cyrilzakka/clinical-trials huggingface dataset:
A Study of LP-168 in Participants with Relapse or Refractory B-Cell Lymphoma

This is an open-label, multi-center Phase 1/2 study of oral LP-168 in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

This study includes 2 parts: phase 1a (LP-168 monotherapy dose escalation) and phase 1b (LP-168 dose expansion). In phase 1a, patients will be enrolled using an 3+3 design. The starting dose of LP-168 in oral tablet form is 100 mg/day (e.g., 100 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in phase 1a dose escalation, enrollment will continue to phase 1b dose expansion. Cycle length will be 28 days.

Eligibility Criteria:
Key Inclusion Criteria:

* Per 2017 revised WHO lymphoma classification criteria, subject must have either:

Diagnosed with relapsed or refractory DLBCL or FL and require treatment in the opinion of the Investigator and have received 2 lines SOC.

Diagnosed with relapsed or refractory non-Hodgkin's lymphoma associated with B-cell proliferation (such as CLL\\ SLL \\ MCL \\ MZL \\ WM, etc.) in need of treatment in the opinion of the Investigator and have received 1 line SOC.

* Adequate hematologic function.
* Adequate hepatic and renal function.
* Ability to receive study drug therapy orally and willing to receive examinations.
* Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control.

Key Exclusion Criteria:

* According to the 2017 revised WHO Lymphoma Classification Criteria, patients diagnosed with the following diseases: Burkitt lymphoma or Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, and post-transplant lymphoproliferative disease(PTLD).
* Prior malignancy (other than the disease under study) within the past 3 years, except for curatively treated basal or squamous cell skin cancer, carcinoma in situ of the cervix or breast cancer.
* Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of LP-168:

Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy.

* Subjects who have received the following treatments within 2 weeks before the first dose of LP-168:

Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia.

* Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections; Disease affects the central nervous system with obvious symptoms; Autoimmune hemolytic anemia or Idiopathic thrombocytopenic purpura. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.
* Subjects who cannot tolerate urine collection, venipuncture, lymph node biopsy, and bone marrow aspiration.
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.

High pathological complete response (pCR)-rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II - III breast cancer patients. However, a subset of patients with stage II-III HER2-positive breast cancer can be treated with HER2-blockade alone. These patients can potentially be totally spared from chemotherapy-associated toxicity. The proportion of patients whom can successfully be treated without chemotherapy could potentially be increased by selecting great responders using DCE-MRI and by adding tucatinib to trastuzumab and pertuzumab alone. The aim of this study is to evaluate the safety and efficacy of neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Histologically confirmed primary invasive breast cancer
3. Stage II - IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter on DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology)
4. HER2 overexpression defined as circumferential membrane staining that is complete, intense and in \>10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy
5. Known estrogen- and progesterone-receptor expression of the invasive tumor

   a. ER-negative or PR-negative is defined as \<10% of invasive tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER and/or PR
6. WHO performance status 0-1
7. Age ≥ 18 years
8. LVEF ≥50% measured by echocardiography or MUGA
9. Eligible for neoadjuvant treatment
10. Laboratory requirements within 21 days prior to enrollment:

    1. Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l);
    2. Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists.
    3. Adequate renal function: creatinine clearance \>50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement.

Exclusion Criteria:

1. Current pregnancy or breastfeeding
2. Current or previous other malignancy unless treated without systemic therapy and more than five years ago
3. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
4. Use of a strong CYP3A4 or CYP2C8 inhibitor within five half-lives of the inhibitor, or used a strong CYP3A4 or CYP2C8 inducer within five days prior to first dose of study treatment
5. Known chronic liver disease
6. History of inflammatory bowel disease or bowel resection
7. Contraindications for MRI
8. Inflammatory breast cancer, cT4 and/or cN3 tumors
9. Occult breast cancer (cT0)
Cryoballoon Ablation for Early Persistent Atrial Fibrillation (Cryo4 Persistent AF)

The purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (CFE) ablations for patients with early persistent atrial fibrillation (\<1 year from first diagnosis of persistent AF).


