cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Inotuzumab Ozogamicin in Treating Adult Patients With Ph Negative ALL With Minimal Residual Disease Positive After Induction Chemotherapy

A single-center, single-arm, open-label, interventional, phase II clinical trial to evaluate the efficacy and safety of InO in B-ALL achieved CR/CRi after 1L induction chemotherapy with positive minimal residual disease.


Eligibility Criteria:
Inclusion Criteria:

1. New diagnosed B-ALL in hematologic complete remission (CR) after 1L induction chemotherapy with MRD positive. Molecular disease or MRD is defined by a value of at least of 10-4 (0.01%) by multicolor flow cytometry.
2. Age ≥18 years
3. ECOG PS score: 0 to 2
4. Functions of the main organs are normal, if the following criteria are met:

   1. Total bilirubin (BIL) ≤ 1.5 × upper limit of normal (ULN)
   2. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 × ULN
   3. Serum creatinine ≤ 1.5 × ULN
   4. Creatinine clearance ≥ 30 ml/min
5. No active or co-existing malignancy with a life expectancy of less than 12 months
6. Patients are voluntarily enrolled into the study and have good compliance, and the Informed Consent Form (ICF) needs to be signed.

Exclusion Criteria:

1. Mixed lineage leukemia
2. Clinically significant liver disease such as history of veno-occlusive disease (VOD)/ sinusoidal obstruction syndrome (SOS)
3. Patients with severe and / or uncontrolled diseases, such as:

   1. Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmias; uncontrolled blood pressure (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
   2. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis
   3. Known to be human immunodeficiency virus positive (HIV+)
   4. Active and uncontrolled disease/infection as judged by the treating physician
   5. Active central nervous system (CNS) or extramedullary disease
   6. Patients who have other malignant tumors at the same time; patients who are evaluated by the investigator to have concomitant diseases that seriously endanger the safety of the patients or affect the patients to complete the study
4. Pregnant or nursing women
5. Unable or unwilling to sign the consent form
6. Monoclonal antibodies therapy within 2 weeks before study entry
7. Radiotherapy or cancer chemotherapy (except for induction chemo) or any investigational drug within 2 weeks before study entry
8. Patients who have severe allergies (≥ grade 3) to active ingredients and any excipients of InO
9. Patients in other situations who are evaluated by the investigator to be ineligible
NK Cell Deregulation in HBV Patients

Natural Killer (NK) cells play a large role in the innate immune response as they are equipped to kill infected or tumor cells. They express a panel of activating and inhibitory receptors that regulate the destruction of the target cell. Many reports have shown that NK cell function is suppressed in CHB patients. Exhaustion occurs when activating receptors become over stimulated leading to the loss of NK function. The investigators hypothesize that NK cells are rendered dysfunctional/ exhausted by HBV. The primary objective is to determined the phenotypical modifications and mechanisms associated to NK cell dysfunction, during different phases of CHB infection, in not treated patients.

Using a previous cohort from the Limoges Hospital, the investigators have identified by multi-parametric flow cytometry phenotypic, cytokine and signaling molecules that are altered in NK cells from CHB patients during the inactive phase. Phenotypic changes observed include the downregulation of CD160, NKp30, CD16 and Tim-3. The expansion of 'adaptive' NK cells (FCεRg- NKG2C+ or CD57hi), and the upregulation of CD107a (steady state), NKG2D and 41BB. Functional changes include the decrease in the levels of IFNγ, TNFα and MIP1β. Cellular metabolism is now recognized to regulate functional properties of immune cells such as T or NK cells. The mammalian target of rapamycin (mTOR) kinase is a key regulator of cellular metabolism, integrating environmental cues to control downstream metabolic pathways. mTOR is the catalytic subunit of two different complexes: mTORC1 and mTORC2, the activity of which can be measured by measuring the level of phosphorylation of the proteins S6 and Akt respectively. The lab has previously shown that the mTOR pathway regulates NK cell development and activation 2. The investigators have observed that pS6 and pAkt are also decreased in CHB patients.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

* Male or female, age ≥18 years
* HBV infection or chronic HBV infection
* Willing and able to provide written informed consent

Healthy donors must meet all of the following inclusion criteria to be eligible for participation in this study:

* Male or female, age between 18 and 50 years
* Willing and able to provide written informed consent

Exclusion Criteria:

* Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
* Infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
* Chronic liver disease of a non-HBV etiology
* Immune or cancerous disease
A Study to Assess the Severity of Psoriasis in Brazilians Participants With Chronic Plaque-type Psoriasis

The purpose of this study is to assess the severity of plaque-type psoriasis (common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region) in brazilian participants with chronic plaque-type psoriasis.

