cyrilzakka/clinical-trials huggingface dataset:
Autoimmunity After Checkpoint Blockade

The purpose of this study is to better understand how the treatment of cancer with immune checkpoint inhibitors (ICI) leads to the development of autoimmunity. Specifically, we wish to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitor therapy to develop an immune-related adverse event (irAE).

The goal of this study is to understand how the treatment of cancer with checkpoint inhibitors leads to the development of autoimmunity. Specifically, to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitors to develop autoimmunity. At least 300 patients will be enrolled when they are initially prescribed any checkpoint inhibitor. Peripheral blood and serum from patients when they enroll and examine the genetics, serum factors, and phenotype of the immune system. There is no planned intervention. Subjects will be asked to provide peripheral blood and serum at established time points when they are getting therapeutic infusions and routine clinical labs, as well as, at the time they develop any autoimmune symptoms. Urine may also be collected at the time of enrollment, standard study visits, and/or at the time of an autoimmune complication. Inclusion criteria include a diagnosis of cancer, prescription for a checkpoint inhibitor, and fluency in English. Exclusion criteria include any subjects not willing or able to give consent, children under the age of 18, and history of transplant. There will not be any interventions. Clinical data will be extracted from electronic medical records. Coded data will be stored in a REDCap database. PHI and study key stored at UPenn on a password-protected database on an encrypted drive that is institutionally secured and managed by the University of Pennsylvania.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of cancer and prescription for a checkpoint inhibitor

Exclusion Criteria:

* Any subjects not willing or able to give consent
* Children under the age of 18
* A history of transplant
Treatment of Mature B-cell Lymphoma/Leukaemia

This is an international trial conducted by three cooperative groups: SFOP (France, Belgium, Netherlands), CCG (USA, Canada, Australia), and UKCCSG (UK and Ireland). Children with mature B-cell lymphoma/leukaemia are stratified into three different risk groups (A, B, C) and receive treatment of progressive intensity. Randomized trials in the 2 biggest groups (B and C) test whether "reduced" therapy is equivalent to standard intensive therapy (LMB-89 B and C) in terms of event free survival. The reason for the modification is to reduce the long term toxicity which includes cardiotoxicity, impaired fertility and secondary malignancy. In group B, the modifications of treatment consists of a reduction of cyclophosphamide in COPADM2 and/or the elimination of COPADM3. In group C, the modification consists in a reduction of the doses in the CYVE courses and the elimination of the last 3 courses of maintenance treatment

Group B: Randomized trial with factorial design. The 4 treatment arms are standard LMB89 therapy B, reduction of cyclophosphamide (CPM) in COPADM2, deletion of COPADM3, both reduction and deletion. Randomization occurs following COPADM1 and is stratified for national group, histology (large cell; small non cleaved cell) and stage (Murphy I orII; Murphy III+LDH\<2N; Murphy III+LDH\>2N or Murphy IV).

The primary analysis questions are whether reducing CPM dose in COPADM2 results in a smaller long-term EFS whether omitting COPADM3 results in a smaller long-term EFS

Group C: Randomized trial. The 2 treatment arms are standard LMB89 therapy C versus reduction of CYVE + deletion of the last 3 maintenance courses. Randomization occurs following COPADM2 and is stratified for national group, histology (large cell; small non cleaved cell) and CNS disease.

The primary analysis question is whether reducing CYVE and omitting the last 3 maintenance courses result in a smaller long-term EFS than standard LMB 89 treatment C

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed B lineage non-Hodgkin's lymphoma with Revised European American Lymphoma (REAL) II 9 (diffuse large cell lymphoma), 10 (Burkitt's lymphoma), or 11 (high grade B cell lymphoma, Burkitt's like) or bone marrow \> 5% L3 blasts.
* Pre treatment imaging studies adequate to document Murphy disease stage
* Group B and C patients are eligible for randomization (Therapy stratification by group : Group A=completely resected stage I or completely resected abdominal stage II lesions, Group B= All cases not eligible for Group A or Group C, Group C= Any CNS involvement and/or bone marrow involvement ³ 25% blasts)
* Patients should be available for a minimum follow up of 36 months
* Informed consent prior to study entry

