cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.

After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent from patient or legal representative.
* Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
* Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
* Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:

  i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.

Exclusion Criteria:

* Participating in another RCT in the past 12 months;
* Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:

  * HIV or HTLV virus infection;
  * Chronic hepatitis C (HCV) treated with direct antiviral drugs;
  * Liver failure;
  * Severe renal failure, including dialysis;
* Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
* Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
* Participants who underwent treatment with other antiviral drugs;
* Subject in antineoplastic treatment with chemotherapy or radiation therapy;
* Subject with severe autoimmune diseases in immunosuppression;
* Transplanted participants;
* Pregnant or lactating women;
* Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.
Study of PK/PD, Safety and Tolerability of LIK066 in Patients With Decreased Renal Function.

The purpose of this trial was to evaluate whether the study drug, LIK066, causes glucose excretion in urine in patients with varying degrees of decreased kidney function and in subjects with normal kidney function. Blood samples were collected to measure the concentrations of LIK066 and to study the pharmacokinetics of LIK066. Pharmacokinetics is meant to study how LIK066 is absorbed, distributed and eliminated, in other words what the body does to the drug. The results of this study may be used to help determine whether LIK066 can be used to treat people with reduced kidney function and the proper dosing regimen.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained before any assessment is performed.
* Male and female subjects age 18-78 years, inclusive, with controlled health condition as determined by past medical history, physical examination, electrocardiogram and laboratory test at screening.
* patients with Type 2 diabetes, HbA1c \<10% at screening.
* Body mass index (BMI) ≤ 50 kg/m\^2 at screening.

Exclusion Criteria:

* Patients with Type 1 diabetes
* Evidence of clinically significant liver function test: ALT, AST, gamma-GT, alkaline phosphatase \>3 X ULN; serum bilirubin \> 1.5 X ULN.
* Patients undergoing any method of dialysis
* clinically significant GI disorder related to malabsorption or that may affect drug or glucose absorption.
* subjects who experienced ketoacidosis, lactic acidosis or hyperosmolar coma within 6 months of screening visit.
Human Electrical-Impedance-Tomography Reconstruction Models

Current EIT analyses are based on the assumption of a circular thorax-shape and do not provide any information on lung borders. The aim is to obtain the body and lung border contours of male subjects by multi-detector computed tomography (MDCT) in defined thresholds of anthropometric data (gender = male; height; weight) for calibration of more realistic EIT reconstruction models.

A major drawback of EIT is its relatively poor spatial resolution and its limitation in measuring changes in bioimpedance as compared to a reference state (and not absolute quantities). Therefore, the technique cannot differentiate between extrapulmonary structures (muscles, thorax, heart, large vessels, spine, etc.) and non-aerated lung tissues - which is a major limitation for the clinical use of information derived from EIT-imaging. Moreover, current EIT-reconstruction algorithms are based on the consideration of a complete circular thoracic shape and do not take into account the body contours and lung borders.

The investigators are convinced that EIT-derived dynamic bedside lung imaging can be advanced by morphing computed tomography (CT) scans of the respective thoracic levels with concomitant EIT images - thus enhancing EIT-image information with CT-data. Integrating the anatomy of thoracic shape and lung borders provided by high-spatial resolution multi detector CT-scans (MDCT) with high-temporal resolution EIT has the potential to improve image quality considerably. This data can be used to compute mean EIT-reconstruction models that further offer the possibility to develop novel and clinically meaningful EIT parameters.

Therefore, the investigators hypothesize that by integration of CT-scan information of body and lung contours (and by computing different EIT reconstruction models) the current methodological limitations of EIT technology can be overcome.

