cyrilzakka/clinical-trials huggingface dataset:
A Study of JNJ-73763989 in Healthy Japanese Adult Participants

The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of JNJ-73763989 in healthy Japanese adult participants following single-dose subcutaneous administration of 3 different doses of JNJ-73763989, Dose Level 1 (Panel A), Dose Level 2 (Panel B) or Dose Level 3 (Panel C).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese, as determined by participant's verbal report
* Participant must have a body mass index (BMI; weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 30.0 kilogram per square meter (kg/m\^2) extremes included, and body weight not less than 45.0 kg
* Participant must be healthy on the basis of physical examination, clinical laboratory tests, medical history, and vital signs performed at screening. In case of abnormalities (except for those listed in the exclusion criteria) a participant may be included after all if the investigator judges the abnormalities not clinically significant or appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
* A female participant of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and a negative urine pregnancy test on Day -1
* A male participant must agree not to donate sperm after enrollment (Day 1) in the study until at least 90 days after receiving the study drug

Exclusion Criteria:

* Participant with a history of cardiac arrhythmias (for example, premature ventricular contractions), history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome)
* Female participant who is pregnant, breast-feeding, or planning to become pregnant during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
* Male participants who plan to father a child during the study or within 90 days after receiving the study drug (or longer, if dictated by local regulation)
* Participant with human immunodeficiency virus type 1 (HIV-1) or type 2 (HIV-2) infection (confirmed by antibodies) at screening
* Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B infection (confirmed by Hepatitis B surface antigen \[HBsAg\]), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at screening
Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

The investigators will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

Postoperative surgical site infections pose a significant challenge to the orthopaedic oncologist, especially in wounds that have been previously irradiated with neo adjuvant external beam radiation therapy (EBRT). There are many studies demonstrating the relatively high risk of wound complications after lower extremity sarcoma resection. Published data suggest that these preoperatively radiated wounds have a postoperative infection rate of 17%-44% with "traditional" dressings (e.g. dry gauze surgical dressings).

A prospective series of 190 patients and showed a wound complication risk of 35% in preoperative irradiated wounds. The morbidity associated with wound complications can range from moderate (prolonged dressing changes) to severe (life or limb threatening infection). Patients who develop wound complications have been shown to longer hospitalizations and higher costs \[ref\]. Anatomic location of the tumor has been shown to be a risk factor for the development of wound complications with lower extremities being higher risk than upper extremities. There are several published studies examining the effect of negative pressure wound therapy (NPWT) on high risk surgical wounds. Abdominal wound complications can be reduced with the use of incisional NPWT. In the orthopaedic literature the use of negative pressure incisional dressings have been shown to lower the risk of wound complications in total hip arthroplasty, acetabular fractures, and extremity fractures.

To our knowledge, there have not been any published studies on the utility of negative pressure wound therapy in previously irradiated soft tissue sarcoma wounds. The investigators feel that this high risk patient cohort could potentially benefit from reducing wound complications through NPWT and is an ideal population to study its effect.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18
* Willing to consent to randomization and able to participate in the study
* Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection
* Primary closure of wound
* Patients scheduled for surgical resection

Exclusion Criteria:

* Flap coverage or skin graft
* Patients scheduled for amputations as local control of their tumor
* Sarcomas where radiation is not planned preoperatively
* Repeat surgeries for oncologic reasons (positive margins)
* Known allergy to adhesive tape
Vincristine Sulfate Liposome Injection (Marqibo®), Bendamustine and Rituximab-Phase I Trial in Indolent B-cell Lymphoma

This study evaluates addition of Vincristine Sulfate Liposome Injection (Marqibo®) to the standard regimen of Bendamustine and Rituximab in adult patients with indolent B-cell lymphoma. This is a dose-escalation study.

Bendamustine-rituximab is a standard chemotherapy regimen for treatment of many indolent B-cell lymphomas, but most patients experience a recurrence of the lymphoma. Vincristine sulfate has been a traditional component of chemotherapy regimens in non-Hodgkin lymphoma and it is possible that adding it to the bendamustine-rituximab regimen might provide a better quality of remissions or longer duration of remissions with acceptable toxicity.

