cyrilzakka/clinical-trials huggingface dataset:
The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema

The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.


Eligibility Criteria:
The following is an abbreviated list of inclusion criteria:

* Adults between 18 to 80 years of age, inclusive
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Decrease in vision in the study eye determined to be primarily the result of DME
* Definite retinal thickening due to diffuse DME involving the central macula in the study eye
* Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal fluid in the study eye
* ETDRS BCVA letter score ≤ 76 and ≥ 24 in the study eye

The following is an abbreviated list of exclusion criteria:

* Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
* History of non infectious uveitis
* Decrease in visual acuity due to causes other than DME in the study eye
* History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

  1. Prior pars plana vitrectomy
  2. Any ocular surgery within 3 months prior to Day 1
  3. YAG capsulotomy within 3 months prior to Day 1
  4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study
  5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
  6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1
Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

This study is designed to evaluate the short-term and long-term results after Tubeless NOSES for the resection of Rectosigmoid Cancers compared with traditional laparoscopic radical resection.

This is a randomized, single-center, open-label, non- inferiority study designed to evaluate the safety, efficacy and potential benefits of Tubeless NOSES compared with traditional laparoscopic radical resection in approximately 458 subjects with Rectosigmoid Cancers.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed Rectosigmoid Cancers
2. Clinical stage at T 1-3 N0-2 M0
3. Tumors on peritoneal reflection，Tumor size is no more than 3 cm
4. Eastern Cooperative Oncology Group (ECOG) scale is 0-2
5. American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
6. BMI ≤ 30 kg/m2
7. Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.

Exclusion Criteria:

1. Heart, lung, liver or renal or any organ function that are intolerance for surgery
2. History of treated colorectal malignant disease
3. Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
4. Subjects with previous malignancies
5. History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
6. Treatment with any other clinical trial within 28 days prior to randomization
7. History of severe mentally disease
8. pregnant or lactating women
9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.
Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery

Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.

This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Women ≥ 24 weeks viable gestation
* Will be undergoing cesarean delivery

Exclusion Criteria:

* Patient unwilling or unable to provide consent.
* No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
* Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 \<200, or other
* Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
* Current skin infection
* Coagulopathy
* High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
* Incarcerated individuals
* Intraamniotic infection
* Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of thalidomide, doxorubicin, and dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma.

OBJECTIVES: I. Determine the response rate of patients with previously untreated stage II or III multiple myeloma treated with thalidomide, doxorubicin, and dexamethasone. II. Determine the safety and toxicity of this regimen in this patient population.

OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20, doxorubicin IV on day 1, and oral thalidomide daily. Treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within approximately 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma Stage II disease Symptomatic due to progressive disease OR Stage III disease No stage I multiple myeloma or smoldering myeloma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: More than 4 months Hematopoietic: Absolute granulocyte count at least 1,500/mm3\* Platelet count at least 100,000/mm3\* \*Unless due to multiple myeloma Hepatic: Bilirubin no greater than 2.0 mg/dL ALT and AST no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN Renal: Elevated creatinine allowed Cardiovascular: LVEF at least 50% by MUGA or ECHO No active angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception at least 4 weeks prior to, during, and for at least 4 weeks after study No grade II or greater pre-existing neuropathy No other concurrent or prior active malignancy within the past 2 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix Prior T1a or T1b prostate cancer (detected incidentally at transurethral resection of prostate (TURP) and comprising less than 5% of resected tissue) allowed if PSA normal since TURP HIV negative No AIDS-related illness No other medical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for multiple myeloma Endocrine therapy: No more than 1 course of prior pulse dexamethasone Prior steroids of less than 1 month duration for emergent indications or life-threatening lesions (e.g., hypercalcemia or spinal cord compromise) allowed Radiotherapy: Prior radiotherapy allowed Surgery: Not specified
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)

The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).

The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed solution will be injected into the common extensor tendon.