Exclusion Criteria:

* Anaplastic large cell Ki 1 positive lymphomas
* Previous chemotherapy.
* Congenital immunodeficiency
* Prior organ transplantation
* Previous malignancy of any type
* Known HIV positivity
Clinical Value of Next Generation Sequencing in Chinese Childhood Solid Tumors

Samples of 200 patients with pediatric malignant solid tumors will prospectively be collected. Selected samples are sufficient for next generation sequencing(NGS) and available for follow-up information. Multi-omics techniques such as DNA and RNA panel will be used to study driver genes for the development of malignant solid tumors in children, and to explore the pathogenic mechanism. The aim of this study is to explore new biomarkers for the diagnosis and treatment for childhood malignant solid tumors.

DNA and RNA extracted from tumor tissues and leukocytes will be analyzed by Onco PanScan/whole exon sequencing(Genetronhealth), and comprehensive gene mutation information such as single nucleotide variation, insertion deletion mutation, gene copy number variants and structure variants will be obtained.

Through in-depth mining of genomic data generated by clinical tumor tissue detection, the differences among different subtypes of pediatric solid tumors in TCGA data will be compared with previous studies. Combined with clinical pathological and molecular subtyping results, auxiliary diagnosis was performed. Analyzing therapeutic targets and identifying pathogenic cancer-predisposing variants may provide molecular reference for children's malignant solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are diagnosed by histology and pathology as pediatric malignant solid tumors (including soft tissue sarcoma, osteosarcoma, pediatric glioma, neuroblastoma, nephroblastoma, retinoblastoma, hepatoblastoma, atypical teratoid/rhabdomymoma, embryonal tumor, etc.);
2. Age: \< 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) PS score: 0-2, estimated survival \>6 months;
4. Complete clinical laboratory examination and pathological examination information of patients;
5. Patients can be evaluated on time, and samples can be obtained throughout the whole test process;
6. Informed consent signed by the patient or his/her legal representative shall be obtained after the patient is informed of the project;

Exclusion Criteria:

1. As determined by the investigator, the patient had other major diseases that might affect follow-up and short-term survival;
2. Any social/psychological problems that the researcher determines are not suitable for the study;
Efficacy of A Novel in Prevention of Neonatal Hypothermia

The research was carried out to determine the effect of baby warmer swaddle, which has a heating system used after the birth of preterm babies, on the development of hypothermia.

Design: Randomized controlled clinical trial Setting: The research was carried out in the NICU of a training and research hospital in Istanbul.

Method: A total of 65 babies between 32-37 weeks of gestation were included in the study. In accordance with the routine procedure of the clinic, preterm babies wrapped in polyethylene bags after birth formed the control group (n=33), while babies wrapped in polyethylene bags and placed in a swaddle with a heating system formed the experimental group (n=32).

Although neonatal hypothermia has higher rates especially in underdeveloped and developing countries, it is a global health problem also seen in developed countries. In a meta-analysis study, the prevalence of neonatal hypothermia was reported as 57.2% in East Africa. In a multicenter, prospective study, 79.6% of preterm newborns were admitted to NICUs with hypothermia in Ethiopia. In a study, the incidence of hypothermia to be 53% in the first 24 hours of life in preterm infants they conducted in a hospital in France. In a study, in 28 countries with upper-middle income status, admission temperature data of a total of 454,617 very low birth weight infants from 2009 to 2016 were analyzed. Although these data showed an improvement in hypothermia rates ranging from 52.6% (2009) to 38.2% (2016), approximately 4 out of 10 infants experienced hypothermia when admitted to the NICU. Similarly, in the United Kingdom, the National Neonatal Monitoring Program reported the prevalence of hypothermia as 28% and 25% for babies born in 2015 and 2016, respectively, emphasizing hypothermia as an ongoing problem.

