cyrilzakka/clinical-trials huggingface dataset:
First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

Primary Objective:

To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses

Secondary Objectives:

To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses

To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)

Study duration per participant is approximately 8 weeks including a 21-day screening and baseline phase, a 4-day treatment phase and a 28-day follow up period after dosing.

Eligibility Criteria:
Inclusion criteria :

* Male and female subjects, between 18 and 55 years of age, inclusive
* Body Mass Index ≥20 and ≤30 kg/m2
* Body weight between 65 and 90 kg, inclusive
* No concomitant medication
* Fasting Plasma Glucose \<126 mg/dL
* Hemoglobin A1c \<6.5%
* Triglycerides \<300 mg/dL
* Low-density lipoprotein (LDL) Cholesterol \<200 mg/dL
* Permanent sterile or postmenopausal, if female

Exclusion criteria:

* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, gynecologic (if female), ocular, or infectious disease, or signs of acute illness.
* Any medication (including over the counter products and any other herbal/alternative remedies such as St John's Wort) within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the medication; any vaccination within the last 28 days and any biologics (antibody or its derivatives) given within 4 months before inclusion.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
The Effects of Cognitive Functioning on Gait Rehabilitation

The present study is designed to investigate whether the behavioral and cognitive functioning might predict the outcome of the rehabilitation of gait related abilities in orthopedic patients submitted to elective surgery (total hip arthroplasty). The evaluation of gait related abilities will be performed with specific physiatric tests, while cognitive functioning will be studied by means of an extended neuropsychological battery.


Eligibility Criteria:
Inclusion Criteria:

* Age comprised between 50 and 80 years
* Submission to total hip arthroplasty
* Admission to the local rehabilitation program
* Signature of the informed consent

Exclusion Criteria:

* Major medical issues (e.g. neurologial or neurodegenerative diseases)
* Assumption of psychiatric drugs
* Pregnancy
Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid, and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some participants. The build-up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some participants. In this trial, participants who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study.

Preliminary results from this study (H6L-MC-LFAN \[LFAN\]) and another similar study (H6L-MC-LFBC \[LFBC; NCT00762411\]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will reflect results of analyses from the original LFAN protocol in addition to those from the amended LFAN protocol.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination (MMSE) score of 16-26 at Visit 1
* Modified Hachinski Ischemia Scale score of less than or equal to 4
* Geriatric Depression Scale score of less than or equal to 6
* A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD
* If female, must be without menstruation for at least 12 consecutive months or have had both ovaries removed

Exclusion Criteria:

* Is not capable of swallowing whole oral medication
* Has serious or unstable illnesses
* Does not have a reliable caregiver
* Chronic alcohol or drug abuse within the past 5 years
* Has ever had active vaccination for AD
Prospective Study on Prognosis of Cardiac Resynchronized Therapy (CRT), Implantable Cardioverter Defibrillator (ICD) Implantation in Patients With Congestive Heart Failure (CHF)

CRT and ICD has known as decreasing cardiac mortality in patient with heart failure. Especially, it has reported that CRT improved cardiac systolic function, quality of life of patients with heart failure. However, CRT and primary ICD was not generalized in Korea. So the investigators will register patients who implant CRT or ICD (primary), and follow them up. During scheduled follow up, all patients will perform echocardiography, 6 minute walking test, EKG, Holter monitoring and questionnaire on QOL.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>=18
2. LV ejection fraction \<40% or Clinical HF Symptom with (LV ejection fraction \>40%)
3. medication for at least 3month

Exclusion Criteria:

1. patient who refuse to enroll the study
Serum Sclerostin Level & Treatment of Vitamin D Deficiency

The aim of this study is to determine serum sclerostin levels and change in serum sclerostin levels in patients with Vitamin D deficiency treated with calcium and vitamin D.

Healthy premenopausal Patients with Vitamin D deficiency diagnosed and routinely treated with calcium and vitamin D will be included in the study. This is an observational study. The serum sclerostin levels will be measured before and after Vitamin D treatment.

This study is a prospective, observational, single-center study. Ethical approval was obtained from the Institutional Review Board.

This study will be completed with patients with Vitamin D deficiency. An intravenous cannula will be inserted into the antecubital vein. Blood samples will be obtained before and after treatment.

Serum will be collected and will be centrifuged for 15 minutes at 1000Xg within 30 minutes of collection. Aliquots of serum will be added to eppendorf tubes and stored at -20°C.

Serum sclerostin levels will be measured using a Human Sclerostin ELISA kit (Cusabio, Catalog No: CSB-E13146h, Newark, DE, USA). All assays will be performed according to the manufacturer's instructions. The minimum detectable concentration of human sclerostin is typically \<0.012 ng/ml. Intra-assay precision is less than 8%.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal
* Serum 25(OH)D \< 10 ng/mL

Exclusion Criteria:

* Anemia
* Tumor-induced osteomalacia (hypophosphatemia)
* Hypothyroidism
* Hepatic / renal disease
* Primary hyperparathyroidism
* Fibromyalgia
* Polymyalgia rheumatica
* Serum 25(OH)D \> 10 ng/mL
* Vitamin D and calcium treatment commenced prior to study participation
Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)

Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (TBI).

