cyrilzakka/clinical-trials huggingface dataset:
Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies

This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies.

This study consists of 2 parts:

Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years (≥ 20 years in Japan; ≥ 19 years in South Korea)
* Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate bone marrow function, renal and liver functions Phase 1b
* Histological or Cytological diagnosis of advanced solid tumor with clinical evidence of response to anti-PD-1 or PD-L1 agent
* Participant must have received at least 1 prior line of therapy for recurrent or metastatic disease, and must have progressed/relapsed, be refractory, or intolerant to standard therapy approved for the specific tumor type Phase 2
* Participants must have a documented diagnosis of stage III where participants are not candidates for surgical resection or definitive chemoradiation, or stage IV NSCLC
* EGFR mutation, BRAF mutation, and ALK or ROS1 translocation/rearrangement are not permitted
* Participants whose tumor is known to be PD-L1 positive (Tumor Proportion Score \[TPS\] ≥1%) or unknown are eligible
* Up to 1 line of prior therapy in advanced or metastatic disease settings allowed
* Participant should not have received prior treatment with anti PD-1/PD-L1 drugs
* At least one measurable lesion as defined by RECIST version 1.1

Exclusion Criteria:

* Participants with known symptomatic brain metastases requiring steroids
* Participants with Interstitial Lung Disease history or complication
* Q-T interval corrected for heart rate QTc \> 450 msec for male participants or QTc \> 470 msec for female participants or QTc \> 480 msec in participants with right bundle branch block.
* Hypertension that cannot be controlled by medications (eg, systolic \> 150 mmHg and diastolic \> 90 mmHg) despite optimal medical therapy.
* Known or suspected hypersensitivity to active ingredient or excipients of the study drug.
* History of Grade ≥3 immune mediated AE (including AST/ ALT elevations that where considered drug related and cytokine release syndrome \[CRS\]) that was considered related to prior immune modulatory therapy (eg, immune checkpoint inhibitors, co-stimulatory agents, etc.) and required immunosuppressive therapy (For Phase 1b only).
* Vaccination with live attenuated vaccines within 4 weeks prior to randomization is prohibited; however inactivated vaccines are permitted.
Effect of Multidimensional Physiotherapy in Chronic Nonspecific Low Back Pain

This study compares the effect of multidimensional physiotherapy to usual evidence-based physiotherapy in the treatment of chronic nonspecific low back pain in adults. Half of the participants will receive multidimensional physiotherapy based on biopsychosocial approach while the other half will receive usual evidence based physiotherapy.

multidimensional physiotherapy treatment include: psychoeducation based on cognitive behavioral therapy (CBT), education, graded exposure, postural correction exercise, lifestyle change, and electrotherapy.

usual evidence-based physiotherapy include: electrotherapy, education, and trunk general exercises.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50
* Low back pain for 3 months or more
* Disability based on Oswestry Disability Index (ODI) between 20-60
* Fear of movement based on Tampa scale of kinesiophobia \>37
* Minimum level of education
* Native Persian speaking

Exclusion Criteria:

* Any evidence of e specific medical diagnosis
* Rheumatoid disease,fibromyalgia, neuropathy, progressive neurological disease
* History of headache, dizziness, nausea, epilepsy, migraines and mental disorder
* Beck's Anxiety Inventory\> 26
* Beck's Depression Inventory II\> 29
* Pregnancy
* Having other therapies during the present research
Physician Mental Health Study for Medical Trainees

The purpose of this study is to determine whether use of a suite of smart phone enabled mobile health devices can reduce burnout in medical trainees. Such applications can then be used in more general populations with the same goal in mind.

Wearable sensors and mental health platforms delivered via smartphones offer an opportunity to passively and actively acquire quantifiable signs and symptoms related to mental health status. These features include both physiological and cognitive performance measures. Collectively they serve as a set of metrics whereby an estimation of a person's mental state can be gauged. Additionally, use of these platforms allows those who are identified as high risk for mental illness to have targeted therapy delivered via their smartphone and if necessary connected with a suitable healthcare provider. Applications of such technology platforms serve to potentially reduce the substantial morbidity and mortality in a population at increased risk for mental illness and burnout.

