cyrilzakka/clinical-trials huggingface dataset:
A Study of ICP-022 in the Treatment of Recurrent or Refractory Waldenstrom Macroglobulinemia

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022.

Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R WM will be evaluated in approximately 44 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.


Eligibility Criteria:
Key Inclusion criteria:

1. Clinical and histologically confirmed giant globulinemia Fahrenheit (WM Ii International Working Group Standards, IWWM-2, 2003) (Owen et al., 2003)
2. At least one treatment indication is met (7th WM International Working Group standards, IWWM-7) (Dimopoulos et al., 2014)
3. With the lowest serum IgM value \>2 times ULN as the efficacy evaluation index
4. ECOG physical strength score 0-2
5. Voluntary written informed consent prior to trial screening.

Key Exclusion Criteria:

1. Present or prior history of other malignant neoplasms, unless radical treatment has been performed and there is no evidence of recurrence or metastasis in the last 5 years
2. Amyloidosis and central nervous system (CNS) involvement caused by WM
3. Demonstrate disease transformation
4. Patients who had received autologous stem cell transplantation within the previous 6 months
5. A history of organ transplantation or allogeneic bone marrow transplantation

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Internalized Stigma in Patients With Bipolar Disorder or Schizophrenia

The aim of this study is to explore the levels of internalized stigma in a sample of young patients with bipolar disorder or schizophrenia.

The stigma is considered by patients, government organizations and health professionals a key point in mental illness (Griffiths et al, 2006). The related literature has focused on individuals with schizophrenia although there are indications that stigma act negatively in patients with bipolar disorder; this, in turn, is described in a few studies, always with heterogeneous samples, chronic and symptomatic patients (Perlick et al, 2001). It is also known that there is a significant association between affective symptoms and the presence of stigma, (Vázquez et al, 2010).

There are reports of higher levels of public stigma towards people with schizophrenia, compared to patients with bipolar disorder or unipolar depression, however there are no studies available on internalized stigma in such samples, especially in remitted patients . Since schizophrenia coexists with significant impairment of insight, such individuals may exhibit more difficulty internalizing the external bias and stereotypes. On the other hand, patients with bipolar disorder - despite being less discriminated by the public in relation to schizophrenia - probably have a high potential for self-stigma and its fearsome consequences, justified by higher levels of insight.

The investigators would like to examine whether the lower impairment of insight in young bipolar patients(in relation to young people with schizophrenia) could be accompanied by an increase in internalized stigma in this sample. It´s an observational, cross-sectional study with no intervention.

Hypothesis: the internalized stigma in young adults with bipolar disorder is identical to that of young patients with schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder and schizophrenia according to DSM-IV-TR, presenting in euthymia (bipolar disorder) or without positive symptoms (schizophrenia), based on clinical assessment and confirmed by structured clinical interview SCID-P
* Age between 18 and 40 years
* Literate and able to understand the tasks required.
* Residents of Greater Sao Paulo.
* Patients and / or legal representatives must understand the nature of the study and sign an informed consent.

Exclusion Criteria:

* Patients with Schizoaffective Disorder or Mental Retardation.
* Unstable serious diseases including kidney disease, gastroenterology, respiratory, cardiovascular, endocrine, neurological, immunological or haematological.
Validation of Stroke Volume Measurement by a New Noninvasive Hemodynamic Monitoring System (NexFin)in Comparison to Different Invasive Procedures as Picco2, FloTrac and TEE

Main hypothesis: there is no difference between stroke volume measurements recorded by a new noninvasive finger cuff system (NexFin) and invasive hemodynamic monitoring systems as Picco2-system, FloTrac and transesophageal echocardiography

In high risc patients undergoing orthopedic surgery an extended cardiopulmonary observation improves patients safety and postoperative outcome. Therefore invasive procedures as Picco2-system, FloTrac and transesophageal echocardiography (tee) have the advantage to measure or calculate stroke volume. Disadvantage of this treatments is the need for a vascular access with all its complications.

In this study the stroke volume measured by a new noninvasive finger cuff system (NexFin) should be validated in comparison to invasive hemodynamic monitoring systems as Picco2-system, FloTrac and tee.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing orthopedic surgery with need for invasive blood pressure measurements
* age ≥ 18 years
* signed informed consent
* no participation on another interventional study

Exclusion Criteria:

* refusal of participation
* patients who are not able to sign informed consent
* atrial fibrillation with arrhythmia
* peripheral arterial disease \> Fontain IIa
* scleroderma
* presence of an arterio-venous shunt on upper limb
* contraindication for femoral arterial vascular access
* contraindication for transesophageal echocardiography
* stage III heart valve defects
* shunt heart defects
* solitary regional anaesthesia
* pregnant or breastfeeding women
Effect of Milk on the Vaccination Response

Rationale: Oral vaccination is known to induce a systemic immune response as well as an immune response in mucosal tissues, and can therefore serve as a model to study systemic and mucosal immunity. In this study, the oral cholera vaccine Dukoral® was chosen as model vaccine. The kinetics of the immune response and the interaction with a raw milk matrix have been evaluated in a previous, pilot study (NL49042.081.14). Based on the outcomes of this pilot, in this study oral cholera vaccination will be applied to study the support of immunity by raw milk, compared to heat-treated milk. The study design has been optimised based on previous results: study duration is extended and sample size is based on relevant change and known variation in the primary outcome parameters.

