cyrilzakka/clinical-trials huggingface dataset:
Study of Epratuzumab in Systemic Lupus Erythematosus

Epratuzumab is an investigational antibody designed to help treat Systemic Lupus Erythematosus (SLE). The purpose of the study is to obtain additional long-term information regarding the safety and efficacy of continued maintenance-cycle administrations of Epratuzumab.

Due to the logistical considerations, UCB has decided to consolidate the Phase II and Phase III open-label extension trials. Subjects completing this study will be offered the option of continuing to receive epratuzumab through participation in Phase III open-label extension study SL0012 (NCT01408576).

Eligibility Criteria:
Inclusion Criteria:

* Must have participated in SL0003 or SL0004 and benefitted from participation in those studies

Exclusion Criteria:

* Development of toxicity to epratuzumab
* Significant protocol deviations during the SL0003 or SL0004 studies
* Evidence of significant infection
Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI).

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. Additionally, clopidogrel resistance has been linked with the CYP2C19 polymorphism. The hypothesis of the study is to define in consecutive patients undergoing PCI those that are clopidogrel resistant PCI following routinely used loading as estimated predischarge with the VerifyNow point of care system of platelet reactivity. Clopidogrel resistant patients will be randomized in 1:1 fashion to prasugrel 10 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 30, when treatment crossover will be performed. At day 60 platelet reactivity will be determined as well. In addition, in all patients genetic determination of CYP polymorphisms (including the CYP2C19)known to affect clopidogrel metabolism will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Patients having PCI with stenting 24-48 hours prior randomization, for 1. Stable angina 2.Ischaemia in provocative test 3.Acute coronary syndrome (unstable angina or myocardial infarction)
* Written Informed consent
* Platelet reactivity units (PRU) (VerifyNow) \>230

Exclusion Criteria:

* A history of bleeding diathesis
* Chronic oral anticoagulation treatment
* Contraindications to antiplatelet therapy
* Known platelet function disorders
* PCI or coronary artery bypass surgery \< 3 months
* Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3)
* Planned staged PCI in the next 60 days
* Hemodynamic instability
* Cancer or hemodialysis
* Platelet count \<100 000/ μL, hematocrit \<30%
* Creatinine clearance \<25 ml/min
* A life expectancy\<1 year, inability to give informed consent
* High likelihood of being unavailable for the Day 60 follow up
A Double-blind, Parallel Group, Placebo-Controlled Outpatient Trial of PD 00200390 in Adults With Nonrestorative Sleep

In a Phase II trial in subjects with nonrestorative sleep, PD 0200390 demonstrated a positive treatment effect relative to placebo on the primary endpoint, the weekly version of the Restorative Sleep Questionnaire (RSQ-W). In this study, the dose-response relationship of varying doses of PD 0200390 using the Restorative Sleep Questionnaire (RSQ-W), will be explored in Nonrestorative Sleep subjects.


Eligibility Criteria:
Inclusion Criteria:

* Awake unrestored or unrefreshed, associated with significant distress or impairment in social, occupational, or other important areas of functioning during the daytime, for at least 3 nights for the past 3 months prior to screening
* Self-report wake after sleep onset \<45 mins for past 3 mos; self-report latency to sleep onset \<20 mins for past 3 mos
* PSG (Polysomnography) sleep criteria of wake after sleep onset \< 45 mins; Latency to persistent sleep \<20 mins.

Exclusion Criteria:

* MAP (Multivariable Apnea Risk index) index \> or = 0.5 at screening
* BMI = or \> 32 kg/m2
* History or presence of breathing related disorders
* PSG findings consistent with and periodic limb movement disorder, narcolepsy or other dyssomnia or parasomnia including apnea-hypopnea index \> 10/hr; or period limb movement with arousal index \> 10/hr.
Rituximab and Combination Chemotherapy in Treating Patients With Previously Untreated Mantle Cell Lymphoma

The investigator(s) hypothesize that Rituximab together with combination chemotherapy, followed by Rituximab maintenance therapy, will provide better disease control with improved response rates and overall survival in patients with previously untreated Mantle Cell Lymphoma (MCL).


