cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics Study of XG005 Capsule

This was a Phase 1, single-center, randomized, placebo-controlled, 2-period, ascending single-dose study assessing the PK, safety, and tolerability of single ascending doses of XG005 (Period 1) and the naproxen and pregabalin combination (Period 2), in 5 dose groups each with 10 subjects.

Period 1 was double-blind and randomized 8 subjects (1:1 allocation ratio by gender) to XG005 and 2 subjects (1:1 allocation ratio by gender) to placebo. Subjects were enrolled sequentially into a total of 5 ascending dose levels pending safety review, and PK review where possible, of Period 1 of the prior dose level. Sentinel dose participants (1 for XG005 and 1 for placebo) were included as the first dose administered at each dose level in Period 1.

In Period 2, all subjects in the last three XG005 dose groups received approximate molar equivalents of naproxen and pregabalin corresponding to XG005 doses after a 7-day washout period. Period 2 was open-label with 10 subjects per group.

PK blood samples in each treatment period were collected at 0 (pre-dosing), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hrs after drug administration.

Eligibility Criteria:
Inclusion Criteria:

* BMI range of 18-30 kg/m2
* Medically healthy subjects
* Creatinine clearance ≥ 80 mL/min

Exclusion Criteria:

* History or presence of significant diseases
* History or presence of alcoholism or drug abuse
* Consumption of alcohol 48 hours prior each dose
* Hypersensitivity or idiosyncratic reaction to the study drug
* Abnormal diet (for whatever reason) during the 30 days prior to the first dosing;
* Donation (standard donation amount or more) of blood or blood products
* Plasma donation within 7 days prior to the study;
* Participation in another clinical trial within 30 days prior to the first dose;
* Female subjects who are pregnant or lactating;
* Hemoglobin \< 120 g/L
Effects of Trigger Point Dry Needling in Individuals With Patello Femoral Pain Syndrome : A Randomized Controlled Trial

A double blinded clinical controlled trial will be performed on individuals with patello femoral pain syndrome in which Trigger Point Dry Needling will be given to experimental group while Sham Needling will be given to the control group, targeting the trigger points present in the Quadriceps of affected individuals assessing the pain,functional disability and range of motion of the affected individuals.

A double blinded Randomized Controlled Trial of 6 months study after the approval of synopsis, will be conducted. Convenience sampling technique will be used to enroll the patients. Patients will be selected according to predefined inclusion and exclusion criteria. All patients who fulfill inclusion criteria will be allocated in two group through randomization by lottery method. Group A will receive TrP-DN and group B will receive Sham Needling. Both groups will be asked to perform stretching exercise of Quadriceps daily after needling. The patients' outcomes will be measured by VAS for pain intensity and Kujala Questionnaire for functional status. The comparison between pre-treatment and post-treatment data will be done after 3 months. Informed consents will be taken from each patient. Data entry and analysis will be done with SPSS 23.

Eligibility Criteria:
Inclusion Criteria:

- 1. Both genders 2. Ages range from 18-40 years 3. They have clinical diagnosis of PFPS (the diagnosis was confirmed by a positive patellar grind test and tenderness of medial and lateral patellar facets) 4. Participants are also required to have a minimum pain score of 3 on Numeric Pain Scale 5. Kujala patellofemoral questionnaire score of 50 to 80 before the intervention.

6. Patients willing to participate

Exclusion Criteria:

* History of any following conditions

  1. Participants who have received any treatment for PFPS within the 3 months
  2. A history of lower extremities fracture or surgery
  3. Presence of MSK diseases such as Acute Herniated Disc or Spondylolisthesis
  4. History of any chronic disease e.g. Diabetes Mellitus
A Study of the Drug I131-Omburtamab in People With Desmoplastic Small Round Cell Tumors and Other Solid Tumors in the Peritoneum

The purpose of this study is to test any good and bad effects of the study drug 131I-omburtamab. 131I-omburtamab could prevent the cancer from returning, or delay the cancer from getting worse, but it could also cause side effects. Researchers hope to learn more about how 131I-omburtamab works in the body, and how effective it is in treating cancer. 131I-Omburtamab is not approved by the FDA to treat DSRCT or other cancers of the peritoneum.


