cyrilzakka/clinical-trials huggingface dataset:
Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* CLL1 positive relapsed/refractory acute myeloid leukemia
* Age 6-65 years
* Left ventricular ejection fractions ≥ 0.5 by echocardiography
* Creatinine \< 1.6 mg/dL
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal
* Total bilirubin \<2.0 mg/dL
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* Patients are pregnant or lactating
* Uncontrolled active infection
* Class III/IV cardiovascular disability according to the New York Heart Association Classification
* Active hepatitis B or hepatitis C infection
* Patients with HIV infection
* Patients with history of seizure
* Active central nervous system leukemia
Effect of L-ornithine-L-aspertate (LOLA) on the Gut Microbiome

Study to test the effect of the drug "L-ornithine.L-aspertate" (LOLA) on microorganisms in the digestive tract in patients with liver cirrhosis (damage of the liver due to liver disease)

Liver cirrhosis is associated with gut microbiome dysbiosis, which may drive intestinal inflammation, gut barrier dysfunction and the development of complications. LOLA is a well-established drug against elevated ammonia levels that contribute to hepatic encephalopathy and sarcopenia. In a recent retrospective study, LOLA has been shown to improve gut microbiome dysbiosis.

In this study we aim to investigate whether LOLA therapy over three months in patients with liver cirrhosis (irrespective of the etiology) and covert or overt hepatic encephalopathy (HE) leads to an improvement in gut microbiome dysbiosis, as well as markers of gut permeability, inflammation, muscle function and ammonia levels.

Eligibility Criteria:
Inclusion Criteria:

* • Liver cirrhosis (clinical/radiological/histological diagnosis)

  * Indication for LOLA use (covert or over hepatic encephalopathy, Grad 0-2))
  * Written informed consent
  * Age 18 -100 years

Exclusion Criteria:

* • Allergy to LOLA or its constituents, or to medications with a similar chemical structure (oral nutritional supplements are allowed when stable \>/= 8 weeks before and during the study)

  * Recent (\</= 8 weeks) changes of the dose of the lactulose therapy for hepatic encephalopathy
  * Rifaximin or any other antibiotic therapy within the past 4 weeks
  * Intake of LOLA in the past four weeks before inclusion
  * Intake of L-dopamine
  * Renal insufficiency with a serum creatinine \>3mg/dl
  * Hepatocellular carcinoma BCLC D under best supportive care
  * Inability to give informed consent
  * Pregnancy or breastfeeding
  * Participation in another interventional trial within the last 30 days
Prospective Evaluation of Reverse End to Side Anterior Interosseous Nerve to Ulnar Nerve Transfer for Severe Compressive Ulnar Neuropathy at the Elbow

Ulnar nerve compression at the elbow is a common problem and can significantly affect hand function in severe cases. The current, standard treatment is Ulnar nerve decompression with or without transposition (moving the ulnar nerve to a site where there is less compression). In severe compression, the clinical results after this surgery are typically poor. Distal transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve (anterior interosseous nerve to ulnar motor fascicles) have been suggested to "supercharge" or augment hand muscles while nerve axons regenerate from the level of the elbow after decompression/transposition. In fact, this treatment is becoming widely adopted without clear evidence that it changes outcomes. The investigators propose to prospectively compare the effectiveness of ulnar nerve decompression/transposition versus decompression/transposition and distal nerve transfer.

The purpose of this study is to prospectively compare the outcomes of patients with severe (intrinsic hand muscle dysfunction) compressive ulnar neuropathy at the elbow treated with ulnar nerve decompression and subcutaneous transposition alone versus ulnar nerve decompression with subcutaneous transposition and AIN to ulnar nerve reverse end-to-side transfer. The study objectives of this project are the following: 1. To prospectively compare the clinical outcomes of patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with subcutaneous transposition and AIN to ulnar motor reverse end-to-side nerve transfer versus decompression and subcutaneous transposition alone. 2. To prospectively compare the electrophysiologic outcomes (nerve conduction studies and EMG) of patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with subcutaneous transposition and AIN to ulnar motor reverse end-to-side nerve transfer versus decompression and subcutaneous transposition alone.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (greater than 18 years) with severe compressive ulnar nerve neuropathy (McGowan grade III) at the elbow who consent to either ulnar nerve decompression with transposition alone or ulnar nerve decompression with transposition plus nerve transfer.

Exclusion Criteria:

* Patients under the age of 18 and over 70.
* Patients with ulnar neuropathy at multiple anatomic locations along the course of the nerve.
* Patients with mild to moderate ulnar neuropathy (McGowan grade I and II).
Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC) Compared to Placebo and Best Available Care (BAT), for the Treatment of Moderate to Severe COVID-19 Patients.

