cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects.

The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects.

The trial is conducted in a single center, randomized, double blind, placebo controlled, dose increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-718 injection in Chinese obese subjects. The study consists of three dose groups, each of which is planned to include 12 subjects (9 receiving the study drug and 3 receiving placebo), for a total of 36 patients. Subjects will receive 12 weeks（for cohort 1 and 2） or 18 weeks(for cohort 3) of treatment after screening and complete 8 weeks of safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese male or female subjects aged 18-60 years (both inclusive).
2. Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI) ≥28.0 kg/m2 at screening.
3. Weight change \<5% in the past 3 months before screening.

Exclusion Criteria:

1. FPG ≥7.0mmol/L or glycosylated hemoglobin (HbA1c) ≥6.5% or diagnosed diabetes
2. FPG \<3.9 mmol/L at screening and/or a history of hypoglycemia.
3. History of Cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones.
4. Abnormal Thyroid-Stimulating Hormone(TSH), free triiodothyronine(FT3), Free thyroxine(FT4) or diagnosed thyroid dysfunction
5. History of multiple endocrine neoplasia syndrome type 2 (MEN-2) or medullary thyroid carcinoma (MTC).
6. Diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening
7. Systolic blood pressure \> 160 mmHg and/or diastolic blood pressure \> 100 mmHg at screening or randomization.
8. PR intervals \> 210 msec and/or QRS wave group time limit \> 120 msec and/or Corrected QT interval using Fridericia's formula（QTcF）\> 450 msec at screening or randomization.
9. Serum amylase or lipase \> 3× upper limit of normal (ULN) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis.
10. Low density lipoprotein cholesterol(LDL-C) ≥4.40 mmol/L or triglyceride (TG) ≥5.65 mmol/L.
11. Use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening
12. History of bariatric surgery for weight loss 1 year before screening.
Effectiveness of a Home-based, Self-administered Exercise Program for Hands in Patients With Systemic Sclerosis

Systemic sclerosis (SSc) is a heterogeneous autoimmune disease characterized by fibrosis of the skin and internal organs. Hand involvement is one of the most observed musculoskeletal involvements in patients with SSc, which can impact on general health, quality of life, and psychological status. Hand exercise programs can help patients to improve not only hand function but also general health status; nevertheless, further randomized control trials (RCTs) are needed to clarify its effect. Hence, the investigators aimed to investigate the effectiveness of home-based, self-administered exercise program for hands in patients with SSc and demonstrate the improvements in general health status.

The current study was designed as a single-blind, prospective, randomized controlled, comparative study with a 2-month follow-up period, conducted in a rheumatology outpatient clinic of a university hospital, between July 2016-June 2019. Female patients with SSc who fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis were included in the study. Patients with neurological disorders, arthritis, myositis, amputation of fingers, serious contracture resisting handgrip, and history of undergoing hand surgery were excluded from the study. Patients were enrolled in the study after they signed the written informed consent. Following the assessment of patients in terms of eligibility, patients were randomized into an exercise and a control group. The computerized block randomization method was used to randomize subjects into groups. Both groups were informed about systemic sclerosis and they received the printed materials that include recommendations such as avoiding cold and trauma. The treatment group participated in a single hand exercise training (isometric hand exercise and self-administered stretching) applied by a physiatrist. They additionally received the printable instructions for exercises. Compliance was assessed by a checklist, which included all information on how to exercise and how many times to do them. The investigators aimed to investigate the impact of hand exercise program on hand function and demonstrate its influence on health status, quality of life, and psychological status of patients with SSc.

Eligibility Criteria:
Inclusion Criteria:

- Female systemic sclerosis patients who fulfilled the 2013 ACR/EULAR classification criteria for systemic sclerosis

Exclusion Criteria:

* Patients with neurological disorders,
* Arthritis,
* Myositis,
* Amputation of fingers,
* Serious contracture resisting hand grip
* History of undergoing hand surgery
The PROGRAM-study: Awake Mapping Versus Asleep Mapping Versus No Mapping for Glioblastoma Resections

