cyrilzakka/clinical-trials huggingface dataset:
CAR-T CD19 for Acute Myelogenous Leukemia With t 8:21 and CD19 Expression

Chimeric antigen receptor (CAR-T) engineered T cells against the CD19 protein have been shown to be effective against acute lymphoma and lymphocytic leukemia and are approved by the US (FDA), European (EMA) and Health Basel.

However, little information exists on using CD19CAR for treatment of recurrent or irresponsible to previous treatment acute myeloid leukemia.

The proposed study will include patients with recurrent disease or those with disease irresponsible to common treatments and they will be treated with CAR-T CD19.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 .

Exclusion Criteria:

* Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45%
* Active involvement of CNS
* Active infection
* Pregnancy or lactation
* Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment
* A positive result for the HIV infection (serum)
* Active hepatitis infection
* Life-threatening allergies to cyclophosphamide or fludarabine
* No informed consent signed by candidate
* Candidate enrolled in other study
Web-based Family History Tool

The purpose of this pilot study is to determine if a web-based tool that collects family health history is useful for patients being seen in a gynecologic oncology office setting. This research study is being done because collecting a comprehensive family health history is critical as it allows physicians to appropriately refer patients for genetic counseling and genetic testing. However, prior research indicates that the family health history collected in clinical settings is often inadequate to truly assess the risk of genetic disease. Therefore we plan to explore a web-based program that guides patients through the collection of their family health history and uses this information to create clear concise pedigrees (family tree information) and risk assessment models that can be used by a physician during the office visit.

Patients presenting for a new patient visit with a gynecologic oncologist will be randomized to one of three methods of collection of family health history (Arm 1 - standard of care consisting of interview with the physician; Arm 2 - completion of a web-based family health history tool completed in the clinic waiting room on a computer; Arm 3 - completion of a web-based family health history tool completed prior to the visit and accessed by an email link). A new 4th arm was added with 200 chart reviews to retrospectively look back at how previous family health history was taken for new patients in 2019. The study will evaluate the quality of the family health history collected, the resulting referral to genetic services and patient and physician satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Female \> 18 years of age. Scheduled for new patient visit with one of the gynecologic oncologists at Weill Cornell Medicine (Melissa Frey MD, Kevin Holcomb MD, Evelyn Cantillo MD, Eloise Chapman MD).

Exclusion Criteria:

Subjects who cannot communicate in English as the FHH collection tool and surveys are available only in English.

Subjects who were adopted and have no information about their family health history.

Subjects who do not present for the new patient visit.
A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement

The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).

A randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at Aarhus University hospital by two orthopaedic consultants. Randomization in 10 blocks of ten patients distributed with five patients for Palacos Cement and five patients for Hi-Fatigue Cement.

* 25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
* 25 CPT femoral stems fixed with Palacos Bone Cement.

All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.

Eligibility Criteria:
Inclusion Criteria:

* primary hip osteoarthritis
* sufficient bone quality for total hip arthroplasty
* age 71 years and above
* no upper age limit if the patient is capable
* informed and written consent
* patient can only enter the project with one hip

Exclusion Criteria:

* planned bilateral hip surgery
* neuromuscular or vascular disease in the affected leg
* preoperatively not found suitable for a hip arthroplasty
* patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
* fracture sequelae, osteonecrosis or previous extensive hip surgery
* patients who cannot refrain from taking NSAID post-operatively
* continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bone mass by a factor of 5
* patients with metabolic bone disease
* patients with rheumatoid arthritis
* postmenopausal women in systemic estrogenic hormone substitution
* patients with a continuous need of systemic cortisone treatment
* non-Danish citizenship
* patients who do not comprehend the Danish language (read and speak)
* senile dementia
* alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week
* drug abuse
* major psychiatric disease
* metastatic cancer disease and treatment with radiation therapy or chemotherapy
* severe systemic disease (e.g. hemi paresis and Parkinson disease)
* systemic hip and spine disease
* employee at the orthopaedic department, Aarhus University Hospital
* ongoing case regarding industrial injury insurance of the knee
* patients with poor dental status (risk of infection)
Comparative Study Using Negative Pressure Dressing With & Without Silver Alginate to Promote Healing in Chronic Wounds.

The randomized control trial will be conducted in the Department of Plastic and Reconstructive Surgery at Dr. Ruth K.M. Pfau Civil Hospital Karachi.General population admitted in Civil Hospital Karachi, for wound coverage with skin grafting meetimg inclusion criteria will be included.