Eligibility Criteria:
Inclusion Criteria:

1. Previously untreated, histologically confirmed mantle cell lymphoma,
2. Measurable or evaluable disease (at least one site with \>1.5 cm in diameter
3. All stages are eligible
4. Age \> 18 years
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
6. Adequate hepatic function:

   * Bilirubin \< 3 mg/dL
   * Transaminases (serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamate-pyruvate transaminase (SGPT)) \< than 2.5 times the upper limit of normal for the institution, unless due to lymphomatous involvement
7. Serum creatinine\< 1.5 mg/dl
8. Ability to give informed consent
9. Women of childbearing potential must have a negative pregnancy test within 72 hours of entering into the study. Males and females must agree to use adequate birth control if conception is possible during the study. Women must avoid pregnancy and men avoid fathering children while in the study.
10. Life expectancy greater than 6 months.

Exclusion Criteria:

1. Previous chemotherapy, immunotherapy or radiotherapy for this mantle cell lymphoma
2. Concurrent active malignancies, with the exception of in situ carcinoma of the cervix and basal cell carcinoma of the skin.
3. Grade 3 or 4 cardiac failure and/or ejection fraction \< 50.
4. Psychological, familial, sociological or geographical conditions that do not permit treatment and/or medical follow-up required to comply with the study protocol.
5. Patients with a known history of human immunodeficiency virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS).
6. Presence of hepatitis or hepatitis B virus (HBV) infection.
7. Pregnant or breast-feeding women.
8. Central Nervous System (CNS) involvement.
Survival Thermal Blanket Versus Draping Fabric to Prevent Hypothermia in Geriatric Surgical Patients

This study compare effect of using survival thermal blanket and draping fabric as substitute for perforated blanket to reduce the incidence of inadvertent perioperative hypothermia in geriatric patients.

Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.Study design was randomized single blinded. Total of 126 geriatric subjects from March-April 2021 were allocated into survival thermal blanket group (n=63) dan draping fabric group (n=63). Preinduction temperature was measured using timpanic membrane termometer. Intraoperatively, temperature is measured using nasopharynx.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years old
* Physical status ASA 1-3
* Undergo elective surgery under general anesthesia with or without regional anesthesia

Exclusion Criteria:

* Thermoregulation disturbance
* Abnormal thyroid function
* Fever caused by infectious disease in 7 days prior to surgery
* Pre-induction hypothermia with temperature below 36 degree
* On routine antipiretic
* Unstable hemodynamic preoperative and intraoperative
Prevention of Non-Surgical Bleeding by Management of HeartMate II Patients Without Antiplatelet Therapy

This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.

This is a post-market clinical study of HM II patient management practices to be conducted in the United States.

Subjects will be randomized in a 1:1 fashion to the following research drug groups:

1. Treatment Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + Placebo (1 pill/day)
2. Control Arm: Warfarin (INR target: 2.0-2.5, median: 2.25) + ASA Therapy (81mg/day)

The study will investigate if subjects in the Treatment Arm experience a reduced incidence of non-surgical bleeding, without an increased risk of thromboembolic events.

Eligibility Criteria:
Inclusion Criteria

* Subject is receiving the HM II per standard of care (SOC) in accordance with the FDA approved indications for use
* Subject is ≥ 50 years of age
* Subject is receiving the HM II as their first LVAD
* Subject or legally authorized representative (LAR) has signed an informed consent form (ICF).

Exclusion Criteria

* Existence of ongoing mechanical circulatory support (MCS) other than intra-aortic balloon pump or Impella® devices
* Participation in any other clinical investigation(s) involving an MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
* Antiplatelet therapy is mandated for other conditions, in particular: a) recent coronary artery stenting (≤ 6 months), b) carotid artery disease, and c) other conditions where the investigator is not comfortable leaving subjects off-ASA or starting ASA post LVAD implantation. In situations where the investigator is uncertain, the Steering Committee can provide recommendation to the investigator as needed.
* Subjects in whom heart transplantation is expected in ≤ 6 months
* Subjects with a known ASA allergy
Long-term Safety and Efficacy of Nemolizumab With Moderate-to-severe Atopic Dermatitis

Long-Term Safety and Efficacy of Nemolizumab in Subjects with Moderate-to-Severe Atopic Dermatitis Description

Long-term study to assess the safety and efficacy of nemolizumab in subjects with moderate-to-severe AD

Eligibility Criteria:
Key Inclusion Criteria:

1. Subjects who may benefit from study participation in the opinion of the investigator and had participated in a prior nemolizumab study for AD
2. Female subjects of childbearing potential (ie, fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the last study drug injection, or to use an effective and approved method of contraception throughout the study and for 12 weeks after the last study drug injection.

