cyrilzakka/clinical-trials huggingface dataset:
A First in Man Study of MABp1 in Patients With Advanced Cancers

The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process.

An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for \>/= 3 months
* measurable or non-measurable disease at baseline
* at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
* will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
* age \>/= 18 year, male or female
* Eastern Cooperative Oncology Group performance status 0,1,or 2
* Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the low limit of normal.
* Adequate renal function, defined by serum creating \</= 1.5 x ULN
* Adequate hepatic function
* Adequate bone marrow function WOCBP, a negative serum pregnancy test result at screening.
* WOCBP or men whose sexual partners are WOCBP who are willing to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
* Signed and dated IRB approved ICF before any protocol specific screening procedures are performed

Exclusion Criteria:

* serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy.
* Uncontrolled or significant cardiovascular diseae
* dementia or altered mental status that would prohibit the understanding or rendering of informed consent
* not recovered from the adverse effects of prior therapy at the time of enrollment \</= grade 1
* symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy
* received extensive prior radiation therapy to the bone marrow
* immunocompromised, including subjects know to be infected with HIV
* history of hypersensitivity to compounds of similar chemical or biologic composition to the antibody women how are pregnant or breastfeeding
* WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
Long-term Efficacy of Physical Therapy for TMDs

Physical therapy is one of the initial conservative treatments for TMD. Many studies and previous studies in our department have proved that it can improve the pain, mouth opening and mandibular function of patients with TMD. However, the current research on physical therapy for TMD has a short follow-up period, which cannot prove that the patients' long-term mandibular function has improved, and few studies have analyzed the relevant factors affecting the curative effect. Therefore, this study is intended to adopt a retrospective cohort study to include TMD patients who received physical therapy in our department from 2016.01-2021.12. The patients' pain, joint area noise, mandibular range of motion, mandibular function and other conditions will be followed up by remote telephone or online questionnaire, and the patients' demography, clinical symptoms, pain, oral habits, depression, anxiety, sleep status, head and neck posture and other information will be collected. The multiple regression analysis model will be used to compare and analyze the relevant factors affecting the prognosis of patients, and to intervene in advance the factors that have a significant impact on the prognosis of the disease, so as to improve the treatment effect.


Eligibility Criteria:
Inclusion Criteria:

* The first-episode TMD patients with pain, limited mouth opening and abnormal noise in the joint area; 12-80 years old; regardless of gender; The patient received physical therapy in the outpatient department; MRI or CBCT imaging was completed before enrollment

Exclusion Criteria:

* Patients with recurrent TMD; Patients who had previously undergone TMJ surgery; Patients with nervous system diseases, immune system diseases, tumors and other diseases that the attending physician considers unsuitable for inclusion in the study; Cognitive impairment
The Feasibility of TECH: Tablet Enhancement of Cognition and Health for Healthy Adults

This study assess the feasibility of novel cognitive intervention utilizing tablet apps (TECH protocol: Tablet Enhancement of Cognition and Health) in terms of relevance, adherence, suitable challenges, training time etc. for healthy older adults. Older adults with normal cognition will be randomly allocated to the TECH protocol (experimental group) or the control group (no treatment). Assessments will be administered pre and post the 6-week TECH protocol by assessors blind to group allocation.

A pre-post pilot study will be conducted. Participants will be referred to the study from 'Maccabi Healthcare Services' by family physicians and geriatric physician of 'Maccabi Healthcare Services Central District'. The majority of TECH protocol training will take place in the participants' home as self-practice. The assessment and weekly group meetings will take place at clinics of Maccabi Healthcare Services in the Central District. A Helsinki approval (#2016009) has already been obtained. Participants will receive information regarding the study and if eligible will sign a consent form, undergo the screening and then the pre-intervention assessments. Then they will receive the TECH protocol, and following the intervention a second assessment will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Aged 65 and above.
* Without cognitive decline (score 26 points or above in MoCA).
* ) live independently in the community (as reported by the participants, regarding their independence in BADL and IADL, excluding motor difficulties which are not caused due to neurological conditions or lack of performance with no changes compared to the past.
* Have normal or corrected vision and hearing.
* Speak, write and read Hebrew.
* Able to understand and follow use of the touchscreen of a tablet after initial demonstration.

