cyrilzakka/clinical-trials huggingface dataset:
Study to Compare PK and Safety of Subcutaneous Injection of Ustekinumab and CT-P43 in Healthy Subjects

This study is a Phase 1, 2-Part, Randomized, Double-Blind, Parallel-Group, Single-Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Three Subcutaneous Injection Formulations of Ustekinumab (CT-P43, EU approved Stelara, and US licensed Stelara) in Healthy Male Subjects.

CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab). This study will be conducted in 2 parts. In Part 1, subjects will be enrolled and randomized in a 1:1 ratio to receive a single dose (45 mg) of either CT-P43 or EU-approved Stelara to collect preliminary safety data for CT-P43. In Part 2, subjects will be enrolled and randomized in a 1:1:1 ratio to receive a single dose (45 mg) of CT-P43, EU-approved Stelara, or US-licensed Stelara to demonstrate PK similarity. Each part will proceed independently, and subjects will be randomized to either Part 1 or Part 2 of the study subsequently. All subjects in Part 1 and Part 2 will undergo the same assessments. In each treatment arm in Part 1 and Part 2, all subjects will receive a study drug subcutaneously via PFS. The randomization to treatment assignment will be stratified by study center and body weight as measured at baseline to balance subject weight across treatment groups. Subjects will be confined to the study center until all required 24-hour post-dose assessments have been completed and will be discharged on Day 2. Subsequent visits will be carried out on an out-patient basis up to EOS.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects, between the ages of 18 and 55 years.
2. Subject with a BMI between 18.5 and 29.9 kg/m2. Weight between 60 to 100 kg.
3. Subject must agree to use medically acceptable methods of contraception consistent with local regulations during the course of the study and for 18 weeks after administration of the study drug.
4. Subject is informed and able to understand the full nature and purpose of the study, including possible risks and side effects, and is given ample time and opportunity to read and understand this information.

Exclusion Criteria:

1. Subject has a prohibited medical history and/or current condition.
2. Subject is planning to father a child or donate sperm within 18 weeks after the administration of the study drug (Day 1).
3. Subject previously received any biologic agents
4. In the opinion of the investigator, the subject is not eligible for the study participation for any reason.
5. Subject is vulnerable.
A Feasibility Study on Prediction of an ICD Shock by ICD-derived Data

The primary hypothesis is that an ICD shock may be predicted days in advance by a combined score derived from different data obtainable from the ICD


Eligibility Criteria:
Inclusion Criteria:

1. Age ≧ 18 and ≦ 80
2. Patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment
3. Patients who are in sinus rhythm, have dual-chamber ICD or CRT-D implanted at least one month before enrollment
4. Patients who are in atrial fibrillation, have single-chamber ICD or CRT-D implanted at least one month before enrollment
5. Patients who are compliant to CareLink follow-up

Exclusion Criteria:

1. Patients who are pregnant
2. Patients who are incapable of giving consent to the study
3. Patients who have a life-expectancy of less than 2 years
Evaluation the Operative Procedure Among Patients That Suffer From Tear of the Distal Tendon of the Biceps

Background: rupture of the distal tendon in biceps muscle is a rare injury. The state of the art treatment is surgical procedure.

Objective: Evaluation of the Surgical procedure among patients that suffered from Methods: The investigators will review files from 2003-2010 of patients that gone through the operation. The investigators will record pre-operation and post-operation process including complications and rehabilitation. The investigators will invite them to the clinic for exams, clinical questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1.see population description

Exclusion Criteria:

1. Unwillingness to come to the clinic visit.
Movement and Sensation for Advanced Prosthetic Hands

The purpose of this study is to learn more information about nerves. This study is also designed to learn how the information in nerves could be used to develop new prosthetic devices.

The general design of the study is broken down into two parts: the pre- and post-implantation schedules:

During the 30 days before implantation the participant will be asked to take home a small computer with an Oculus Rift headset and Leap Motion hand tracker. The participant will be asked to use these items five (5) times a week for 30 minutes a session and interact with a displayed virtual reality environment. In this environment the participant will move their intact hand and the Leap Motion will display the hand movements in the virtual environment with the intact hand movements being mirrored between two hand facsimile. The participant will be instructed to move and stretch both their phantom and intact hand in a mirrored fashion. The purpose of these exercises are to allow the participant to become accustomed to the virtual reality setup (equipment and display) as well as providing a mirror box like effect where the virtual hand facsimile for their phantom hand is mapped to their body.