Eligibility Criteria:
Inclusion Criteria:

* Patients with documented symptomatic persistent AF refractory or intolerant to at least 1 class I or III antiarrhythmic medication. Persistent AF defined as:

  * Episode lasting longer than 7 days, but less than 1 year documented by consecutive ECG recordings of 100% AF greater than 7 days apart OR
  * Episode requiring electrical or pharmacological cardioversion after 48 hours of AF documented by continuous recording
* Date of first diagnosis of persistent AF within the last 12 months preceding the consent date
* Age between 18 and 75 years
* Willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study

Exclusion Criteria:

* Long-standing persistent AF (has lasted for ≥1 year)
* Current diagnosis of paroxysmal AF
* Anteroposterior LA diameter \> 5.0 cm by TTE
* Current intracardiac thrombus
* Presence of one or more pulmonary vein stents
* Presence of any pre-existing pulmonary vein stenosis
* Primary pulmonary hypertension
* NYHA class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) \< 40% measure by acceptable cardiac testing (e.g. TTE)
* Hypertrophic cardiomyopathy
* Previous LA ablation or surgery
* Unstable angina
* Presence of any cardiac valve prosthesis
* Thrombocytosis, thrombocytopenia
* Any condition contraindicating chronic anticoagulation
* Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
* Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
* Cryoglobulinemia
* Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
* Uncontrolled hyperthyroidism
* Any woman known to be pregnant or breastfeeding
* Active systemic infection
* Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators
* Life expectancy ≤ 1 year
* Currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the Medtronic study manager
* Exclusion criteria as per local laws (for France, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the French social security system)
MRSA Colonization in Peripartum Women and Their Offspring

We hypothesize that pregnant women are at baseline risk for carrying community-acquired MRSA, but also have frequent contact with healthcare workers which may put them at risk for hospital-acquired MRSA carriage. Our study aimed to identify the colonization rate of women in active labor and whether transmission to infants may occur.

Mothers are at risk for carrying MRSA. What this risk is is not known. We have seen a dramatic increase in neonatal intensive care unit MRSA infections. Could mothers transmit MRSA to their newborns if they are asymptomatic carriers? Mothers come into close contact with health care providers, often have other children in daycare (known risk factor) and may have other exposures to MRSA. Our study was designed to sample 300 mother-infant pairs to determine whether MRSA carriage is present in asymptomatic women. The study consisted of obtaining informed consent, then performing a sterile swab of mothers' nares and vaginal area, then babies' nares and umbilicus once the baby was born.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy expected to deliver next 24 hours

Exclusion Criteria:

* Cesarean sections
The Effect of Perioperative Lidocaine Infusion on Neutrophil Extracellular Trapping

To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping after minimally invasive surgery for stomach cancer

To investigate the effect of perioperative lidocaine infusion on the neutrophil extracellular trapping, especially citrullinated histone3, neutrophil elastase, myeloperoxidase

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stomach cancer
* ASA class I-III
* no metastatic disease

Exclusion Criteria:

* hepatic, renal disease
* chronic inflammatory disease, eg. rheumatoid arthritis
* steroid or anti-inflammatory drug medication
* allergies to study drugs
* neuropsychiatric disease
* refusal of participation
* breast feeding or pregnancy
* weight \< 40 kg
Interactionality of Music Preference and Individual Variables in Pain Perception and Management

The purposes of this study were 1) to delineate any differences in general musical taste (trait) and context-specific music preference (state), as well as preferred music characteristics in cancer patients, 2) to investigate the contributions of individual variabilities, personality, behavioral coping styles, and pain levels in predicting changes from trait to state preferences and preferred music characteristics under various pain conditions.

Cancer patients were recruited to fill in questionnaires pertaining to their demographic information (age, gender, religious preference, ethnicity, music background and experience), personality traits, music preferences, preferences for music characteristics, coping styles, and pain experiences.


Eligibility Criteria:
Inclusion Criteria:

1. Stage IV cancer diagnosis
2. Between 40 - 70 years old
3. Normal or corrected hearing
4. Able to communicate (speak, comprehend, read, write) in English
5. Signed informed consent form

Exclusion Criteria:

1. Under 40 or over 70 years old
2. Not able to communicate in English
3. Uncorrected hearing loss/impairment
4. Dementia, psychosis (hallucinations, delusions) that interferes with cognitive processing (verbal and music)
Safety, Tolerability, and Effect of LY2405319 After Multiple Injections in Subjects With Type 2 Diabetes

This study intends to evaluate how safe and well tolerated the LY2405319 compound is when given to people for 7 days (in Part 1) and 28 days (in Part 2). This study intends to also determine if there is a positive effect on lowering the level of glucose in people with type 2 diabetes.