Eligibility Criteria:
Inclusion Criteria:

1. Man or woman aged 18 - 80 years old.
2. Clinical diagnosis of lateral epicondylitis based on site of pain, pain

   elicited with active extension of the wrist in pronation and elbow

   extension.
3. Documented ultrasonography diagnosis of common extensor

   tendinosis and possible tear based on abnormal echotexture (tendon

   thickening, anechoic areas, areas of hypoechogencicity, loss of

   fibrillar pattern).
4. Chronic symptoms (equal or greater than 3 months).
5. PRTEE questionnaire score of at least 50 out of 100.
6. For child-bearing potential females, documentation of birth

   control.
7. Signing informed consent form. -

Exclusion Criteria:

1. Acute symptom onset (less than 3 months).
2. History of acute elbow trauma.
3. History of Rheumatoid Arthritis.
4. History of Inflammatory disease
5. History of Fibromyalgia
6. The patient has active malignant disease of any kind. A patient who

   has had a malignant disease in the past, was treated and is currently

   disease-free for at least 5 years, may be considered for study entry.
7. The patient is treated with anti-coagulant medication
8. The patient previously underwent a surgery for lateral

   epicondylitis.
9. The patient previously received local injections, including steroids

   within the last 30 days
10. Signs of other causes for lateral elbow pain (posterior interosseous

    nerve entrapment, osteochondral lesion).
11. Wounds around the elbow
12. Likely problems, in the judgment of the investigator, with maintaining follow-up.
13. Clinically significant abnormalities in hematology and blood

    chemistry lab tests at screening that in the opinion of the

    investigator might interfere with the patient's safety or participation

    in the study.
14. Known as positive HIV, hepatitis B, or hepatitis C.
15. Known history of a significant medical disorder, which in the

    investigator's judgment contraindicates the patient's participation.
16. Known hypersensitivity and/or allergy to collagen.
17. Drug or alcohol abuse (by history).
18. Pregnancy of child-bearing potential females.
19. Participation in another study within 30 days prior to screening

visit.

-
Hyponatremia Registry for Patients With Euvolemic and Hypervolemic Hyponatremia

The registry is a multi-center, prospective, observational study designed to collect data in patients with euvolemic and hypervolemic hyponatremia in the hospital setting in the USA and hyponatremia secondary to syndrome of inappropriate antidiuretic hormone secretion (SIADH) in Europe; patients with hypovolemic hyponatremia will be excluded from the registry. The registry is observational in design, and the registry will collect data on patients with a serum sodium ≤130 mmol/L. Data from the patients' chart will be collected throughout the duration of the hospital, from admission to discharge, and the data will be entered into the case report form (CRF) or into an electronic data capture (EDC) system. These patients will be entered into the registry over the duration of 18 months at community, tertiary, and academic medical centers from diverse multiple regions of the USA and Europe.

A patient's treatment will be determined by their caregiver and not by this protocol. Thus, the registry will provide a unique opportunity to evaluate how the patients are managed under real-world management conditions.


Eligibility Criteria:
Inclusion Criteria:

* Adults ≥18 years old who are hospitalized
* Euvolemic or hypervolemic hyponatremia with serum sodium ≤130mmol/L
* For euvolemic hyponatremia:

  * Euvolemia is defined as: absence of clinical and historical evidence of extracellular fluid volume depletion or sequestration; and absence of edema and ascites; or
  * Physician diagnosis of SIADH
* For hypervolemic hyponatremia (applies to USA sites only):

  * Hypervolemia is defined as: excess extracellular fluid volume manifesting as dependent edema or ascites
  * Patients may have one or more of the following underlying co-morbid conditions:

    * Congestive heart failure
    * Cirrhosis and/or liver failure
    * Nephrotic syndrome

Exclusion Criteria:

* Patients with hypovolemic hyponatremia
* Use of investigational drug, biologic, or device during the study
NANOTECH RCC Biomarkers

The incidence of renal cell carcinoma (RCC or kidney cancer) in men exceeds that of pancreatic cancer or leukemia. In women, the incidence of RCC is similar to that of leukemia, ovarian, or pancreatic cancer; thus, RCC is significant health issue. This study focuses on identifying specific molecules \[biomarkers\] of RCC that can be used to develop a reliable low-cost screening method at the point of service. If successful, our method would provide a diagnostic test to distinguish benign kidney masses from malignant ones, eliminating the need to surgically remove a kidney with a benign tumor.