Infections are an important worldwide cause of death, both in elderly and young children. Therefore, support of immunity could help to reduce the incidence of infections. To screen the potential of specific foods or food ingredients to support immunity, oral vaccination can serve as a model. In a previous study, this model was developed using oral cholera vaccination in human adult volunteers. In that study, raw milk was shown to support the immune response to vaccination. In this follow-up study, the effect of raw milk will be compared with pasteurized and ultra-heat treated (UHT) milk.

Objective: To investigate whether pasteurized milk and/or UHT milk are able to enhance the immune response as induced by oral cholera vaccination, in comparison to raw milk and to regular vaccination.

Study design: The study is designed as a single-blind randomized controlled trial of 6 weeks.

Study population: Healthy subjects of 18-50 years of age.

Interventions: 1) Raw milk, obtained from farms that comply to the high quality requirements for production of raw milk, and that has been screened according to the safety criteria for raw milk; 2) commercially available full-fat UHT milk; 3) commercially available full-fat pasteurized milk.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 yr
* Signed informed consent
* Availability of internet connection
* Male or female
* Willing to stop blood donation at the blood bank during the study period

Exclusion Criteria:

* Currently participating in another clinical trial
* Previous Cholera, Salmonella, or E. coli vaccination
* Tonsillectomy
* Acute gastroenteritis in the past 2 months
* Use of antibiotics in the past 2 months
* Hypersensitivity to the vaccine, to formaldehyde or to any of the excipients (sodium salts)
* Pregnancy or lactating
* Not willing to drink raw milk
* Allergic to milk or lactose-intolerant
* Disease of GI tract, liver, gall bladder, kidneys, thyroid gland
* Immune-compromised
* Use of immunosuppressive drugs
* Drug abuse, and not willing/able to stop this during the study
* Excessive alcohol usage (men: \>4 consumptions/day or \>20 consumptions/week; women: \>3 consumptions/day or \>15 consumptions/week)
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery

The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

Patients will be randomly assigned to PMI-150 (intranasal ketamine) or placebo and will receive repeated doses and be assessed for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* patient is scheduled for elective orthopedic surgery or procedure

Exclusion Criteria:

* patient has received an investigational drug or participated in a clinical trial within 30 days or 5 half-lives (whichever is longer) of entering this study
Perioperative Cardiac Troponin Levels in Healthy Adults

This study will determine the extent of high-sensitivity cardiac troponin (hs-cTn) release in patients without cardiac risk factors undergoing extremity orthopedic surgery. This study will provide important evidence on how to interpret postoperative cardiac troponin elevations.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years
* Extremity orthopedic or trauma surgery: leg, hip, arm, shoulder.
* Planned overnight hospital admission
* No cardiac risk factors (Lee's Revised Cardiac Risk Index Class 1)
* American Society of Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

* Any history or symptoms of cardiac disease
* Kidney or liver disease
* Recent or current trauma to the trunk or head
* Persons with increased vulnerability (e.g. cognitive limitations, prisoners,...)
* Pregnancy
Proton Beam Therapy for Chordoma Patients

The goal of this clinical research study is to learn if proton beam therapy, with or without photon beam radiation therapy, is effective in the treatment of skull base chordoma. The safety of this treatment will also be studied.

Proton therapy is a kind of external beam radiation therapy where protons are directed to a tumor site. Researchers are trying to determine what level of proton therapy gives the most benefit without causing toxic side effects. Researchers will also be testing the treatment's effect.

If your doctor feels it is necessary, the proton beam therapy may be combined with standard photon therapy.

If you are eligible to take part in this study, you will receive proton beam therapy at The University of Texas (UT) MD Anderson Cancer Center (MDACC), and possibly photon beam, no sooner than 2 weeks after the last surgery to remove the tumor. You will receive proton beam therapy once a day for about 35 treatments (7 weeks). Treatment will be given for 5 days in a row each week (except for Saturdays, Sundays and holidays) at the MDACC Proton Center in Houston. The whole process should take up to 1 hour each day.

This is an investigational study. The proton beam machine used to deliver treatment is approved by the FDA for patient use. The doses being studied are experimental. About 15 participants will take part in this study. All will be enrolled at MDACC.

Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed chordoma of the skull base
2. Contrast enhanced postoperative MRI (CT in case MRI is contraindicated) of the skull base obtained within 90 days of study registration
3. MDACC surgeons have determined that optimal debulking of disease has been performed.
4. Karnofsky Performance status greater than or equal to 60
5. Signed informed consent

Exclusion Criteria:

1. Previous irradiation of the skull base
2. Documented evidence of disseminated metastatic disease
3. Any concurrent malignancy (other than non-melanoma skin cancers) in the last 3 years
Double Blind Placebo Controlled Bellis Perenis and Arnica Montana as a Drug for PPH

To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana

To look at the antihemmorhagic effect of 2 homeopathic drugs in women post delivery Bellis Perenis and Arnica montana compare it with placebo

Eligibility Criteria:
Inclusion Criteria:

* healthy women during delivery

Exclusion Criteria:

* Scarred uterus, multifetal ,multiparty,bleeding problems,cesarean sectons,chorioamnionitis
Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic Reactions in an Emergency Department

To determine if intravenous unfractionated heparin (with standard therapy) for treatment of anaphylaxis results in faster time to recovery.

Anaphylaxis is a potentially life-threatening entity that requires both immediate recognition and aggressive treatment. Although anaphylaxis is infrequent, comprising only 1% of approximately 1.03 million visits to the ED each year that are related to allergic reactions, it is none the less a generally under-recognized and under-treated disease, that is worthy of study due to the potential for a fatal outcome. Recently, there has been renewed interest in a commonly used and inexpensive drug (heparin) as a novel component of therapy for anaphylactic/anaphylactoid reactions. Heflin eft al. induced anaphylactoid reactions in pigs and compared intravenous unfractionated heparin in one treatment arm to standard therapy (intravenous epinephrine and diphenhydramine) versus placebo. The study revealed that heparin rapidly reversed the shock similar to that of standard emergency treatment. Of course this single study done in pigs will not change practice, but it does warrant further investigation into the role that heparin plays in anaphylaxis in humans.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* English speaking
* Meets one of the above definitions of anaphylaxis
* Signs/symptoms onset \<12 hours will get epinephrine or will not get epinephrine because of contraindication to epinephrine administration.

Exclusion Criteria:

* History of Intracranial Hemorrhage at anytime
* Known Cerebral Vascular Lesion (i.e. Aneurysm, Arteriovenous malformation)
* Ischemic CVA within the last 3 months
* Suspected Aortic Dissection
* Active Bleeding
* Known Bleeding/Clotting Disorder
* Closed Head Trauma within the past 3 months
* Major Surgery (Abdominal/Thoracic) within the last 3 weeks
* Active GI Bleeding
* Currently taking Warfarin
* Allergy to Heparins
* History of Heparin-induced Thrombocytopenia (AHA contraindications to fibrinolytic therapy 2005, Micromedix 2007)
Long-term Evaluation of the Quality of Life of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy

Surgery and radiation therapy play a major role in the treatment of bone and soft tissue tumors. Osteosarcomas, rhabdomyosarcomas, and Ewing tumors are the most common histologic types. Surgery may require multiple techniques and radiation therapy may be conformational, or more recently IMRT (Intensity Modulated Radiation Therapy). If surgery is possible, lower limb surgery is generally the recommended treatment, even if a poor functional result can be expected.

The literature is very poor regarding the impact of radiotherapy on quality of life and functional results, mainly with the use of prosthetic materials.

Tools such as the Toronto Extremity Salvage Score (TESS) are now available for self-assessment of functional outcomes. The presence of large cohorts such as FCCSS, COHOPER and SALTO facilitates these studies.

The SF-36 is a short 36-question health questionnaire that consists of a generic, consistent, and easy-to-administer set of measures. These measures are based on self-report by patients and are now widely used by organizations managing the care of adult patients.

The TESS Functional Questionnaire is a patient-completed self-questionnaire widely used for motor stimulation in patients with musculoskeletal tumors. This score is based on the definitions of handicap, impairment and handicap as documented by the World Health Organization (WHO). It includes 30 questions assessing overall function and daily activities. The final score varies from 0% to 100%, 100% being the best possible score. So far, several studies have reported the validation of TESS in Portuguese, Danish, Korean, Japanese and since this year in French. Indeed, the TESS questionnaire was validated in French by the study "Transcultural validation of TESS and MSTS questionnaires" promoted by the Nantes University Hospital.


