cyrilzakka/clinical-trials huggingface dataset:
Anti-CD19 CAR-T Therapy Bridging to HSCT for CD19+ B-Cell Malignancies

This is the second stage of the previous anti-CD19 CAR-T therapy (NCT02965092). The study aims to evaluate the safety and efficacy of consolidative allo-HSCT following CAR-T therapy in patients with relapsed or refractory B cell Malignancies.

Anti-CD19 CAR-T therapy has been confirmed effective for relapsed/refractory B-cell malignancies. However, its ability to keep patients in maintained remission is limited. In order to keep patients in long-term remissions, patients who had achieved MRD-negative complete remissions through CAR-T therapy (NCT02965092) will, on their own accord, receive allo-HSCT if there are no previous HSCT, contraindications, and other restrictions.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is pathologically and histologically confirmed as CD19 + B cell malignancies, and has achieved MRD-negative CR through CAR-T therapy (NCT02965092);
2. B cell hematological malignancies include the following three categories:

   * B-cell acute lymphocytic leukemia (B-ALL);
   * Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
   * Aggressive B-cell lymphoma (DLBCL, BL, MCL);
3. \< 70 years old;
4. Expected survival time \> 6 months;
5. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
6. Voluntarily participate in this experiment and sign informed consent by themselves, or legally authorized representative.

Exclusion Criteria:

1. With a history of epilepsy or other central nervous system diseases;
2. Previous allogeneic hematopoietic stem cell transplantation;
3. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
4. Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
5. Not curable active infection;
6. Patients with active hepatitis B or hepatitis C virus infection;
7. Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
8. Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L);
9. Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
10. Patients with HIV-infection;
11. Any situation that may increase the risk of patients or interfere with test results.
The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study

Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Because of the complex nature of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved with strong opioids. Recently this has been addressed in the literature, as prescribed opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of the common risk factors for persistent postoperative pain, which is a major burden for both the individual patient and the society.

In this prospective, observational cohort study we aim to describe current standards of practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for postoperative pain relief at home.

Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Because of the complex nature of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved with strong opioids. Recently this has been addressed in the literature, as prescribed opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of the common risk factors for persistent postoperative pain, which is a major burden for both the individual patient and the society.

In this prospective, observational cohort study we aim to describe current standards of practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for postoperative pain relief at home.

The data is collected prospectively from the care provider and the patient in a webrobol questionnaire at three time points: the day of surgery (care provider), one week after surgery (patient) and three months after surgery (patient).

Eligibility Criteria:
Inclusion Criteria:

* 18-85 years
* speaks and reads Finnish fluently
* has access to internet and email
* Undergoes elective shoulder surgery

Exclusion Criteria:

* persistent pain in an area other than the shoulder in question
* longterm pain medication for any other purpose than the shoulder in question
* schitzophrenia
* diabetes mellitus with complications
RCT for Women With a Persisting Pregnancy of Unknown Location

This is a randomized controlled trial to compare three currently available management strategies for women with a persisting pregnancy of unknown location (PPUL), which makes them at-risk for ectopic pregnancy. We will recruit hemodynamically stable women with a confirmed PPUL to be randomized to one of three strategies: 1) Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non visualized ectopic pregnancy) 2) Empiric treatment with MTX for all, and 3) Expectant management. Randomization will be 2:2:1 into these three arms. After randomization, they will be followed and treated clinically as is indicated by the progression of their condition. Primary outcome measures: uneventful decline of hCG to 5 IU/mL. Secondary outcome measures: re-interventions, treatment complications, health-related quality of life, financial costs, future fertility, and patient's preferences.


Eligibility Criteria:
Inclusion Criteria:

1. Female with a persisting pregnancy of unknown location:

   1. A pregnancy of unknown location is defined as a women with a positive pregnancy test but no definitive signs of pregnancy in the uterus or adnexa on ultrasound imaging (Ultrasound must be performed within 7 days prior to randomization)
   2. Persistence of hCG is defined as 3 serial hCG values over 4-14 days or 2 serial hCG values over 7-14 days, showing less than 30% rise, or less than 30% fall between the first and last value. (This abnormal pattern of serial hCG confirms that the gestation is nonviable.)
2. Patient is hemodynamically stable, hemoglobin greater than 10 mg/dL,
3. Greater than or 18 years of age

Exclusion Criteria:

1. Hemodynamically unstable in need of acute treatment
2. Most recent hCG greater than 5000 IU/mL
3. Patient obtaining care in relation to a recently completed pregnancy (delivery, spontaneous or elective abortion),
4. Diagnosis of gestational trophoblastic disease,
5. Subject unwilling or unable to comply with study procedures,
6. Presence of clinical contraindications for treatment with methotrexate (ACOG guidelines, Appendix B),
7. Prior medical or surgical management of this gestation.
Virtual Reality Used During Tooth Extraction and Extirpation Treatment

This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

Aims and Objectives: Virtual reality glasses can be used as a distraction method in dental practices for children. This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.