Eligibility Criteria:
Inclusion Criteria:

* spontaneous breathing male subjects
* age \> 18,
* clinical indication for thoracic CT scanning,
* matching of weight and height to the predefined model-thresholds

Exclusion Criteria:

* pre-existing chronic pulmonary disease
* skin lesions / wounds in the thoracic plane where the EIT SensorBelt will be attached
* known allergy against any ingredient of the used ContactAgent
* abnormalities in thoracic shape as defined by the radiologist in charge (e.g. extreme kyphosis, funnel chest, pigeon breast, multiple rip fractures)
* pneumothorax
* pace maker (external and internal)
* other implanted electrical devices
* other methods measuring bioimpedance
Effects of Technology-based Physical Activity Interventions for Women After Bariatric Surgery

Regular physical activity (PA) is essential throughout bariatric surgery (BS) management, especially for the long-term maintenance of weight loss. To optimize physical activity counseling and monitoring, the use of technology seems appropriate and effective. A recent meta-analysis provided proof of efficacy for mobile technology to increase physical activity or weight loss in the short term. Videoconferencing may also be effective, especially as it reduces the barriers related to face-to-face physical activity interventions. Both technologies (mobile and videoconferencing) seem particularly interesting for bariatric surgery management, but their long-term effects on physical activity maintenance are unknown. Moreover, the mechanisms underlying their effectiveness, such as technology acceptability and motivational processes, have not been examined.

The purpose of this study is to determine the effects of two technology-based (mobile technology and videoconferencing) PA programs after BS compared to standard care and to assess the contribution of acceptability and motivational mechanisms in explaining these effects on behavioral measure of PA, physical measures, and health indicators.

One hundred and twenty young women who have undergone BS in the last 3 to 6 months will be included. The volunteers will be randomly assigned to one of three arms: standard care (CONTROL), access to an internet-based physical activity program delivered by an eHealth platform associated with an activity bracelet (ACTI-MOBIL), or access to a physical activity program delivered via videoconferencing (ACTI-VISIO). The primary outcome is the distance traveled during a 6-minute walk test relativized according to Capadaglio's theoretical distance. Secondary outcomes are behavioral measures of physical activity, physical measures, health indicators, technology acceptability, and motivational concepts. Data will be collected baseline (T0), 3 months (T3) and 6 months later (T6). The technology groups will receive a PA program for 12 weeks (between T0 and T3). A mixed model approach will be used to analyze the change in outcomes over time for each group.

This study will provide information on the effects of two technology-based physical activity programs (mobile technology and videoconferencing) after bariatric surgery. Based on the results, recommendations for implementing these programs will be made.


Eligibility Criteria:
Inclusion Criteria:

* Undergone bariatric surgery at a tertial referral center for bariatric surgery (Nice University Hospital, France) 3 to 6 months ago
* Respect with the national recommendations (e.g., BMI ≥ 40kg/m² or ≥ 35kg/m² with at least one co-morbidity among blood hypertension, type 2 diabetes, invalidating arthritis, and sleep apnea syndrome; and no physical disability to practice PA)
* Having a smartphone compatible with the proposed technologies.

Exclusion Criteria:

* Serious adverse events
* Withdrawal of informed consent or violation of the protocol
The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak in Robotic Colorectal Surgery

In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time.

Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subject is able to give informed consent for participation in the study
* Subject is willing and able to comply with the study procedures
* Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision
* Subject is scheduled for robotic colon or rectal resection
* A negative pregnancy test for women of childbearing potential prior to surgery

Exclusion Criteria:

* Subjects present with bowel obstruction or perforation
* Subject undergo emergency surgery
* Subject with ASA IV, V
* History of allergy or hypersensitivity against indocyanine green
* Pregnant or breast-feeding women
* Subject has uremia (serum creatinine \>2.5 mg/dl)
* Subject is undergoing palliative surgery or who is terminally ill
* Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery
* Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid
Ibritumomab Tiuxetan (Zevalin)+ Rituximab Maintenance

Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression

The objective of this study is to estimate the median progression-free survival for patients receiving this regimen, along with the rate of complete response at 6 months, toxicities associated with this regimen, and laboratory correlates. Subjects will receive the Ibritumomab Tiuxetan (Zevalin) therapeutic regimen; then rituximab consolidation and maintenance therapy every 3 months until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Patients with biopsy-proven non-hodgkins lymphoma of follicular grade 1, 2, or 3
* Meeting FLIPI criteria for intermediate or high risk.
* No prior chemotherapy, radiotherapy or immunotherapy for lymphoma;
* Patients may not have known HIV infection, and must not be Hepatitis B Surface Antigen positive.

