cyrilzakka/clinical-trials huggingface dataset:
To Evaluate Safety and Efficacy of Autologous CD19 Chimeric Antigen Receptor (CAR)-T Cells in Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL)

A Phase II Open-Label Single-arm Study to Evaluate Safety and Efficacy of locally manufactured autologous CD19-directed CAR T-cells in Patients with Relapsed/Refractory B- Non-Hodgkin Lymphoma (B-NHL) or patients not eligible for hematopoietic stem cell transplantation (HCT)


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed diagnosed with CD19 positive B cell NHL in accordance with WHO classification
* Patients who are refractory to second-line treatment or patients who relapsed after first-line treatment with no available curative options such as autologous or allogeneic haematopoietic stem cell transplantation (HSCT) or relapse within one year of autologous HSCT
* At least one measurable lesion according to revised IWG response criteria
* Age between ≥13to ≤75 years
* Adequate organ function as defined by a creatinine clearance \>40 ml/min, serum alanine transaminase (ALT) \< 5 times the normal value, serum bilirubin \< 3 times the normal value, left ventricular ejection fraction\> 45%
* Absolute neutrophil count ≥ 1500/μl, haemoglobin level ≥ 7 g/dl, platelets ≥ 50000/μl.
* Life expectancy \>12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Female of childbearing age must have a negative pregnancy test and is on two effective contraception methods
* Male patients must use two effective contraception methods

Exclusion Criteria:

* Active central nervous system (CNS) lymphoma (detected by Imaging study or cerebrospinal fluid (CSF) analysis)
* Active cancer(other than NHL) or receiving cancer treatment
* Evidence of severe lung, heart (New York Heart Association class III/IV, arrhythmia, heart block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder
* Presence of active autoimmune disease requiring immunosuppressive therapy
* Human Immunodeficiency Virus (HIV) positivity
* Active Hepatitis B, and Hepatitis C infection
* Uncontrolled infection
* Pregnant/nursing female.
* Receiving autologous or allogeneic stem cell transplant within 12 weeks of enrolment
Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of GC3106 after single intramuscular administration in Korean healthy adults.

This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa to ensure participants protection. Part A is an open-label and single arm study in 9 healthy volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1), double-blind, active controlled study and a total of 75 volunteers will participate in this part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.

Eligibility Criteria:
Inclusion Criteria:

* Given written informed consent
* Healthy Korean adults (age: between over 19 and under 65)
* Korean adults who agree with 21 days follow up after vaccination and good compliance to study procedures
* Those who are able to comply with the requirements for the study

Exclusion Criteria:

* Inability in written/verbal communication
* Subjects who have participated in other interventional study within 30 days
* Alcohol or drug abuse within 6 months
* Heavy drinkers or subjects who do not agree to stop drinking for 3 days before vaccination and other 3 days after vaccination
* Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6 months of enrollment
* Hypersensitivity with drug or active ingredient
* Disorders in immune function
* History of Guillain-Barré syndrome
* Disease/medications which are likely to cause any severe bleeding
* Active infection or experience of fever (\>38.0 ℃) within 72 hours following vaccination
* Oral temperature \>38.0 ℃ at the vaccination day
* Erythema, tattoo, injury at shoulder (vaccination site)
* Influenza vaccination within 6months
* Any vaccination within 30 days
* Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products, or anti-cancer chemotherapy or radiation therapy within3 months
* Pregnant or breast-feeding women
* Clinically significant underlying diseases or medical history at investigator's discretion
NeoRad Breast Cancer Study

The NEORAD trial tests whether preoperative radiotherapy results in an improved DFS and less radiation induced late effect compared to postoperative radiotherapy in higher risk breast cancer after NACT.

The standard of care for high-risk breast cancer consists of neoadjuvant chemotherapy and surgery followed by postoperative whole breast/chest wall irradiation+/- an additional boost (= irradiation restricted to the tumour bed in the case of breast-conserving therapy). In case of lymph node involvement in most patients require additional radiation of the regional lymph nodes. Adjuvant radiotherapy significantly reduces ipsilateral breast cancer recurrences, breast cancer specific mortality, and overall mortality. The optimal time of radiotherapy in patients, who are candidates for neoadjuvant chemotherapy (NACT) has never been addressed in a randomised controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Histopathological confirmation of breast cancer
* Indication for neoadjuvant chemotherapy
* Indication for radiotherapy
* Informed consent for NACT signed by the patient.
* T2-T4 a-d
* T1, if G3, triple negative, HER2 positive, or cN+/pN+
* Hormone receptor and HER2 status: no restrictions
* All grades G1-G3
* Age ≥18 years at the time of randomisation
* Performance status ≤ 2
* No pre-existing conditions that prohibit study therapy
* Signed consent form regarding registration, randomisation, collecting, and saving of personal data.