Sublingual tizanidine, a novel test formulation of the known effective antispasticity agent, has been shown to have a unique pharmacokinetic profile \[(i.e., nearly twice the bioavailability/AUC), but with little or no increase in peak plasma levels (Cmax), as compared to oral tizanidine (Zanaflex)\]. When administered nightly to CP (Cerebral Palsy) patients to more effectively reduce the muscle spasms that disrupt sleep, it was shown to improve sleep efficiency, decrease sleep fragmentation and improve the sleep cycle. This improvement in night-time sleep was translated into a potential improvement in next-day functioning (improvement in next-day measures of spasticity and movement).

It is hypothesized that a similar type of improvement in sleep with consequent positive impact on next day improvement in spasticity, cognition and function, may also be manifest in a similar patient population, children with traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

* Males/Females 8-18 years of age with documented history of TBI
* Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8
* Current Spasticity that interferes with task performance
* Patient is able to cooperate and understand general explanations

Exclusion Criteria:

* History of allergy to tizanidine or any inactive component (including lactose intolerance)
* Use of other hypnotic medication within 3 days of baseline visit and during the study
* Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial
* Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study
* Female patients on oral contraceptives
* Significant abnormalities in clinical screening laboratory parameters (ALT, AST, Bilirubin\>2 x uln; Creatinine\>2 mg/dl;WBC \<2300/mm3, platelets\<80,000/mm3)
* Taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit
What Should be the Next Vasopressor for Severe Septic Shock? Methylene Blue or Terlipressin

The ICU mortality rate of patients with septic shock was still high upto 54.1%.In first 6 hours of resuscitation, the goals of resuscitation in sepsis shock after adequate fluid resuscitation is MAP ≥65 mmHg. In refractory septic shock patient, prolong shock correlate with poor outcome due to multiple organ failure. Alternative vasopressor in septic shock with catecholamine resistance has been studied such as terlipressin, methylene blue

* Terlipressin (TP) mediate vasoconstriction via V1 receptors coupled to phospholipase C, and increases intracellular Ca2+ concentration
* Methylene blue (MB) directly inhibits nitric oxide synthase (NOS) by inhibit the enzyme guanylate cyclase (GC)


Eligibility Criteria:
Inclusion Criteria:

* Age \>15 years old
* Diagnosis septic shock as SCCM/ACCP
* Refractory septic shock defined as hypotension although adequate fluid resuscitate and high dose vasopressor(NE \>0.5 mcg/kg/min)
* Concent form

Exclusion Criteria:

* Known case G6PD deficiency
* Acute respiratory distress syndrome (ARDS)
* Hx of drug allergy MB, NE, terlipressin
* Hx of Raynaud's phenomenon, systemic sclerosis, PHT
* Known case coronary heart disease without treatment
* Current drug use serotonin reuptake inhibitors (SSRI), Serotonin and norepinephrine reuptake inhibitors (SNRIs)
* Reject to join project
Effects of Discharge Readiness on Success Following Discharge From Sub-Acute Rehab

Study's purpose is to determine if a patient's perception of readiness for discharge from sub-acute rehabilitation, as measured by Readiness For Hospital Discharge Scale Patient Self-Reports Form, correlates with the patient's success after discharge, measured by patient reported number of falls, emergency room visits and hospitalizations 30 days post discharge.

All sub-acute rehabilitation patients will be approached for study participation one day prior to discharge day from the facility. Patients will be approached in their private room within the facility to obtain consent. Consent will be reviewed with patient by investigators. Patients will be asked to demonstrate understanding of the study and what consent will imply utilizing the teach back method. If patient is able to demonstrate understanding and gives consent the MoCA will be administered. If MoCA scores falls between 22-30 they will be included in study. If MoCA score falls below 22 they will not be included in study and that will be explained to them at that time. MoCA scores will be included in patient medical record. Patient name and assigned ID number, phone number, second contact and consent will be recorded on the confidential roster sheet and stored in a locked file cabinet located in director's office at Peconic Landing. The day of discharge patients will complete the RHDS survey. Investigators will complete the study data sheet including ID number, MoCA score, RHDS score, length of stay, discharge date, and recommended discharge therapy- home care, outpatient, none. Thirty to thirty-seven days after discharge investigators will call patient and ask 3 questions from scripted form. "How many falls have you had since discharge home:, "How many visits to the emergency room have you had since your discharge home","How many admissions to the hospital have you had since your discharge home." Following completion of telephone questions, confidential roster sheet and consent form will be shredded.