Eligibility Criteria:
Inclusion Criteria:

* Have the diagnosis of DSRCT confirmed at MSKCC
* Age \>1 year and able to cooperate with radiation safety restrictions during therapy period.
* Prior to intraperitoneal catheter placement

  * At least 1 weeks must have elapsed since prior chemotherapy
  * At least 2 weeks must have elapsed since biologic therapy
  * Toxicities of prior therapy must have resolved to grade 1 or less or to the patient's baseline

At the completion of surgery, patients must fulfill all of the additional following criteria:

* Have no definitive radiological evidence of disease active in liver or outside the abdomen/pelvic OR have had GTR of this disease at the time of catheter placement

Exclusion Criteria:

* Prior progression of disease
* Prior hypothermic intraperitoneal chemotherapy (HIPEC)
* Cardiac, pulmonary, and neurologic toxicities are greater grade 1 per NCI CTCAE version 5
* Renal, gastrointestinal, and hepatic, toxicities are greater than grade 2 (per NCI CTCAE version 5)
* History of allergy to mouse proteins
* Patients with grade 4 hypersensitivity reaction to radiolabeled iodine
Twice Daily Versus Twice Weekly Soak-and-Seal Baths in Pediatric Atopic Dermatitis

There are few studies evaluating best bathing practices in the management of pediatric atopic dermatitis (AD). Trans-epidermal water loss plays a key role in the pathophysiology of AD. In concert with application of topical corticosteroids (TCS), we sought to investigate whether frequent soaking baths (i.e. twice daily for two weeks), followed immediately by application of an occlusive moisturizer (i.e. soak-and-seal), would be more effective than infrequent soaking baths (i.e. twice weekly for two weeks) in the management of AD.

To evaluate the effectiveness of twice daily soak-and-seal baths for improving severity of disease in children with AD, we implemented a randomized clinical trial using a single-blind, crossover-controlled design. Patients received the same moisturizer, cleanser, and class VI topical corticosteroid (TCS), and only bathing varied. After a 1 week run-in, children were randomized 1:1 into 2 groups: Group 1 underwent twice weekly soak-and-seal baths for 2 weeks ("dry method") followed by twice daily soak-and-seal baths for 2 weeks ("wet method"), and group 2 did the converse. A single treating physician assessed outcomes and, along with those analyzing the data, was masked to group assignment. Participants and their caregivers could not be masked. Analyses were based on intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* Infants and children ages 6 months to 11 years of age with moderate to severe atopic dermatitis according to the criteria of Hanifin and Rajka.

Exclusion Criteria:

* Patients with suspected or established primary immune deficiency, patients receiving systemic corticosteroids, ultraviolet light therapy, immuno-therapeutic agents, and/or anti-infective drugs less than 1 month from the onset of the study.
To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)

The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).

Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.

Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.

Eligibility Criteria:
Inclusion Criteria:

1. A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
2. Proteinuria \> 2.5 g/24 h
3. serum creatinine \< 3 mg/dl
4. age 35-65 years

Exclusion Criteria:

1. Co-existence of anther chronic glomerular nephritis.
2. Severe disfunction of the liver
3. White blood cell \< 3000/ul
4. Severe infection in the past 1 month
5. Malignant hypertension which in hard to control
6. Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month
Short or Long High Intensity Training

To compare the effects of short and long high intensity interval training (HIT) conducted with the same total accumulated duration on physiological- and performance parameters during a 4-week training period.

Studies among elite athletes have documented the importance of large amounts of training volume in order to perform at a high level in endurance sports. It is also well documented that both low intensity training (LIT), moderate intensity training (MIT) and high intensity training (HIT) should be included in the overall training efforts. It is well documented that HIT has a positive effect on the aerobic endurance among both elite athletes and recreational athletes.

Despite the fact that there is general agreement that HIT is an important part of the overall training, it is unclear how this part of the training should be organized in order to optimize the training effects. The adaptions of endurance performance seem to depend on both the intensity and the accumulated duration of the HIT sessions. Therefore, the aim of this study was to compare the effects of SI and LI training, including equal accumulated HIT duration, during a 4-week intervention period, conducted as 4x8-min with 2-min recovery periods, 4x(12x40/20-sec) with 2-min recovery periods and 4x(8x40/20-sec) with 2-min recovery periods, in different physiological- and performance parameters among well-trained cyclists.