The study is designed as an international, multicenter prospective cohort study. Patients with presumed glioblastoma (GBM) in- or near eloquent areas on diagnostic MRI will be selected by neurosurgeons. Patients will be treated following one of three study arms: 1) a craniotomy where the resection boundaries for motor or language functions will be identified by the "awake" mapping technique (awake craniotomy, AC); 2) a craniotomy where the resection boundaries for motor functions will be identified by "asleep" mapping techniques (MEPs, SSEPs, continuous dynamic mapping); 3) a craniotomy where the resection boundaries will not be identified by any mapping technique ("no mapping group"). All patients will receive follow-up according to standard practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤ 90 years
2. Tumor diagnosed as GBM on MRI as assessed by the neurosurgeon
3. Tumors situated in or near eloquent areas; motor cortex, sensory cortex, subcortical pyramidal tract, speech areas or visual areas as indicated on MRI (Sawaya Grading II and II)
4. The tumor is suitable for resection (according to neurosurgeon)
5. Written informed consent

Exclusion Criteria:

1. Tumors of the cerebellum, brain stem or midline
2. Multifocal contrast enhancing lesions
3. Medical reasons precluding MRI (e.g. pacemaker)
4. Inability to give written informed consent (e.g. because of severe language barrier)
5. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin
Chronotherapy for Radiotherapy of Glioma

This study aims to determine if there is any difference in the efficacy of radiotherapy for glioma outcomes in the morning or in the evening. The study team believes that there may be a benefit to taking the radiotherapy at a certain time of day. To test this theory the study asks participants who are already taking radiotherapy for glioma consistently at either the morning or in the evening based on when they currently take their radiotherapy. There will be this study visits where the participant will be asked to fill in questionnaires related to their neurological symptoms, their sleep habits, sleep quality, survival situation, and general health information followed by a blood draw.

The objective of this study is to determine whether the timing of radiotherapy to treat glioma has an effect on patient outcomes.

Primary objective: Determine whether there is a difference in outcomes seen when patients are assigned to take their radiotherapy at either a morning time or evening time.

The Investigator hypothesize that administration time of radiotherapy during the day can affect the clinical outcomes in glioma patients.

Specific Aims Include:

* Determine whether morning vs. evening dosing radiotherapy could affect the survival time of glioma patients.
* Determine whether morning vs. evening dosing radiotherapy could affect the KPS score of glioma patients.
* Determine whether morning vs. evening dosing radiotherapy could affect the cognitive function of glioma patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Pathological or cytological diagnosis of glioma;
3. Normal liver and kidney function.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Second primary malignancy;
3. Severe lung infection;
4. with high blood pressure although treated with medication;
5. Patients with myocardial ischemia or myocardial infarction, arrhythmia (including QT interval \> 440 ms) or grade II cardiac insufficiency;
6. Arteriovenous thrombosis in 6 months prior to first administration, Such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;
7. Serious heart, lung and bone marrow impairment;
8. History of severe hypertension or cerebral hemorrhage
Impact of Decision Aids on Bariatric Surgery Choice

Sleeve gastrectomy, Roux-en-Y gastric bypass, laparoscopic gastric banding, and bioenteric intragastric balloon insertion are common types of bariatric surgeries. These treatment strategies have diverted outcomes in body weight loss, metabolic diseases control, surgical complications, and life quality improvement. Thus, shared decision making (SDM) is necessary to aid patients to choose an appropriate treatment that suits thier needs. Investigators have developed a decision aids (DAs) and plan to conduct a randomized controlled trial (RCT) to evaluate its impact on obese patients. The measurements include a battery of interview-based questionnaires and evaluations of decision regret and knowledge improvement. Investigators expect the DAs would benefit the intervention group in the aspects of knowledge, communication and anxiety status during and after their treatment sessions.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) ≧ 32 kg / m2 with obesity-related comorbidity
2. Body mass index (BMI) ≧ 37 kg / m2

Exclusion Criteria:

1. Endocrine system abnormalities in patients
2. Drug abuse or mental illness
3. Major organ dysfunction and can accept surgery
4. Patients cannot understand Chinese
5. Age less than 20 years old or more than 70 years old
Use of WhatsApp for Communication Between Consulting Physicians and the Emergency Physicians

The aim of this study is to determinate outcomes of WhatsApp Messenger (a messaging program for smart phones) usage for Communication Between Consulting Physicians and the Emergency Physicians.