Exclusion Criteria:

* Pregnancy or lactation
* Prior radiotherapy of the affected or contralateral breast
* Connective tissue disease, including rheumatoid arthritis and thromboangiitis obliterans.
* Pre-existing symptomatic chronic lung disease (fibrosis, pneumoconiosis, adult-onset allergies such as farmer's lung, severe lung emphysema, COPD ≥°III)
* Cardiac comorbidities: symptomatic coronary heart disease, prior heart attack, heart failure NYHA ≥II or AHA ≥C, pacemaker and/ or implanted defibrillator
* Malignoma except for basalioma or in-situ-carcinomas in complete response
* Distant metastasis
* Plexopathies of the arm of the treated side
* Stiffness of the shoulder from any cause (e.g., after a car accident) of the arm of the side of the breast cancer
* Lymph edema ≥°II of the arm at the side of the breast cancer
* Missing signature on consent form
* Participation in other clinical trials
* Other medical conditions that prohibit the neoadjuvant chemotherapy (i.e., HIV, psychiatric diseases, noncompliance, etc.)
* Male patients
Placebo Effects on Blood Pressure

A relevant reduction of blood pressure (BP) in placebo-treated control groups is a phenomenon often observed in pharmacological studies of hypertension. This effect was shown to differ from spontaneous remission tendencies and regression to the mean effect by comparing placebo groups with untreated controls. However, it is not fully understood whether these effects are due to a global reaction of the autonomous nervous system (affecting the overall organ systems of the body) or a specific reaction (affecting the cardiovascular system only). We therefore aim to differentiate specific effects (reduction of blood pressure) from global effects (e.g. changes in electrodermal and gastric activity).

In our study we aim to test the following hypotheses:

1. Placebo administration leads to a significant changes of blood pressure compared with untreated controls.
2. The direction of blood pressure change depends on the type of suggestion (either decrease or increase)
3. This effect is specific for blood pressure; changes in electrodermal and gastric activity do not differ between groups.
4. The placebo response can be enhanced by a prestige intervention (information about the suggested drug action given by doctor or in written form).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent

Exclusion Criteria:

* Not meeting inclusion criteria
* Untreated hypertension (BP \> 140/90) or hypotension(BP \< 100/60)
* Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
* Diseases with influence on cardiovascular or gastrointestinal system
* Pregnancy and lactation phase
* Body mass index \> 30
* Regular intake of drugs with influence on the autonomic nervous system
* Insufficient compliance
* Simultaneous participation in another trial
Ginger Capsules for the Prophylactic Treatment of Migraine

The main objective of the study is to evaluate ginger efficacy as an prophylactic treatment of migraine.

Patients with the diagnosis of migraine according to the IHS criteria will receive capsules of 200 mg of ginger extract (5% active ingredient) or placebo (cellulose) to be taken three times a day for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 60 years old;
* Migraine diagnosis;
* Agree to sign the informed consent.

Exclusion Criteria:

* Patients with headaches not characterized as migraine;
* Pregnant or lactating women;
* Fertile and sexually active women who do not use contraception;
* Abuse of painkillers, alcohol or other drugs;
* People with hypersensitivity to ginger compounds;
* People with severe neurological diseases (e.g. epilepsy)
* People in use of anticoagulant drugs.
Rh-Endostatin (Endostar®) Continuous Intravenous Infusion

Endostar is a anti-angiogenesis product and has been launched in China . The efficacy and safety have been defined. However, the compliance is unsatisfactory since routine i.v of Endostar is needed for 3 to 4 hours daily during one cycle of 14 days. The continuous intravenous infusion by using venous pump can improve the compliance.


Eligibility Criteria:
Inclusion criteria:

Primary non-small cell lung cancer confirmed by cytology and histology, excluding sputum examination;

Phase IIIB/IV based on TNM criteria (8th);

At least one measurable tumor based on RECIST 1.1;

Without the known active mutation of EGFR/ALK/ROS1/RET;

Male or female, age≥18 or ≤70 years old;

ECOG PS: 0 or 1;

Estimated time of survival: ≥ 3 months;

Suitable hematologic function: ANC≥2×109/L, PLC≥100×109/L and Hb≥9 g/dL;

Suitable liver function: Total bilirubin≤ normal ULN, AST and ALT≤2.5×normal ULN, ALP≤ 5×normal ULN;

Suitable renal function: Cr≤normal ULN,or Ccr≥60 ml/min;

EKG normal;

Without healing wound;

No history of anti-cancer therapy, or adjuvant/neo-adjuvant chemotherapy for non-metastatic tumor finished for more than 6 months before enrollment;

For the female subject with productive ability, urine pregnancy test must be done and is negative within 7 days before enrollment;

No history of serious allergic to biologic agents, especially E.Coli products;

The authorized ICF must be signed.

