cyrilzakka/clinical-trials huggingface dataset:
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 and \</= 80 years of age at time of study inclusion
* Histologically confirmed, previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL) according to the WHO classification system
* Patients with an International Prognostic Index (IPI) score 1-5, or IPI score 0 with bulky disease, defined as one lesion \>/= 7.5 cm
* At least one bi-dimensionally measurable lesion defined as \>/= 1.5 cm in its largest dimension on CT scan, PET-CT scan or MRI
* Adequate hematologic function
* Eastern Cooperative Oncology Group (EOCD) performance status \</= 2

Exclusion Criteria:

* Primary or secondary central nervous system lymphoma, histologic evidence of transformation to Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, primary cutaneous DLBCL, or primary DLBCL of the testis
* Transformed lymphoma or follicular lymphoma IIIB
* Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
* History of other malignancy, except for curatively treated basal or squamous cell carcinoma or melanoma of the skin, carcinoma in situ of the cervix, or a malignancy that has been treated without curative intent and has been in remission without treatment for \>/= 5 years prior to enrolment
* Inadequate renal or hepatic function
* Known human immunodeficiency virus (HIV) infection or HIV seropositive status
* Active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. Patients with occult or prior HBV infection as defined by protocol may be included. Patients positive for HCV antibody are eligible only if polymerase chain reaction testing for HCV ribonucleic acid is negative.
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* Prior treatment with cytotoxic drugs or rituximab for another condition (e.g. rheumatoid arthritis) or prior use of an anti-CD20 antibody
* Pregnant or lactating women
Functional Eletrical Stimulation in Post Stroke Patients

The FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks. The results of this project will contribute to the definition of the therapeutic window of FES to improve upper limb function in stroke rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* First and unilateral ischemic or hemorrhagic stroke, in the middle cerebral artery, confirmed by imaging;
* Age equal ou greater than 30 years old;
* Preserved congnitive function, corresponding to a score higher than 23 in the Mini Mental State Examination (MMSE);
* Ability to perform active movement in the contralesional upper limb (UL) of at least 15° in the shoulder and elbow.

Exclusion Criteria:

* Body mass index (BMI) less than 18,5 and greater than 30;
* Hemi-spatial neglect and/or uncorrected visual changes;
* Musculoskeletal or neurological conditions which may affect ULs and/or trunk function;
* Pain in the ULs;
* Severe sensorimotor impairment, corresponding to a score less than 39 in the Fugl-Meyer Assessment Scale - Upper Extremity (FMAS-UE);
* Lesions on the skin of the affected forearm;
* Severe spasticity (modified Ashworth \>3);
* Severe muscle contractures on the affected forearm;
* Pacemaker;
* Osteosynthesis or metallic implants;
* Pregnancy;
* Adverse skin reaction to electrodes' gel.
Tear Dynamics After Restasis Treatment in Dry Eye Patients

Observe the changes of tear volume in dry eye patients after Restasis treatment of 3 months and during 6-month follow-up after discontinuation of study treatment.

Using an imaging device name optical coherence tomography to image the tear volume in dry eye patients before and after Restasis treatment.

Eligibility Criteria:
Inclusion Criteria:

The participant will be eligible for entry in the study if s/he:

1. Is at least 18 years old and has full legal capacity to volunteer;
2. Has read and signed the IRB Informed Consent Document;
3. Is willing and able to follow participant instructions;
4. Has clear corneas;
5. Has 20/100 uncorrected visual acuity or better;
6. Has dry eye according to the study definition of DES (study subjects);
7. Has not use Restasis within 3 months.