This is a phase 1, single-center, open-label, single-arm trial in patients with indolent B-cell non-Hodgkin lymphoma otherwise appropriate for bendamustine-rituximab as initial or subsequent line of therapy. Patients will receive the of rituximab and bendamustine in combination with escalating doses of vincristine sulfate liposome injection (Marqibo®). The objective of this study is to assess safety of this combination by establishing the maximum tolerated dose of vincristine sulfate liposome injection (Marqibo®) in the combination.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed indolent B-cell non-Hodgkin lymphoma.
* Radiological measurable disease.
* Previous treatment for lymphoma is allowed, with the exception of use of bendamustine within 6 months or any prior use of vincristine sulfate liposome injection
* Eastern Cooperative Oncology Group performance status 0 or 1;
* Life expectancy of at least 6 months;
* Adequate organ and marrow function;
* Women of child-bearing potential and men must agree to use adequate contraception.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions attributed to any drug used in the study.
* Any lymphoma-directed therapy within 4 weeks.
* Any prior treatment with vincristine sulfate liposome injection.
* Prior treatment with bendamustine or vincristine sulfate within 180 days of enrollment.
* Patients who are receiving any other investigational agents with the exception of endocrine therapy for breast or prostate cancer.
* Central nervous system involvement.
* Peripheral sensory or motor neuropathy.
* History of a demyelinating condition.
* Positive test for the Human Anti-Chimeric Antibody (HACA).
* Patients receiving any medications or substances that are strong inhibitors or inducers of Cytochrome P450, family 3, subfamily A (CYP3A) enzyme are ineligible.
* Uncontrolled intercurrent illness.
* Prisoners.
* Pregnant or breast-feeding women.
* Known Human Immunodeficiency Virus (HIV) or active Hepatitis B infection
* Any prior or active cancer, which in the opinion of the investigator would preclude safe participation in this study.
Abdominoplasty Under Epidural Anesthesia

Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among the most hazardous aesthetic procedures currently performed. It was shown, in many studies, to be associated with a significant complication rate, some of which are life-threatening. This study describes the investigators experience with a series of abdominoplasties performed under epidural anesthesia. Outcomes are presented, especially in terms of complication, and the practical advantages of this method are discussed.


Eligibility Criteria:
Inclusion Criteria:

* All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.

Exclusion Criteria:

* Patients with concurrent operations requiring general anesthesia.
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary hyperparathyroidism receiving hemodialysis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is a Chinese male or female greater than or equal to 20 years old.
2. Subject is diagnosed with Chronic Kidney Disease Stage 5 and must be on maintenance hemodialysis three times a week for at least 2 months prior to the Screening Visit and expected to remain on hemodialysis for the duration of the study.
3. For entry into the Treatment Phase, the subject must have:

   * Intact parathyroid hormone greater than or equal to 300 pg/mL
   * Serum calcium less than 10.2 mg/dL (2.55 mmol/L)
   * Calcium-phosphorus product less than 65 mg\^2/dL\^2

Exclusion Criteria:

1. Subject has a history of an allergic reaction or significant sensitivity to vitamin D or vitamin D related compounds.
2. Subject received a partial parathyroidectomy within one year prior to the Screening Phase.
3. Subject with New York Heart Association (NYHA) Class III or IV.
4. Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the Screening Phase, or requires such medications for greater than 3 weeks in the study.
5. Subject has a current malignancy (with the exception of basal or squamous cell carcinoma of the skin), or clinically significant liver disease, in the opinion of the Investigator.
6. Subject has a history of drug or alcohol abuse within 6 months prior to the Screening Phase.
7. Subject is known to be human immunodeficiency virus (HIV) positive.
8. Subject has evidence of poor compliance with diet, medication or hemodialysis that may interfere, in the Investigator's opinion, with adherence to the protocol.
CONECCT (Colorectal Neoplasia Endoscopic Classification To Chose the Endoscopic Treatment)

Prospective study so as to evaluate CONECCT score to determine both histological tissue and therapeutic choice


Eligibility Criteria:
Inclusion Criteria:

* N/A

Exclusion Criteria:

* N/A
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.