This is a cross-sectional (studies in which the presence or absence of disease or other health-related variables are determined in each member of the study population or in a representative sample at one particular time), observational (clinical study in which participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to specific interventions), non-interventional, multicenter study (when more than one hospital or medical school team work on a medical research study). Participants with plaque psoriasis will be followed up at specialized dermatology centers. Participants will undergo assessment at a single time point and all assessments will be conducted on the same day. Information will be collected about disease severity/ socioeconomic variables and demographics; clinical characteristics; treatment (current and past procedures and therapies to treat psoriasis); quality of life; and comorbidities identified after plaque psoriasis was diagnosed. The information will be obtained from the medical records, as requested, and during the medical interviews. The primary objective of this study is to assess the severity of plaque-type psoriasis.

Eligibility Criteria:
Inclusion Criteria:

* Participant diagnosed with chronic plaque psoriasis
* Participant is at least 18 years old
* Participant is able to understand and sign the Informed Consent Form

Exclusion Criteria:

* In the opinion of the investigator, the participant is unable or unavailable to complete all study procedures
* Participant suffers from a psychiatric condition or any other clinical condition that might interfere with the ability to understand the study requirements
* Participant refuses consent or is unwilling to supply the required information within the required period
* Participant is taking part in an interventionist clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventionist clinical trial sponsored by Johnson \& Johnson
* Participant is an employee of the investigator or study site and is directly involved in the conduction of this study or other studies conducted by the same investigator at the same site, or is a family member of the employee or investigator
Indoor Air Quality Monitoring and Impact on Children's Health

This study aims at understanding the relation between indoor air quality in schools, including both chemical and microbiological determinants, and cognition in children by gathering data across different parts of Europe

The LEARN project, funded by the European Commission, aims to gain an in-depth understanding about indoor air quality in schools and its impact on children's cognitive development. This involves evaluating school cohorts in three different countries (Belgium, Greece and Denmark). In participating schools, we measure and characterise indoor and outdoor air pollutants and evaluate the presence of exposure biomarkers and their effect on children's cognition. Measuring indoor air quality, exposure and creating remedial strategies are crucial steps to improve air quality in the school environment and ensure the well-being of children.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls
* Attending school in the 4th -6th grade in elementary schools included in the study
* Signed informed consent form by legal representative

Exclusion Criteria:

* Insufficient knowledge of local language (ie. Dutch, Greek, Danish) by child or parents
Infant Feeding, Non-nutritive Sucking and Speech Development

This study will look at whether there is a relationship between how babies are fed, whether they suck a dummy/hand and how they develop speech.

Background:

In the UK every year around 48,000 children aged 2-5 years are referred to NHS Speech \& Language Therapy (SLT) services with difficulties using the right sounds in their talking. This is known as speech sound disorders (SSD). This is the largest population seen by Speech and Language Therapists and costs the NHS about £24 million per year.

Children with SSD are more at risk of mental health problems and difficulties making relationships with those around them. They are also more likely to struggle with learning at school and be involved with the criminal justice system at some point in their early lives. When a baby is born parents make different choices about feeding their baby. Some breastfeed, some bottle-feed and some use a mixture of both. Some babies also like to have a dummy, while others suck their hand and some don't suck anything. Some studies have found that breastfeeding is linked to better language and learning in later childhood, while others have found that dummy sucking has the opposite effect.

However, the effect that different types of feeding have on speech development has not been looked at in as much detail.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 2;0-5;6 on current speech and language therapy clinical caseloads in Hampshire (Solent NHS Trust) who have a diagnosis of speech sound disorder.

Exclusion Criteria:

* Genetic Disorder (including Downs Syndrome and other identified syndromes) Other congenital anomaly (e.g Cerebral Palsy, Global Developmental Delay) Diagnosed Learning Disability Permanent Hearing Loss (Sensorineural) Cleft lip and/or palate and/or submucous cleft palate Premature birth (before 37 completed weeks gestation) English as second or additional language
Data Collection and Analysis of Patients Who Have Had an Electrophysiological Procedure

The purpose of the database is to complete outcomes research of electrophysiological procedures.

The purpose of the database is to complete outcomes research (risk factors, follow-up, procedural data) Perhaps the most important research for any busy clinical laboratory is to appreciate the tendencies and trends that are occurring in their own laboratory setting. This will have a tremendous impact on educating the OSU staff as well as perhaps other centers on best medical practices.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* have or had a procedure preformed in the Electrophysiology Laboratories at the Ross Heart Hospital
* Ability to consent

Exclusion Criteria:

-
Outcomes of Trabecular Metal Augments Used in the Flying Buttress Position

This study hypothesize that trabecular metal augments used in the flying buttress position is a valid option with good results in the management of uncontained acetabular defects.