Eligibility Criteria:
Inclusion Criteria: Preterms;

* between 32-37 GH,
* with an indication for hospitalization in the NICU,
* with a body temperature of 36.4 °C and above in the axillary route immediately after birth,
* with a maternal body temperature between 36.4 °C and 38 °C in the tympanic route are included in the study

Exclusion Criteria: preterms;

* with congenital anomalies,
* who were transported to another hospital, or who were transported to the hospital where the research was conducted from an external center
Supplemental Oxygen in Pulmonary Fibrosis

To enhance understanding of supplemental oxygen-its utility in and adoption by patients with pulmonary fibrosis-by examining how patients perceive it and by determining how perceptions and patient-centered outcome measures change from before to after supplemental oxygen is prescribed.

The investigators aim to recruit patients with PF to participate in interviews and/or a one-year study of supplemental oxygen (O2). In the one-year study, the investigators will collect data before and for one year after PF patients are prescribed daily-use supplemental oxygen and compare outcomes, including shortness of breath, quality of life, fatigue, cough, and day-to-day functioning before and after O2.

Eligibility Criteria:
Inclusion Criteria:

Patient-Participants

(Using daily 02 therapy at time of enrollment)

* Diagnosis of PF
* Able to read and speak English
* Has been on daily-use supplemental oxygen for more than one year

(Not using daily 02 therapy at time of enrollment)

* Diagnosis of PF
* Able to read, speak and write in English
* Has not been prescribed daily-use supplemental oxygen
* Forced vital capacity \<75% and diffusing capacity \<65% of predicted values
* Subject's physician allows the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection

Primary Supporters

* Self-report status of providing care or support to a person living with pulmonary fibrosis who has used supplemental oxygen for more than one year
* Able to speak English

O2 Prescribers

* Self-report status of being a prescriber of daily-use supplemental oxygen to PF patients
* Able to speak English

Exclusion Criteria:

Patient-Participants (Using daily 02 therapy at time of enrollment)

* No diagnosis of PF
* Unable to read and speak English
* Has been on daily-use supplemental oxygen for less than one year

(Not using daily 02 therapy at time of enrollment)

* No diagnosis of PF
* Unable to read, speak and write in English
* Using supplemental oxygen during the day
* Subject's physician does not allow the subject to abstain from daily-use supplemental oxygen for 7-10 days after prescription to allow data for collection

Primary Supporters • Not meeting inclusion criteria

O2 Prescribers

• Not meeting inclusion criteria
Pressure Intensity of a Chinese Massage Technique for Treating Low Back Pain

The Investigators conduct this study to compare two different massage methods with "buffalo horn technique": the deep massage and the superficial massage. To explore the effects of the two interventions on low back pain, the investigators evaluated the outcome measurements regarding pain severity and physical functions before and after 6 times of treatment through a 3-week period.

Background: Nonspecific lower back pain is an important global health issue, with high prevalence over the world and causing huge economic loss.

This research is a double-blind randomized controlled trial. In this study the investigators introduce a technique derived from traditional Chinese massage using a special tool made from buffalo's horns to perform the massage, so called "buffalo horn technique". The tool is like a short rod in about 15-cm length with a cone-like end. During the massage, the therapist presses the cone-like end against the painful region of back. Because the cone-like end has a small contact area with the participant's body surface, it may release deep layer fascia with higher pressure produced by the therapist toward the treatment area. During the intervention of shallow massage, the therapist applies a lower force then that used in the deep massage. Thus it produces a lower pressure on the painful region due to a larger contact surface when pressing the rod end against the body of the participant.

Participants are randomly assigned to either deep-massage group (DM) or superficial-massage (SM) group. The participants received two sessions a week for a total six sessions. The outcome measures include the structured questionnaire to investigate the pain-related outcomes and back pain-related disabilities. The investigators also perform the clinical assessments such as range of motion of trunk. All the outcomes are assessed before-intervention (pretest) and after the end of intervention (posttest).

