaluation will inform iterations of the training.


Eligibility Criteria:
Inclusion Criteria:

* Nurses working in acute or intensive care units at Harborview Medical Center

Exclusion Criteria:

-
Phase II Evaluation of Gemcitabine- Rituximab-Oxaliplatin Combination (GROC) in Relapsed Aggressive Lymphomas

Study Proposal:

Other drugs where synergy with Gemcitabine has been observed are Cisplatinum, Taxol, Taxotere, Etoposide and alkylating agents. However in view of Oxaliplatin's superior activity as a single agent against lymphoma, the combination of Gemcitabine with Oxaliplatin is more attractive and should be explored in this group of disorders. Based on these data and considering the advantage of its favorable toxicity profile, we propose a phase II study in patients with either refractory or relapsing aggressive non-Hodgkin's lymphomas including peripheral T-cell lymphomas which are known to have a poor outcome when compared with equivalent aggressive B-cell lymphomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with refractory or relapsed aggressive non-Hodgkin's Lymphoma. The definition of refractory includes patients who either did not respond to prior therapy or those whose best response was a PR after at least 4 courses of chemotherapy. Aggressive histologies include follicular large cell, diffuse large cell, peripheral T cell, transformed lymphomas, Lymphoblastic lymphomas, Burkitt and Burkitt like lymphomas.
* Histologic or cytological confirmation of refractory or relapsed aggressive non-Hodgkin's Lymphoma is desirable but not mandatory and will be left to the discretion of the investigator.
* Must have measurable or evaluable disease.
* No more than 4 previous regimens of chemotherapy will be allowed, including stem cell or bone marrow transplant.
* Patients must be more than 18 years old.
* No evidence of grade 3 or more neurosensory or neuromotor dysfunction (see appendix- toxicity criteria)
* Written Consent
* Those patients who have previously received a platinum or nucleoside analogue-containing regimen are eligible.
* Patients who are candidates for stem cell or marrow transplant will be included

Exclusion Criteria:

* Patients with a previous or concurrent history of cancer with the exception of: 1-treated carcinoma in situ of cervix or breast. 2- treated squamous or basal cell skin cancer, or 3- any other surgically cured malignancy from which the patient has been disease free for at least 5 years.
* HIV positive patients and those with Hepatitis B or C will be excluded from this protocol.
* Patients with severe neuropathy will be excluded.
* Chemotherapy or Radiotherapy within the previous 3 weeks prior to entering study.
Quantification of Microbiota in Health and Diseases

Microbiota consists of trillions of microorganisms located in all the biological cavity. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). The impact of dysbiosis on today's society affects over 70% of the world population

Intestinal microbiota is defined as the strongest modulator of the human genome and it is considered the "second brain" of our organism for its bi-directional communication with the central nervous system. Microbiota consists of trillions of microorganisms located in all the biological cavity, In the intestine it is distributed in ecological niches having multiple metabolic activities which influence individual health. Microbiota acts as barrier against pathogens, regulating the absorption of nutrients, the production of energy and the development of the immune system4. Intestinal bacteria are generally divided into 4 Phylum: Firmicutes, Actinobacteria, Proteobacteria and Bacteriodetes, in which their proportion shows a correlation with individuals health status. When in equilibrium among them, these bacteria are essential for the good health of the digestive tract, the good function of immune system and for brain performace. The relationships between individual health status and microbiota are based on a sort of "mutual cooperation." The balance of the microbiota can be compromised by various factors such as environmental, psycho-physical stress, malnutrition (over or low), breastfeeding, chronic diseases, oncology and pharmacological treatments (especially antibiotics and chemotherapics). This disequilibrium leads to altered capability of bacteria to properly extract calories from food affecting the trend of many pathophisilogical status such as obesity, allergic states, inflammatory bowel syndromes cardiovascular diseases, metabolic, oncological and neurodegenerative diseases. The impact of dysbiosis on today's society affects over 70% of the world population

Eligibility Criteria:
Inclusion Criteria:

* all patients will be enclosed in each group in agreement with the characteristics of the groups

Exclusion Criteria:

* Patients who will not sign the informed consent
Targeted Radionuclide Therapy for Metastatic Melanoma [131I] ICF01012

This study is a phase I clinical trial aimed to determine the recommended dose of \[131I\]ICF01012 to administer for the treatment of patients with pigmented metastatic melanoma (binding \[131I\]ICF01012 ). The \[131I\]ICF01012 is a targeted radionuclide therapy with a high affinity for melanin.