Eligibility Criteria:
Inclusion Criteria:

Montreal Cognitive Assessment score 22 or greater

* consent with observed teach back confirmation
* discharge from sub-acute rehabilitation

Exclusion Criteria:

* Montreal Cognitive Assessment score less than 22
* inability to "teach back" during consent process
* non english speaking
Intraoperative Monitoring of the Pelvic Autonomic Nerves

One of the major problems of rectal cancer surgery is pelvic autonomic nerve damage, which is the main cause of urogenital dysfunction influencing postoperative quality of life. Costs for diagnostics and treatment of short and long-term urogenital dysfunction are immense. Varying degrees of urogenital dysfunction are found in up to 32% and 55% of patients with rectal cancer despite potentially nerve-sparing total mesorectal excision (TME).

The study will examine the impact of a newly developed continuous monitoring device for preservation of urogenital function in patients with TME for rectal cancer. 188 patients will be included in the prospective, randomized, single-blind, parallel group multi-centre trial including two arms (TME with and without intraoperative continuous monitoring of pelvic autonomic nerves). The primary efficacy endpoint is the change in urinary function measured by International Prostate Function Score (IPSS) 12 months after surgery. Genital functions measured as secondary endpoints. The application of the continuous intraoperative neuromonitoring device could enhance the objective intraoperative confirmation of pelvic nerve sparing surgery. The investigators hypothesis is that the use of his device minimizes the risk of postoperative urogenital dysfunction in patients with TME for rectal cancer. An enormous reduction of treatment costs is to be expected.


Eligibility Criteria:
Inclusion Criteria:

* informed consent
* histologically confirmed carcinoma of the rectum (≤ 16 cm from anal verge)
* fit for radical surgery
* total mesorectal excision
* age 18-80 years

Exclusion Criteria:

* history of operation of the urinary tract (e.g. prostatectomy)
* pacemaker
* emergency operation
* multivisceral resection in the pelvis
* partial mesorectal excision
* eligibility for local excision (TEM, intestinal wall resection)
* ongoing infection or sepsis
* severe untreated physical or mental impairment
* pregnancy or breastfeeding
* women of childbearing potential who are not using a highly effective birth control method
* missing preoperative data on urogenital or anorectal function
* simultaneous participation in another clinical trial
* previous participation in this clinical trial
* lack of cooperation with the trial procedure
Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.

This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part.

In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks.

In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, male or female
2. Life expectancy≥12 weeks;
3. Phase 1b: Patients with advanced solid tumors diagnosed by histology or cytology, who have been failure to previous standard treatments; Phase 2: Patients with HNSCC, NPC, OC, NSCLC, SCLC, HCC, cHL and other solid tumors diagnosed by histology or cytology, who have been failure to first-line standard treatment (including PD-1/L1) at least;
4. ECOG PS of 0 or 1;
5. Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation.
6. Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0);

Exclusion Criteria:

1. Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein;
2. Patients with symptomatic or progressive central nervous system (CNS) metastasis;
3. Uncontrolled hypertension, pulmonary hypertension or unstable angina, myocardial infarction within 6 months prior to administration; a history of chronic heart failure (NYHA G3/4); severe arrhythmia;
4. A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
5. A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency;
6. With other malignant tumors;
7. Diseases that may cause gastrointestinal bleeding or perforation;
8. Uncontrollable pleural, peritoneal or pericardial effusions;
9. A history of immunodeficiency;
10. A history of autoimmune diseases;
11. Uncontrolled severe active infections.
Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. According to published studies, it was hypothesized that acute ischemic stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and lower NIHSS score compared to the control group.

There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects in the control group.The participants were divided into an interventional group and a control group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7 days, while the control group was given placebo.

Eligibility Criteria:
Inclusion Criteria:

* 40-65 years old
* Has acute ischemic stroke with an onset of less than 48 hours before hospital admission
* NIHSS score of less than or equal to 15
* Can consume food orally or enterally
* Has given their consent to be a participant in the study

Exclusion Criteria:

* Renal failure
* Liver failure
* Is taking supplements other than his or her main stroke medications
* Has taken antioxidant supplements in the last 3 months before stroke onset
Health Behaviors in Pregnancy

To assess health and lifestyle behavior of pregnant women in Baton Rouge including women receiving traditional obstetrical prenatal care and delivering in a hospital and those receiving prenatal care from a midwife and delivering at the birth center.

It is of scientific interest to learn what the health and lifestyle behaviors are for women receiving prenatal care in a non-traditional birth center and the impact of these behaviors on pregnancy and birth outcomes.Participants will be offered a questionnaire packet to complete at a prenatal appointment in the third trimester of pregnancy by their obstetrical prenatal care provider. The questionnaire packet will take approximately 10-15 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the third trimester of pregnancy ≥ 28 weeks GA

Exclusion Criteria:

* None
Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results

The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.

The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≤43 years of age.
* Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
* Willing to have all 2PN embryos monitored by Eeva
* Not previously enrolled in this study.
* No concurrent participation in another clinical study.
* Willing to comply with study protocol and procedures and able to speak English.
* Willing to provide written informed consent.

Exclusion Criteria:

* BMI ≥ 40
* Prior IVF cycle with \< 4 x 2PN
* Diminished ovarian reserve as demonstrated by any one of the following:

  * BAFC \< 6 at time of cycle start
  * Maximum prior FSH \> 15
  * AMH \< 0.5