Wound will be covered with negative pressure dressings that are composed of a sterile foam dressing surrounded by an occlusive film that adheres to the nearby, normal skin. Suction is applied to the dressing and a draining tube connect to a wall fixed assisted vacuum canister.

Patients will be provided with paper chits with A or B marked on it. Patients picking up A chit will be dealt as A group where wound will be covered with VAC dressings only where by patients picking up B chit will be dealt as B group where wound will be covered with a single layer of Ag+ hydrocolloid dressings. Such pattern of dressing will be followed in every change of dressing in 48 hours. The wound site will be photographed after every change of dressings. The wound site will be photographically monitored by a team of plastic surgeons to assess granulation tissue, by noting the size of wound, color and shine of granulation tissue and edema.

Eligibility Criteria:
Inclusion Criteria:

* Both genders above 18 years
* Wounds for more than 6 weeks
* History of trauma, tumor, congenital physical abnormalities
* Hemoglobin levels more than 10 g/dl
* Platelet count above 150 x 10E9/L
* Size of wound \> 10\*10cm.

Exclusion Criteria:

* Pressure ulcers
* Co-morbidities like diabetes or hypertension
* Bleeding vessels
* Presence of Necrotic tissue
* Malignancy in wounds
Study of DS-5670a (COVID-19 Vaccine) in Japanese Healthy Adults and Elderly Subjects

This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.


Eligibility Criteria:
Inclusion Criteria:

* Japanese citizen
* Healthy adults aged ≥20 and \<65 years, or healthy elderly aged ≥65 and \<75 years (at the time of informed consent)
* Body Mass Index (BMI) is ≥17.5 and \<30.0 kg/m\^2 (at screening)
* Participants who can follow the compliance requirements during clinical trials, undergo medical examinations and tests specified by the protocol, and report symptoms, etc.

Exclusion Criteria:

* Have a history of immunodeficiency or having a close relative with congenital immunodeficiency.
* Have a history of SARS-CoV-2 infection.
* Have previously participated in an investigational study of SARS-Cov-2 vaccine or involving LNPs.
* Have a history of anaphylaxis or severe allergies due to food, cosmetics, medicines, or vaccination
* Have alcohol or drug dependence.
* Have a fever of ≥39.0°C or symptoms of suspected allergies such as systemic rash within 2 days after past vaccination, etc.
Validity of Pain Threshold Index in Children

Comparison of total infused dose of remifentanil between pain threshold index monitoring group and control group

Investigators plan to enroll pediatric patients aged between 3 and 12 years old undergoing surgery under general anesthesia with continuous infusion of 2% propofol and remifentanil.

After dividing them into two groups, investigators monitor pain threshold index and wavelet index in test group and adjust remifentanil infusion to maintain both indices in desirable range, while monitoring only wavelet index and adjust remifentanil infusion to maintain wavelet index and conventional vital signs in desirable range in control group.

Investigators compare consumption of remifentanil, time to extubation after surgery, and post-anesthesia care unit length of stay between both groups.

Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 12 years old undergoing orthopedic surgery at extremities under general anesthesia

Exclusion Criteria:

* History of adverse drug reactions to opioids
* Underlying neurological disease or taking medication for neurologic purpose
* Patients who were transferred to intensive care unit after the surgery
Mangement of Spine Fracture

Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2.

Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3


Eligibility Criteria:
Inclusion Criteria:

* 1-Skeletally mature patients (18yrs and older). 2-Thoracolumbar fractures.

Exclusion Criteria:

* 1-skeletally immature patients. 2-pathological fractures.
Resync-AF (Rate vs Rhythm Control in AF Patients With CRT-D)

This study is being done to find out if controlling rate or controlling rhythm is better for heart failure patients who also have AF. Patients with AF who are receiving a CRT-D device and AV node ablation as part of their clinical care will be followed for one year. One group will have their heart rate controlled by the ICD and AVN ablation alone and the second group will be treated with the ICD, AVN ablation and standard medical therapies to restore the heart's normal rhythm. The study doctors will compare the information collected from all of the subjects in this study to see if treating rate or treating rhythm is better in patients with heart failure and AF, resulting in a better quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Having persistent AF, defined as AF that does not self terminate for at least 24 consecutive hours.
* In AF upon entry into the operating room for CRT-D implantation and AV node ablation.
* Being on a stable dosage of an ACE inhibitor or ARB for at least 1 month preceding implant
* Being on a Beta-blocker for at least 3 months preceding implant and a stable dosage within 1 month of implant
* Not taking or able to be taken off all type I/III antiarrhythmic medications.
* Taking Coumadin so as to maintain an INR of between 2 and 3.
* A Class I or IIa ICD indication
* NYHA Class III/IV within 1 month of baseline
* Intrinsic QRS duration ≥ 130 ms within 1 month prior to baseline
* Left ventricular ejection fraction ≤ 35% (method per physician discretion) within 1 month prior to baseline
* Left ventricular end diastolic dimension (LVEDD) ≥ 55 mm (method per physician discretion) within 1 months prior to baseline
* Willing to provide written informed consent
* Are expected to survive for 6 month of study participation
* Able to tolerate an urgent thoracotomy
* Able to tolerate \< 1 mg dexamethasone sodium phosphate (steroid)

