cyrilzakka/clinical-trials huggingface dataset:
Gestational Weight Gain and Postpartum Weight Loss in Active Duty Women (Moms Fit 2 Fight)

The purpose of this study is to enroll approximately 450 subjects to see if a behavioral weight management program is successful in helping TRICARE beneficiaries who are pregnant or post-partum to manage their weight during and after their pregnancy.

Investigators will randomize 450 consented participants to 1 of 3 interventions: a) a gestational weight gain intervention (GWG-only); b) a postpartum weight loss intervention (PPWL-only), or c) a combined gestational weight gain and postpartum weight loss intervention (GWG+PPWL) to determine the efficacy of the interventions on GWG as well as PPWL.

Procedures: Interested individuals will be directed to call the study telephone number to learn more and determine whether eligibility criteria is met. Individuals who meet the telephone screening eligibility criteria will be invited to schedule a Screening Visit, during which written informed consent will be obtained. At this visit, eligibility will be assessed and measures will be administrated. The potential participant will also be asked to complete a one-week dietary and exercise self-monitoring run-in and receive medical clearance from their obstetrician to participate. Should she continue to be interested, she will return for a Baseline Visit and will be randomized.

Randomized participants will have 5 in person scheduled visits after their Screening Visit and Baseline Visit to the Wilford Hall Ambulatory Surgical Center (WHASC) or San Antonio Military Medical Center (SAMMC) Obstetrics (OB) clinic. These visits will be scheduled at gestational week 32, 36, as well as at 6- weeks, 6-months, and 12- month postpartum. At these visits, physical measurements will be collected and participants will complete various questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be active duty military, dependents or retired with TRICARE benefits
* Participants must be less than 12 weeks gestation upon recruitment (based on the date of their last menstrual period and then confirmed by their physician at their first prenatal visit, which typically occurs at 6-8 weeks gestation at WHASC and SAMMC)
* Participants also must be within the normal, overweight, or obese BMI ranges
* Are generally in good health
* Currently not smoking more than 5 cigarettes per day at the time of conception

Exclusion Criteria:

* Expecting multiple babies (e.g. twins)
* Diabetic
* Not interested in participating in a program for 21 months
A Study of Cell Therapy for Subjects With Acute Kidney Injury Who Are Receiving Continuous Renal Replacement Therapy

The purpose of this study is to assess the safety and tolerability of the investigational product, SBI-101, in subjects with Acute Kidney Injury (AKI) who require continuous renal replacement therapy. SBI-101 is a biologic/device combination product designed to regulate inflammation and promote repair of injured tissue using allogeneic human mesenchymal stromal cells.

The study will be conducted in two cohorts, with an interim analysis performed in between the cohorts. In the first cohort, subjects will be randomized to receive one of two treatments - low dose SBI-101 or sham control. In the second cohort, subjects will be randomized to receive one of two treatments - high dose SBI-101 or sham control. SBI-101 or sham control will be integrated into the renal replacement circuit and subjects in both cohorts will be treated for up to 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* AKI, as determined by the Investigator based on his/her clinical judgment
* Able to tolerate indwelling intravascular access
* Has tolerated Continuous Renal Replacement Therapy for at least 12 hours prior to IP treatment
* Likely to require Continuous Renal Replacement Therapy for at least an additional 48 hours
* Ability to give informed consent

Exclusion Criteria:

* Female subjects who are pregnant, planning to become pregnant, or lactating
* Known end-stage liver disease
* Hepatorenal syndrome
* Acute glomerulonephritis (e.g. rapidly progressive glomerulonephritis; membranoproliferative glomerulonephritis; post-streptococcal glomerulonephritis); acute interstitial nephritis (e.g. toxin- or drug- induced interstitial nephritis) or hereditary renal disease (e.g. Alport's Syndrome; polycystic kidney disease)
* AKI due to post-renal outflow obstruction
* Acute or chronic vasculitis of any etiology
* At the time of randomization, clinical evidence (e.g. febrile) suggestive of an uncontrolled or inadequately treated systemic infection
* History of a chronic systemic infection of any etiology regardless of therapy
* Active malignancy(-ies) and/or receiving active treatment for a malignancy(-ies), with the exception of non-melanoma skin cancer
* Subjects, who in the opinion of the Investigator, are likely to require escalating doses of vasopressors to attain and/or maintain hemodynamic stability
* Systemic immunosuppressive therapy that has not been stabilized for greater than 4 months, or in the case of chronic corticosteroid therapy, a dose of \>15 mg/day of prednisone or the equivalent within the past 30 days
* Organ failure affecting more than 2 non-renal organs
* Platelet count \<25,000/uL or other serious hematological abnormalities that would place subject in imminent danger of death
* Any prior medical condition that, in the judgment of the Investigator, would prevent the subject from safely participating in and/or completing all study requirements
Comparison of Cardiotoxicity Induced by Selective Estrogen REceptor Modulators and aNti-Aromatase

Selective estrogen receptor modulators and aromatase inhibitors for the treatment of breast cancer seems to have an impact on the cardio-vascular system. This study investigates reports of cardiovascular toxicities for treatment including Anatomical Therapeutic Chemical (ATC) classification: L02 in the European pharmacovigilance database, Eudravigilance.

