cyrilzakka/clinical-trials huggingface dataset:
Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia

To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite, PF-01001252, after multiple doses of PF-02545920 administered orally.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with DSM-IV diagnosis of schizophrenia or schizo-affective disorder for whom antipsychotic monotherapy is indicated.
* Subjects must be free from an acute exacerbation of psychosis for at least 3 months prior to screening.
* Current Clinical Global Impression (CGI) of Severity of Illness score ≤ 3.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of a primary DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
* Any condition possibly affecting drug absorption (e.g., gastrectomy).
Wrist Extension Dynasplint (WED) Distal Radius Fracture

The purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.


Eligibility Criteria:
Inclusion Criteria:

* Distal radius fracture treated with surgical management and wrist flexion contracture upon follow up

Exclusion Criteria:

* Carpal Fractures (Scaphoid, Lunate, Hamate, and Trapezium)
* Radial nerve entrapment
* Arthrodesis
* Traumatic dislocation of the distal ulna
Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.

Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®).

The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of BOP and/or SOP and no further bone loss) at 1 year of follow-up.

The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group.

The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group.

The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.

Eligibility Criteria:
Inclusion Criteria:

1. Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible;
2. Presence of Peri-implantitis;
3. No implant mobility;
4. Treated periodontal disease;
5. No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication).
6. Non-smoker or light smoking status in smokers (\<10 cigarettes/day).

Exclusion Criteria:

(1) Pregnant, lactating women and non-collaborating patients will be excluded from the study.
Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

This single-center, randomized, double-blind, placebo-controlled, parallel-group trial will evaluate pain and quality of life outcomes associated with 6 months of treatment with testosterone or placebo in men aged 18 years or older with chronic non-cancer spinal pain who are taking opioid analgesics for at least 6 months and have opioid-induced hypogonadism.

Eligibility Criteria:
Inclusion Criteria:

* Men, age 18 years and older.
* Chronic non-cancer spinal pain.
* Use of opioid analgesics for at least 6 months.
* Serum total testosterone (measured by mass spectrometry) \<348 ng/dL and/or free testosterone \<70 pg/mL.
* Ability and willingness to provide informed consent.

Exclusion Criteria:

* History of prostate cancer or breast cancer.
* Known history of organic hypogonadism (e.g., due to hypothalamic, pituitary or testicular disease).
* Use of testosterone within the past 6 months.
* Baseline hematocrit \>48%.
* Prostate-specific antigen (PSA) level \>4 ng/mL in Caucasians or \>3 ng/mL in African-Americans.
* Presence of prostate nodule or induration on digital rectal examination.
* Uncontrolled congestive heart failure.
* Myocardial infarction, acute coronary syndrome, revascularization surgery or stroke within 3 months.
* Serum creatinine \>2.5 mg/dL.
* Alanine aminotransferase (ALT) level 3 times above the upper limit of normal.
* Diagnosis of bipolar disorder or schizophrenia.
* Presence of metallic implants (pacemakers, aneurysm clips, etc.) that preclude the patient from undergoing functional magnetic resonance imaging (MRI). In subjects who are otherwise eligible and either do not qualify for MRI or are reluctant to undergo imaging, the investigators may consider enrolling such participants on a case-by-case basis.
Nutritional Therapy for Diabetic Cardiomyopathy

The goal of this study is to determine if nutritional therapy can effectively treat/prevent T2DM and its consequent cardiomyopathy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be \>30 and \<65 years of age, in order to limit the confounding affect of age on our endpoints.
* Subjects must have an ejection fraction \>45% (based on their echocardiogram)
* Patients with T2DM and nonalcoholic fatty liver disease or steatohepatitis may be included since they have extensive evidence of steatosis.