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Non-specific low back pain over 1 months
3. 20-65 years old
4. No experience of massage therapy within 2 months prior to the study inclusion.

Exclusion Criteria:

1. Pregnancy
2. Back pain associated with systemic disease (autoimmune, infectious, vascular, endocrine, metabolic, or neoplastic disease)
3. Previous spine surgery.
4. Presentation with neurological signs such as radiating pain.
5. .Skin diseases (psoriasis, urticaria, wounds, etc.)
A Warmer Temperature Decrease Propofol Injection Pain

Propofol injection pain will be surfed by up to 70-80 percentage by the Patients who induced by propofol. Temperature of Operating room was set to a certain range in normal clinical practice, which is 22- 26 centigrade. Warm feeling will make skin vassal dilated and more blood will pass through to bring more heat out of our body. It had been reported that a bigger venous vessels will get less propofol injection pain.

The investigators hypothesis that Patients who stayed in a warmer room temperature will surf less injection pain while compare to a normal setting room temperature.


Eligibility Criteria:
Inclusion Criteria:

* ASA I\~III, aged 18，scheduled or emergency surgery with general anesthesia.

Exclusion Criteria:

* a history of allergy to propofol, allergy to soybean oil
* with peripheral blood diseases.
Operant Conditioning of Reflex Pathways to Improve Walking in Individuals Post-stroke

The purpose of this study is to examine the changes in reflex pathways in the paretic ankle plantarflexors in individuals with post-stroke hemiparesis using operant conditioning. We are recruiting 5 individuals with chronic post-stroke hemiparesis with foot drop in the affected leg to participate in the reflex training procedure. The study involves 40 visits with a total study duration of about 4 months.


Eligibility Criteria:
Inclusion Criteria:

* At least 6 months following a single, unilateral stroke, resulting in hemiparesis.
* Ambulatory with or without assistive device, but must demonstrate a gait deficit which is indicative of foot drop from reduced activation of the tibialis anterior muscle.
* Able to follow verbal directions.
* Able to see icons on computer monitor (with or without corrective lenses) from at least 4 feet away.
* All subjects will be adults at least 18 years old.
* Know history and current medication management for lower limb spasticity, if any.

Exclusion Criteria:

* No history of ear disease or balance problems outside of those caused by the stroke.
* Cerebellar stroke
* No other neurological disease or injuries other than the stroke affecting the use of the legs and/or walking.
Cryoablation Versus BCG Instillation Therapy for High-risk NMIBC

This trial plans to enroll 190 eligible patients and randomize them into two groups with a 1:1 ratio, with 95 patients in each group. The experimental group will receive immediate cryoablation therapy at the resection site after TUR, while the control group will only undergo TUR and receive conventional BCG instillation therapy postoperatively. Both groups of subjects will undergo Re-TURBT or cystoscopy 10-12 weeks after surgery to compare the tumor-free residual rates and adverse events between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18 and 85, male or female;
2. Preoperatively diagnosed with T1 stage or meeting the criteria for high-risk bladder cancer (accord with the "2023 NCCN Bladder Cancer Guidelines");
3. Good compliance and able to cooperate with observation;
4. Able to understand the purpose of the trial, agree to participate in this study, and have signed the informed consent form.

Exclusion Criteria:

1. Patients with severe infectious diseases such as bacteremia and toxemia;
2. Patients with severe coagulation dysfunction;
3. Patients with severe heart, brain, lung, liver, kidney and other diseases who cannot tolerate surgery;
4. Patients with other concurrent malignancies;
5. Postoperative pathological diagnosis of bladder cancer patients in Tis, Ta, or T2 stages;
6. Preoperative CT/MRI assessment showing tumor invasion beyond the bladder (T3 stage or above);
7. Preoperative assessment indicating distant metastasis or enlarged pelvic lymph nodes;
8. Pregnant or breastfeeding women;
9. Other situations assessed by researchers as unsuitable for inclusion in this study, such as inappropriate anatomical structure, mental or psychological disorders.
Biomarker Differences in Samples From Patients With Undifferentiated Sarcomas

This clinical trial studies biomarker differences in samples from patients with undifferentiated sarcomas. Studying biomarker in tissue samples from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer

Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Patients from ARST0332 study Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To determine what proportion of unclassifiable sarcomas are unclassifiable because the initial evaluation was not sufficiently comprehensive versus what proportion can be regarded as "true" undifferentiated sarcoma when a comprehensive assessment has been performed.