This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery
* Subject requiring a radiosurgical treatment with LGK

Exclusion Criteria:

* Subject having hurts of the brainstem or para-optics
* Pregnant women or in feeding period
* Subject having received previously a whole brain radiotherapy
Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training

Fibromyalgia is a painful syndrome of unknown etiology, which affects 2% of world population, with symptoms such as: pain, unrefreshing sleep, fatigue and mood disorders. It is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia. The big gap is about the quantity adequate and/or recommended exercise volume, despite some studies with exercise volumes different resistance trainings show improvements, we do not have a direction, besides We still do not know whether there is a preference for these patients in different resistance training volumes.

Objective: Assess training volume preference resisted in women with fibromyalgia.

Method: Crossover randomized clinical trial, randomized and blind. 36 women with fibromyalgia will be evaluated, who will undergo three resistance training programs with different training volumes. The primary outcome will be patient preference in relation to training volumes, and the secondary ones will be the patient expectation, pain intensity, affect and subjective perception of exertion.

Analysis statistics: For the primary outcome preference, the number of choices will be counted of the 3 types of training in percentage form. Regarding the analysis of the primary outcome we will summarize the patient's preference in a contingency table, we will compare the proportions using the Chi-square test, and finally we will check the effect size of the observed differences. For secondary outcomes, statistical analyzes will be performed by a blind statistician using commercial software. The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levene's test will be used to analyze the homogeneity of variance. The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times. One 5% significance level and 95% CI will be adopted for all statistical analyses. ethic and dissemination: The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 to 65
* Have a diagnosis of fibromyalgia according to the ACR 2016 criteria

Exclusion Criteria:

* Have performed resistance training in the last 6 months
* Having another associated rheumatic condition
* Have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey;
* Women with musculoskeletal injuries in the upper and/or lower limbs
* Have heart problems that prevent maximal efforts and submaximums
Goal Directed Versus Conventional Weight Loss Program

The aim of our study is to determine if the goal directed weight loss program improves weight loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy.

The aim of our study is to determine if a goal directed program improves weight loss outcomes after sleeve gastrectomy. Bariatric patients are managed by a multidisciplinary team comprising of bariatric surgeons, dieticians, physiotherapists, and physicians. In the conventional weight loss program, patients were only given their ideal weight to strive toward after surgery. Previous patients undergoing bariatric surgery in the standard program often enquired about the expected excessive weight loss targets after bariatric surgery. This patient driven need led to the development of the goal directed weight loss program. This modified program involves a component of behavioural intervention. Bariatric patients in this modified program will be counselled prior to LSG and EWL targets will be set for patients to achieve at fixed intervals post LSG. These targets are charted on a graph, with the patient's actual weight charted on the same graph at each clinic consultation, providing a strong visual aid to counseling and motivation.

The aim of the study is to recruit 120 patients undergoing laparoscopic sleeve gastrectomy. These patients will be randomized to either the goal directed program or a standard program. Patient demographics, preoperative weight, and post operative weights at 3, 6, 9, 12, 18 and 24 months post laparoscopic sleeve gastrectomy will be collected. Univariate and multivariate analyses will be performed between each group with excess weight loss being the primary endpoint.

Such a trial would allow evaluation to know if the effort spent in implementing a goal directed weight loss program translates to improved weight loss outcomes in bariatric surgery patients. There are no significant risks involved in implementing such a program for our patients. This is based on a retrospective review of patients who have undergone the goal directed program in NUH. If such a program is shown to improve weight loss outcomes post surgery, it could potentially be adopted by bariatric centers worldwide. If the goal directed program is shown to have no bearing on weight loss outcomes, the extra efforts by the bariatric team into implementing such a program could be better directed to other endeavours.