Exclusion Criteria:

The subjects will ineligible for entry into the study if s/he:

1. Has any systemic disease affecting ocular health except for Sjögren's syndrome;
2. Is using any systemic or topical medications that will affect ocular health except for artificial tears;
3. Has an active ocular disease other than DES, or Sjögren's syndrome
4. Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
5. Has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to DES;
6. Has worn rigid gas permeable lenses within 1 year and during the study;
7. Has had surgery or an eye injury within 6 months;
8. Was a soft contact lens wearer within 2 weeks and during the study.
Criteria Analysis for Ventilatory Support Adjustment of Mechanical Ventilation

The indications for mechanical ventilation (MV) include excessive work of breathing, with or without evidence of respiratory muscle fatigue. The setting of the MV is still a challenge because it is based on criteria understudied, often subjective and observer-dependent. Despite several studies, to our knowledge has never been done before is the precise definition of the optimal range of ventilatory support. Novel and recognizable diagnostic techniques will be applied. No single parameter of the breathing pattern has good accuracy for the adjustment of ventilatory support. Non-invasive measures such as P0.1 and rate of muscle relaxation may have good accuracy for the adjustment of ventilatory support.

Use of excessive pressure support

Eligibility Criteria:
Inclusion Criteria:

* patients under invasive mechanical ventilation for 48h
* patients without the objective of complete rest of the respiratory muscles. This decision will be on the discretion of the attending physician,
* spontaneous breathing,
* clinically stability.

Exclusion Criteria:

* Previous disease of the central nervous system that can lead to respiratory changes.
* Previous disease of the peripheral nervous system that can lead to respiratory changes
* Previous muscular disease.
A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)

This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.


Eligibility Criteria:
Inclusion Criteria:

* negative clinical history of measles, mumps, rubella, varicella, and zoster

Exclusion Criteria:

* received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
* any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
* received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study
* history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™
* received salicylates within 14 days prior to study vaccination
* exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination
* received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
* received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
* received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination
* fever illness (≥102.2°F \[39.0°C\]) within 72 hours prior to study vaccination
* born to a human immunodeficiency virus (HIV)-infected mother
* participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment
A Study of Standard and Individualized Prophylactic Treatment With Advate in Men and Boys With Severe Hemophilia A

The main aim of this study is to learn about changes in the lowest blood levels of Factor VIII in men and boys when upgraded from standard prophylaxis with Advate to individualized prophylaxis with Advate.

No study medicines will be provided to participants in this study. The study sponsor will not be involved in how participants are treated but will provide instructions on how the clinics will record what happens during the study. Participants will need to visit the study doctor 3 times in total during the study. During these visits, study data will be collected by the study doctor.

Local, Multicenter, Non-interventional, Ambispective Study in Severe Hemophilia A Patients on Standard and PK-tailored Prophylaxis With Octocog Alfa (Advate®) in the Russian Federation

Eligibility Criteria:
Inclusion Criteria:

* Male participants of all ages with severe hemophilia A (FVIII ˂1%) or moderate hemophilia A with severe bleeding phenotype who:

  * had been on standard prophylaxis or PK-tailored prophylaxis with octocog alfa during at least 12 months prior to the study enrollment (150 participants) or who started Advate® treatment in 2021 (20 participants),
  * is being treated with octocog alfa at the moment of enrolment with any of the above mentioned treatment modalities, and
  * had been assigned octocog alfa provision in Federal reimbursement program 2021
* Availability of participants' records sufficient for data collection according to the study objectives during the retrospective period of the study for participants who had been on standard prophylaxis or PK-tailored prophylaxis with octocog alfa during at least 12 months prior to the study enrollment
* Written informed consent provided by the participant or, in case of children below 14 years of age, by participant's parent or participant's legally acceptable representative.

Exclusion Criteria:

* Failure to obtain the participant's written informed consent
* Participation in any interventional study of products for hemophilia or other hemostasis disturbances treatment during 12 months prior to the study enrollment for participants who has retrospective data collection period and during 12 months after the study enrollment for all participants.
A Study Investigating the Bioavailability of a High Concentration Liquid Formulation Versus a Reference Lyophilized Formulation of Gantenerumab in Healthy Volunteers