Hormone replacement therapies and contraceptive pills are responsible of a wide range of cardio-vascular side effects, particularly thrombo-embolic disorders and ischemic heart disease. The difference of incidence and type of cardio-vascular events between men and women are strongly related to sex hormones. This study investigates the main characteristics of patients affected by cardiovascular side effects (of which ventricular arrhythmia's, QT prolongation and Torsade de Pointe) imputed to drugs classified as L02 according to ATC.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the Eudravigilance from 01/2002 to 08/2017
* Adverse event reported were including the MedDRA terms: SOC Cardiac Affections and the HLT Death and Sudden Death

Exclusion Criteria:

-
Immediate Effects of Postural Repositioning on Voice Production Tasks in Seated Individuals With Acquired Dysarthria:

To determine the effectiveness of a single 10-min postural repositioning session on the maximum phonation duration in individuals with acquired dysarthria.

The impact of dysarthria goes beyond communication. However, there have been no clear directives guiding clinical practice to date, and despite increasing evidence directing treatment, research remains limited and predominantly consists of case studies or case series. Despite the importance of postural control in voice production, the effects of postural alignment on speech production efficiency are either little investigated or not at all explored in the dysarthric population. This study determined the effectiveness of a single 10-min postural repositioning session on the maximum phonation duration (MPD) in individuals with acquired dysarthria.

Eligibility Criteria:
\*\*Participants with dysarthria Inclusion criteria

* sustained a stroke or traumatic brain injury
* diagnosed with dysarthria
* impaired postural control following a neurological injury
* are approaching the end of intensive rehabilitation or have finished intensive rehabilitation
* express a desire to participate in the research
* have the capacity to read.

Exclusion criteria

* had any cognitive impairment that could prevent them from understanding directives or from expressing their opinion about their posture A neurologist clinically assessed the cognitive function of PWDs

  \*\*Control participants
* never diagnosed with dysarthria or any other voice impairment
* no comorbidities.
* no breathing deficits (e.g., asthma, chronic obstructive pulmonary disease)
* no pathologies in the spinal cord, spinal column, or thoracic cage that could prevent them from freely moving their trunk
* no neurological or cardiac problems.
Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs)

An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ).Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is copidogrel loading dose administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg) loading dose of Rosuvastatin administered within 24h before the procedure may be effective in reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single center,prospective randomized study to assess whether a single,high (40mg) loading (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stable angina

Exclusion Criteria:

* Baseline myocardial enzyme rise
Medina Embolization Device In Neurovascular Aneurysm Study

A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements
* Subject is 18- 85 years old
* Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device

Exclusion Criteria:

* Aneurysm is partially thrombosed
* Aneurysm has been previously treated with surgery or endovascular therapy
* Subject has had major brain surgery including endovascular procedures within the past 30 days
* Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm
* Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation
* The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment
Abiraterone Acetate in Asymptomatic or Mildly Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

This is a phase 3 study to compare the clinical benefit of abiraterone acetate plus prednisone with placebo plus prednisone in asymptomatic or mildly symptomatic patients with metastatic castration-resistant prostate cancer (CRPC).