Eligibility Criteria:
Inclusion Criteria:

* Trainee Physician at Scripps Green Hospital or Clinic.
* Older than 18 years.
* Must be reliable, cooperative and willing to comply with all protocol-specified procedures.
* Able to understand and grant informed consent
* Have a pre-existing smart phone capable of running all study software.

Exclusion Criteria:

* Has a significant medical condition that in the investigator's opinion may interfere with the study subject's optimal participation in the study.
* Known mental health condition including diagnosis of depression, schizophrenia, suicidality or anxiety disorder.
* Does not have suitable smart phone to allow all relevant software to run.
Endometrial Effects of Lipiodol

The goal is to investigate whether endometrial flushing with Lipiodol enhances fertility. Therefore, anatomo-pathological, histochemical and transcriptional changes of the endometrium after Lipiodol bathing in a general population of healthy volunteers will be determined.

A single-centre, cross-over, open-label trial will be performed. Healthy volunteers, fulfilling the inclusion/exclusion criteria, will be asked to do blood samples and ultrasounds for the detection of the LH (luteinizing hormone) surge in a natural cycle. The intervention group will undergo endometrial flushing with Lipiodol between day 6 and 8 of the cycle, while the control group between day 6 and 8 of the cycle will have a mock catheter introduction without any Lipiodol flush. An endometrial biopsy will be performed 7 days after the LH peak in all the participants. Furthermore, all the participants will undergo one cycle with flushing and one cycle with introduction of a mock catheter but without flushing with any medication. The wash-out period between the 2 biopsies will be 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥18 and \<36 years
* Regular cycle (25-35 days)
* Signed informed consent
* Participants can be included only once in the trial
* Contraceptive: barrier method only.

Exclusion Criteria:

* known iodine allergy
* Body mass index 30 or ≤18.5
* Smoking
* Previous diagnosis of PCO (Polycystic Ovary Syndrome) (\>12 antral follicles in one ovary, Rotterdam criteria 2003)
* Previous diagnosis of endometriosis, uterine malformations or intrauterine pathologies (submucosal fibroids, endometrial polyps, and intrauterine adhesions)
* Systemic diseases such as thyroid dysfunction
* Breast-feeding or pregnancy within the last 6 months
* Intrauterine devices (IUD)
* History of recurrent miscarriage
* Known history of infertility
* Previous uterine surgery
* Pregnancy wish during the course of the study
* Women who have been previously enrolled in the trial
* Those unable to comprehend the investigational nature of the proposed study
Association Between Labor Induction and Birth Weight in Cases of Fetal Macrosomia: The MACROMODA Cohort Study

The rising prevalence fof fetal macrosomia represents a significant challenge in obstetrics, affecting both maternal and neonatal outcomes. Such challenges include complications like perineal tears and postpartum hemorrhage. Concurrently, the frequency of labor induction practices on the rise, yet the implications for neonatal weight are inadequately understood. To address this gap, our study aims to evaluate the association between labor induction and neontal birth weight through a population-based cohort study. The findings have the potential to inform more accurate clinical guidelines, thereby enhancing the quality of maternity care.


Eligibility Criteria:
Inclusion Criteria:

* Full-term deliveries (≥ 37 weeks of gestation)
* Singleton
* Birth weight \> 4000g
* Complete medical records available for analysis

Exclusion Criteria:

* Delivery \< 37 weeks
* Uterus \> bi-scarred
* Presentation of the headquarters
* Maternal or fetal pathology modifying the route/time of delivery (pre-eclampsia, fetal heart rate abnormalities, cholestasis, chorioamnionitis, metrorrhagia, covering placenta, etc.)
A Novel Probiotic-antibiotic Combination to Prevent Recurrent Urinary Tract Infections

Patients with recurrent UTI were randomized to receive either the probiotic Sacchromyces Boulardii at enrollment, and the intracellularly active Ciprofloxacin with their first UTI episode after enrollment, or they received standard of care treatment.