This single-center, randomized open-label, single-dose, parallel group study will investigate the relative bioavailability of a high concentration liquid formulation (HCLF) versus the reference lyophilized formulation (LyoF) of gantenerumab. Healthy volunteers will be randomized 1:1 to receive single-dose gantenerumab by subcutaneous injection.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects, 40 to 70 years of age inclusive. Healthy status is defined by absence of evidence any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, coagulation, serology and urinalysis. Some medical conditions are allowed that are well controlled by single stable medication
* A BMI between 18.0 to 30.0 kg/m2 inclusive
* Use of highly effective contraception until 6 months after study follow-up visit
* Agree not to donate blood or blood products for transfusion for the duration of the study and for one year after their dosing

Exclusion Criteria:

* Suspicion of alcohol or drugs abuse addiction using DSM IV criteria
* Regular smoker (\> 5 cigarettes, \> 1 pipeful or \> 1 cigar per day), tobacco users and subjects on nicotine replacement therapy
* Prior administration of gantenerumab
* Participation in an investigational drug or device study within 60 days before dosing
* Donation of blood over 500 mL within three months before dosing
* Pregnancy or breast-feeding
* Any abnormal skin conditions or potentially obscuring tattoos, pigmentation or lesions in the area intended for subcutaneous injection
* Any familial history of early onset Alzheimer's disease
* Claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin or body which would contraindicate an MRI scan
A Study to Determine the Inter/Intra Observer and Intra-subject Variability of Whole Blood Clotting Time Measurements

The purpose of the study is to characterize the distribution and sources of variability in whole blood clotting time (WBCT) measurements in human blood collected from healthy volunteers by 5 different technicians.

No investigational product was administered to any subject in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Signed and dated, written informed consent (Institutional Review Board \[IRB\]-approved informed consent form \[ICF\]).
2. Healthy male and female subjects aged 18 to 65 years (inclusive) with suitable veins for venipuncture. (Healthy as determined by medical history)

Exclusion Criteria:

1. Healthy subjects who do not conform to the above inclusion criteria.
2. Healthy subjects who cannot communicate reliably with the Investigator.
3. History of major bleeding or major trauma within the past 6 months
4. Healthy volunteer with a propensity to bleed (i.e. due to recent trauma, recent surgery, peptic ulcer, active or recent gastrointestinal bleeding or bleeding from hemorrhoids).
5. Significant infection or known inflammatory process within 2 weeks of screening.
6. Treatment with any investigational products or therapies within 30 days (or 5 half lives, whichever is greater) prior to screening.
7. Received non-steroidal anti-inflammatory (NSAID) or medications (including any type of anticoagulant or aspirin \[ASA\]) with a direct effect on hemostasis within 7 days of testing
8. Unwillingness or inability to comply with procedures required in this protocol.
9. Subjects who are concurrently enrolled in any other clinical study.
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s

A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s

A prospective single center registry including all patients treated with Rotational Atherectomy in Coronary Lesion/s at the Heart Center, Bad Segeberg, Germany. Patients undergo a routine clinical follow-up schedule, including a long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing a rotational atherectomy of coronary lesion/s

Exclusion Criteria:

* None
Prognostic Relevance of Coagulation Activation in RIsk Assessment and Stratification

Carcinogenesis and coagulation activation are closely related processes. In a previous study of coagulation activation in stage I-IIA breast cancer patients, we developed a prognostic model that includes coagulation activation biomarkers and demonstrated efficacy to in distinguish between risk categories and survival. Here, we propose a study useful for the validation of this prognostic model in an independent cohort of 108 patients with locally advanced breast cancer and indicated for neoadjuvant chemotherapy, followed by breast surgery. Within this study population, we will validate our prognostic model for risk assessment and risk stratification with respect to the following endpoints:

1. Complete pathological response rate to definitive breast surgery;
2. Rate of thromboembolic events.


Eligibility Criteria:
Inclusion Criteria:

* Patients with normal organ functions
* Cytologically/histologically proven breast cancer, stage IIB-IIIC
* Participants must not have prophylactic or therapeutic indications for anticoagulants.

Exclusion Criteria:

* Pregnacy
* Metastatic breast cancer
* Previous chemotherapy, hormone therapy, radiotherapy
* Previous malignancies or contralateral breast cancer
Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.

Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.

* Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each.
* Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved.

Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores.

Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study.

Study will be conducted over a period of 6-8 months.