Exclusion Criteria:

* Subjects who have had a myocardial infarction or resting ischemia (by history or as evidenced by hypo/akinesis on the pre-intervention echocardiogram) will be excluded because hypo/akinesis would affect our endpoints of LV mass and diastolic function.
* Subjects who are unstable, not able to lie flat for the imaging studies, unable to give informed consent, pregnant, lactating, with atrial fibrillation (which would compromise measurement of E'), or current smokers will be excluded.
* Subjects with other major systemic diseases per their clinical charts, history, physical exam, or significant renal insufficiency will also be excluded, as these other system diseases may affect our study endpoints and subject follow-up.
* We will exclude patients with significant LV systolic dysfunction (ejection fraction \<45%)
* We will not exclude patients with sleep apnea because it does not detrimentally affect LV diastolic function.
* Subjects will be excluded a priori if they have any history or evidence of liver disease other than NAFLD, consumed \>20 g alcohol per day.
Screening of Low Responders for Aneuploidy to Improve Reproductive Efficiency

The purpose of this study is to assess the impact of Comprehensive Chromosome Screening(CCS) on patients with low ovarian reserve in an effort to improve success during in vitro fertilization and decrease the time to successful pregnancy.

Patients will undergo a stimulated IVF cycle culminating with an ultrasound guided egg retrieval procedure and either a fresh or frozen embryo transfer as clinically appropriate and without regard to study. All embryology laboratory procedures will be conducted per routine. Once the embryo(s) have reached the blastocyst stage of development patients will be randomized into either the study group or the control group. The SOLAIRE Trial is "blinded" which means neither patients nor the RMANJ study doctor/staff will know to which group the embryos were randomized. The study group will have their embryo(s) biopsied for CCS on day 5, if appropriate, for a fresh day 6 embryo transfer. The control group will not have CCS testing performed on their embryo(s) and may proceed with a fresh or frozen embryo transfer as clinically appropriate. The maximum amount of embryos that can be transferred is two per RMANJ protocol. All post-transfer care and pregnancy monitoring will be identical and per routine protocol regardless of study participation.

Eligibility Criteria:
Inclusion Criteria:

* Age of female partner \< 43 y/o AMH \< 1.1 OR BAFC \< 8 (within previous year) Male must have \>100,000 motile sperm BMI \< 32

Exclusion Criteria:

* Diagnosis of endometrial insufficiency Use of oocyte donor/gestational carriers Use of surgical sperm or DNA Banking Communicating hydosalpinges (HSG) Single gene disorders or sex selection Participation in another study
A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease

To determine if subjects with steroid refractory cGVHD can tolerate imatinib mesylate and whether their cGVHD responds to imatinib mesylate.


Eligibility Criteria:
INCLUSION CRITERIA

* Chronic graft-vs-host disease (cGVHD) requiring systemic therapy occurring \> 100 days after hematopoietic cell transplant with either:

  1. Persistent steroid dependence defined as the inability to taper steroid treatment to less than 0.25 mg/kg/d prednisone or its equivalent for at least 3 months.
  2. Progression of cGVHD signs and symptoms on steroid therapy equivalent to prednisone 0.5 mg/kg/d for at least 1 month.
* At least one of the following manifestations:

  1. Skin changes (rash, sclerosis, fasciitis, or ulceration).
  2. Abnormal eye wetness ≤ 5 mm as measured by Schirmer's test.
  3. Oral mucosal changes (erythema, lichenoid changes, ulcers, or mucoceles).
  4. Thrombocytopenia (platelets \< 50,000/uL).
  5. Abnormal liver function testing defined as alkaline phosphatase, AST, ALT, or total bilirubin \> upper limit of normal (ULN).
  6. Bronchiolitis obliterans (diagnosed by a \> 5% annual decline in FEV1 with the lowest post-transplant FEV1/FVC \< 0.8 and an appropriate CT scan or lung biopsy).
* Has been on a fixed dose of steroids or a fixed dose of steroids and one other immunosuppressant (cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or extracorporeal photopheresis) for ≥ 30 days before starting imatinib.
* Life expectancy ≥ 6 months.
* Ability to understand and willingness to sign a written informed consent document.
* Karnofsky performance status ≥ 3 50% (Appendix B).
* At least 18 years of age.
* If a female of reproductive potential (defined as having at least 1 menstrual period in the past 12 months), must have a negative pregnancy test performed ≤ 7 days before starting study drug.
* If a female of reproductive potential, agrees to use contraception for the duration of the trial.
* Total bilirubin \< 1.5X ULN.
* Aspartate transaminase (AST) \< 2.5 x ULN.
* Alanine aminotransferase (ALT) \< 2.5 x ULN.
* Alkaline phosphatase \< 2.5 x ULN.
* Absolute neutrophil count (ANC) \> 500/uL (growth factor supplementation is allowed).
* Hematocrit \> 26% (transfusion support is allowed).
* Platelet count \> 20,000/uL.