* At the time of consent, participants will be given 20 mg/kg of the antibiotic, ciprofloxacin. If the participant has symptoms of a UTI or have a positive urine culture at enrollment, they will take the antibiotic every 12 hours for 14 days. If the participant does not have symptoms of a UTI at enrollment, the antibiotic will be taken only if needed at home upon the first occurrence of a UTI.
* At the time of consent, participants will also be given 250 mg of the probiotic, S.

boulardii, taken once daily for 6 months, irrespective of symptoms.

- Throughout the study, participants will receive their standard clinical care for recurrent UTI treatment, which includes bowel and bladder dysfunction management and other prescribed non-antibiotic interventions at the managing provider's clinical discretion.

Eligibility Criteria:
Inclusion Criteria:

* A history of 3 or more UTI episodes in the past 12 months, or 2 or more episodes in the past 6 months
* no evidence of vesicoureteral reflux or only low-grade (grade 1-2) vesicoureteral reflux
* no other genitourinary anatomical abnormality
* not receiving prophylactic antibiotics at the time of enrollment
* Ages 2-17 years.

Exclusion Criteria:

* high grade (grade 3-5) vesicoureteral reflux
* neurogenic bladder
* anatomical abnormalities of the gastrointestinal tract
* any history of urologic or gastrointestinal surgery
* on prophylactic antibiotics
* a urine culture positive for pathogens that are not susceptible to ciprofloxacin in the last 3 months
* history of an allergic reaction to ciprofloxacin or other quinolones, or a history of severe adverse reactions
* As stated on the package insert for Ciprofloxacin, individuals with a known history of myasthenia gravis should avoid taking Ciprofloxacin and therefore will be excluded from this study.
* Based on the black box warning for Ciprofloxacin, individuals taking tizanidine as concomitant administration, or those taking other drugs known to interact with ciprofloxacin will be excluded from the study.
* individuals with known QT prolongation, hypokalemia, or on other drugs that prolong the QT interval should also avoid taking Ciprofloxacin and will be excluded from this study.
* Individuals under 2 years old. In the BFIT clinic, because they do bladder, bowel movement, and constipation management, it is harder to manage if the patient is not potty trained. Therefore, we are excluding participants under 2 years of age.
Desarda Tissue Technique Vs Lichtenstein Technique for Primary Inguinal Hernia Repair

This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary inguinal hernia.
* Body mass index below 31
* Indication for inguinal hernia repair via anterior approach, either as outpatient surgery (CMA) or elective admission.
* Legal capacity to provide informed consent.

Exclusion Criteria:

* Patients with a weak, thin, or divided external oblique aponeurosis.
* Participants diagnosed with any of the following conditions:

  * Ongoing oncological disease
  * Cirrhotic patients classified as Child B or higher
* Women who have previously undergone a cesarean section
* Cognitive or affective conditions that limit the ability to cooperate with the study procedures
Treatment of Spastic Equinovarus Foot After Stroke

This study evaluates treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox).

This prospective, multicentric open trial evaluates the efficacy of a combined treatment for spastic foot after stroke using ankle foot orthosis with or without selective injection of BTA (Botox) into the tibialis anterior and/or posterior and/or the long toe flexor, and/or medial and lateral gastrocnemius, and/or soleus muscles \[300 BTA U per injection (Botox - Allergan), diluted with saline to a concentration of 5U/0,1 mL, with electromyography guided injection\]. The patients are followed for one year after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stroke patient with equinovarus foot due to severe lower limb extensor spasticity with impaired foot contact during walking
* Ability to walk for at least 10 meters with or without aid
* Stroke interval \< 12 months
* Age \> 18 years old
* Weight \> 30 kg and \< 100 kg
* Written informed consent

Exclusion Criteria:

* Stroke interval \> 12 months
* Age \< 18 years old
* Pregnancy
* Neuromuscular disease
* Previous treatment with BTA
* Fixed contractures impairing mobility
* Mini-Mental Status Examination \< 25
* Aminosides treatment.
The Bacterial Composition of the Stomach in Reflux Disease

Gastric and oesophageal (OG) cancer associated with poor long term outcome as overall less than 25% of patients survive for more than 5 years due to late recognition of the disease. Growing evidence suggests an important role for bacteria in OG cancer and gastro esophageal reflux disease (GORD) development. About 1 in 10 people suffer from GORD and this one of the most common conditions leading to gastric and oesophageal cancer.