This is a randomized (individuals will be assigned by chance to study treatments), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 1,000 medically or surgically castrated male patients with metastatic CRPC who have shown tumor progression and are asymptomatic or mildly symptomatic. The study period will consist of screening, treatment, and follow-up phases. Patients will receive study treatment (abiraterone acetate or placebo) plus prednisone until radiographic progression of disease and/or unequivocal clinical progression. Efficacy evaluations will be performed throughout the treatment period and safety will be assessed until 30 days after the last dose of abiraterone acetate. throughout the study. Follow-up will continue for up to 60 months (5 years) or until the patient dies, is lost to follow-up, or withdraws informed consent. At the interim analysis of overall survival (OS; 43% of death events), the independent data monitoring committee (IDMC) reviewed the efficacy and safety data and concluded that all of the data pointed to a significant advantage for patients in one arm of the study compared with the other arm thereby unanimously recommending unblinding the study and allowing crossover from the placebo arm to active therapy. Patients currently receiving placebo will be offered crossover therapy to abiraterone acetate. Treatment for patients who were originally randomized to the abiraterone acetate treatment group will not change. Patients will be discontinued from long term follow-up at the time of the Clinical Cut-Off Date for Final Analysis (CCO-FA); however, patients still receiving treatment with abiraterone acetate at the CCO-FA will be offered to receive continued treatment for an additional period of up to 3 years or until disease progression or unacceptable toxicity. For these patients, safety assessment will be performed while continuing treatment, and for 30 days after the last dose of abiraterone acetate.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic castration-resistant prostate cancer (CRPC)
* Previous anti-androgen therapy and progression after withdrawal
* ECOG performance status of either 0 or 1
* Medical or surgical castration with testosterone less than 50 ng/dL
* Life expectancy of at least 6 months

Exclusion Criteria:

* Prior cytotoxic chemotherapy or biologic therapy for CRPC
* Prior ketoconazole for prostate cancer
* Known brain metastasis or visceral organ metastasis
* Use of opiate analgesics for cancer-related pain, including codeine and dextropropoxyphene, currently or anytime within 4 weeks of Cycle 1 Day 1
The Effect of Erythropoietin Usage in Renal Function After Kidney Transplantation, in Early Phase, in Contrast to Placebo Group

The study hypothesis is that erythropoietin usage after kidney transplantation, in early phase, can improve the outcome for patients and their graft increasing patient and graft survival.


Eligibility Criteria:
Inclusion Criteria:

* Hb: \>8 and \<10 gr/dl
* Age: \>18 and \<55 years
* Cholesterol: \<300 mg/dl
* Triglyceride: \<400 mg/dl
* First Transplantation
* Protocol of Immunosuppression: CSA + MMF + Prednisolone
* Systolic BP: \<14
* Diastolic BP: \<9

Exclusion Criteria:

* History of specified cardiac disease
* Second Transplantation or more
* Hb: \<7gr/dl
* The patient needs to infusion of blood
* Evidence of local or systemic infection, at the time of EPO injection
* Presence of ATN / DGF after transplantation
* Presence of emergent hypertension
* High risk patients ( Like; PRA\>50%)
* Past history of hypersensitivity
Gefitinib in Combination With Chemoradiation in Resectable Gastric Cancer

To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer


Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed intestinal GC (T2-T4)
* Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
* Lymph node positive or negative
* Metastasis negative
* Resection with curative intent (R0, D2)
* Chemo- and radiotherapy naïve
* Measurable lesion according RECIST
* Written informed consent

Exclusion Criteria:

* Aged below 45 or over 70
* Prior gastric surgery
* Active ILD
Efficacy Of Pregabalin In Subjects With Post-Stroke Central Neuropathic Pain

Efficacy and Safety of flexibly dosed pregabalin compared to placebo among subjects with central post stroke pain (CPSP)


Eligibility Criteria:
Inclusion Criteria:

* Positive history of clinical stroke at least 4 months prior to randomization CPSP--3 months prior to screening

Exclusion Criteria:

* History of dementia or any other severe cognitive impairment
* Diabetic Peripheral Neuropathy (DPN)
Masitinib in Treatment of Patients With Severe Persistent Asthma Treated With Oral Corticosteroids

The study objective is to compare the efficacy and the safety of masitinib at 6 mg/kg/day versus placebo in the treatment of patients with Severe Persistent Asthma treated with oral corticosteroids.

Masitinib is a selective tyrosine kinase inhibitor. It is known that activation of inflammatory cells, such as mast cells, and fibrous tissue remodeling are associated with c-Kit, Lyn and PDGFR kinase signaling pathways; all key targets of masitinib. The objective of this study is to compare the efficacy and safety of masitinib at 6 mg/kg/day versus matched placebo in severe persistent asthma patients that is uncontrolled with oral corticosteroids. The primary outcome measure will be severe asthma exacerbation rate over duration of the treatment.