Eligibility Criteria:
Inclusion Criteria:

* individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities.

Exclusion Criteria:

* individuals with two or more co-morbidities or known cases of chronic liver disease.
Oxytocin for Couples Conflict Resolution

Oxytocin is a promising new medication found to have positive effects on prosocial behavior, reduce negative affect such as fear and anxiety, and reduce stress-induced addictive behaviors. This study aims to investigate the extent to which a 40 IU dose of intranasal oxytocin improves couples' conflict resolution skills and subjective, physiological, and neuroendocrine responses to conflict. Conflict resolution discussions will take place in the laboratory and will be videotaped.

Substance use disorders (SUD) are characterized by dysregulation of the hypothalamic-pituitary axis (HPA). The neuropeptide oxytocin, commonly administered as an intranasal spray, is a drug that has prominent anxiolytic and prosocial effects on human behaviors. While the mechanisms of action facilitating the behavioral effects of oxytocin in humans is complex and many questions about this process remain, there is a consensus in the existing literature that oxytocin modulates HPA axis reactivity to stressful social stimuli. Preliminary studies suggest that oxytocin is known to reduce couple conflict among normative couples. A more developed line of research indicates that oxytocin mitigates addictive behaviors in the context of various drugs of abuse. Given the high prevalence and severity of dyadic conflict among couples where one or both partner has substance abuse, and given the salience of dyadic conflict as a precipitant to substance use behaviors, it is critical to investigate the therapeutic effects of oxytocin among couples with substance use problems. Namely, oxytocin holds promise as a potential augmenter for conjoint couples therapies, particularly those targeting the reduction of substance use problems. However, only two studies have examined the effects of oxytocin on couples' communication behaviors. Those two studies found that couples' communication skills improved following the administration of oxytocin. It is important to extend this line of research to examine conflict resolution skills among couples with substance use problems. To date, no studies have examined the effects of oxytocin on subjective, physiological, or neuroendocrine reactivity to dyadic conflict. The present study aims to fill that gap in the literature.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years of age
2. both partners are willing to participate, and
3. at least one partner has engaged in hazardous drinking (i.e. 4 or more drinks for women, 6 or more for men) or illicit drug use during the past 60 days

Exclusion Criteria:

1. pregnancy for women
2. current psychotic or bipolar disorders
3. active suicidal or homicidal ideation and intent
4. subjects who would present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study
5. severe, unilateral intimate partner violence in the past year
6. BMI greater than 39.
Anxiety, Depression and Eating Attitudes of Diabetes Mellitus Patients During COVID-19 Lockdown in Greece

The aim of this observational, cross-sectional study is to evaluate the impact of the second national COVID-19 lockdown in Greece, regarding the aspects of depression, anxiety and eating habits, in relation to the adjusted work and family conditions, among diabetes mellitus patients.

The national Lockdown was an attempt by the Governments around the world to prevent the spreading of the SARS-CoV-2. This pandemic turned out to be a major public health challenge. In Greece two national lockdown were imposed in 2020, among other measures, in order to minimize the spread of the SARS-CoV-2. The national lockdown consists of the temporary closure of the sports arenas, theaters, cafeterias, restaurants, cinemas, archaeological sites, schools, churches universities and most of the businesses . The first national lockdown in Greece was imposed from March 23th to May 4th and the second one took place from November 6th until now. Such a lockdown that forces the majority of individuals to stay at home for a prolonged period of time, except the controlled movement of the individuals for some cases, could expectedly enough have quite an impact on the daily life of people with diabetes mellitus. Changes to dietary habits, limitation of physical activity, as well as the psychological aspects like those of depression and anxiety have been detected. The aim of this study is to evaluate the impact of the second national lockdown in Greece, regarding the aspects of depression, anxiety and eating habits, in relation to the adjusted work and family conditions, among diabetes mellitus patients.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* Type 1 Diabetes Mellitus
* Type 2 Diabetes Mellitus
* MODY Diabetes Mellitus

Exclusion Criteria:

* age \<18 years
* gestational Diabetes