Exclusion Criteria:

* Experience severe depressive symptoms (10 points or more in The Geriatric Depression Scale).
* Are diagnosed with dementia, or other neurological or psychiatric condition (such as stroke, Parkinson's disease).
An Open-Label, Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112

This is an open-label, dose escalation study to evaluate the safety of oral PRX-112 and pharmacokinetics of GCD in subjects with Gaucher disease naive to enzyme replacement therapy. The dose levels of PRX-112 are 50 units, 100 units, 200 units and 400 units GCD. Subjects will receive once daily oral administrations of PRX-112 for 5 consecutive days at each dose level with a 2-day washout period between doses.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 or older
* Historical diagnosis of Gaucher disease by low leukocyte GCD activity level
* Haemoglobin ≥ 10 g/dL
* Body mass index (BMI) of 18 kg/m2-30 kg/m2 inclusive
* Subject is able to provide written informed consent
* Female subjects of child bearing potential must not be pregnant or lactating with a negative urine pregnancy test result at the screening visit.
* Female subjects of child-bearing potential and male subjects with female partners of childbearing potential must use two methods of contraception at all times during the study, one of which must be a barrier method. Acceptable methods of contraception are oral contraceptives, barrier methods (male condom, female condom, diaphragm, cervical cap, spermicide or intrauterine device), surgical sterility (documented doctor's report of vasectomy, hysterectomy and/or bilateral oophorectomy) and/or postmenopausal status (defined as at least 1 year without menses as demonstrated by medical history or subject report).
* Negative laboratory tests for HIV, HBsAg and HCV at the screening visit
* Naïve to any previous ERT or have received the last ERT treatment 12 months before signing IC

Exclusion Criteria:

* Presence of a gastrointestinal (GI) disease affecting motility or absorption
* Subjects with any history of allergic response to biological drugs or other allergies deemed clinically significant by the Investigator
* Reported history of alcohol or drug abuse
* Subject has donated blood in the 3 months prior to screening or subject has received plasma derivatives in the 6 months prior to screening
* Use of any investigational drug or participation in another clinical trial in the 3 months prior to screening (subject report)
* Subjects who have previously received ERT with positive anti-human plant recombinant GCD (prGCD) antibodies
* Clinical evidence of any active significant disease that could potentially compromise the ability of the Investigator to evaluate or interpret the effects of the study treatment on safety assessment, thus increasing the risk to the subject to unacceptable levels
* Presence of any medical, emotional, behavioural or psychological condition that, in the judgement of the Investigator, would interfere the compliance requirements of the study
* Subject has used any medication (excluding acetaminophen or dyprione) within 7 days of screening, including laxatives, teas and food additives known to be used for the treatment of constipation or diarrhea
Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure

Several lines of evidence have suggested that Advanced Glycation End-products (AGEs) play a role in the development and progression of heart failure. The AGE-crosslink breaker Alagebrium improved cardiac function and symptoms in experimental preclinical and small human heart failure studies. These results have not yet been confirmed in a randomized controlled clinical trial. Objective: to evaluate the safety and efficacy of alagebrium in subjects diagnosed with heart failure. This is a randomized, double-blind, placebo-controlled trial to assess the effects of 400 mg (2 x 100 mg bid) of alagebrium versus placebo over 9 months. 100 subjects will be studied (50 per treatment group) in approximately 6 centers. Procedures: exercise testing (VO2 max; the primary variable), ECGs and blood sampling.


Eligibility Criteria:
Inclusion Criteria:

* NYHA II-IV heart failure
* Echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction \< 40%)
* Duration of heart failure \> 3 months
* Stable heart failure medical therapy for \> 1 month
* Patients need to be able to understand content of and willing to provide informed consent

Exclusion Criteria:

* Patient ≤ 18 years
* History of myocardial infarction in previous 6 months
* History of stroke/TIA/RIND in previous 6 months
* Severe valvular dysfunction
* Severe pulmonary disease
* History of systemic inflammatory or collagen vascular disease
* Active and or treated malignancies within 12 months prior to inclusion
* Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol
* Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation
* Pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation
* History of valve replacement or surgery
* Uncontrolled diabetes mellitus (HbA1c \> 9.5%)
* Clinically significant renal disturbance (sMDRD calculated GFR≤30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)
* Clinically significant liver disease (ASAT/ALAT \> 2,5 times the upper limit of normal)
* Severe anemia at baseline (Hemoglobin \<10 g/dl or \<6.2 mmol/l)
* Use of any investigational drug(s) within 30 days prior to screening
* Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)\*
* Active pericarditis/myocarditis
* The inability of patients to undergo exercise testing
Study Using Eculizumab in Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.