Effective communication between consulting physicians and the emergency physicians is critical for patients in the emergency department. WhatsApp Messenger (a messaging program for smart phones), is the most commonly used for communication in at present. WhatsApp Messenger is the most globally popular messaging application. Also, it has been started to be used for communication in healthcare. The aim of this study is to determinate outcomes of WhatsApp Messenger usage for communication between consulting and the emergency physicians.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years

Exclusion Criteria:

* Patients who were not known the reason of admission to Emergency Service
* Patients who were not determined consulting Physicians' arrival duration to emergency department
* Patients who were not known the outcomes of consultation
* Patients transferred other hospitals from Emergency Service
* Patients who were not determined the time of consultation call
The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study

Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been reported as 7-40% depending on the type of surgery, and is known to increase to about 50% when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is still unknown. Therefore prevention of occurrence is very important.

Known factors related to the development of CSA-AKI include hemodynamic, inflammatory, metabolic, and nephrotoxic factors, and since there is a close connection between hypotension due to deterioration of cardiac function, preventive measures to prevent hypotension in juicing It is only possible.

To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported to protect against renal ischemia/reperfusion injury. Various studies have been attempted to prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed only for surgery with extracorporeal circulation that causes severely.

Therefore, this study would like to verify the effectiveness of ulistine's medicine in the prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without extracorporeal circulation.


Eligibility Criteria:
Inclusion Criteria:

* From January 2015 to June 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou University Hospital.

Exclusion Criteria:

* Patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study.
Efficacy and Safety of Carbon Dioxide Insufflation During Endoscopy

The purpose of this study is to assess the differences of safety and efficacy of carbon dioxide insufflation instead of air during sedated or unsedated endoscopy.

Total 640 participants who are indicated to accept endoscopic examinations or procedures will be enrolled in this study. The participants will be divided into 2 groups according to the examination field, esophagogastroduodenoscopy group (320 participants) and colonoscope group (320 participants). The participants in each group will be divided into sedated endoscope subgroup and sedated and unsedated endoscope subgroup (each subgroup is inclusive of 160 participants). Carbon dioxide (CO2) or room air will be used randomly to insufflate the bowel lumen during the procedure in each subgroup.

Eligibility Criteria:
Inclusion Criteria:

* outpatients referred for panendoscopy or colonoscopy examination

Exclusion Criteria:

* pregnancy, breast feeding, severe chronic obstructive lung disease or severe heart failure, renal function impairment, inability to understand participant information, a history of abdominal surgery, or refusal to participate in this study
Assess the Efficacy and Safety of Alefacept With Narrow Band Ultraviolet B Phototherapy (nbUVB) vs. Alefacept Alone in Chronic Plaque Psoriasis Subjects

Assess the efficacy and safety of alefacept with nbUVB compared to alefacept alone in chronic plaque psoriasis subjects. Combination therapy may improve the clinical response to psoriatic subjects as both modalities have an effect on T cells


Eligibility Criteria:
Inclusion Criteria:

* Subject has given written informed consent
* Subject has a diagnosis of moderate to severe chronic plaque psoriasis involving \>=10% with a Psoriasis Area and Severity Index (PASI) score \>=10 at Baseline
* Subject has CD4+ T lymphocyte (CD4) count at or above the lower limit of normal
* Male and female subjects must use an adequate means of contraception from screening to end of study.

Exclusion Criteria:

* Subject who received alefacept in the past
* Subject who has shown no improvement following an adequate course of nbUVB in the past
* Subject who has been treated in the past with either therapy or cyclosporine
* Subject with any active cancer, including skin cancer at Baseline
* Subject with erythrodermic, pustular or predominantly guttate psoriasis
* Subject who has used treatment for psoriasis prior to Baseline as follows:

  * Topical treatment within 14 days
  * Oral treatment within 28 days
  * Broad band UVB (bbUVB) or nbUVB treatment within 56 days
  * Biological treatment within 84 days
* Serious local infection or serious systemic infection within the 3 months prior to the first dose of study drug
* Subject with a history of drug or alcohol abuse within the past 2 years
* Subject that is known to be infected with the AIDS virus
* Subject with any other skin disease or other disease that might interfere with psoriasis status assessments
* Female subject who is nursing, pregnant or planning to become pregnant while in this study
* Subject who is currently enrolled in any other investigational drug or device study
Hymovis™ Versus Placebo in Knee Osteoarthritis

Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline \[PBS\] in subjects with symptomatic osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study

Exclusion Criteria:

1. Clinically significant apparent large effusion of the target knee;
2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
4. Medical history of anaphylactic reactions
5. History of septic arthritis in any joint
6. Females who are pregnant or breast-feeding
AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

Necrotizing Fasciitis (NF) is a potentially life-threatening soft tissue infection. This study is comparing acellular fish skin graft (AFS) to standard of care allograft (AHC) in the treatment of NF. The purpose of this study is to compare clinical outcomes and time until autograft take in patients that were treated with AHC or AFS prior to permanent autografting to treat NF.