Subjects in Part 1 will be randomized to receive LY2405319 or placebo over 7 days in one of 4 dose level groups, in ascending order: 1 mg, 3 mg, 10 mg, or 20 mg.

Subjects in Part 2 will be randomized to receive LY2405319 or placebo over 28 days, and will receive the dose level determined to be the most well tolerated in Part 1.

Eligibility Criteria:
Inclusion Criteria:

* Men and women without child bearing capability
* Ages 35 to 70 years
* Type 2 diabetic subjects, diagnosed for at least 3 months
* Average body weight (relative to height)
* Willing to be available for the duration of the study

Exclusion Criteria:

* Significant medical illnesses (except Type 2 diabetes)
* Abnormal 12-lead electrocardiogram (ECG )
* Current or previous use of insulin for greater than 7 days for control of diabetes
* Regular use of drugs of abuse
* Excessive alcohol use
Chest Physiotherapy on Immediate Postoperative in Patients Submitted to High Abdominal Surgery

Abdominal surgical procedures can increase risks of pulmonary complications.The aim of the study was to evaluate the benefits of an early intervention of chest physiotherapy during immediate post-operative in patients submitted to elective abdominal surgery.

Thirty-one adults were randomly assigned to control and chest physiotherapy groups. Spirometry, pulse oximetry and anamneses were performed before (pre-operative) and in the second post-operative day. Chest physiotherapy group received treatment at the post-anesthesia unit care and control group did not. Chest physiotherapy improved oxygen-hemoglobin saturation in elective post-operative abdominal surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Pre-operative for elective upper abdominal surgery, such as - hernia repair, gall bladder or large bowel removal, exploratory laparotomy, and submitted to general anesthesia or other interventions in abdominal cavity accomplished by conventional laparotomy

Exclusion Criteria:

* Patients with indication of liver transplant or bearers of aneurysm of any arterial segment.
* Patients submitted to video-laparoscopy surgery.
Use of Biopsies of Abdominal Subcutaneous Fat to Study the Role of the Activation of Endocannabinoid 1 Receptors (CB1R) on Adipocyte Glucolipid Metabolism

Obesity is associated with hyperactivation of the endocannabinoid system, and its inhibition by the administration of CB1 receptor (CB1R) antagonists, leads to a decrease in food intake, weight loss and an improvement in metabolic parameters. Even though the reduction in food intake following central CB1R inactivation seems to be the principal cause of weight loss and the improvement in metabolic parameters, several studies in animals and humans have indicated that peripheral CB1R could also be implicated in the regulation of glucolipid metabolism. As a result, it has been suggested that the long-term beneficial effects of inactivation of the endocannabinoid system are due to both central effects on food intake and peripheral effects involving adipose tissue, the liver, skeletal muscle and the pancreas. It appears essential to determine the role of CB1R located in peripheral tissues and in particular in adipose tissue, which plays an active role in maintaining glucolipid homeostasis. The experiments conducted in this project consist in studying in biopsies of abdominal subcutaneous fat whether activation of adipocyte CB1R modifies adipocyte metabolism by determining the mechanisms. The investigators hypothesize that activation of CB1R in adipose tissue will lead to the stimulation of lipolysis dependent on the alteration of the insulin signal, and therefore that inactivation of the endocannabinoid system by blocking peripheral CB1R could constitute a therapeutic approach to improve obesity-related insulin resistance and dyslipidaemia.


Eligibility Criteria:
healthy subjects

Inclusion Criteria:

* men aged 18 to 70 years
* persons who have provided oral consent
* persons undergoing surgery for hernia

Exclusion Criteria:

* persons without health insurance cover
* BMI \> 30
* diabetes
* associated diseases: cancer, chronic inflammatory diseases
* adults under guardianship

obese subjects

Inclusion Criteria:

* men aged 18 to 70 years
* BMI \> 30
* persons who have provided oral consent
* persons undergoing surgery for hernia

Exclusion Criteria:

* persons without health insurance cover
* diabetes
* associated diseases: cancer, chronic inflammatory diseases
* adults under guardianship

diabetic obese subjects

Inclusion Criteria:

* men aged 18 to 70 years
* type 2 diabetic not treated with Insulin or GLP-1 agonist
* BMI \> 30
* persons who have provided oral consent
* persons undergoing surgery for hernia