Eligibility Criteria:
Inclusion Criteria:

1. Patients having met the indications for laparoscopic sleevel gastrectomy, determined preoperatively by the attending surgeon
2. Age \>21 or \<65
3. BMI \>32.5 and \<45
4. Mentally Sound
5. Agreeable to commit to the length of follow up
6. Agreeable for randomization and signed consent form

Exclusion Criteria:

1. No signed consent form
2. Age \<21 or \>65
3. BMI \<32.5 or \>45
4. Previous Bariatric surgery
5. Mentally Unsound
6. Unable to commit to follow up schedule
7. Pregnant women or women who are breast-feeding
Psychotropic Medication and Psychotherapeutic Treatment of Adults With Intellectual Disabilities

Mental health service provision of adults with intellectual disabilities (ID) is often criticized. There is a lack of empirically studies targeting the psychotropic and psychotherapeutic treatment in this population. The PROMPT-ID study therefore aims to assess the prevalence of psychotropic medication and psychotherapeutic treatment in adults with mild to profound ID and the quality of psychotropic medication. It further aims to identify predictors of psychotropic medication, of barriers into psychotherapeutic treatment and of good clinical psychotropic medication prescription practice. It is a cross-sectional, epidemiological study carried out in Saxony, Germany. Approval of the responsible ethics committee was obtained. The inclusion criteria are mild to profound forms of ID and an age of 18 years or older. A representative sample is realized by a two-stage sampling procedure. Sheltered working and accommodation service providers are stratified by type of service provider and workshop size/type of accommodation. The stratified cluster sampling is realized by a random selection of service providing institutions followed by a random selection of adults with ID. An estimated total number of n = 200 study participants via sheltered workshops and n = 400 via residential accommodations need to be contacted to obtain data of approximately n = 131 study participants recruited through sheltered workshops and n = 232 participants through sheltered living institutions. Based on a psychotropic medication prevalence of 30%, in- depth interviews about psychotropic prescription practice of an estimated number of n = 109 adults with ID are carried out. Data collection is realized in interviews with key carers in the living environment and, if applicable, with the prescribing physician. If the adults with ID are currently medicated with psychotropics, basic information e.g. about kind, agent, dosage and treatment duration are obtained and a newly developed interview targeting the quality of the psychotropic medication treatment is conducted with the carers. In addition to the prevalence and quality of psychotropic and psychotherapeutic health care utilisation, other parameters like psychiatric symptomatology, problem behavior, sociodemografic and institutional factors and parameters of the provision area are assessed using well- established instruments. Findings will fill the lack of representative data that is urgently needed in this often criticized health service area.


Eligibility Criteria:
Inclusion Criteria:

* Mild to profound levels of ID
* Age of 18 years or older

Exclusion Criteria:

-
An Evaluation of the NJSPB SCF Project for Opioid-Involved High-Risk Parolees

This study entails an evaluation of the New Jersey State Parole Board Swift, Certain, and Fair (SCF) Supervision Program. The purpose of the evaluation is to test whether subjects assigned to SCF Supervision perform better than those assigned to parole-as-usual (PAU).

The Swift, Certain, and Fair (SCF) Supervision Program - Including Project HOPE Program provides funding to states, units of local government, territories, and federally recognized Indian tribes (as determined by the Secretary of the Interior) in an effort to enhance public safety, foster collaboration, and to improve the outcomes of individuals under the supervision of community corrections. The goals of this program are to develop and enhance SCF initiatives and implement the SCF model with fidelity, resulting in reduced recidivism and better outcomes for program participants. SCF approaches are intended to: (a) improve supervision strategies that reduce recidivism; (b) promote and increase collaboration among agencies and officials who work in community corrections and related fields to enhance swift and certain sanctions; (c) enhance the offenders' perception that the supervision decisions are fair, consistently applied, and consequences are transparent; and (d) improve the outcomes of individuals participating in these initiatives. The grantee will use awarded grant funds to support programming that provides services to up to 75 opioid involved parolees with services to divert them from a return to prison and manage underlying addictions with a combination of behavioral therapy and medication assisted treatments. The program combines sanctions with targeted reentry and treatment services.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years of age or older
* Participants must have a history of opioid use or addiction
* Participants have a history of parole violations or active parolees who are at risk for violation (this can include anyone who is reentering the active population from prison)
* Participants reside in or are moving to Ocean County; and
* Participants must have at least 6 months remaining on their Parole term

Exclusion Criteria:

-