Exclusion Criteria:

* May not be pregnant or breastfeeding, have documented CNS (Central Nervous System) disease, G-CSF (Granulocyte Colony Stimulating Facto) or GM-CSF (Granulocyte/Macrophage Colony Stimulating Factor) within 2 weeks prior
A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy volunteers between 18 and 55 years of age.
* Body weight less than 110.00 kg inclusive at Screening.

Exclusion Criteria:

* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
* Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.
Physiological and Biomechanical Data Collection Study in Epilepsy Subjects

The purpose of this study is to gather changes in physiological and biomechanical data during daily activity and sleep in epilepsy subjects.

The purpose of this study is to gather changes in physiological and biomechanical data such as ECG, respiration, and accelerometry data during daily activity and sleep in pediatric and adult subjects with epilepsy. Subjects will use a device that enables monitoring of the human state in everyday, free-living environments.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be six (6) years of age or older
2. Subject has a clinical diagnosis of epilepsy
3. Subject is currently taking at least one antiepileptic medication.
4. Subject must be in good general health and fully ambulatory.
5. Subject or guardian must be willing and able to complete informed consent and/or assent for children and HIPAA authorization.

Exclusion Criteria:

1. Subjects with chest circumference smaller than 29 inches or greater than 47 inches.
2. Subjects with existing signs of skin irritation, rash, damage or infection on the torso that in the opinion of the investigator would prevent the subject's participation in the study.
3. Subjects with a medical condition that in the opinion of the investigator would affect his/her ability to participate in the study.
4. Subjects with implanted defibrillators, pacemakers or neurostimulators (e.g., vagus nerve stimulators or pain stimulators).
5. Subjects who are pregnant or lactating.
6. Subjects with severe psychiatric disease that in the opinion of the investigator would prevent the subject's successful completion of the study.
7. Subjects 6 to 16 years of age with moderate/severe learning difficulties or those who may be at risk of self-harm.
8. Subjects prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response unless the patient has ictal tachycardia while taking said drugs. These include, but are not limited to, beta adrenergic antagonists ("beta blockers").
9. Subjects with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to activity, stress, or seizure. This would include but not be limited to chronic atrial fibrillation or chronotropic incompetence.
10. Subjects with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.
11. Subjects currently participating in another clinical study.
Montelukast in Seasonal Allergic Rhinitis: Fall 2001 Study (0476-240)

This is a study to evaluate the treatment effect of montelukast 10 mg taken in the morning, versus placebo, in patients with seasonal allergic rhinitis. Loratadine is included in the study as an active control.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of seasonal allergic rhinitis that worsens during the study season
* Patient is a nonsmoker
* Patient is in good health physical and mental health

Exclusion Criteria:

* Patient is hospitalized
* Patient is a woman who is \< 8 weeks postpartum or is breastfeeding
* Patient plans to move or vacation away during the study
* Patient has had any major surgery with in past 4 weeks
* Patient is a current or past abuser of alcohol or illicit drugs
Total Knee Replacement Using Simplex® or Cobalt™ Bone Cement

The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

The purpose of this study is to collect radiographic and clinical outcomes of total knee replacement using Simplex® or Cobalt™ Bone Cement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
* Patients requiring correction of varus, valgus, or posttraumatic deformity
* Patients requiring correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure

Exclusion Criteria:

* Infection, sepsis, and osteomyelitis
Monitoring Risks for Hematological Changes in Gas Station Workers

Gas station workers are exposed to carcinogenic substances.This increases risk of their exposure to hematological diseases such as lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), myelodysplastic syndromes (MDS), and myelogenous leukemia (AML), as well as different forms of non-Hodgkin's lymphoma (NHL) and multiple myeloma. Thus, the early identification of this condition between the gas station workers may prevent the hematological disease progression.