EXCLUSION CRITERIA

* Received another investigational agent ≤ 30 days before starting the study drug.
* Ongoing intercurrent illness such as an infection not responsive to antibiotics, antiviral medicines, or antifungal medicines.
* Progressive malignant disease.
* Secondary malignancy that has not been effectively treated within the past 5 years (except localized basal cell or squamous cell carcinoma).
* Imatinib intolerance or allergy.
* Participant is breast-feeding.
* Not willing to comply with treatment or response evaluation.
* Received an allogeneic cell product \[including donor lymphocyte infusion (DLI) or hematopoietic cell boost\] ≤ 100 days before starting study drug.
* Steroid and/or immunosuppressant dose has changed ≤ 30 days before starting study drug.
Concomitant or Sequential Phlebectomy After Endovenous Laser Therapy for Varicose Veins

Varicose veins of the leg often have superficial tributaries, which are often symptomatic and a major reason for coming to the doctor. When treating the main varicose vein inside the leg, some doctors prefer to remove these tributaries while others prefer to leave them. This trial aims to see if it is better to remove these veins at the time of the first laser procedure or better to leave them and only remove them when asked.

Endovenous laser therapy (EVLT) for varicose veins is associated with high initial occlusion rates, minimal complications and low recurrence rates at 5 years. Randomized trials and meta-analyses have confirmed the efficacy of EVLT in comparison with surgery and other endovenous techniques. There is also evidence that it may be associated with early quality of life (QoL) benefits compared with surgery. The general efficacy of EVLT has therefore been demonstrated and current research focuses on refinement of the procedure. A fundamental question concerns the management of residual varicosities following truncal laser ablation. One approach is to leave these varicosities to regress untouched, minimizing the procedure time and surgical trauma6. This approach, however, is associated with a significant number of secondary and tertiary interventions (sclerotherapy and/or ambulatory phlebectomy). Another option is to combine in a single procedure ambulatory phlebectomy with initial truncal laser ablation (EVLTAP). The aim of this randomized controlled trial was to assess the advantages of performing ambulatory phlebectomy as a concomitant procedure to truncal laser ablation.

Eligibility Criteria:
Inclusion Criteria:

* primary, symptomatic, unilateral varicose great saphenous veins (GSV), with isolated saphenofemoral junction (SFJ) incompetence and GSV reflux on venous duplex imaging,
* perigenicular vein diameter exceeding 4 mm,
* acceptance by the patient of a local anaesthetic procedure.

Exclusion Criteria:

* saphenopopliteal, small saphenous or deep venous incompetence on duplex imaging
* did not give consent to trial participation.
Combination of Chemotherapy and Gefitinib as First-line Treatment

The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators need a head-to-head study to reply.


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent
2. Age \>=18 years
3. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
4. A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology)
5. Measurable or non-measurable disease
6. Able to comply with study and follow-up procedures

Exclusion Criteria:

* Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology
* Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer
* Symptomatic or untreated brain metastases
* Prior systemic chemotherapy for NSCLC
* Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible)
* History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
* Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
* Pregnancy or lactation
A Safety Study of SGN-LIV1A in Breast Cancer Patients

This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of breast cancer with radiographic evidence of incurable, unresectable, locally advanced or metastatic disease (LA/MBC)
* One of the following:

  * Part A: Triple-negative disease (ER/PR/HER2-negative) and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting; or ER-positive and/or PR-positive/HER2-negative disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting and are no longer a candidate for hormonal therapy (not enrolling new patients);
  * Part B: Combination Arm: HER2-positive disease and received at least 2 prior cytotoxic regimens in the incurable, unresectable, LA/MBC setting (not enrolling new patients);
  * Part C: Triple-negative disease and received 2-4 prior non-hormonally-directed therapies in the MBC setting (not enrolling new patients);
  * Part D and Part E (dose-expansion cohort): Triple-negative disease and received 1 prior non-hormonally-directed or cytotoxic therapy in the MBC setting; or
  * Part E: HR+(ER-positive and/or PR-positive)/HER2-negative disease who are chemotherapy-eligible and not considered a candidate for further hormonal therapy. Must have received no more than 1 prior non-hormonally-directed or cytotoxic therapy in the LA/MBC setting.
* Part F: All of the following:

  * Triple negative breast cancer
  * No prior cytotoxic chemotherapy for unresectable locally advanced or metastatic stage disease
  * Tumor tissue PD-L1 expression CPS \<10 expression
* Parts A, B, C, and D: Newly obtained or archived tumor tissue biopsy, must be collected for central pathology determination of LIV-1 expression
* Parts E and F: Archival or fresh baseline tumor sample is required.
* Measurable disease
* Eastern Cooperative Oncology Group performance status 0 or 1
* Combination Arm: adequate heart function

Exclusion Criteria:

* Pre-existing neuropathy Grade 2 or higher
* Parts A, B, C, and D: Cerebral/meningeal disease that is related to the underlying malignancy and has not been definitively treated. Parts E and F: Known or suspected cerebral/meningeal metastasis that has not been definitively treated.
* Prior treatment with LV or prior treatment with an MMAE-containing therapy
* Combination Arm: hypersensitivity to trastuzumab
Assessment of the Effect of Restriction on Alimentary AGE in Progression of Chronic Kidney Disease

Normal-protein and low-AGE through raw or rare proteins diet versus normal-protein and high-AGE diet in stage IIIa-b renal failure patients


Eligibility Criteria:
Inclusion Criteria:

* Patients with a grade IIIA-B CKD (GFR with CKD-EPI ≥ 30 mL/min and \< 60mL/min)
* Informed consent signed
* Aged 18 to 89 years

Exclusion Criteria:

* Protected adult
* Acute renal failure
* Patient already on a low-AGE diet (\< 1kU AGE/day) following a dietetic consultation
* Current participation in another interventional research
GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients

Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.

The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>40 years) undergoing non-emergency (urgent or scheduled) cardiac surgery using cardiopulmonary bypass (CABG or combined CABG/valve).
* Patients must be able to understand English and be willing to sign informed consent.

Exclusion Criteria:

* Emergency surgery
* Off-pump coronary bypass grafting
* Aortic aneurysm repair
* Congenital heart disease repair
* Heart transplant or left ventricular assist device patient
* Severe heart failure (left ventricular ejection fraction \<25%)
* Hemodynamic instability or requiring preoperative vasopressors or IABP
* Pre-existing kidney disease (eGFR \<30 mL/min/1.73 m2) or renal transplantation.
* Presence of major active infection (chronic or acute, eg, sepsis, HIV, pneumonia)
* Chronic liver disease/cirrhosis
* Participation in an additional trial at the time of surgery or anytime within 30d of surgery where intervention could potentially alter renal health (unless in the control arm)
Serological Study of the Exposure of Personnel to COVID-19

A seroconversion test for SARS-Cov-2 will be offered to all the employees of a care institution, which has treated 240 patients hospitalized for COVID disease between 28/02 and 30/04/2020. The seroconversion test will be with a questionnaire to determine:

* whether the subject has shown signs of infection in the last 3 recent months
* if the subject has been in contact with COVID-diagnosed subjects (RT-PCR diagnosis or scanner) outside of the activity or within the professional activity (patient or colleague)
* Working conditions during the period
* The level of knowledge and respect of the barrier measures practices.
* Respect for distance during meals professional. Overall seroprevalence and stratified seroprevalence by care and administrative areas will be determined.


Eligibility Criteria:
Inclusion Criteria:

* Subject who worked at Saint Joseph Saint Luke's Hospital during the epidemic wave (male or female).

  * Free and informed consent
  * Social security affiliation

Exclusion Criteria:

* Subject refusal
* Subject on leave during the entire period