Eligibility Criteria:
Main inclusion criteria:

1. Patient with severe asthma and already treated with oral corticosteroids at a minimal daily dose of 7.5 mg prednisone or equivalent for at least 3 months prior to screening visit
2. Patient treated with oral corticosteroids during at least one period of 21 days, from 1 year prior to screening to 3 months before screening
3. Patient with no significant change in the regular asthma medication, no severe asthma exacerbation for at least 4 weeks prior to screening visit
4. Non-smoker patient for at least 1 year and with a prior tobacco consumption \< 10 packs/year

Main exclusion criteria:

1. Patient with active lung disease other than asthma (e.g. chronic bronchitis)
2. Female patient who is pregnant or lactating
3. Asthmatic patient still exposed to allergens or to triggering factors influencing asthma control
4. Patient with history of acute infectious sinusitis or respiratory tract infection within 4 weeks prior to screening visit
SUBLOCADE Long-term Outcomes

This study will provide the opportunity to generate data on the long-term use of SUBLOCADE under real-world conditions, and to observe enduring changes in lifestyle, health, and sociodemographic factors that are part of the recovery process. Long-term patterns of abstinence/opioid misuse as well as measures of participants' physical, psychological, social, and economic well-being will be monitored to better understand factors associated with recovery from opioid use disorder (OUD). Therefore, this study will observe participants up to a maximum of 4 years.

This is a Phase IV, prospective, multicentre, multinational, open-label, real-world observational study in participants with current or a history of OUD/opioid dependence.

Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria:

* Is an adult ≥ 18 years of age who has signed the informed consent form
* Plans to receive additional SUBLOCADE injections and

  * Has initiated treatment for OUD/opioid dependence with SUBLOCADE within the last 3 months prior to Baseline Visit

    * OR
  * Has completed an Indivior SUBLOCADE study (eg, INDV-6000-401, INDV-6000-405) and has received the last dose of SUBLOCADE on that study within 3 months prior to Baseline Visit
* Is not currently participating in any clinical trial requiring medical intervention
* Is not currently using opioids to treat a diagnosis other than OUD/opioid dependence
Predicting Progression of Developing Myeloma in a High-Risk Screened Population (PROMISE)

The PROMISE Study aims to establish a prospective cohort of individuals with precursor conditions to multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

The goal of the PROMISE research study is to determine clinical/genomic alterations present in individuals with MGUS and SMM, who are diagnosed through screening of a high-risk population. We also seek to determine clinical/genomic/epigenetic and immune environmental predictors of progression to multiple myeloma in patients with MGUS and SMM.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 30 years
* AA race (self-identified) and/or first-degree relative of a patient with a plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia, or another blood cancer.
* Those over 18 are also eligible if they have 2 or more family members with a blood cancer

Exclusion Criteria:

\* • Persons diagnosed with cancer at any site (including hematologic cancers) with symptomatic disease requiring active therapy.

• Persons with an already diagnosed plasma cell dyscrasia such as MGUS, SMM, MM, and Waldenström's Macroglobulinemia

First-degree relatives would not need to be identified by the participant.

This study includes all special populations who fall within the eligible high-risk age range, ≥ 30 years of age, including adults unable to consent, pregnant women, and prisoners. These populations will not be excluded as this is a non-therapeutic study.
Multi-Center PAMPA Study

This is a multi-center (North-America), randomized, double-blind, placebo-controlled, wait-list, interventional, preventive trial of guselkumab in high-risk psoriasis patients compared to non-biologic standard of care.

The primary objective of our proposed trial will be to test the hypothesis that a prolonged, unresolved skin inflammation coupled with musculoskeletal power-doppler ultrasound (MSKPDUS) abnormalities driven by IL-23 increase the risk for transition into PsA and that an intervention that targets one of these pivotal molecules (i.e., Guselkumab) will:

1. Diminish MSKPDUS findings at 24 weeks, and
2. Significantly reduce or prevent the emergence of synovio-enthesial phenotype at year 2.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older;
2. Both male \& female;
3. Psoriasis diagnosis (per dermatologist) for at least 2 years (in at least 30% of participants);
4. Willing and able to provide informed consent;
5. Fulfillment of HR-PsO criteria (Psoriasis (PsO) patients will meet the definition of HR if they fulfill the following criteria: a) PsO duration \>2 years and Psoriasis Body Surface Area (BSA) \>3% and positive imaging findings in MSKPDUS defined as a RM-PsASon score of \>3.36

Exclusion Criteria:

1. Evidence of inflammatory joint pain, enthesitis and/or dactylitis on exam;
2. Current systemic immunosuppressive medication use (i.e., methotrexate, apremilast) at the time of enrollment or biologic therapy (ever);
3. RA seropositivity (mid-high RF/ACPA titers);
4. Current active malignancy;
5. History of symptomatic polyarticular OA or other joint conditions (such as RA, gout, etc) that may impair the ability to assess for PsA development
6. Conditions where initiation of guselkumab is prohibited in the prescribing information, including clinically important active infection and untreated latent tuberculosis;
7. Known hypersensitivity to the study agent.