Eligibility Criteria:
Inclusion Criteria:

* both sexes
* 18 years or older
* acetabular defect paprosky 2b or 3a segemntal defect reconstructed with trabecualr metal augment in the flying buttress position.

Exclusion Criteria:

* patients presented with active infection
* pathological defects
* pelvic discontinuity
Combination Chemotherapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy with or without epirubicin and cyclophosphamide is more effective in treating patients with extensive stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without epirubicin and cyclophosphamide in treating patients who have extensive stage small cell lung cancer.

OBJECTIVES: I. Compare the overall survival and survival without recurrence of patients with extensive stage small cell lung cancer after receiving cisplatin and etoposide with or without epirubicin and cyclophosphamide. II. Compare the relative dose and intensity of cisplatin and etoposide between the two groups of patients. III. Compare the complete and objective response rate and quality of life of these patients. IV. Compare the toxic effects of these 2 regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive etoposide IV on days 1 and 3 and cisplatin IV on day 2. Arm II: Patients receive etoposide and cisplatin as in arm I, plus epirubicin IV on day 1 and cyclophosphamide IV on days 1 and 3. Treatment is repeated in both arms every 28 days for up to 6 courses. Patients who achieve a partial or complete response receive cerebral and/or thoracic radiotherapy. Patients with residual tumor may receive oral etoposide for 3 of every 4 weeks. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 2.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven extensive stage small cell lung cancer Extends beyond hemithorax and supraclavicular lymph nodes Pleural effusions allowed Bidimensionally measurable disease Bone marrow metastases allowed No symptomatic CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 to 75 Performance status: 0-2 Life expectancy: Not specified Hematopoietic: Neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal Renal: Creatinine less than 1.24 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No cardiac insufficiency No uncontrolled cardiac disease LVEF greater than 50% OR ECHO greater than 30% Other: Not pregnant Fertile patients must use effective contraception No psychoses No active infection No loss of weight greater than 10% during the last 3 months No other malignancy except nonmelanomatous skin cancer or stage I cervical cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior or concurrent immunotherapy Chemotherapy: No prior or other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior or concurrent radiotherapy Surgery: No prior or concurrent surgery
Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors

Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.


Eligibility Criteria:
Inclusion Criteria:

* Stage 0-III Breast Cancer
* No any cancer treatment in the following year
* Perceived emotional distress and poor sleep quality
* Agree to follow the protocol of this study

Exclusion Criteria:

* Stage IV Breast Cancer
* Pregnant women
* Abnormal liver, kidney, gastric, internal , immune, sleep disorder, metabolic, psychic functions and need to take the prescription medications or medical treatments regularly
* could not follow the protocol of this study
Effect of Transcranial Direct-current Stimulation in Eating Behavior of Women With Fibromyalgia

Introduction: Fibromyalgia (FM) is a syndrome characterized by generalized musculoskeletal pain, fatigue, non-repairing sleep, cognitive changes, depressive symptoms and other correlates of autonomic dysfunction. A high prevalence of overweight in patients with fibromyalgia is observed, about 80% according to current data, which affects the course and prognosis of the disease, besides overburdening health costs and further compromising quality of life. life of these patients. Evidence shows possible pathophysiological pathways shared by these two pathologies, as well as aspects related to food behavior. It is known that dopaminergic neurotransmission is altered in both, suggesting an increase in the sensitivity or density of D2 dopamine receptors. Non-pharmacological options for pain management and dysfunctional eating behavior include the important contribution of neuromodulatory techniques of non-invasive cerebral stimulation, such as transcranial direct current stimulation (tDCS), which aims to increase resisting hyperpalatable foods and reducing caloric intake. Objectives: To evaluate the association between dopamine receptor-2 (DRD2) Taq1A allele A1 polymorphism (rs1800497) and to observe the possible effect of tDCS on the dorsolateral prefrontal cortex (DLPFC) on homeostatic and hedonistic aspects of eating behavior in women with FM. Methods: A randomized, double blind, parallel group, controlled trial with simulated treatment will be performed. Will be included in the study women literate, right-handed, with confirmed diagnosis of FM. The evaluation will be done through questionnaires on pain and eating behavior, anthropometric evaluation and biochemical measurements. The intervention will take place through active or simulated home for 4 weeks. Perspectives: To evaluate dysfunctional neuroplastic changes in eating behavior and biological markers and also to serve as a basis for future effective treatment strategies through neuromodulation and nutritional counseling.