Key Exclusion Criteria:

1. Subjects who, during their participation in a prior nemolizumab study, experienced an AE which in the opinion of the investigator could indicate that continued treatment with nemolizumab may present an unreasonable risk for the subject.
2. Pregnant women, breastfeeding women, or women planning a pregnancy during the clinical study.
3. Body weight \< 30 kg
4. Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 2 weeks before the baseline visit, or any confirmed or suspected coronavirus disease (COVID)-19 infection within 2 weeks before the screening or baseline visit. Subjects may be rescreened once the infection has resolved. Resolution of COVID-19 infection can be confirmed by recovery assessment methods.
5. History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody)
6. Any clinically significant issue, based investigator judgement
Refinement and Assessment of New Magnetic Resonance Imaging Technologies for Neurological Exams

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine head and neck regions.

This study is being done to assess new Magnetic Resonance Imaging (MRI) technologies such as new hardware or software designed to improve MRI examinations of the brain, spine, and head \& neck regions.

Software and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better MRI images.

Eligibility Criteria:
Inclusion Criteria:

* If you are a male or a non-pregnant female patient
* Normal volunteer
* presenting to MRI for a clinically-ordered neurological or head and neck MRI exam

Exclusion Criteria:

* Patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients or patients who are lactating.
* A patient who is claustrophobic
Comparison of the Hemodynamic Safety of Two Common Alveolar Recruitment Manoeuvres With Regard to Cardiac Output in a Surgical Intensive Care Unit

Protective ventilation - combining a low tidal volume (between 6 and 8 ml/kg) and alveolar recruitment (AR) manoeuvres repeated every 30 minutes - is currently the standard of care for decreasing morbidity associated with mechanical ventilation.

In contrast, there is no consensus on the type of recruitment manoeuvre, which varies from one centre to another and from one study to another.

The investigators intend to compare two currently used AR techniques with regard to their ventilatory efficacy and hemodynamic safety:

* An end-tidal plateau at 30 cmH20 for 30 seconds.
* An end-tidal plateau at 10 cmH20 above the patient's plateau pressure for 30 seconds, without exceeding 30 cmH20.


Eligibility Criteria:
Inclusion Criteria:

* All sedated, intubated, mechanically ventilated adult patients (over-18) admitted to the surgical intensive care unit and equipped with a central venous catheter and an arterial catheter.
* Good echogenicity
* Social security coverage

Exclusion Criteria:

* Pregnancy
* Cardiac arrhythmia
* Poor echogenicity
* Legal guardianship or incarceration
* Systolic blood pressure ≤90 mmHg
* Respiratory distress
* Patients admitted on an emergency basis (first 24 hours), i.e. not for elective surgery
Taxol® in Monotherapy or in Combination With Topotecan or Carboplatin in Patients With Epithelial Ovarian Cancer in Early Relapse

This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.

The main purpose of this research study is to find out if treatment of early relapse of ovarian or fallopian tube or peritoneal cancer with paclitaxel (Taxol\*) weekly administered, in lower doses in combination with topotecan (Hycamtin\*) or carboplatin will improve efficacy compared to weekly administration of paclitaxel in monotherapy. Tolerance in the three groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 18
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
* Peritoneal and/or nodes and/or visceral metastases
* Disease in progression under treatment or within 6 months after a first or second platinum-based line
* A period of 3 weeks between last chemotherapy and inclusion
* Measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup \[GCIG\] criteria)
* ECOG performance status \< 2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Previously received weekly administration of paclitaxel chemotherapy
* Involved in a trial within the last 30 days
* Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
* Prior diagnosis of malignancy
* History of ischemic cardiopathy, congestive heart failure (New York Heart Association \[NYHA\] \> 2), arrhythmia, hypertension, or significant valvulopathy
* Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade \> 2
* Bone marrow, renal, or hepatic insufficiency
* Severe active infection or occlusive or sub-occlusive disease
* History of symptomatic brain metastases
* Fertile women not using adequate contraceptive methods
* Pregnant or breast feeding women
* Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
Efficacy and Tolerance of Potassium Hydroxide (10% and 15%) in Molluscum Contagiosum

BACKGROUND:

Molluscum contagiosum is a non-serious children viral infection. Because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting.