Design: A randomized controlled experimental study design will use. Methods: The sample of the study consisted of 120 seven to ten-year-old children, including 60 in the experimental group and 60 in the control group, who will receive tooth extraction and extirpation treatment in the pediatric dental clinic of an oral and dental health center. Data collection tools included a Child and Family Information Form, the Children's Fear Scale, and the Child Anxiety Scale-State. During the procedure, the children in the experimental group will watch a video that they chose through virtual reality glasses. No intervention will apply to the control group. Data will analyz using the Chi-square test, t-test, Shapiro-Wilk, mean, and percentage distributions.

Eligibility Criteria:
Inclusion Criteria:

* Children who will between the ages of 7-10,
* Children who have Tooth Extraction
* Children who have Extirpation Treatment
* Have no cognitive development problems,

Exclusion Criteria:

* Children who will not want to participate in the study,
* Leave the research during the study,
* Have an audio-visual disorder that could prevent the use of virtual glasses.
Danish Breast Cancer Group Internal Mammary Node Study

The DBCG IMN study is a nationwide prospective population-based cohort study allocating node-positive breast cancer patients with right-sided tumors to internal mammary node irradiation (IMNI) and patients with left-sided tumors to no IMNI.


Eligibility Criteria:
Inclusion Criteria:

* Patients with macrometastatic node-positive breast cancer treated with loco-regional radiotherapy.

Exclusion Criteria:

* Prior malignancies, bilateral breast cancer, neoadjuvant systemic therapy, recurrence before radiotherapy, and non-standard radiotherapy.
Comparison of a Tacrolimus Hexal® Based Regimen Versus a Prograf® Based Regimen in de Novo Renal Transplant Recipients

The purpose of this study was to investigate if Tacrolimus Hexal® has similar pharmacokinetic properties compared to Prograf® in de novo renal transplant patients and whether the comparable exposure resulted in similar renal function.

In Phase II of this study there was a high patient drop-out rate and an associated long recruitment timespan. Eighty-one patients were recruited to Phase I and only 45 of the required 54 patients were available for PK analysis. To complete Phase II, 245 (in addition to 81) patients were to be required to achieve calculated sample size. Therefore the protocol was amended to stop recruitment and analyze Phase I patient data of CERL080ADE27 (PK-Phase I). Patients that were still ongoing were scheduled for an end of study (EOS) visit. During this visit patients were informed by the investigator about the end of study and advised about further treatment course.

Eligibility Criteria:
Inclusion:

primary or sec. kidney transplanted patiens, written consent, cold ischemia \< 24 h

Exclusion:

multi organ, immunological risc pts., PRA \>20%, Antibodys against HLA-type of donor organ, hypersensitivity against Tacro or MMF,

Other protocol-defined inclusion/exclusion criteria may apply
Effectiveness of Mobile Phone Reminder Applications in Improving Oral Hygiene Compliance of Orthodontic Patients

The aim of this Randomized Controlled Trial (RCT) was to investigate the effectiveness of mobile application as an active reminder for improving oral hygiene compliance of patients undergoing orthodontic treatment using fixed orthodontic appliances.

eligible participants will be randomly assigned to either control or intervention group. Group l (control): Only verbal instructions on oral hygiene including brushing using soft bristles, brushing for 2 minutes, flossing once daily, the use of fluoridated oral rinse, orthodontic appliance care and avoiding hard and sticky food.These instructions were given at the baseline visit. Then, these subjects were re-examined after 4 weeks. Group II (intervention): the subjects received the same oral hygiene instructions that were described to the control group with the addition of downloading two mobile applications: Brushout app and Brush teeth reminder app. These applications were adjusted to send notifications twice daily in the morning and night as reminders to practice oral hygiene. In addition, oral hygiene practice was tracked by a link that was sent electronically and checked by study researchers as a compliance protocol. Like the control group, subjects were re-examined after 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