Eligibility Criteria:
Inclusion Criteria:

* Must have required at least 4 transfusions in the past 12 months
* PNH type III red blood cell (RBC) clone by flow cytometry of \>10%
* Lactate dehydrogenase (LDH) level \> 1.5 x upper limit of normal
* Platelet count \> 100,000/mm3
* Patient taking erythropoietin must be on a stable dose for at least 26 weeks
* Patient taking immunosuppressants must be on a stable dose for at least 26 weeks
* Patient taking corticosteroids must be on a stable dose for at least 4 weeks
* Patient taking coumadin must be at a stable INR for at least 4 weeks
* Patient taking iron supplements or folic acid must be on a stable dose for 4 weeks
* Willing and able to give written informed consent
* Must avoid conception

Exclusion Criteria:

* Mean hemoglobin level prior to transfusion over the previous 12 months is \>10.5 gm/dl
* Absolute neutrophil count \<500/ul
* Active bacterial infection
* Hereditary complement deficiency
* Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days
* Pregnant, breast-feeding, or intending to conceive
* History of meningococcal disease
* History of bone marrow transplantation
Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure

Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska.

Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier.

Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary function testing, exercise tolerance, quality of life and mood disorder screening.

All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were screened for eligibility in January 2014. Patients living abroad (including non-Swedish citizens), patients treated for non-respiratory conditions, diseased patients and patients with a known pre-ECMO mental handicap were excluded.

Eligible patients were contacted, and patients who agreed to participate gave their written informed consent. All studied patients underwent the same study protocol during a day at the hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax, pulmonary function testing, neuropsychological examination, walking test, self assessment questionnaires for quality of life, anxiety, depression and post-traumatic stress.

Patient charts were reviewed for relevant clinical information, including age, gender, ECMO mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical ventilation; preexisting diseases, blood gas values and ventilator settings before initiation of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure, hemoglobin, lactate and oxygenation parameters during an observation period, which was defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10 days). This information was added to a digital database for the purpose of this study.

At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate and venous saturation values were used as indicators of sufficient (lactate \< 2 mmol l-1 , SvO2 ≥ 70%) or insufficient tissue perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009

Exclusion Criteria:

* Diseased patients
* Patients living abroad (including non-Swedish citizens)
* Patients treated for non-respiratory conditions
* Patients with a known pre-ECMO mental handicap
INSIGHT (Insight Into Nephrotic Syndrome)

INSIGHT is a longitudinal study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression.

INSIGHT is a longitudinal observational study of childhood nephrotic syndrome to determine genetic, serologic and environmental factors contributing to nephrotic syndrome and disease progression. This is a large multiethnic cohort to test hypotheses of gene and environmental risk factors and disease progression. Participants are recruited from Toronto, Ontario and surrounding regions. Additional sites will be added on in the future.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of nephrotic syndrome
2. signed informed consent and assent appropriate for age
3. ages 6 months -18 years old and
4. ability to complete questionnaires

Exclusion Criteria:

1. congenital nephrotic syndrome (less than age 1)
2. syndromic disease with multiple organ involvement
3. inability to provide consent by primary care providers
4. conditions such as systemic lupus erythematous.
A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection

The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.

This study consists of 2 parts:

Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled, randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting.

Volunteers are followed for at least 1 year.

Eligibility Criteria:
Inclusion Criteria

Volunteers may be eligible for this study if they:

* Are HIV-negative.
* Are in good health.
* Are between ages 18 and 55.
* Are available for at least 1 year.
* Are a resident of the United States of America.
* Agree to practice sexual abstinence or use birth control.

Exclusion Criteria

Volunteers will not be eligible for this study if they:

* Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.)
* Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection.
* Have certain psychiatric, medical, or substance abuse problems.
* Are allergic to eggs or other vaccines.
* Are an employee at a participating site and have access to study information.
* Are taking certain medications.
* Have received blood transfusions within 3 months before entering this study.
* Are pregnant or breast-feeding.
Neuroimaging of Diet in ADHD: Phase I

Children with Attention Deficit Hyperactivity Disorder (ADHD) aged 9-12 years of age will be placed on a restriction diet for a 5 week period. Children will be randomized to either receive daily snacks that conform to the diet or will violate the diet (Ruse diet) in a double blind fashion. It is hypothesized that children who are consistently on the restricted diet (relative to those on the ruse diet) will show improvements in ADHD symptoms.

