cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients

To measure the effect of Ivermectin (sub-cutaneous) with or without zinc in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..

Eligibility Criteria:
Inclusion Criteria:

* Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
* Age 18 and above
* BMI 18-28 kg/m

Exclusion Criteria:

* Allergy to any drug
* Co-morbidities: any pre-existing cardiac disease, pulmonary disease
* Arrhythmias
* Pregnancy
* RT-PCR performed \>3 days prior to enrollment
A Patient Registry Evaluating Closure Following Access With the ArstasisOne Access System

The goal of this study is to observe the clinical safety and effectiveness of the ArstasisOne Access System in patients undergoing diagnostic angiographic procedures through the femoral artery.


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 85 years of age.
* Patient is clinically indicated for a diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
* Patient is able to ambulate without assistance prior to the procedure and can be expected to ambulate (20 feet) post-procedure.

Exclusion Criteria:

* Patient is unable to routinely walk at least 20 feet without assistance (e.g., requires a walker or wheelchair to mobilize or has known paralysis).
* Patient has an active systemic or cutaneous infection or inflammation (e.g., septicemia at the time of the procedure).
* Patient has systemic hypertension unresponsive to treatment (\>180mmHg systolic and \>110mmHg diastolic).
* Patient has received thrombolytic therapy within the 72 hours prior to catheterization.
* Patient has a previously diagnosed significant bleeding coagulopathy, is on warfarin and has an INR ≥ 1.5 or has a platelet disorder, including known thrombocytopenia (platelet count \<100,000), thrombasthenia, Von Willebrand's disease, Factor V deficiency, or anemia (Hemoglobin\< 10 g/dL, or Hct\<30%).
* Patient has a compromised femoral artery access site.
* Patient procedure requires an introducer sheath size of\> 6F.
* Patient has had prior vascular surgery or vascular grafts at the femoral artery access site.
* Patient presents with hemodynamic instability or is in need of emergent surgery.
* Patient has received femoral artery closure on the target access vessel with a collagen/PEG closure device within 90 days of the current procedure.
* Patient has a pre-existing severe non-cardiac systemic disease or illness that results in an expected life expectancy of\< 30 dys or for other reasons has a life expectancy of less than 1 yaer.
* Patient is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.
* Pregnant or lactating patients.
Myeloid Derived Suppressor Cells in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

The objectives of this study is to assess the involvement of MDSC in SLE through accurate phenotypical and functional assessment, as well as characterizing their immunometabolic profile, and to identify innovative therapeutic strategies.

Systemic Lupus Erythematosus (SLE) is a chronic invalidating chronic condition, with potential articular, cutaneous, renal, and neurologic involvement. Its pathophysiology is complex, and involves genetic, environmental and hormonal factors, leading to tolerance rupture. Among regulatory cells, Myeloid Derived Suppressor Cells (MDSCs) have been described as being increased during SLE, furthermore during flares. MDSCs are defined phenotypically as being HLA-DR-CD3-CD19-CD33+CD11b+, and either CD14+ (Monocytic MDSCs), CD15+ (Granulocytic MDSCs), or CD14-CD15- (Early-stage MDSCs). However, data regarding their immunosuppressive properties are conflicting, some studies identifying regulatory properties, while other have demonstrated a pro-inflammatory involvement through the induction of Th17 lymphocytes.

To gain insight into the involvement of MDSC in SLE, both deep phenotypical characterization of MDSC and functional assessment will be performed, as well as immunometabolic characterization. This data will be correlated to the clinical presentation and activity of SLE.

Eligibility Criteria:
Inclusion Criteria:

* Active systemic lupus erythematosus (SLEDAI \> or = 1)
* Written informed consent

Exclusion Criteria:

* Chronic or acute infection
* Other active auto-immune condition
* Active cancer
* Age below 18
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer

Both TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety of TCH (docetaxel/carboplatin/trastuzumab) and EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) regimens as Neoadjuvant Treatment in HER2-Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed HER2 positive invasive breast carcinoma
* Clinical stage Ⅱ-ⅢC
* Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
* Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
* Signed informed consent
* Adequate organ function within 2 weeks of study entry:

Absolute neutrophil count \>1500/mm3, Hgb \>9.0 g/dl and platelet count \>100,000/mm3 Total bilirubin \< upper limit of normal Creatinine \< 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) \>50mL/min using the Cockcroft Gault equation serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility

* Patients must be over 18 years old.
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
* Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.