- 1- Subjects having orthodontic treatment using fixed appliances

2- The use of a smartphone to download Brushout app and Brush teeth reminder app

Exclusion Criteria:

* Subjects having orthodontic treatment using removable appliances
Metabolic Imaging of Neurological Disease

Multiple Sclerosis is a chronic condition that shows changes in the way that the brain consumes sugar. It is also known that there are a number of metabolic and inflammatory sequelae following a transient ischemic attack/stroke (hereby referred to collectively as 'stroke'). This study will use a powerful new technology ('hyperpolarised magnetic resonance imaging') to detect these changes in the brains of people with multiple sclerosis and Clinically Isolated Syndrome (CIS) or following a stroke when compared to a group of healthy volunteers. It will be undertaken at the University of Oxford, and each participant will undergo up to 4 scans over the course of three years.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS or stroke

Exclusion Criteria:

-
Noninvasive Markers of Functional Nausea in Children

The researchers propose to study how functional nausea in adolescents may be characterized noninvasively by the use of multichannel electrogastrogram (EGG) and magnetogastrogram (MGG) recordings.

Functional nausea (FN) is a GI disorder that affects millions of Americans, particularly adolescents, but diagnoses remain largely exclusionary relying on symptomology with an otherwise normal diagnostic workup.

Successful completion of the project could contribute to understanding the altered physiology of functional nausea (FN), to stratification of FN patients according to physiological and/or psychological phenotypes, to improve diagnosis and provide objective measures of nausea and to inform and guide treatment options.

The analysis of slow wave activity represents the first physiologically-quantifiable noninvasive assessment method for pathological processes associated with functional nausea in adolescents.

Eligibility Criteria:
Inclusion Criteria:

* children ages 8-17 with functional nausea
* normal control participants ages 8-17 who have no known gastrointestinal complications

Exclusion Criteria:

* Those with claustrophobia who cannot lie still under the SQUID for the length of time required.
* Normal participants with known intestinal complications
* Patients with cyclic vomiting syndrome, gastroparesis, malignancy, primary eating disorders, pregnancy, or hyperglycemia
* Morbid obesity (these patients are presumably unable to lie under the current generation of SQUID devices).
* Patients with a history of cardiac arrhythmias or taking anticoagulants will be excluded
Effects of Physical Therapy on Gait Parameters in Patients With Parkinson Disease

Parkinson disease is a progressive neurologic disorder characterized by motor impairments which alter the walking capacity, and lead to reduced walking speed, decreased stride length and increased double support time. Physical therapy interventions are an important part of the non-pharmacological treatment for Parkinson disease. The purpose of this study is to assess whether there is a different outcome regarding improvement of gait parameters, when applying a physical therapy program in an individual or in a group manner.

The study setting is the Clinical Rehabilitation Hospital in Cluj-Napoca, Cluj county, Romania. Patients will be randomly divided into 2 groups, and were prescribed either individual (1 patient and 1 physical therapist) or group physical therapy (6 patients and 1 physical therapist). Treatment protocol includes 10 sessions of physical therapy, in the same room setting and performed the same routine of exercises, except for the 3 breaks during the sessions in the group therapy for informal socialization. Walking speed will be measured by two validated instruments, the 6-minute walk test and the 10-meter walk test, before and after treatment.

The rehabilitation protocol for the individual physical therapy will consist of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the group protocol will follow the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session.

Also, both groups will have access to external cues, which will be applied during a variety of tasks and environmental situations, like gait initiation and termination, heel strike and push-off, sideways and backwards stepping, walking while dual tasking, and walking over various surfaces and long distances.

All patients will be evaluated at the beginning and at the end of the physical therapy program. The evaluation includes the 6-minute walking test and the 10-meter walking test. Gait speed for each participant will be calculated as the ratio between the walked distance and the time unit, and it was measured in meters/seconds.

Eligibility Criteria:
Inclusion Criteria:

* stable medication usage;
* Hoehn and Yahr stage 2, 3 or 4;
* ability to walk independently or by using an assistive walking device;
* no severe cognitive impairments (Mini-Mental State Examination - MMSE score, ≥24);
* no other severe neurologic, cardiopulmonary or orthopedic disorders;
* not having participated in a PT or rehabilitation program in the previous 2 months.