The ADHD rating scale (RS) will be the principal behavioral outcome measure. We hypothesize that children on restriction diet will have significantly lower ADHD RS scores after 5 weeks relative to the Ruse diet group. In addition children will undergo functional magnetic resonance imaging (fMRI) at baseline and again at 5 weeks. Children will perform a flanker task known to engage the dorsolateral prefrontal cortex (DLPFC) and the anterior cingulate cortex (ACC) during attention tasks. The children will also perform will look at pictures of appealing and unappealing food and rate whether they would like to eat it or not. This task is known to activate the ventral striatum (VS) (reward processing). A secondary hypothesis is whether children on the restricted diet will show changes in activity and connectivity of areas (DLPFC, ACC, VS) relative to those on the Ruse diet.

Eligibility Criteria:
Inclusion Criteria:

* Age 9-12 years
* Meets criteria for Attention Deficit Hyperactivity Disorder
* Parent must agree to use Study Diet Manual

Exclusion Criteria:

* Any Axis I psychiatric disorder other than Oppositional Defiant Disorder or Anxiety Disorder not requiring psychopharmacological management
* Not currently on any pharmacological agent other than medication for ADHD
A Study to Investigate the Pharmacokinetics of RO7223280 in Critically Ill Participants With Bacterial Infections

The main aim of the study is to investigate the plasma pharmacokinetics (PK) and safety of intravenous (IV) administration of a single dose of 400 milligrams (mg) or 600 mg RO7223280 in critically ill participants with bacterial infections.


Eligibility Criteria:
Inclusion Criteria:

* Illness requiring treatment in an intensive care unit (ICU) at the time of enrolment
* Ongoing clinical syndrome meeting at least one of the following criteria:

  1. HABP: bacterial pneumonia diagnosed after more than 48 hours of hospitalization or within 7 days after a hospital discharge
  2. Ventilator-associated bacterial pneumonia (VABP): bacterial pneumonia diagnosed after more than 48 hours of mechanical ventilation or within 72 hours after weaning
  3. Bacteremia confirmed by the presence of a bacterial pathogen in a blood culture drawn within 7 days prior to dosing and with the defined focus of infection.
  4. For Cohort 4 only: mechanically ventilated participants who have a BAL procedure planned as part of routine practice for a day that can function as Day 1.

Exclusion Criteria:

* Ongoing documented catheter-related bacteraemia as the sole ongoing infection
* Major surgery within 48 hours prior to dosing or major surgery expected within 48 hours after the start of the infusion
* Known chronic severe hepatic impairment (Child-Pugh class C). Note: acute severe hepatic impairment is not exclusionary
Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension

The purpose of this study is to investigate the safety and clinical efficacy of HGP1207 (Sildenafil) in subjects with pulmonary hypertension associated with systolic heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of chronic heart failure (NYHA Class II and III)
* LVEF ≤ 40%
* Elevated systolic PAP: ≥ 40 mmHg
* Patients must be treated with an ACE inhibitor, ARB, beta-blocker, aldosterone antagonist at a stable dose for at least 4 weeks prior to visit 1

Exclusion Criteria:

* Patients with pulmonary hypertension associated with chronic obstructive pulmonary disease, interstitial lung disease, chronic thromboembolism or unclear/multifactorial mechanisms
* Patients who have received Nitrates/NO donor or Cytochrome P450 3A4 inhibitors within 30 days prior to visit 1
* Patients who have received calcium channel blocker, endothelin receptor antagonist, prostacyclin analogues, phosphodiesterase 5 inhibitors within 90 days prior to visit 1
* History of hypersensitivity or allergy to sildenafil or any excipients of its formulation
* Patients with hypertension (sitSBP \>170 mmHg or sitDBP\>100 mmHg) or hypotension (sitSBP\<90 mmHg or sitDBP\<50 mmHg)
* Patients with other medical condition (i.e.,alcoholism, drug abuse) that may cause the patient to be non-compliant with the protocol, confound the data interpretation
* Pregnant females or those of child bearing potential who have not had a negative pregnancy test