Exclusion Criteria:

* Metastatic disease
* Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
* History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
The Use of Ketamine and Dexmedetomidine in Intensive Care Sedation

The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-80 years old
* Admitted to Intensive care unit at LAUMCRH
* Need for sedation for at least 24 hours
* Informed Consent Form signed by patient or surrogate

Exclusion Criteria:

* Pregnant patients
* At risk of increased intracranial pressure
* Aortic dissection
* Acute coronary syndrome
* Hypertension (SBP \> 180 mmHg)
* Chronic alcoholism
* Acute alcohol intoxication
* Alcohol withdrawal
* Refractory status epilepticus
* History of psychiatric disorder
* Known allergy or contraindication to use of dexmedetomidine or ketamine
* Baseline hypotension (MAP\<65 mmHg)
* Baseline bradycardia (HR\<48 bpm)
* Patients receiving neuromuscular blocking agents
* Patients requiring deep sedation as determined by the ICU attending
Tissue Engineering for Hair Follicle Regeneration

This study is to try to maintain cultured dermal papilla cells in spherical structure in vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying actual mechanism of inducing hair follicle by dermal papilla cells.

Hair transplantation is an well-documented way of treating hair loss. Hair transplantation is based on redistribution of hair follicles without any new follicle formation. It has been long that a lot of researchers have focused on developing skills in regenerating hair follicles. However, cultured dermal papilla cells lose the ability of inducing hair follicle formation after several generations in vitro culture. Our study is aiming in culturing dermal papilla cells in vitro and maintain their spherical structure before transplanting into dermis in vivo. Meantime, this study may help clarify the actual mechanism of inducing hair follicle by dermal papilla cells.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving cosmetic surgeries such as removal of moles

Exclusion Criteria:

* No special exclusion criteria
Improvement of Cocaine Use Disorder Treatment Through Cognitive Behavioral Therapy Web-based Treatment (CBT4CBT)

Addictions are among the most serious and expensive public health problems in Europe and Spain and they present high morbimortality. There is an increasing amount of studies emphasizing the role e-health for improving current treatments in mental health but research in addictions is still scarce. Over the last years, there have been several indicators that show an upward trend in the consumption of cocaine and the highly treatment-resistant patients.

Objectives: 1) To evaluate whether adding a web-based cognitive behavioral therapy (CBT4CBT) to standard cocaine use disorder treatment improves treatment outcomes in a Spanish sample of patients with severe addiction 2) To explore differences between men and women in treatment response and psychopathological risk factors of treatment response. Design: Randomized clinical trial. Selection criteria: patients consecutively admitted to the inpatient treatment unit for cocaine detoxification and meet inclusion criteria. Sample: the total sample will be of 70 individuals (randomly assigned to TAU + web-based CBT4CBT (n=35) or to TAU (n=35)). Assessment: Patients will be assessed at the beginning and during inpatient treatment, before and during outpatient treatment (CBT4CBT or TAU), after outpatient treatment (CBT4CBT or TAU) and at follow ups. Treatment retention, changes on craving and related psychological variables as well as presence of benzoylecgonine in urine will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* inpatients for cocaine detoxification in our addiction unit who live in Barcelona or surroundings
* abstinent at the time of the study assessment (from the third day of hospitalization)
* 18 years of age or older.

Exclusion Criteria:

* indication of treatment for reasons other than cocaine detoxification,
* presence of serious psychopathological or neuropsychological alterations that hinder the participation in the study (including severe intoxication)
* opioid abuse or dependence during the last year (this criteria includes maintenance treatment with methadone or another opioid substance)
* a lack of Spanish or Catalan knowledge or difficulties to read or write that hamper the participation in the study,
* Non-acceptance of the study procedures, such as the signing of informed consent.
Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Haemophilia A
* Body Mass Index (BMI) below 35 kg/m2
* History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)

Exclusion Criteria:

* Any history of FVIII inhibitors
* Surgery planned to occur during the trial
* Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
* Congenital or acquired coagulation disorders other than haemophilia A
Evaluation of a Prototype for an Innovative Room for the Elderly

The Groupement de Coopération Sanitaire des Hôpitaux Universitaires du Grand Ouest (GCS HUGO) (health cooperation group for university hospitals in the west of France), is proposing to improve the quality of geriatric care by modernizing hospital rooms. The GCS HUGO has embarked on a project to co-design a hospital room adapted for the elderly, called "Hospi'Senior", with the help of the "Dépendance et Grand âge" (Dependency and Old Age) steering committee, made up of experts from HUGO's establishments and experts from several companies.

The main objective is to evaluate the effect of hospitalization in a Hospi'Senior room on the length of stay of elderly people compared with hospitalization in a conventional room for a similar admission reason.

The secondary objectives are to evaluate the effect of hospitalization in a Hospi'Senior room for elderly people, compared with hospitalization in a conventional room for a similar admission reason, on :

2) Changes in functional abilities during the hospital stay and in the 30 days following discharge from the short-stay geriatric unit 3) Occurrence of behavioral disorders 4) Occurrence of falls during the hospital stay and in the 30 days following discharge from the short-stay geriatric unit 5) Occurrence and/or worsening of stage bedsores ≥ 2 during the hospital stay as classified by the National Pressure Ulcer Advisory Panel (NPUAP) 6) Occurrence of early rehospitalization

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years
* Admission in a short-stay geriatric department following initial emergency care department
* Hospitalization in single room: Hospi'Senior or conventional
* Affiliation to a social security scheme
* Informed consent to participate in the study from the patient or his/her representative (tutor/curator if applicable, or in order of priority a trusted person, the family or a person with whom the person concerned has a close and stable relationship)