Eligibility Criteria:
Inclusion Criteria:

Patients 18 years of age and older undergoing surgery. Patient samples are divided into 2 groups based on their surgery: Patients with an imaged renal mass, encompassing about 300 patients/year (about 1200 total) of both malignant (about 80-85% of time) and benign (about 15-20% of time), and patients with non-kidney cancers, encompassing about 6,000 patients/year (about 24,000 total),

Exclusion Criteria:

Age \<18 years and prisoners.
Intraperitoneal Mesh-Implementation After Laparotomy

Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Median Laparotomy

Exclusion Criteria:

* Bowel perforation
* Pregnancy
* Palliative surgery
* Drug abuse
* Age under 18
* Mental disability
* Allergy to mesh components
"Opinion of Doctors,Nurses and Key Informants About Independent Nurse Midwifery Practitioner in Northern India

"A Study to assess the Opinion of Doctors, Nurses and Key informants regarding Independent Nurse Midwifery Practitioner at selected Hospitals and Colleges of nursing in Haryana."

Abstact Introduction: Despite improvement in coverage of institutional deliveries and skilled birth attendants, India has missed its Millennium Development Goal to reduce maternal mortality rate. In order to increase access to primary care services, the Independent Nurse Practitioner (INP) is one of the best solutions.

Objectives: The objectives of the study were to assess the opinion of doctors, nurses and key informants regarding Independent Nurse Midwifery Practitioner (INMP) and to determine the association of opinion score of doctors, nurses and key informants with their selected demographic variables.

Material and Methods: A Quantitative Non Experimental Research Approach and Descriptive Survey Design was adopted. A total of 400 subjects (120 doctors, 120 nurses and 160 key informants) were selected using purposive sampling technique from selected hospitals and nursing colleges of Ambala, Panchkula and Yamunanagar districts of Haryana. The tool used for the study consisted of structured performa regarding sample characteristics and likert scale. Research tool was submitted to 11 experts from various departments for validity. Reliability was calculated by Cronbach's alpha and it was 0.75 for likert scale. Data Collection was done from December 2016 to February 2017. The obtained data was analyzed and interpreted in terms of objectives and research hypothesis. Descriptive and inferential statistics were used to analyze the data.

Eligibility Criteria:
Inclusion Criteria:

* Doctors, nurses and key informants who were

  * available at the time of data collection in study setting.
  * willing to participate in the study.
  * able to read and write Hindi or English.

Exclusion Criteria:

* Key informants who were not having minimum qualification as graduation.
A Study of Jaktinib Hydrochloride Tablets in the Treatment of Severe Novel Coronavirus Pneumonia

A randomized, double-blind, placebo parallel control study and is expected to enroll 20-60 eligible patients with severe novel coronavirus pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years old, regardless of gender;
* There is a history of novel coronavirus antigen- or nucleic acid-positive infection within 1-2 weeks;
* HRCT is consistent with the manifestation of viral pneumonia (judged by the investigator)
* Participants who voluntarily sign informed consent.

Exclusion Criteria:

* Participants who cannot take orally, or are suspected to be allergic to Jaktinib hydrochloride, similar drugs, or their excipients, or have severe gastrointestinal dysfunction that affects drug absorption;
* Critical pneumonia Participants with other organ failure requiring ICU monitoring and treatment;
* Participants who have received the following treatments within the specified time window before randomization:

  1. Participants have received Janus kinase (JAK) inhibitor, interleukin 6 (IL-6) inhibitor, IL-1 inhibitor, tumor necrosis factor (TNF) inhibitor, T cell or B cell depletion agent, interferon and other immunosuppressive drugs within the first two weeks of randomization, except glucocorticoid;
  2. Systematically used CYP 3A4 potent inhibitor or potent inducer in the first five drug half-lives at random;
* Immune deficiency;
* Participants who have received the novel coronavirus vaccine within 1 week before randomization;
* Prior to randomization, there were the following active and uncontrolled infections: tuberculosis, HIV, syphilis, mycoplasma, chlamydia, parasites, and viral infections other than SARS CoV-2 that required systemic anti-infection treatment;
* Renal diseases requiring dialysis treatment;
* Pregnant and lactating women;
* Any other Participants that were considered unsuitable by the investigator.
Effects of Probiotics Improves the Endurance and Explosiveness Exercise Performance on Healthy Human.