METHODS:

A double blind, randomized clinical trial, in three groups of topic treatment is designed. The intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance.

The main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. Secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.


Eligibility Criteria:
Inclusion Criteria:

* Who are diagnosed with a molluscum contagiosum (MC) infection (clinical diagnosis).
* Who are between the ages of two and six.
* Whose parents or guardians have provided written informed consent for participation.

Exclusion Criteria:

* Immunocompromised patient (congenital or acquired).
* Patient has received other topical treatment within the last month.
* Patient has lesions on face, neck or genital area.
* Patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.
RCT of Efficacy and Safety of CP003 on CFS/ME or Post-COVID Fatigue

The goal of this clinical trial is to test if a Lingzhi supplement (CP003) helps people with chronic fatigue or post-COVID fatigue feel better. It will also check if the supplement is safe to use. The main questions it aims to answer are:

Does the Lingzhi supplement reduce fatigue symptoms? Is it safe to take? How does it affect the body's immune system and inflammation?

Researchers will compare people taking the Lingzhi supplement to those who don't take anything (waitlist group) to see if it works.

Participants will:

* Take 5 capsules once daily for 6 weeks (or wait to start treatment if in waitlist group)
* Visit the clinic 2 times for blood tests (before and after taking the supplement)
* Complete questionnaires 3 times about their fatigue and quality of life (4 times questionnaires for waitlist group)


Eligibility Criteria:
Inclusion Criteria:

* Meet the Fukuda diagnostic definition of CFS/ME or have persisting fatigue after the infection of SARS-CoV-2
* Are able to complete a 6-week course of intervention;
* Able to complete the online validated fatigue surveys.

Exclusion Criteria:

* Have participated in any type of complements or herbal medicine within the past six months;
* Have serious medical conditions that might limit their participation in this intervention;
* Diagnosed with acute inflammation;
* Are pregnant or are planning a pregnancy in the next 3 months.
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects

The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women between 18 to 55 years of age
* Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and no clinically significant abnormalities on 12-lead electrocardiogram (ECG)
* History of nonsmoker for at least 1 year

Exclusion Criteria:

* Presence or history of any disorder or significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure), or psychiatric disease that may prevent the completion of the study
* Known or suspected alcohol abuse or consumption of more than 2 standard units per day within past 6 months or known or suspected abuse of prohibited drugs or other substances
* Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day -1 until the end of the study
Comparing Alternative Ranibizumab Dosages for Safety and Efficacy in Retinopathy of Prematurity

This study is designed as an exploratory study to assess safety and efficacy of two different doses of the anti-VEGF agent ranibizumab (0.12 mg vs. 0.20 mg) in the treatment of infants with retinopathy of prematurity. Furthermore it shall help to improve safety in the treatment of ROP and provide explorative data on long-term effects of ranibizumab after intravitreal injection in neonates.

The primary objective is to assess clinical efficacy of ranibizumab in children with ROP


Eligibility Criteria:
Inclusion Criteria:

* Bilateral ROP in zone I (stage 1+, 2+, 3+/-, AP-ROP) or ROP in central (=posterior) zone II (stage 3+, AP-ROP). Zone I is defined as twice the distance from the optic disc to the fovea measured temporally, posterior zone II is defined as three times the distance from the optic disc to the fovea measured temporally.
* Legal representatives or their designates willing and able to attend regular study visits with the study infant.
* Written informed consent to participate in the study (signed by all patient's legal representatives).

Exclusion Criteria:

* Pediatric conditions rendering the infant ineligible to anti-VEGF treatment or to repeated blood draws as evaluated by a neonatal ICU specialist and a study ophthalmologist.
* Congenital brain lesions significantly impairing optic nerve function.
* Severe hydrocephalus with significantly increased intracranial pressure.
* Advanced stages of ROP with partial or complete retinal detachment (ROP stage 4 and 5).
* ROP involving only the peripheral retina (i.e. peripheral zone II or zone III).
* Known hypersensitivity to the study drug or to drugs with similar chemical structures.
* Contraindications for an intravitreal injection as listed in ranibizumab SmPC.
* Systemic use of anti-VEGF therapeutics.
* Use of other investigational drugs - excluding vitamins and minerals - at the time of enrollment, or within 30 days or 5 half-lives prior to enrollment, whichever is longer.