Eligibility Criteria:
Inclusion Criteria:

* male \< 40 years,
* peak oxygen uptake (VO2peak) \> 55 ml.kg-1.min-1,
* training volume \>3 sessions per week (within cycling)
* absence of disease and injuries.

Exclusion Criteria:

* disease/injuries
* frequent absence of HIT sessions during the period.
Causes and Outcomes of Community Acquired Pneumonia

This is a descriptive clinical research aiming:

* To describe the clinical spectrum and clinical characteristics of community acquired pneumonia (CAP) in patients admitted to hospital
* To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms
* To identify the risk factors that influence the severity of CAP

In Vietnam, the range and relative contribution of organisms causing CAP remain unclear, largely because diagnostic tools are limited and clinical research uncommon. An improved understanding of the risk factors, etiology and clinical outcomes of CAP in Vietnam would contribute to improved approaches to patient diagnosis and clinical management. This will be achieved by following the clinical and laboratory progress and treatment outcomes of in-patients diagnosed with CAP from admission to discharge. Comparative analyses will be between subgroups including survivor and non-survivor, severe CAP and non-severe CAP, known etiology and unknown etiology, SIRS, sepsis, severe sepsis and shock septic.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = 18 years of age
* Patient meets the criteria of pneumonia (below), established within 36h of hospitalization
* Patient is not hospitalized or residing in a long-term-care facility within 14 days before the onset of symptoms
* Patient has not been at a referral hospital for \>2 days before admission to the study hospital
* Informed consent to participate in the study is provided

Exclusion Criteria:

* Severe immunosuppression as judged by the enrolling physician (e.g. HIV, leukemia, lymphoma, chemotherapy for solid tumors, long-term corticosteroid use or other immunosuppressive drugs)
* Known active tuberculosis or current treatment for tuberculosis
Effects of Alcohol History on Effects of Sevoflurane and Nitrous Oxide - 13

The purpose of this study is to evaluate the effects of alcohol history on the subjective and reinforcing effects of sevoflurane and nitrous oxide in healthy volunteers. All subjects underwent psychomotor testing during 4 sessions of placebo, drug/placebo, and choice of intervention.


Eligibility Criteria:
Please contact site for information.
Study of Chlorhexidine as the Hub Antiseptic to Prevent Catheter Related Infections in Newborn Infants

The purpose of this study is to prevent catheter-related infections in newborn infants admitted to the Neonatal Intensive Care Unit (NICU). This study will compare the effectiveness of daily chlorhexidine versus isopropyl alcohol in preventing the growth of microbes in catheters.

Catheter-related bloodstream infections (CRBSIs) are a major cause of morbidity and mortality in infants admitted to the NICU. In adults, chlorhexidine used as a skin antiseptic has been shown to reduce the incidence of CRBSIs, and recent evidence indicates the inner surface of long-term central catheters as the likely route of infection. This study will evaluate 3.15% chlorhexidine as the daily catheter hub antiseptic to reduce catheter tip microbial colonization, an indication of high risk for acquiring CRBSI. The purpose of this study is to compare the antiseptic capability of 3.15% chlorhexidine versus isopropyl alcohol in reducing central catheter-related infections in neonates. This study also aims to compare the time to catheter hub microbial colonization in the two groups and to determine the route of catheter tip colonization by comparing cultures taken from the catheter tip, hub, and skin insertion site.

This study will last 1 year. There are no study visits. The placement and removal of the catheter will be determined by the discretion of the attendant caring for the participant. Participants will be randomly assigned to one of two groups. Catheters of Group 1 participants will be treated with 3.15% chlorhexidine at the time of the daily intravenous tubing change. Catheters of Group 2 participants will be treated with isopropyl alcohol. For both groups, cultures of the inner surface of the catheter hub will be performed twice a week, and cultures of the inner surface of the catheter hub, tip, and skin insertion site will be performed upon removal of the catheter.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the NICU
* Umbilical vein catheter or peripherally inserted central venous catheter (PICC) anticipated to be in place for more than 48 hours
* Parent or guardian able to give informed consent prior to first hyperalimentation and total parenteral nutrition tubing change

Exclusion Criteria:

* Known CRBSI-positive blood culture at the time of catheter line placement.
* Not expected to survive for more than 48 hours
* Broviac or any other surgically-placed central catheters
* Any condition that, as determined by the investigator, would interfere with evaluation of the line or be a potential health risk to the participant
Feasibility 3D Perfusion Ultrasound for Liver Cancer SABR Planning and Response Evaluation

The purpose of this study is to prospectively analyze the value of 3D ultrasound perfusion imaging for treatment planning, the prediction of therapy success, and to monitor the treatment response in patients with a primary or metastatic liver tumor undergoing radiation treatment.