The second phase of the general design continues for 30-90 days post-implantation. We shall perform electrophysiological recordings from a single microelectrode array implanted into either the median, radial, or ulnar nerve. Neural signals (single and compound action potentials) evoked by variegated movements of the fingers and thumb will be recorded on the implanted microelectrode array. By recording electrical signals from the nerves the investigators hope to decode finger movements in real-time using machine learning algorithms. The participants will be asked to complete tasks in controlled virtual environment during the training phase. The virtual environment, which includes virtual arms and hands, will be presented to the participant via the Oculus rift, a pair of virtual reality goggles. The task will require recording the position of arms in space which will be accomplished using the Vicon motion capture system that will use infra-red reflecting markers attached to the participant's arms. The investigators will also use a marker-less motion capture system, Leap Motion, to track the specific movements of the intact hand. Post training, the investigators aim to perform real-time decoding of finger movements in the virtual reality environments.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has previously undergone a transradial (below elbow) or transhumeral (above elbow) amputation.

Exclusion Criteria:

1. Pregnancy
2. Incarceration
3. Inability to consent
4. Serious, untreated comorbidity
5. Patient is diagnosed with a medical condition(s) that seriously increase the risk of electrode implantation
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.

OBJECTIVES:

* Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
* Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen.
* Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 19-36 patients will be accrued for this study within 1.7-3 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of metastatic colorectal carcinoma
* Bidimensionally measurable disease

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* At least 12 weeks

Hematopoietic:

* WBC at least 4,000/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 8 g/dL

Hepatic:

* Bilirubin no greater than 1.2 mg/dL
* AST and ALT less than 2.5 times upper limit of normal (ULN)
* PT no greater than ULN (not on anticoagulation therapy)

Renal:

* Creatinine no greater than 1.5 mg/dL
* Creatine clearance greater than 60 mL/min

Pulmonary:

* DLCO at least 60%

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study
* No other concurrent active malignancies
* Prior malignancies presumed to be cured allowed
* No other concurrent uncontrolled severe medical problem that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 6 months since prior adjuvant chemotherapy without disease recurrence
* No more than 1 prior chemotherapy regimen for metastatic disease

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior adjuvant radiotherapy allowed
* No prior radiotherapy to more than 25% of total bone marrow

Surgery:

* Not specified

Other:

* No other prior therapy for advanced disease
Effectiveness of the ARTH-e Application on Adherence to Physical Exercises in Patients Suffering From KOA: RCT

The aim of this study is to investigate the effectiveness of a smartphone-based e-health application (intervention group) compared with standard care (control group) in terms of changes in adherence in patients with knee osteoarthritis using the EARS questionnaire. In addition, other questionnaires presented in the appendix (KOOS, TSK, EPAP, EQ-5D-3L, pain) will be given to all patients in order to meet the secondary evaluation criteria.

Knee osteoarthritis is the most common joint disease affecting the joint itself as well as the peri-articular structures in a global and progressive manner. It can affect all the joints of the body, with a predominance for those which undergo strong mechanical constraints such as the rachis, the hip or the knee. It is a chronic pathology correlated with age, since nearly one adult in two is affected by osteoarthritis.

Today, connected objects have taken a predominant place in the daily life of the majority of the population, including seniors. It is an object of communication and socialization as well as a major information tool. E-health applications are more and more numerous in the stores and are a tool for assistance, information and support already used in many fields. In the context of therapeutic education, it is a motivational tool that can accompany patients by adapting to their needs and progress compared to traditional self-exercise methods. Studies of the obstacles and levers for the use of smartphone applications in chronic pathologies such as low back pain support the development of this tool.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 40 and 85 years with uni or bilateral knee osteoarthritis according to EULAR (European League Against Rheumatism) criteria, symptomatic and diagnosed prior to inclusion by a specialist or not.
* Having an involvement of at least one knee.
* Own a smartphone or tablet running at least Android 5 or iOS 11.
* Able to give written consent to participate in the study.
* Beneficiary of a social security plan.