II. To develop formal diagnostic criteria for establishing the diagnosis of undifferentiated sarcoma.

III. To determine whether undifferentiated sarcoma can be subdivided into separate and distinct pathologic entities that are distinguishable by light microscopy, immunohistochemistry, single nucleotide polymorphism (SNP) array profiling, or clinical features.

IV. To determine whether undifferentiated sarcomas with specific "actionable mutations" can be identified based on their histologic appearance, immunohistochemical staining characteristics, or SNP array profiling features.

OUTLINE:

Tissue samples are analyzed for loss of heterozygosity (LOH) and SNP array profiling using microarray and immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* 49 cases of undifferentiated sarcomas from ARST0332 (additional cases may be ascertained as eligible for this current project that also fall under ARST0332 to be requested later if necessary)
A Study to Evaluate the Safety and Tolerability of Arbaclofen Placarbil (XP19986) in Subjects With Acute Back Spasms

The purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.


Eligibility Criteria:
Inclusion Criteria:

1. Acute moderate to severe muscle spasms in the lumbar region, as indicated by a minimum Visual Analog Scale pain severity score of 4.0 cm, beginning either:

   * within four days prior to screening for subjects who do not require a 24-hour washout

   Or
   * within three days for subjects who require a 24-hour washout
2. Willing to discontinue all analgesics (e.g. NSAIDS, COX-2 inhibitors, acetaminophen), aspirin \>81 mg/day, short-acting muscle relaxants (i.e. carisoprodol, Soma®), and herbal remedies for pain at least 24 hours prior to first dose and to refrain from use during the study (cardio-protective doses of aspirin ≤ 81 mg /day are allowed).

Exclusion Criteria:

1. Clinically significant abnormal neurological history or examination at screening (excluding back spasm), including lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus, or other structural defects
2. Subjects with back spasm related to major trauma to the region
3. Subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation
4. Subjects using any of the following medications at screening:

   * Opioids, both short- and long-acting including but not limited to: morphine, fentanyl patch, oxycodone, tramadol)
   * benzodiazepines, such as valium and lorazepam
   * cyclobenzaprine containing drugs (e.g., Flexeril, Amrix)
   * carisoprodol (e.g., Soma®) within 24 hours of screening
Clinical Outcome of Arthroscopic Lateral Release for Lateral Patellar Compression Syndrome

We performed a prospective case series study of 48 patients who suffered Lateral patellar compression syndrome who were diagnosed by clinical examination and confirmed by M.R.I. and failed conservative management and underwent isolated arthroscopic lateral patellar retinaculum release in Erbil Teaching Hospital, PAR Private Hospital and Hawler Private Hospital between December 2016 and August 2019.


Eligibility Criteria:
Inclusion Criteria:

* Lateral patellar compression syndrome proved by clinical,MRI and Arthroscopic examination

Exclusion Criteria:

1. Dislocated or history of dislocation.
2. Patellar instability.
3. Bony abnormality (trochlear groove hypoplasia or flat).
4. Osteoarthritis of the knee 3rd and 4th grades.
5. Infected knee.
6. Varus and valgus knee.
7. Rotational deformity of the lower extremity.
8. Miserable malalignment triad.
9. Anterior cruciate ligament, posterior cruciate ligament and medial collateral ligament rupture.
10. History of fracture around knee.
11. Focal Osteoarthritis of the lateral facet joint.
12. Chondral lesion (Outerbridge 3 and 4).