Exclusion Criteria:

* not stable medication usage;
* Hoehn and Yahr stage 1;
* inability to walk independently or by using an assistive walking device;
* severe cognitive impairments (Mini-Mental State Examination - MMSE score, below 24);
* other severe neurologic, cardiopulmonary or orthopedic disorders;
* having participated in a PT or rehabilitation program in the previous 2 months.
Evaluation of Brain Activity Changes After a Behavior Change Weight Loss Intervention

The aim of this study is to compare brain changes in individuals with overweight or obesity enrolled in either the Noom Healthy Weight program or a matched control. The study objectives (primary and secondary) are to measure brain change reported as ERP and EEG data over a 16-week timeframe. Additionally, we will explore changes in the default mode network (resting-state asymmetry in EEG measurements), changes in executive functioning, quality of life, mood, and salivary markers as they relate to EEG data.


Eligibility Criteria:
Inclusion criteria:

* Each subject must be able to understand and provide informed consent
* Between the ages 18-60 years
* Self-report of good health
* Overweight or obesity (BMI ≥ 25)
* Able to meet our criteria of adherence to the program
* Able to attend in-person visit in Long Island, NY

Exclusion criteria:

* Inability or unwillingness to give written informed consent or comply with the study
* Visual impairment that cannot be corrected with glasses or contact lenses
* Any indication of drug, alcohol or medicine abuse.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
* Presence of a brain injury, psychiatric disorders, seizure disorders, and other neurological conditions
* Reported eating disorder
* Currently pregnant or 6 months postpartum
* Planning to become pregnant within the next 5 months
Observational, Bivariate Analysis of Clinical Big Data in Patients With Cervical Cancer

This is a large non-interventional observational bidirectional study planned to collect clinically relevant data and prognostic follow-up information of patients with cervical cancer who were seen at our center from 2010.01.01 to the end of this study.

This study is a large-scale observational, bi-directional analytical study, which collects clinical data from patients with cervical cancer who have received treatment in the Department of Gynecologic Oncology of the First Hospital Affiliated to the University of Science and Technology of China (Anhui Provincial Hospital), including age, weight, BMI, menopausal status, history of the current disease, past history, specialized examinations, results of tests, results of genetic testing, pathology-related data, and information related to surgery, etc. The diagnosis, subsequent treatment, and follow-up of the subjects follow the routine clinical procedures of the clinical center. The diagnosis and subsequent treatment and follow-up of the subjects followed the routine clinical procedures of the clinical center, and the follow-up data of the enrolled patients were collected every six months: imaging, tumor markers, recurrence and treatment. And clinical big data analysis. Therefore, patients who meet the enrollment criteria can be included, and the sample size is based on the actual number of cases included.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. patients with a clear pathological diagnosis of cervical cancer;
3. all patients included in this study were diagnosed after 1 January 2010
4. Diagnosis or treatment of cervical cancer at the centres covered by this study;
5. exemption from informed consent or signing of an informed consent form.

Exclusion Criteria:

1. Loss of contact during the follow-up period for no apparent reason;
2. Discharged from the hospital for follow-up treatment at an outside institution with unknown treatment status;
3. The investigator considers the patient unsuitable for participation in this study;
4. cases where the clinical diagnosis is in doubt or unclear.
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants

A comparative study of BMS-986256 with a combined oral contraceptive in healthy female participants to determine the effectiveness when taken together


Eligibility Criteria:
Inclusion Criteria:

* Participants must be a non- smoking genetically female, who has normal renal function, willing to use Loestrin, and of childbearing Potential with intact ovarian function.
* Participants must be healthy, defined as having no clinically significant active or ongoing medical condition Weighing less than or equal to 50 kg and a body mass index between 18.0 and 32.0kg inclusive at screening.
* Participant must have a negative QuantiFeron- TB Gold test at screening and have a normal pap smear result within 3 years.

Exclusion Criteria:

* Participants who are involuntarily incarcerated, have a significant Chronic medical illness or a history of relevant drug allergy to immunologic or related compounds.
* Any serious bacterial, fungal, or viral infection within 3 months or a history of recurrent or chronic infection or Risk for TB.
* A history of any medical condition specifically related to the use of hormonal contraceptives as well as an average intake of more than 21 units of alcohol per week.