A randomized, double-blind, parallel-group controlled trial with sham treatment will be conducted in fibromyalgia patients to assess aspects of eating behavior.

Eligibility Criteria:
Inclusion criteria:

* Right-handers who can read and write,
* Confirmed diagnosis of FM
* Pain score of six or more on the Numerical Pain Scale (SPN 0-10) on most days of the last 3 months.

Exclusion criteria:

Living outside the Greater Porto Alegre area and pregnancy. Contraindications to EMT and ETCC: metallic implant in the brain; medical devices implanted in the brain, cardiac pacemaker; cochlear implant; history of alcohol or drug abuse in the last 6 months; neurological disorders; hx of head trauma or neurosurgery; decompensated systemic diseases, and chronic inflammatory diseases (lupus, rheumatoid arthritis, Sjogren's syndrome, Reiter's syndrome); uncompensated hypothyroidism; personal history of cancer, past or under treatment. Weight loss use and bariatric surgery.
A Dose Escalation Study Of PF-06939999 In Participants With Advanced Or Metastatic Solid Tumors

This is a Phase 1, open label, multi center, dose escalation and expansion, safety, tolerability, PK, and pharmacodynamics study of PF 06939999 in previously treated patients with advanced or metastatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic NSCLC, urothelial carcinoma or HNSCC
* Progressed after at least 1 line of treatment and no more than 3 lines of treatment
* At least one measurable lesion as defined by RECIST version 1.1
* ECOG Performance Status 0 or 1
* Adequate Bone Marrow Function
* Adequate Renal Function
* Adequate Liver Function
* Resolved acute effects of any prior therapy

Exclusion Criteria:

* Known active uncontrolled or symptomatic CNS metastases.
* Major surgery, radiation therapy, systemic anti-cancer therapy or investigational drug(s) within 4 weeks prior to study entry.
* Active, uncontrolled infection, including COVID-19
* Known or suspected hypersensitivity to PF-06939999
* Inability to consume or absorb study drug
AZD0530 Phase II Study in Patients With Advanced Ovarian Cancer

The main purpose of this study is to determine if AZD0530 can improve the efficacy of standard chemotherapy for the treatment of ovarian cancer


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of advanced ovarian cancer
* Have evidence of recurrence or disease progression at least 6 months following treatment cessation of 1st or 2nd line platinum containing therapy
* Estimated life expectancy of more than 12 weeks

Exclusion Criteria:

* Central Nervous System (CNS) metastases
* Received more than 2 prior chemotherapy regimens for ovarian cancer treatment
* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low haemoglobin
* Pregnant, breastfeeding or if of child-bearing status unwilling to use an acceptable method of contraception
A Study of the Safety, Tolerance and Assessment of HE3286 on Insulin Sensitivity and Hepatic Glucose Production

The objectives of this study are to evaluate the safety and tolerance of 20 mg (10 mg BID) of HE3286 when administered orally over 28 days to obese insulin-resistant adult subjects and, to assess the activity of HE3286 on insulin sensitivity and hepatic glucose production in obese insulin-resistant adult subjects.

Hollis-Eden Pharmaceuticals, Inc. is developing a new class of therapeutics for the treatment of Type 2 diabetes mellitus (T2DM). The investigational drug, HE3286, is a synthetic analog of a naturally occurring hormone with a potentially new mechanism of action that may improve the current therapeutic options available to a T2DM patient.

The glucose clamp is the gold standard for measurement of insulin sensitivity. Given the observed activity of HE3286 in reducing insulin resistance in both impaired glucose intolerant subjects and type 2 diabetic patients, it is necessary to evaluate the physiological site of action (i.e. liver vs. skeletal muscle) of HE3286 in order to further understand the mechanism of action and to design future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subject 18-65 years of age
* Body Mass Index (BMI) is at least 29 kg/m2 but no more than 35 kg/m2 for females and no more than 37 kg/m2 for males
* Subject has fasting blood glucose level of \< 126 mg/dL at Screening
* Subject has a 2 hour postprandial (following 75 grams glucose administration) blood glucose of 140-200 mg/dL at Screening
* Subject has fasting plasma insulin \>=10 μU/mL

Exclusion Criteria:

* Subject has a history of clinically significant cardiovascular disease (including coronary artery disease), clinically significant hepatic, respiratory or renal abnormalities, clinically significant endocrine disorders (including history of diabetes); or clinically significant neurological or psychiatric condition;
* Subject has any clinically significant abnormalities in laboratory results at screening