Primary Objective:

The primary objectives of this prospective pilot study is to:

1. determine the feasibility and reproducibility of 3D contrast enhanced ultrasound imaging in liver cancer patients undergoing Stereotactic Ablative Radiotherapy and
2. evaluate whether there are treatment induced early changes in imaging metrics derived from 3D contrast enhanced ultrasound. This study will provide valuable insight as to the potential of baseline and/or early post-treatment 3D ultrasound perfusion characteristics (measurements of blood-flow) of primary and metastatic liver tumors to predict tumor response to Stereotactic Ablative Radiotherapy. The investigators' underlying goal is to assess whether early perfusion changes at 1-7 days after SABR initiation can be used as a non-invasive early biomarker for treatment response assessment.

Secondary Objectives:

Evaluate the feasibility of contrast-enhanced ultrasound-to-CT fusion by assisting three-dimensional (3D) perfusion ultrasound (US) imaging with optical and electromagnetic tracking of the ultrasound probe on patients with liver cancer that will undergo CT for treatment planning and/or response evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand and willingness to sign the written informed consent document
* Patient with primary liver tumor or metastasis scheduled for Stereotactic Ablative Radiotherapy (SABR)
* Patient is at least 18 years of age. No gender/race-ethnic restrictions.
* Performance status (ECOG) between 0-3
* History and Physical done within 4 weeks of enrollment.

Exclusion Criteria:

* Patient has previously been enrolled in and completed this study.
* Known right to left cardiac shunt, bidirectional or transient.
* Patient has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
* History of hypersensitivity to the contrast agent perflutren
* History of pulmonary hypertension
* Patients who are pregnant or are trying to become pregnant
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults

The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥18 years of age.
* Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
* Individuals willing and able to give an informed consent, prior to screening.
* Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
* Individuals who received three doses of inactivated COVID-19 vaccine

Exclusion Criteria:

* Body temperature \>37.8°C (axillary), or any acute illness at baseline.
* Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
* Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
* Any progressive unstable or uncontrolled clinical conditions.
* Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
* History of severe adverse reaction associated with a vaccine or severe allergic reaction.
* History of malignancy within 1 year before screening.
* Individuals who have received any other investigational product.
* Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
* Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
* Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
* Administration of intravenous immunoglobulins and/or any blood products.
* Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors

The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Males ≥ 18 years of age
* Has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

Exclusion Criteria:

* Persistent diarrhea National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 2
* History of concurrent second cancers requiring active and ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply
Metformin Experience on Minimal Hepatic Encephalopathy

Primary aim:

-To assess the effect of metformin use on the treatment of minimal hepatic encephalopathy in patients with liver cirrhosis.

Secondary aim:

-To evaluate if metformin is a safety drug in patients showing liver cirrhosis.

In this study, 30 patients will be included divided in two arms. Investigators and patients will not know the treatment used (double blind).

Arm 1: Metformin 1000mg twice a day (2000 mg/day), during 12 weeks. Arm 2: Placebo 1000mg twice a day (2000mg/day), during 12 weeks.

At the end of the study, patients will be followed-up 8 weeks more to control the appearance of adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with \> 18 years old
* Patients with the results of all the factors evaluable at the time of inclusion
* Patients who have accepted their participation in the study through informed consent
* Patients showing liver cirrhosis by ultrasound, transient elastography or liver biopsy
* Patients showing minimal hepatic encephalopathy (PHES \< 4 or Critical Flicker Frequency \< 39 Hz)

Exclusion Criteria:

* Patients with any contraindications to the drugs used
* Patients showing type 1 diabetes mellitus
* Patients showing type 2 diabetes mellitus and previous or current use of exogenous insulin, metformin or other oral antidiabetic drug