This will be a prospective, randomized, open-label, interventional, single-center study looking at time to autograft placement and time to full closure in subjects treated with acellular fish skin compared to subjects treated with acellular human cadaver skin to prepare the wound bed prior to grafting. Subjects eligible to receive study treatment will be any adult patient (18 years of age or older) admitted to the Joseph M. Still Burn Center or Advanced Wound Clinic at Doctors Hospital Augusta with a diagnosis of NF that has been treated and is stable. Prior wound excisions will be allowed until the surgeon has deemed the wound stable and free from necrotizing processes.

Exclusion criteria will be positive pregnancy test on admission, subject has active diagnosis of any autoimmune process, or cancer that in the opinion of the investigator would prevent the subject from successfully participating in the study.

Eligibility Criteria:
Inclusion Criteria:

* Is ≥18 years of age.
* Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or Advanced Wound Clinic for treatment of NF which has been treated and is considered stable.

Exclusion Criteria:

* Subject has been previously enrolled into this study or is currently participating in another drug or device study that has not reached its primary endpoint.
* Index wounds that due to anatomical location are unable to apply a NPWT device.
Tetra-NIRS Clinical Study

The purpose of this evaluation is to validate the previous clinical study results using a Near-Infrared Spectroscopy (NIRS) device, as compared to the conventional urodynamics (UDS) testing. The experiment will use the commercially available Tetra-NIRS and Laborie UDS equipment.

The hypothesis is that the Tetra-NIRS device, in the clinical environment, provides data to enhance the analysis using the standard urodynamics equipment (stand-alone Urodynamic procedure).

This is a study of the commercially available Tetra-NIRS device to compare the results collected against conventional urodynamics. The study will evaluate male patients with lower urinary tract symptoms (LUTS) as well as female subjects with over-active bladder (OAB).

The Tetra-NIRS unit uses near infrared light at 3 different wavelengths to measure changes in haemoglobin and cytochrome from the detrusor muscle from the human bladder wall. This process is similar to what is used for cerebral and muscle oxygenation monitoring (e.g., pulse oximetry). Previous clinical feasibility studies have identified the correlation between the changes in haemoglobin and cytochrome of the bladder, and bladder pressure values obtained during urodynamics procedures and uroflow procedures.

For this study the Tetra-NIRS results will not be used by the urologist/nurse to guide in patient management and treatment decisions, but rather will only be used to collect measurements from the patient for the purposes of this study. The Tetra-NIRS sensor patch will be adhered externally to the skin surface where the bladder is located.

For this study, a minimum of 30 male subjects with LUTS and 30 female subjects with OAB scheduled to undergo a urodynamics procedure are to be enrolled. Up to 20 female subjects with OAB will be enrolled. The investigators will attempt to equally enrol male subjects into each of the two categories including obstructed and non-obstructed groups according to prostate hyperplasia (equivocal subjects will be determined by the investigator).

Eligibility Criteria:
Inclusion Criteria:

* The selection of subjects enrolled for testing must meet the following criteria:

  * Subjects must be 18 years of age or older.
  * Subjects are patients of one of the institutions and are currently scheduled for UDS
  * Male subjects must have LUTS
  * Female subjects must have OAB
  * Subjects must give their informed consent prior to enrolment.

Exclusion Criteria:

* The patient has an existing health condition which the investigators feel will not allow for safe or accurate measurements with the Tetra-NIRS device.
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older

The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).


Eligibility Criteria:
Key Inclusion Criteria:

* Completed study drug treatment in the parent study VX22-445-122 Part B (NCT05882357) OR had study drug interruption(s) in the parent study but did not permanently discontinue study drug and completed study visits up to the last scheduled visit of the Treatment Period of the parent study

Key Exclusion Criteria:

* History of drug intolerance in the parent study that would pose an additional risk to the participant
* Current participation in an investigational drug trial other than the parent study

Other protocol defined Inclusion/Exclusion criteria may apply.