Exclusion Criteria:

Woman in pregnancy and breast-feeding, or having productive ability without contraception;

Having the serious acute infection uncontrolled or purulent/chronic infection with unhealed wound;

Having the serious heart disease, including congestive heart failure, uncontrolled high-risk arrhythmia, unstable angina, myocardial infarction, valvular disease, and refractory hypertension;

Having uncontrolled nervous or mental disease with low compliance and reluctance to description of response; uncontrolled primary brain tumor or other metastatic brain cancer with obvious intracranial hypertension or mental symptoms;

Having the tendency of bleeding, such as FIB≤2G/L;

Being receiving adjuvant chemotherapy;

On other conditions investigator considers, the subject is not fitful to participate the trial.
Prospective Registry to Evaluate the Effective Incidence of Chronic Thromboembolic Pulmonary Hypertension in Germany

The incidence of chronic thromboembolic pulmonary hypertension (CTEPH) after acute pulmonary embolism ist not clear. It is estimated to be up to 3.8%. Prospective data registration does not exist. Treatment of choice is pulmonary endarterectomy if the thromboembolic lesions are surgically accessible. Otherwise interventional therapy by means of pulmonary balloon-angioplasty (BPA) or medical therapy is indicated. In Germany, the majority of the patients is referred to three CTEPH centers: Kerckhoff Clinic, Saarland University Hospital and Hannover Medical School to evaluate the therapeutic options. Starting in January 2016 all incident patients will be de-identified and included prospectively. Risk factors, outcome and treatment will be documented.

All patients referred to the participating centers will be diagnosed in a standardized manner to confirm the diagnosis "CTEPH". No additional intervention or blood sampling is necessary. The recommended treatment option is the result of weekly CTEPH conferences. Every patient will be discussed.

The registry contains the following data:

Center PLZ Sex Age Body Mass Index History of venous thromboembolism (VTE), Date ff 1st VTE Anticoagulation and type of anticoagulation Blood group V/Q scan CT-agiography Pulmonary angiogram World Health Organisation-Functional Class six-minute walk distance Right heart catheter: RAP, PAPs, PAPd, PAPm, PAWP, CO, CI, PVR, SvO2 Treatment: PEA, Ballon Pulmonary Angioplasty (BPA), medically therapy, Vena cava filter CTEPH special risk factors: thrombophilia, antiphospholipid antibody syndrome, splenectomy, VA shunt; pacemakers

Eligibility Criteria:
Inclusion Criteria:

* diagnosis "CTEPH" confirmed

Exclusion Criteria:

-
Mallampati Score for Prediction and Prognosis of Postoperative Mortality and Morbidity and Safety Profiles of Patients Undergoing Laparoscopic Cholecystectomy in Qassim Region

To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

A preoperative assessment by anaesthetic staff should include the Mallampati Score, as there is a direct correlation between the amount of space in the pharynx and the laryngoscopic view during intubation which has been refined by Cormack and Lehane (1984) Clinical diagnosis one of most important factor indicating the postoperative complications like Mallampati score. As the Mallampati class zero per se is not indicating with any difficulty of airway management unless other airway characteristics indicating to the difficulty. As well as if the epiglottis may be large and overhanging, it's not common with airway difficulty in Mallampati class zero airway.

The Mallampati score idea is to estimate the size of the tongue related to the oral cavity and the displacement of the tongue by the laryngoscope blade was likely to be easy or difficult. It also assessed whether the mouth could be opened adequately to permit intubation

Research objectives To predict the majority of Mallampati score for the patients in Qassim region who undergoing Laparoscopic Cholecystectomy Surgery.

Method:

Observational, Multi hospital, Regional Study

Inclusion Criteria:

1. Age: 20 - 50 years
2. Laparoscopic Cholecystectomy Surgery
3. Body Mass Index (BMI): ≤ 35

Exclusion Criteria:

1. Age Less than 20 years
2. Age More than 50 years
3. Body Mass Index (BMI) \> 35

Data management and analysis plan:

All data will be entered and analyzed using SPSS V28© (IBM Corp., Armonk, NY, USA). Categorical variables will have expressed as frequencies and percentages, while continuous variables will have presented as means ± standard deviations (SDs). The chi-squared test will have used to evaluate demographic and health-related characteristics associated with name of the clinic as well as type of service provided to the patient. A p-value of less than 0.05 was considered to be statistically significant

Ethical considerations:

* All investigators completed the Bioethics certificate from The National Committee of Bioethics at King Abdulaziz City for Science and Technology.
* All investigators declare there is no conflict of interest.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20 - 50 years
2. Laparoscopic Cholecystectomy Surgery
3. Body Mass Index (BMI): ≤ 35

Exclusion Criteria:

1. Age Less than 20 years
2. Age More than 50 years
3. Body Mass Index (BMI) \> 35
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density

This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.