Exclusion Criteria:

* pregnant or breast-feeding women Patients under legal protection measures (guardianship, curatorship or protection of the court)
* Patients who have undergone knee surgery (total or partial prosthesis, tibial transposition surgery, arthrodesis)
* Patients with inflammatory rheumatism
* Patients with neurological sequelae
* Contraindications to physical activity for medical reasons
* Patients with difficulties in understanding the French language
* Refusal to participate
* Patients who have already participated in the ARTH-e 2 study or who are already included in a research protocol that could influence the current protocol
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be currently participating in the 20040138 Amgen study
* Subjects must sign the informed consent before any study specific procedures are performed.

Exclusion Criteria

* Subjects with any prior diagnosis of bone metastasis
* Known hypocalcemia
* Developed sensitivity to mammalian cell derived drug products during the 20040138 study
* Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study
* Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
A Study to Evaluate the Safety and Pharmacokinetics of AG2304 Compared to Coadministration of AG23041 and AG23042

The objective of this study is to evaluate the pharmacokinetic characteristics of AG2304 in healthy subjects.

To evaluate the pharmacokinetic characteristics and safety profiles of AG2304 compared with coadministration AG23041 and AG23042 after a single oral dose administration in healthy Korean subjects under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* A healthy adults aged 19-65 years at the time of screening
* Subjects who are deemed eligible based on the screening tests

Exclusion Criteria:

* Subjects who have taken the investigational drug within 6 months prior to the first dose
* Other exclusions have been applied
Application of Iced Normal Saline Combined With Cocktail Perfusion in Total Knee Arthroplasty

Sixty patients undergoing TKA were divided into three groups, then three different intro-operative articular cavity perfusion treatment was given according to the randomized, double-blind and controlled rule. One way ANOVA analysis on visual analogue scale (VAS) score, functional recovery, drainage, and edema of the affected limb were performed to assess the efficiency of the treatment in the following three days after the operation.

Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study, whilst subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded. After assessment, sixty qualified patients who voluntarily participating in this study have understood the research project were included in the present study and the corresponding consent forms were signed. Patients were randomly classified into three groups with different interventions, each group contains 20 patients. Group A: twenty patients who were given intraoperative joint cavity infusion therapy using 20ml tranexamic and 40ml iced normal saline; Group B twenty patients who were given 20ml of iced normal saline, 20ml of iced cocktail and 20ml of tranexamic; the left twenty patients were given joint cavity infusion therapy with 20ml tranexamic only as the control group. All the study personnel including the patients, their family members, the nursing staff and the leading operator were blind to the treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

Patients with confirmed primary knee osteoarthritis in stage IV by preoperative X-ray were included in present study. Kellgren-Lawrence Radiology standards for stage IV were listed as follows: obviously narrowed joint space; vast osteophytes are formed; severe osteosclerosis under the cartilage; bone hypertrophy and evident deformity

Exclusion Criteria:

Subsequent arthritis (including rheumatoid arthritis, Gouty arthritis, traumatic arthritis, etc.) were excluded.
Prevention of Atrial Arrhythmia in Patients Without Atrioventricular (AV) Conduction Disease

This clinical investigation is a prospective, single-blinded, randomized trial. The primary objective concerns the safety and effectiveness of the AAIsafeR mode with the preventive algorithms.

In this study, patients are randomized to DDD mode, AAIsafeR mode, or AAIsafeR mode plus atrial arrhythmia preventive algorithms. The atrial arrhythmia (AA) burden serves as the primary measure of effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* A pacemaker indication for sinus node dysfunction and/or brady-tachy syndrome OR already implanted for less than three months for the mentioned reasons and supplied with a symphony 2550 DR at time of inclusion AND
* A PR interval \<250ms AND
* Documented atrial arrhythmia in the past year
* Medication for anti-arrhythmic must be stable for at least one month (2 months for amiodarone) prior to enrollment
* Patients must have less than two known cardioversions within the last year
* Patient has signed a consent form after having received the appropriate information

Exclusion Criteria:

* Need a replacement pacemaker device
* Have an unknown PR interval
* Known AV block ≥ 250 ms PR interval
* Minor and/or pregnant woman
* Patients enrolled in other clinical trials
* Patients with sustained ventricular arrhythmia
* Patients with severe coronary artery disease (at the discretion of the investigator)
* Patients with advanced cardiomyopathy (at the discretion of the investigator)
* Patients who have sustained a myocardial infarction or undergone cardiac surgery within the past 30 days
* Patients with unstable angina pectoris
* Patients whose life expectancy is less than 1 year
* Patients who are unlikely to return for required follow-up visits
* Patients who present with permanent atrial arrhythmia or those who usually require cardioversion to terminate such arrhythmia and/or
* Patients whose physician plans to add or change medical treatment because of AA episodes during the follow-up period.
* Patient unable to understand the purpose of the study or refusing to cooperate
The Prism Adaptation Study (PAS)

To determine whether the preoperative use of prisms in eyeglasses can improve the outcome of surgery for acquired esotropia, a type of strabismus.