In GORD surgical therapy is the most successful preventing cancer but around 85% of patient experience complications afterwards. Acid suppressing medications are reducing the risk of oesophageal cancer but equally increasing the risk of gastric cancer. They also shorten patients' life expectancy and often fail to provide relief. Analysis of stool samples of patients with GORD demonstrated different gut bacterial compositions to normal and rather resembled the one found in cancer.

There is a clear need to improve the outcome of OG cancer. This could be achieved by identifying bacteria responsible for cancer development in gastric tissue, gastric content and saliva and potentially eliminate them hence avoid the development of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients who deemed necessary for an upper gastro intestinal endoscopy for clinical reasons and consent for additional gastric mucosal biopsies for study purposes

Exclusion Criteria:

* Patients who have upper GI malignancy
Safety and Immunogenicity of High-dose IN-B001 in Healthy Subjects

This study aims to evaluate the safety and immunogenicity of high-dose IN-B001 after administration in healthy subjects

Enterovirus 71(EV71) and coxsackievirus A16(CVA16) are major causes of Hand-foot-and-mouth disease (HFMD) occurring in pediatric population. Although EV71 vaccine has been licensed in China, vaccine for CVA16-associated HFMD is currently not available anywhere. The purpose of this phase I study is to evaluate the safety and immunogenicity of EV71/CVA16 bivalent vaccine in healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult aged ≥19 to \<50 years at the time of screening tests
* Body mass index(BMI) of ≥18.0 kg/m2 to ≤27.0 kg/m2, with body weight of ≥55.0 kg to ≤90.0 kg for men and ≥50.0 kg to ≤90.0 kg for women at the time of screening tests
* Determined by the investigator to be eligible for study participation based on the results of screening tests
* Intact deltoid muscle that allows administration of the investigational product
* Consent to use medically acceptable contraception throughout the study
* Negative finding from a pregnancy test (urine hCG) at the time of the screening for women of childbearing potential
* Voluntary decision and provision of written consent on participation in this study

Exclusion Criteria:

* History of a hand-foot-mouth disease or history of a disease related with enterovirus(EV) infection within 3 months prior to the 1st IP administration
* Medical history of an anaphylactic or similar acute reaction to IN-B001 or similar vaccine
* Febrile disease or infectious disease within 2 weeks prior to the 1st IP administration
* Whole blood donation within 2 months or apheresis within 1 month prior to the 1st IP administration
* Vaccination with other prevention vaccine within 2 months prior to the 1st IP administration
* Use of an immunomodulator or immunosuppressant within 3 months prior to the 1st IP administration
* History of a Guillain Barre syndrome
* Excessive caffeine intake or continuous alcohol consumption or incapable of abstention from alcohol during the study
* Participation in other clinical trial within 6 months prior to the 1st IP administration
* Pregnant or breastfeeding women
* Clinically significant hepatic, renal, neurological, respiratory, endocrine, hematology and oncology, cardiovascular, urological or psychiatric disease or such history
* Positive serological finding (type B hepatitis test, type C hepatitis test, human immunodeficiency virus(HIV) test)
* History of drug abuse or positive finding from a urine screening test for an abusive drug
* Use or of any prescription medication or oriental medicine within 2 weeks or any over-the-counter(OTC) medication, health functional food or vitamin within 1 week prior to the 1st IP administration or expected use of such products
* Administration of a blood product or blood-derived agent within 3 months prior to the 1st IP administration
* Determined by the investigator to be ineligible for study participation due to other reason including clinical laboratory findings
A Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone in Previously Untreated Subjects With Multiple Myeloma