Exclusion Criteria:

* Having self-terminating or interminable AF
* Having unstable angina, or having experienced an acute myocardial infarction (MI) or received coronary artery revascularization (CABG) or coronary angioplasty (PTCA) within the past 1 month
* Post-heart transplant (patients on heart transplant list for the first time are not excluded)
* Having mechanical right heart valve
* Having an existing CRT or atrial therapy device(s)
* Being enrolled in any concurrent drug and/or device study which would confound the results of this trial
* Having primary valvular disease and indicated for valve repair or replacement
* Having a previous AV node ablation
* Being on a Type I or Type III anti-arrhythmic medication for the treatment of ventricular tachyarrhythmias
* Women who are pregnant or with child bearing potential and who are not on a reliable form of birth control
Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Symptoms and signs of indication of lymphocytic colitis

Exclusion Criteria:

* Infectious diarrhoea,
* Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
* Pregnancy or breast-feeding,
* Participation in an other clinical trial
Bendamustine, Gemcitabine and Vinorelbine (BeGEV) as Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients

Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects

The aim of this study is to evaluate bendamustine, gemcitabine and vinorelbine (BeGEV) scheme efficacy as induction therapy to high dose chemotherapy with Allogeneic Hematopoietic Stem-Cell Transplantation (AHSCT) for patients with relapsed/refractory Hodglin's Lymphoma (HL).

Four BeGEV courses repeated every 3 weeks in the absence of any reasons listed in the paragraph 7.5; whenever an objective response is observed at disease evaluation performed after IV cycle patients undergo to high dose chemotherapy with AHSCT (conditioning regimens based on preference of each Centre).

Eligibility Criteria:
Inclusion Criteria:

* relapsed/refractory disease after receiving one line of standard chemotherapy
* history of classical Hodgkin's Lymphoma (HL)
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* at least one site of measurable nodal disease at baseline ≥ 1.5 cm
* Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L; Platelets count ≥ 75 x 109/L

Exclusion Criteria:

* Diagnosis of Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL)
* prior radiation therapy ≤ 3 weeks prior to start of study treatment
* any concurrent anti-cancer therapy
* evidence of another malignancy not in remission or history of such a malignancy within the last 2 years.
* aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x upper limit of normal (ULN) or ≥ 5.0 x ULN if the transaminase elevation is due to disease involvement
* known history of Human immunodeficiency virus (HIV)seropositivity
* hepatitis B virus (HBV) or hepatitis B virus (HCV)active hepatitis
Nutrition and Outcomes of Hematopoietic Cell Transplantation (HCT)

Retrospective case-note review to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation.

This is a retrospective case-note review of adults undergoing haematopoietic cell transplantation to treat a haematological malignancy who have been admitted to Hammersmith Hospital from 2000 to 2014. All patients receiving an allogeneic haematopoietic cell transplant from a matched sibling or identically matched unrelated donor will be included. We will record the route and assess the broad adequacy of nutritional intakes to determine if nutrition via the enteral compared to the parenteral route results in better outcomes after haematopoietic cell transplantation. Our outcomes are graft versus host disease incidence and severity, transplant related (early) mortality and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing their first HCT for a hematologic malignancy
* Undergoing HCT using a sibling or unrelated donor
* Undergoing HCT infusion between January 2000 and December 2014

Exclusion Criteria:

* HCT using umbilical cord blood donors
* HCT using haploidentical donors
A Study in the United States Using Electronic Medical Records (EMR) to Assess Effectiveness of Afatinib (Gilotrif) Following Pembrolizumab and Chemotherapy in the Treatment of Metastatic Squamous Cell Carcinoma of the Lung