Exclusion Criteria:

* persons without health insurance cover
* associated diseases: cancer, chronic inflammatory diseases
* adults under guardianship
The Influence of Weekly Reminders on Enhancing Patient Compliance in Patients With Fixed Orthodontic Treatment

this study is a randomized clinical trial to evaluate the effect of sending weekly reminders to patients undergoing fixed orthodontic appliance treatment. two groups will be formed and participants of the study will be divided between the two groups randomly. the intervention group will receive weekly reminders about the importance of oral hygiene and appliance care with adherence to scheduled appointments. the difference between these parameters will be evaluated between the control and intervention groups to describe the importance of weekly reminders to enhance the compliance and cooperation of the patient. the oral hygiene of the patient will include plaque level(plaque index), gingival statue level( bleeding index), and white spot lesion . appliance care will be recorded when in case of bracket failure and appointments missed will also be recorded .


Eligibility Criteria:
Inclusion Criteria:

* Patients with a fixed orthodontic appliance
* both gender
* age 15-25 years old
* patient or parent have smartphone and internet connection
* malocclusion of the patient undergoing treatment according to Index of Orthodontic Treatment Need IOTN should be grade 1,2, and 3
* good gingival health.

Exclusion Criteria:

* Patients with a removable appliance
* cleft lip and palate patients
* patients with hypomineralization visible on anterior teeth
* susceptible to periodontal disease
* have diabetes
* handicap patients, a severe malocclusion above IOTN grade 3, ceramic brackets, and a child with parents that cannot read.
Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma

Cholangiocarcinoma, is a malignant gastrointestinal tumor of low incidence with a poor prognosis. Chemotherapy is the most common treatment for advanced disease. On the basis of a phase III clinical study, cisplatin plus gemcitabine is considered standard first-line treatment in advanced cholangiocarcinoma patients, but there is no established second line therapy.

Since fluorouracil and leucovorin combined with irinotecan and oxaliplatin (FOLFIRINOX) appears to be safe and demonstrated efficacy in clinical studies of advanced pancreatic cancer, colorectal cancer and a phase I study in cholangiocarcinoma, this combination could be an effective second-line treatment for patients with advanced cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of cholangiocarcinoma.
* Metastatic disease or irresectable locally advanced cholangiocarcinoma.
* Measurable disease according RECIST criteria version 1.1.
* Age from 18 to 75 year.
* WHO/ECOG performance status 0-2.
* Patients who received at least 3 cycles of gemcitabine/cisplatin in the first line.
* Adequate hematological function (WBC \> 3.0 x 109/L, platelets \> 100 x109/L)
* Adequate hepatic function (bilirubin ≤ 1.5 x upper normal limit (ULN); ALAT or ASAT \<5x ULN in case of liver metastases and \< 2.5 x ULN in absence of liver metastases.
* Adequate renal function (creatinine clearance \> 60 ml/min; creatinine \<120 µmol/L)
* Absence of cardiac insufficiency, chest pain (not medically controlled) and myocardial infarction in the 12 months preceding study entry.
* Signed informed consent.

Exclusion Criteria:

* Concurrent secondary malignancies or other malignancies within 3 years prior to enter this study with the exception of non-metastatic basal cell or squamous cell skin cancer or carcinoma in situ of the cervix treated by cone-biopsy or resection
* Presence of cerebral or meningeal metastases
* Contraindication to any of the substances of the planned treatment.
* History of chronic diarrhea or colorectal inflammatory conditions, or of unresolved occlusion or sub-occlusion for which symptomatic treatment is being administered
* Active infection or other serious underlying conditions which may prevent the patient from receiving the planned treatment. For example: prolonged unresolved bacterial cholangitis with destruction of bile duct branches (e.g. after endoprosthesis insertion) or two or more cholangitis in the last 6 months. Patients with other active or uncontrolled severe infection, cirrhosis or chronic active hepatitis will be excluded.
* Presence of cardiac insufficiency, unstable angina pectoris, symptomatic congestive heart, failure myocardial infarction 6 months prior to randomization, serious uncontrolled cardiac arrhythmia.
* Inclusion in another investigational clinical trial
* Women who are pregnant, breast-feeding or not using adequate contraceptive
* Age younger than 18 or older than 76 years
* Individuals under correctional supervision or guardianship