This study will include a maximum of 36 patients. This study will begin with a preselection part that consists of an injection of \[131I\]ICF01012 at a diagnostic dose (185 MBq) in order to preselect patients who will receive the therapeutic dose according to the dosimetry results : binding of \[131I\]ICF01012 on at least a tumoral lesion and an acceptable radiation absorbed dose to major organs.

The second phase will consist of a therapeutic part with a single administration of \[131I\]ICF01012 at a therapeutic dose. This part is a dose escalation model (4 levels of therapeutic dose were tested)

Eligibility Criteria:
Inclusion Criteria:

* Patient with metastatic melanoma failure to recommended treatments by HAS.
* Initial histological diagnosis of cutaneous melanoma pigmented or unknown status or choroidal melanoma.
* Presence of at least one measurable lesion and / or evaluable in 18FDG-PET as PERCIST criteria.
* Presence of at least one measurable lesion and / or evaluable as CT RECIST 1.1 criteria.
* WHO performance index ≤ 2 .
* Age\&gt; 18 years
* Life expectancy\&gt; 3 months.
* Creatinine ≤ 1,5 x ULN or creatinine clearance ≥ 60ml/min if creatinine \&gt; 1,5 x ULN , Neutrophil \&gt; 1,5.109L-1, Platellets \&gt; 100 x 109L-1, prothrombine time \&lt; 1,3 x control, Hemoglobin \&gt; 9 g/dL, facteur V \&gt; 80% (or AST, ALT ≤ 3 x LNS (≤ 5 x ULN if liver metastasis)).
* Normal cardiac fonction (LVEF\&gt; 40%).

Exclusion Criteria:

* Brain metastases symptomatic
* Patient with a VI skin phototype
* Previous treatment with chemotherapy, radiotherapy, immunotherapy and targeted therapy in the previous 4 weeks, the first injection of \[131I\] ICF01012
* Pregnant woman, nursing or woman of childbearing age refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose.
* Men refusing to follow effective contraception during treatment and 12 months after the administration of therapeutic dose
* Other evolutionary known cancer in the past five years
* Earlier irradiation of more than 25% of the bone marrow
* Suspicion of invasion of more than 25% of the bone marrow on imaging 18F-FDG PET-CT
* External Radiotherapy on target organs or the maximum dose as recommended in force
* Uncontrolled diabetes
* Known history of allergy to the excipients of the solution of \[131I\]ICF01012
* Any comorbidity or severe disease at the discretion of the investigator
COVID-19 Related Health and Infection Control Practices Among Dentists

As dentists begin reopening their practices during a global pandemic, the risk of COVID-19 infection that dentists face in providing dental care remains unknown. Estimating the occupational risk of COVID-19, and producing evidence on the types of infection control practices and dental practices that may affect COVID-19 risk, is therefore imperative. The goal of the proposed study is to understand U.S.-based dentists' health and dental-practice reactions to COVID-19. To estimate this, U.S-based dentists will be surveyed monthly. These findings could be used to describe the prevalence and incidence of COVID-19 among dentists, determine what infection control steps dentists take over time, and estimate whether infection control adherence in dental practice is related to COVID-19 incidence.


Eligibility Criteria:
Inclusion Criteria:

* Primary dental practice is in United States
* 18 years of age or older
* Dentist

Exclusion Criteria:

•Answered "no" to ADA survey sent May 2020 that read "As part of ongoing efforts to monitor the effect of COVID-19 on the dental team, the ADA is interested in collecting data related to infection rates. Would you also be willing to participate in a separate, longitudinal study that would require you to report whether you or your staff have exhibited symptoms of COVID-19, and whether you have been tested or diagnosed? The study would be anonymous and under IRB protocols."