This study aims to characterize the profile and outcomes for patients with Squamous Cell Carcinoma of the Lung (SqCC) who progress on 1L pembrolizumab in combination with platinum based chemotherapy and receive afatinib as second line (2L) therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of squamous or mixed histology non-small cell lung cancer
* Treated with pembrolizumab in combination with platinum-based chemotherapy as initial therapy for advanced or metastatic disease (stage IIIB or IV)

  * First cycle of pembrolizumab received after 06/01/2018
  * Permanently discontinued 1L pembrolizumab treatment
* Initiated second-line treatment at least 3 months prior to the date of data collection, with either :

  * Afatinib
  * Any chemotherapy
* Age ≥ 18 years

Exclusion Criteria:

-Received pembrolizumab in combination with platinum-based chemotherapy as part of an interventional clinical trial
Laser Assisted Nonsurgical Periodontal Treatment

Periodontitis is a chronic inflammatory disease caused by mixed infections with the subgingival microbiota being organized as a biofilm that, if untreated, may result in breakdown of the periodontal tissues in susceptible individuals. Evidence from intervention studies shows that mechanical root debridement significantly improves periodontal health by halting the progression of periodontal tissue breakdown. In order to improve effectiveness and efficacy of the removal of the subgingival biofilm, Er:YAG laser therapy has recently been recommended as an alternative to conventional scaling procedures.


Eligibility Criteria:
Inclusion Criteria:

Greater than 25 years, Clinical diagnosis of moderate to advanced chronic periodontitis, Pocket depth ≥ 5 mm or clinic attachment level ≥ 4 mm at least in two interproximal areas (not on the same tooth), Along with very good oral hygiene scores (GI≤1and PI≤1), At least 4 teeth in each quadrant, Teeth with subgingival plaque sample is collected has no restoration or prothesis

Exclusion Criteria:

Periodontal treatment ( root planning or surgical periodontal treatment) had done before, Systemic disease that could influence the outcome of periodontal therapy, Prophylaxis regime mandatory during periodontal treatment, Use of any drug that could influence the outcome of periodontal therapy, Use of antibiotics within the last 3 months, Use of anti-inflammatory drugs within the last 3 months, Use of removable prothesis Pregnancy, lactation or use of hormone contraceptives, Smoking
An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED)

This trial was a randomized trial to determine a patient's acceptability of unflavored antipsychotic medication compared to raspberry flavored antipsychotic medication. Patients received 6 total doses of study drug (2 doses of each asenapine formulation) over 3 consecutive days: 2 different formulations each day, 1 in the morning and 1 in the evening. The formulations were: white unflavored, white raspberry flavored, and red raspberry flavored. Patients were given a questionnaire following each dose of study medication (one questionnaire twice per day for 3 days) to measure how acceptable each formulation was.

Study drug was administered according to a random selected sequence schedule with 2 constraints: Subjects did not receive consecutive doses of the same formulation, and each formulation was given once in the morning and once in the evening over the course of the 3-day treatment period.

Eligibility Criteria:
Inclusion Criteria:

* are at least 18 years of age and of legal minimum age for trial participation;
* are a male, or a female who is not of childbearing potential
* are free from an acute exacerbation of psychosis for at least 3 months;
* have a current DSM-IV diagnosis of schizophrenia (paranoid, disorganized, catatonic, or undifferentiated subtype), or schizoaffective disorder; delusional disorder, major depressive disorder, or bipolar disorder, for whom chronic antipsychotic therapy is indicated;
* correctly identify 3 out of 4 basic flavors (bitter, sweet, salty, or sour) on a neutral taste paradigm;
* are receiving oral antipsychotic medication.

Exclusion Criteria:

* an uncontrolled, unstable clinically significant medical condition
* clinically significant abnormal laboratory, vital sign, PE, or ECGs findings at Screening;
* previously experienced NMRB (also known as vasovagal reflex) or sensitivity for fainting;
* a positive serum pregnancy test at screening, or the intention to become pregnant within the next 30 days;
* a history of seizures;
* a history of neuromalignant syndrome;
* a current (past 6 months) substance abuse or dependence according to DSM-IV-TR criteria (excluding nicotine);
* an imminent risk of self-harm or harm to others;
* currently receiving a depot antipsychotic, such as fluphenazine decanoate, haloperidol decanoate, or Risperdal Consta, within at least 1 dosing cycle of Day-5;
* any impairment in taste functioning;
* receiving lithium or topiramate;
* judged by the principal investigator (PI) to be unable to reliably respond to the questionnaire based on clinically significant cognitive impairment.