To determine whether patients who respond to prism adaptation by developing a new stable angle of -deviation have a better surgical result than do patients who do not respond to prism adaptation.

To determine whether patients who respond to prism adaptation are more accurately corrected by operating for the prism-adapted angle or the original angle of deviation.

To determine the usefulness of certain input variables (e.g., age at the time of surgery, size of the deviation, visual acuity, binocular function, refractive error) in predicting which patients are more likely to benefit from prism adaptation.

Acquired esotropia (crossed eyes that develop after a child reaches the age of 6 months) accounts for 25 percent of all patients with misaligned eyes. Surgery to correct esotropia is done primarily to attain functional use of the two eyes together. The cosmetic aspect of the surgery is secondary. In 40 to 50 percent of cases, more than one operation is needed to accomplish the primary goal, and in some cases even three and four operations are needed.

Preliminary studies from two eye care centers reported that the use of prisms on eyeglasses for about a month before surgery led to good results after a single operation in more than 90 percent of patients. These uncontrolled preliminary studies pointed to the need for a multicenter, randomized, controlled clinical trial designed to prove or disprove scientifically the beneficial effect of prisms.

The Prism Adaptation Study was a double randomization trial involving 286 patients. Three-fifths of the patients were randomly selected for prism adaptation before surgery. Of the patients who responded to the prisms, one-half were randomly selected to have surgery based on the amount of prism required to stabilize the deviation, and the other half had surgery based on the amount of esotropia originally measured. Patients who did not respond to the prisms also had surgery based on the amount of esotropia measured, as did the two-fifths of the patients who did not undergo prism adaptation.

Patients were examined postoperatively at 1 week, 1 month, 3 months, 6 months, and 1 year. An independent examiner, masked to the treatment assignment, evaluated the patient at the 6-month followup. The results were analyzed to determine whether the outcome was better in patients who underwent prism adaptation or in those who underwent conventional treatment. Because the examiner did not know what type of treatment a patient had received, he or she would have no bias in evaluating the results.

Eligibility Criteria:
An eligible male or female must have been age 3 years or older (adults were included) and must have had esotropia that occurred at age 6 months or older, with no history of previous eye muscle surgery.
Effectiveness of Colchicine Among Patients With COVID-19 Infection

In November 2019, there were a lot of cases of an acute respiratory illness (then named at February 11th as COVID_19) which first case was reported in Wuhan, China,The SARS COV-2 had been spread in a fast way to involve whole world, As it's obvious that Colchicine is a drug that is most commonly and widely used to treat and prevent acute attacks of Gout, other crystal induced arthropathy,colchicine has important role in inhibiting activation of NLRP3 inflammasome these lead to decrease cytokine production , aim of study To evaluate whether colchicine is effective in the treatment of COVID-19 cases. And to measure the effectiveness of colchicine in alleviating and controlling pulmonary and extra pulmonary complications of COVID-19

this is an open label, randomize control clinical trial ,the participant will be randomly assign in to two groups ( Group A and Group B), colchicine (group A) will treat with colchicine tablet alone or add to their Current treatment,Colchicine 0.5 mg twice daily (reduce to 0.5 mg/day, in patients with low body weight or develop side effects like gastrointestinal symptoms ),For 14 days or until symptoms subsides, while the control group will treat according to usual treatment guideline in COVID-19.

Eligibility Criteria:
Inclusion Criteria:

1.patients diagnosed clinically or by RT-PCR in nasopharyngeal swab specimens and/ or lung involvement confirm by computed tomography scan compatible with COVID-19patients 2.Age between 18 year and 70 years, 3.body weight \> 50 kg, 4.with written informed consent from patients or relatives.

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Exclusion Criteria 1 sensitivity to any medications of regimens, 2.e GFR less than 30. 3.pregnancy. 4.malignancy . 5.Participating in another clinical study and refusing to participate in the study at a later date or later, and they are already taking colchicine for other diseases .

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