Exclusion Criteria:

* Contraindication to study participation at the discretion of the medical team
* Hospitalization for more than 3 days (\>3 days) in the short-stay geriatric unit
* Hospitalization in a double room
* Planned hospitalization
* Poor understanding of the French language
* Patient under safeguard of justice
Parentification Among Children Whose Parents Cope With a Serious Mental Illness

The research will examine effects of personal, familial, societal and intergenerational characteristics on parentification, the effects of parentification on the quality of life of the child and what encourages a better quality of life. This research will include 130 children between the ages of 10-18 who live with at least one parent who struggles with serious mental illness in a comparison to 130 children of the same socio-demographic characteristics raised by parents from a non-clinical population. The differences between these two populations with regard to parentification, quality of life, social support and fairness will also be examined. The parents and the children will fill out questionnaires. The research group will be recruited from rehabilitation services, mental health clinics, psychiatric hospitals and social welfare departments with sampling method. The comparison group will be recruited from schools. This research broadens the knowledge of the causes and the repercussions of parentification among children of parents who struggles with serious mental illness in comparison with children raised by parents from a non-clinical population. Few studies have examined children of the mentally ill in Israel, and there are none which examined parentification.


Eligibility Criteria:
Inclusion Criteria:

* children who live with at least one parent who struggles with serious mental illness

Exclusion Criteria:

* Arabic children
Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age

The objective of this study was to evaluate the advanced maternal age as a rationale for performing intracytoplasmic morphologically selected sperm injection (IMSI).

This prospective randomized study included couples undergoing intracytoplasmic sperm injection (ICSI) as a result of advanced maternal age (≥ 37 years old). Couples were randomly allocated to receive one of two sperm selection procedures (ICSI, n = 33; or IMSI, n = 33). The groups were compared with regard to fertilization rate, percentage of high-quality embryos, implantation, pregnancy and miscarriage rates.


Eligibility Criteria:
Inclusion Criteria:

* Good physical and mental health
* Advanced maternal age (≥ 37 years old)
* Regular menstrual cycles of 25-35 days
* Normal basal FSH and LH levels
* Body mass index less than 30 kg/m2
* Presence of both ovaries
* Intact uterus
* No hormone therapy for at least 60 days preceding the study

Exclusion Criteria:

* Polycystic ovaries
* Endometriosis
* Gynaecological/medical disorders
* Positive result in a screening for sexually transmitted diseases
Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging

Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis

Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis .

MRI presents valuable diagnostic information in assessing the mediastinum. In addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique The advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible .

Quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component.

The apparent diffusion co-efficient is inversely correlated with tissue cellularity. It is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .

Eligibility Criteria:
Inclusion Criteria:

* Any age groups
* diagnosis of mediastinal mass (by Multislice Computed Tomography).

Exclusion Criteria:

* chemotherapy radiotherapy.
* thoracic surgery.
* cystic mass .
* mass with large amount of necrosis or calcification.
* contraindication of MRI (e.g. pacemakers , claustrophobia).
PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001

PROBODY is a trademark of CytomX Therapeutics, Inc


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
2. Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
3. Agreement to provide mandatory archival tissue or fresh biopsy.
4. At least 18 years of age.

Exclusion Criteria:

1. Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
2. Serious concurrent illness, including clinically relevant active infection
3. History of or current active autoimmune diseases
4. Significant cardiac disease such as recent myocardial infarction
5. History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
8. Currently receiving anticoagulation therapy with warfarin;
9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.
The Leaflex™ Brazilian Standalone Study

A prospective, multicenter, single-arm study aimed to demonstrate safety and performance of the Leaflex™ Performer in the treatment of symptomatic severe aortic stenosis.

Subjects will be seen at pre- and post procedure, discharge, 30 days and at 3, 6, 9 and 12 months post procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patient with symptomatic, severe aortic stenosis who are not recommended by the heart team for immediate treatment with surgical or transcatheter aortic valve replacement.
* Patient is willing to comply with scheduled visits and tests and is able and willing to provide informed consent.

Exclusion Criteria:

* Severe aortic regurgitation.
* Anatomic contraindications.
* Coronary, carotid, or vertebral artery disease that, in the opinion of the heart team, should be treated; or treatment of coronary artery disease ≤ 1 month prior to index procedure.
* Aortic balloon valvuloplasty ≤ 3 months prior to index procedure.
* Stroke ≤ 12 months prior to index procedure.
* History of a myocardial infarction ≤ 6 weeks prior to index procedure.
* Patients with clinically significant abnormality in cell blood count, history of bleeding diathesis or coagulopathy.
* Hemodynamic instability.
* Hypertrophic cardiomyopathy with obstruction.
* Left ventricle ejection fraction \<30%.
* Ongoing severe infection, including endocarditis, or sepsis.
* Life expectancy ≤ 12 months.