This study may discover that supplementing with probiotics LY-66, PL-02 can promote exercise endurance, explosive power and reduce muscle inflammation index in healthy people.

With the rise of people's health awareness and exercise habit in recent years, and the demand for the use of sports health food supplements has also increased. Probiotics are generally recognized as safe and helpful in digestion in the gastrointestinal tract. Previous animal experiments have found that probiotics LY-66, PL-02 are more effective in promoting the grip and exhausting exercise in mice. The purpose of this study is to further explore the effects of probiotics LY-66, PL-02 on promoting exercise endurance and explosive power in healthy people. This study is to compare supplementary samples with placebo and adopt a double-blind study design. 88 healthy adult males and females (non-sports players) aged 20-40 will be recruited, 44males and 44 females, with an average number of male and female subjects in each group, and they will be randomly assigned to the (A) placebo group, (B) LY-66 probiotic group, (C) PL-02 probiotics group, (D) LY-66/PL-02 doublet probiotics group. Supplemented one time a day, take 15 billion CFU of probiotics each time for 42 consecutive days. During the period of taking probiotics, squats and TABATA training were set for the subjects 2 days a week. From day 0 to day 42 of supplementation, subjects in each group were tested physical fitness and cardiorespiratory endurance every 14 days. On the 21th days, the explosiveness of muscle strength in each group was tested with Wingate. On the 42nd day, the exercise endurance test, NGS and GC-MS technology was used to detect the fecal microbiota and SCFA(Short-chain fatty acids) in each group, body inflammation index of each group were tested and use questionnaire to evaluate subjective experience. This study may discover that supplementing with probiotics LY-66, PL-02 can promote exercise endurance, explosive power and reduce muscle inflammation index in healthy people.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult
2. Age 20-40
3. Not professional athletes

Exclusion Criteria:

1. The patient who Smoking.
2. The patient have cardiovascular disease
3. The patient have hyertension
4. The patient BMI\>27
5. The patient have metabolic diseases
6. The patient have asthma
7. The patient who have experienced limb, neuromuscular, or exercise-related injuries within the past 6 months,.
8. The patient have taken anti-inflammatory or pain-relief medication in the past month,
9. The patient have consumed probiotic-related products will be excluded.
10. Students under the supervision of the principal investigator and individuals with conflicts of interest .
The Effects of Ultrasound-guided Serratus Plane Block During Video-assisted Thoracoscopic Lobectomy

This study evaluates the effects of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Thoracotomy is known as one of the most painful surgery. Thus, there is a development to reduce surgical stress in terms of operation technique, which is video-assisted thoracoscopic surgery. Although it has reduced postoperative pain and complications compared with thoracotomy, VATS is still quite painful operation.

Serratus plane block is a novel technique which provide analgesic effect for lateral chest wall by blocking lateral branch of intercostal nerve. It has been reported to be used for pain management including rib fracture, herpes zoster, and postoperative pain. It has become a popular analgesic modality because it is easy to perform and relatively safe. However, the effect of serratus plane block during intraoperative period has not yet been studied.

In this study, therefore, the investigators decided to assess the effect of serratus plane block on intraoperative opioid consumption, emergence time and hemodynamic stability in patients undergoing video-assisted thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification I-III for three port video-assisted thoracic surgery lobectomy under general anesthesia

Exclusion Criteria:

* History of allergic reaction to local anesthetics, coagulopathy, local infection at the injection site, and systemic infection.