Eligibility Criteria:
Inclusion Criteria:

Patients from the French FCCSS or COHOPER or SALTO cohorts Adult patient (\> 18 years old) when filling out the study questionnaires Patient treated for a bone tumor before the age of 18 Patient with a minimum follow-up of 5 years without cancer treatment (treated before 2014) Patient living in France and speaking French

Exclusion Criteria:

Patient with a 2nd cancer Patient who has already been approached by the Hospital de NANTES as part of the cross-cultural validation of the TESS questionnaire
A Phase I/II Clinical Trial of PepCan in Head and Neck Cancer Patients

This study has been designed to evaluate the safety and efficacy of giving seven injections of PepCan or placebo over approximately a 24-month period in subjects with head and neck cancers who achieved remission. PepCan may prove to be beneficial in treating many stages of HPV-related malignancies starting from infection to cancer. Safety, efficacy in terms of reduced cancer recurrence, immunological responses and profiles, and gut microbiome changes will be assessed.

This is a Phase I/II study to evaluate the efficacy and safety of an HPV therapeutic vaccine called PepCan (HPV-16 E6 peptides) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of PepCan (50 µg per peptide dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment by enzyme-linked immunospot (ELISPOT) assay will be made at 4 time points (Visits 1, 5, 8, and 9), and by fluorescent activated cell sorter analysis will be made at times points at Visits 1, 3, 5, 6, 7, 8, and 9. Oral wash samples and stool samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Able to provide informed consent
2. Male or female 18 years of age or older
3. Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy) therapy within the previous 120 days
4. Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
5. No Evidence of Disease (NED) based on clinical and/or radiographic evaluations
6. Vital Signs recorded

   1. Blood pressure (≤160/95 mm Hg acceptable)
   2. Heart rate (50-100 beats per min acceptable)
   3. Respiratory rate (≥ 12 ≤25 breaths per min acceptable)
   4. Temperature (≤100°F acceptable)
7. Blood work done at Screening Visit

   1. White count (≥3x109/L acceptable)
   2. Hemoglobin (≥ 7 g/dL acceptable)
8. Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

1. Positive urine pregnancy test for women of childbearing potential
2. Being pregnant or attempting to be pregnant within the period of study participation
3. Women who are breast feeding or plan to breast feed within the period of study participation
4. Patients who are allergic to Candin® or yeast
5. History of severe asthma requiring emergency room visit or hospitalization within the past 5 years
6. Patients who have previously received PepCan
7. History of recurrence of squamous cell carcinoma of the head and neck
8. If in the opinion of the Principal Investigator or other Investigators, it is not in the best interest of the patient to enter or continue in this study
Oropharyngeal and Nasopharyngeal Decontamination With Chlorhexidine Gluconate in the Reduction of the Postoperative Morbidity and Mortality After Major Pulmonary Resections

Despite improvement of per and postoperative management, major pulmonary surgery continues to carry out a high morbidity with a significant mortality. Among postoperative complications, respiratory failures (nosocomial pneumonia, ARDS) are currently the most frequent and serious, as well as being the primary cause of hospital death, after major pulmonary resections. Vast majority of these complications are notoriously infectious and should be considered as hospital-acquired infections. These complications result in a dramatic increased of substantial hospital costs in term of length of hospital stay, antibiotics and morbidity. Current management of these complications stands on antibiotics, oxygen supply and physiotherapy. In severe case, a ventilatory support (invasive or non invasive) is justify in near 25 % of cases.

Recent data have suggested that proximal airways colonizations could be an essential first step in the pathogenesis of theses respiratory failures. Previous works have long demonstrated that bacterial colonization was frequent between 21 to 40 % in lung cancer patients. These colonizations could act as a major predisposing factor to these postoperative respiratory failures. Because distal airways and lung parenchyma are free from bacteria at the moment of the surgery, respiratory complications should be the result from contamination by potential microorganisms belonging the upper aero-digestive tract. Consequently, decontamination of the oropharyngeal and nasopharyngeal cavities before and during the first days after surgery could have a beneficial advantage in the prevention of these complications. This decontamination has been demonstrated to be effective in critically-ill patients in intensive care unit, in cardiac surgery and in esophageal surgery. Decontamination of oropharynx and nasopharynx with Chlorhexidine Gluconate has significantly reduced the rate of postoperative global hospital-acquired infections and respiratory infectious as well. To date, data on the efficacy of this decontamination protocol in major pulmonary resections are not available.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 18 years
* Submitted to major pulmonary resections for primary lung cancer or pulmonary metastasis
* Anatomical resections (segmentectomy, lobectomy, pneumonectomy)
* With mediastinal lymph node dissection.
* Patient fit for operation
* After informed consent

Non inclusion criteria:

* Patients \< 18 years
* Pulmonary infectious lesions
* Recent respiratory infections
* Tracheostomy
* Swallow difficulties
* Need for non-invasive ventilation before surgery
* Documented sensibility to Chlorhexidine
* Previous ENT cancer
* Previous thoracic surgery
* Patients with an oral assessment score (OAG) \>9