Gas station workers are exposed to carcinogenic substances.This increases risk of their exposure to hematological diseases such as lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), myelodysplastic syndromes (MDS), and myelogenous leukemia (AML), as well as different forms of non-Hodgkin's lymphoma (NHL) and multiple myeloma.

It is known that severe bone marrow dysplasia is frequently accompanied by early alterations in the immune system and in peripheral cell subsets.

The bone marrow injury by benzene metabolites is a strong predisposing factor in the pathogenesis of Benzene-induced hematopoietic disease .Thus, the early identification of this condition between the gas station workers may prevent the hematological disease progression.

The reactive metabolite of benzene, 1,4-benzoquinone (BQ) is suggested to be a key molecule of benzene-induced hematotoxicity and carcinogenicity as it cause abnormal accumulation of myeloid cells and precursors, which cause benzene induced cytopenia and myeloid dysplasia in humans.

Eligibility Criteria:
Inclusion Criteria:

* This study will be conducted on a group of gas station workers exposed to benzene for more than 3 years .

Exclusion Criteria:

* diagnosed gas station workers with blood malignancies .
* gas station workers exposed to benzene for less than 3 years .
Cavity Shaving in Breast Conserving Surgery for Breast Cancer Patients

This randomized controlled trial is to evaluate the impact of additional cavity shaving (CS) on pathological cavity margin (CM) status in breast cancer patients. Patients receiving standard breast-conserving surgery (BCS) will be randomized to intra-operative CM assessment versus intra-operative CS followed by CM assessment. The primary objective of this study is to assess the impact of CS on intra-operative CM status, intra-operative re-excision rate, post-operative CM status and re-excision rate, cosmetic outcomes, and on intraoperative time and medical costs.

After stratified and blocked randomization, the patients' name, admission ID and treatment assignment will be written on a slip of paper, and will be placed in a sealed envelop. A label with the patients' name and admission ID will be placed on the sealed envelop, which will be kept in a locked file. On the day of surgery, a research coordinator will bring the sealed envelope to the operation room. During the standard-of-care BCS, the tumor was excised with a rim of grossly normal tissue. Additional resections are allowed when any of the margins of the tumor-containing specimen were suspected to be inadequate on the basis of standard gross evaluation by surgeons. Prior to intra-operative CM assessment, the research co-ordinator will unseal the envelop and determine which procedure has been designated to the patient. The cosmetic outcome and the quality of life will be evaluated at the day of discharge, after completion of radiotherapy and one year by the patient herself, her partner and a research co-ordinator.

Eligibility Criteria:
Inclusion Criteria:

* Female
* At least 18 years of age and no more than 65 years of age
* Able to understand and willing to sign an informed consent document
* Willing and planning to undergo the breast-conserving surgery
* ECOG≤ 2

Exclusion Criteria:

* Inflammatory breast cancer
* Preference for mastectomy instead of breast-conserving surgery
* Necessity to undergo oncoplastic breast surgery
* Prior surgical treatment, including ultrasound-guided vacuum-assisted biopsy and excision biopsy.
* Prior systemic therapy for this diagnosis, including neoadjuvant chemotherapy, neoadjuvant endocrine therapy.
* History of prior breast/axillary radiation therapy
* Known metastatic disease
* Diagnosed as bilateral breast cancer or DCIS
* History of other malignancy ≤ 5 years previous
* Preoperation evaluation indicates tumor size\>5cm
* Preoperation evaluation indicates multicenter or multifocal breast cancer(including suspicious calcification on mammography)
* Undergoing other clinical trials
* With sever liver disfunction(Child-Pugh C)
* With sever cardiac insufficiency
* With sever renal disfunction
* Pregnancy