Eligibility Criteria:
Key Inclusion Criteria:

* Postmenopausal, ambulatory women between 50 and 70 years old who are generally in good health.
* Must have low bone mineral density and meet specific eligibility criteria.

Key Exclusion Criteria:

-Subjects must not currently be receiving any medication that affects bone metabolism or have an underlying condition that affects their ability to take alendronate or receive denosumab.
Treatment and Prevention of Severe Anemia in Pregnant Zanzibari Women

The purpose of this research is to compare the efficacy of two low-cost low intervention packages to prevent and treat severe anemia in pregnant women in Zanzibar, Tanzania. The two packages are Standard of Care as described by the WHO (presumptive treatment for malaria and helminths plus daily iron + folic acid supplements) and Enhanced Care (Standard of Care plus daily multivitamins and a 2nd dose of anthelminthic.)

This is a clinic-randomized trial involving 8 antenatal clinics and approximately 2500 women. The specific aims are:

Aim 1: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the prevention of severe anemia among pregnant Zanzibari women. This aim will be achieved through a pre-post intervention comparison.

Aim 2: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to prevent severe anemia among pregnant Zanzibari women.

Aim 3: To evaluate the efficacy of the current internationally recommended standard of care, as described by the WHO, for the cure of severe anemia among pregnant Zanzibari women.

Aim 4: To evaluate the efficacy of an enhanced treatment regimen in comparison to the current standard of care to cure severe anemia among pregnant Zanzibari women.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman

Exclusion Criteria:

* Not a permanent resident of the community
Could Ki-67 be Used as a Diagnostic or Prognostic Marker in Hemato-oncological Diagnostics?

Ki-67 is used as a marker for determination of the proliferative activity in solid tumors. The use within hemato-oncological malignancies is limited. This is related to limited technical possibilities of flow cytometry in the past. Meanwhile, flow cytometry in hemato-oncological malignancies has progressed to assessment of 8 colors and makes it possible to add Ki-67 as an additional marker to the 8-color panels. Adding Ki-67 to these panels could lead to improved diagnosis and prediction of therapy response for a number of hemato-oncological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* MDS and AML patients

Exclusion Criteria:

* Ongoing radio- and/or chemotherapy
Retinal Venous Pressure (RVP) in Normals

Determinate the standard values of the retinal venous pressure in a cohort of healthy subjects.

The retinal venous pressure (RVP) is an increasingly important dimension in the clinical assessment of retinal blood flow.

In literature only very few and also divergent data on the retinal venous pressure in healthy volunteers are described. A normal value study will provide us with an up-to-date database.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* eye diseases
* systemic diseases
* term medication (except contraceptives)
* pregnancy
* allergies to the ingredients Alcaine, Tropicamide and Phenylephrine
Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 85 years
* History of, or at high risk for, cardiovascular disease (CVD) including coronary artery disease, symptomatic peripheral arterial disease, cerebrovascular atherosclerotic disease, or at high risk for a cardiovascular event
* Participant-reported SI due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued resulting in an inability to tolerate:

  * 2 or more statins at any dose, or
  * 1 statin at any dose and unwilling to attempt a second statin or advised by a physician to not attempt a second statin.

Please note that participants currently tolerating very low dose statin therapy (an average daily dose of rosuvastatin \<5 mg, atorvastatin \<10 mg, simvastatin \<10 mg, lovastatin \<20 mg, pravastatin \<40 mg, fluvastatin \<40 mg, or pitavastatin \<2 mg) are considered to be intolerant to that low dose statin. Patients may continue taking very low dose statin therapy throughout the study provided that it is stable (used for at least 4 weeks prior to screening) and well tolerated.

* Written confirmation by both participant and investigator that the participant is statin intolerant as defined above, aware of the benefit of statin use to reduce the risk of MACE including death, and also aware that many other participants who are unable to tolerate a statin are able to tolerate a different statin or dose.
* Men and nonpregnant, nonlactating women
* Fasting blood LDL-cholesterol ≥ 100 (2.6 mmol/L) at screening

Exclusion Criteria:

* Fasting blood triglycerides greater than 500 mg/dL (5.6 mmol/L) at screening
* Recent (within 90 days of screening) history of major cardiovascular events, transient ischemic attack (TIA), or unstable or symptomatic cardiac arrhythmia
* History of severe heart failure
* Uncontrolled hypertension or uncontrolled diabetes