To compare the efficacy of combination oral thalidomide plus oral dexamethasone treatment to that of oral dexamethasone-alone treatments as induction (first-line) therapy for subjects with active multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* Active Multiple Myeloma Stage II or III Durie Salmon
* Measurable levels of myeloma paraprotein in serum (≥1.0g/dL) or urine (≥ 0.2g excreted in a 24-hour collection sample)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
* Women of child bearing potential must agree to abstain for heterosexual intercourse or use 2 methods of contraception, one effective (for example hormonal or tubal ligation) and one barrier (for example latex condom, diaphragm)
* Males must agree to use barrier contraception (latex condoms) when engaging in reproductive activity

Exclusion Criteria:

* Pregnant or lactating females
* Peripheral neuropathy ≥ to grade 2 of the NCI CTC.
* Prior history of malignancy unless subject has been free of disease for ≥ 3 years
* Lab abnormality: Absolute neutrophil count (ANC) \<1,000 cells/mm\^3 (1.0 x 10\^9/L)
* Lab abnormality: Platelet count \<50,000/mm\^3 (50.0 x 10\^9/L)
* Lab abnormality: Serum creatinine \>3.0 mg/dL (265 µmol/L)
* Lab abnormality: Serum glutamic oxaloacetic transaminase (SGOT) /Aspartate aminotransferase (AST) or Serum glutamic pyruvic transaminase (SGPT)/Alanine transaminase (ALT) \>3.0 x upper limit of normal (ULN)
* Lab abnormality: Serum total bilirubin \> 2.0 mg/dL (34 µmol/L)
Dedalo Study Protocol: the Evaluation of a Community-level Multicomponent Lifestyle Intervention Effectiveness

The reduction of non-transmissible diseases (NCDs) is a community health priority and many NCDs are lifestyle related. In order to promote healthy lifestyle in Vercelli, the Local Health Authority (ASL) and the municipality of Vercelli and the University of Novara have realized the Dedalo project: a multicomponent community intervention. In Italy, few are the study evaluating the effectiveness of the multicomponent community intervention. Thus, aim of the study is to evaluate the effectiveness of Dedalo project in promoting lifestyle healthier change in the adult lifestyle general population in Vercelli.

BACKGROUND. The reduction of the non-transmissible diseases (NCDs) is a priority for the health community and for the economical sustainability of the healthcare system. In fact, the NCDs are the main global cause of death. It is demonstrated that many NCDs are lifestyle related; notable, even small lifestyle changes bring a health outcome improvement. The Italian epidemiological survey PASSI (2013-2016) reveals that the 33% of the population aged 50-69 years old living in Vercelli is self-declared sedentary and the 45% is overweight/obese. The Dedalo project, started in March 2018, is finalized to promote evidence-based healthy behaviors in the Vercelli adult population. In Italy the studies of community multicomponent prevention interventions are few. In this regard, the aim of the study is to evaluate the Dedalo project efficacy in the promotion of lifestyle changes.

MATERIALS AND METHODS. The study is a prospective observational one. The socio-economical and behaviors information are detected through an ad hoc questionnaire. The questionnaire is telephone-administered to the population who attended Dedalo activities and to an adult general population sample (40-75 years old) living in Vercelli. The same questionnaire will be administered 12 months later the first interview.

EXPECTED RESULTS. In April 2018 the socio-economics and behaviors description of both the studied population will be available. The fist evaluation of behavioral change will be concluded in April 2019.

CONCLUSIONS. The study will allow to define the efficacy of the community prevention intervention Dedalo is behavioral changes promotion, its capability in involving all the target population promoting equality in health and to improve the community prevention interventions.

Eligibility Criteria:
Inclusion Criteria:

* adult population living in Vercelli municipality

Exclusion Criteria:

* inability to understand the Italian language
* inability to answer to the telephonic interview
* denial of the informed consent