This is a phase I/II study with Amorphous Calcium Carbonate (ACC) administered sublingual and in Inhalation concomitantly with BAT (Best Available Care) as Compared to Placebo and BAT for the treatment of Moderate to Severe COVID-19 patients. The purpose of this study is to assess the Safety, Tolerability and Efficacy of Amorphous Calcium Carbonate (ACC).

This study includes two parts:

Part 1 - A training period of a single arm active treatment open label, to assess the optimal method of study drug administration, as well as the safety of the combined administration, on 5 patients.

Following DSMB review of the data collected in part 1 and the DSMB approval to proceed to next part, part 2 will be initiated.

Part 2 - A randomized (1:1) placebo controlled 2 arms study. Additional 95 patients will be recruited to this arm.

Patients who are hospitalized due to moderate or severe COVID-19 will be recruited to this study.

The following elements are the main elements that will be assessed:

1. Confirmation SARS-CoV-2 infection
2. Respiratory Function (breathing rate, SpO2 Oxygen Saturation
3. Vital Signs (BP, HR), Temperature
4. Blood Tests
5. Disease Severity Scale (8 points ordinal scale)

The whole study period per patient will be 22 days (21 treatment days) or until the patient has recovered and/or is discharged from the hospital, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females of age ≥ 18 years and ≤ 80 years
2. Signed an Informed Consent
3. Agree to undergo blood tests as per protocol
4. Diagnosed with COVID-19
5. Evidence of lung involvement (by chest X rays or lung US)
6. May or may not need for Supplemental Oxygen at enrollment
7. Hospitalized

Exclusion Criteria:

1. Pregnant or breast-feeding females
2. Patients with non-COVID19 related Pneumonia
3. Any pulmonary disease not related to COVID19
4. Tracheostomy
5. High flow oxygen or non-invasive ventilation (Bipap) or Mechanical ventilation
6. Hypercalcemia defined as calcium or corrected calcium \> 10.5mg/dL
7. Hyperphosphatemia defined as \> 4.5mg/dL
8. Urine calcium to creatinine ratio \>0.14
9. Participating in another clinical study
Reiki & Premenstrual Syndrome & Quality of Life

It is planned to perform a triple blind, randomized and placebo -controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome.

Premenstrual syndrome is common as a number of cognitive and emotional symptoms that started about a week before menstruation and has negative effects on the quality of life of women. In this period, symptoms affecting the quality of life are often listed as pain, bloating, edema, appetite changes, weight gain, tenderness, fullness, fatigue, drowsiness, anxiety, depressive symptoms and crying. It is known that women resorted to various methods that are pharmacological or non-pharmacological methods to deal with these symptoms in the premenstrual period. These methods vary from analgesic to hot application or traditional and complementary methods. Reiki is a healing energy that is not exactly included in traditional and complementary practices but has been revealed by research. In short, it is an energy therapy that balances the body and has no negative side effects. There are two types: Usui Reiki and Kundalini Reiki. From this point of view, it is planned to perform a triple blind, randomized and placebo controlled type in order to determine the effect of Kundalini reiki application on the symptoms of premenstrual syndrome. The study is planned to be carried out with Ege University Faculty of Nursing between June 2023 and July 2023. The universe of the study will consist of all students studying at the faculty in 2022-2023. The first stage of the study, which is planned to be carried out in two stages, will be made of descriptive-specific type to determine the students with premenstrual syndrome, no sample selection will not be selected and all the students who meet the criteria of inclusion in the research will be taken. In the second stage, intervention and placebo groups will be identified by randomization among students with premenstrual syndrome. In the Premenstrual periods, Reiki application will be held in the Premenstrual periods and no energy work will be applied to the placebo group. For the second stage, the adequacy of the number of samples will be decided by making power analysis during the study. Research data will be collected by face-to-face interview method using the individual promotion form, premenstrual syndrome scale and SF-36 quality of life scale and SPSS 22.0 package program will be used in statistical data analysis. At the end of the study, although the effectiveness of reiki application against premenstrual symptoms in nursing students is determined, awareness will be created to be used as a applicable method for the development of premenstrual symptom management and quality of life if the result is effective.

Eligibility Criteria:
Inclusion Criteria:

* PMS scale total score is 110 points and above
* Being a volunteer to participate in the reiki application

Exclusion Criteria:

* Having a pacemaker (Reiki application is not recommended.)
* Being pregnant (Reiki application is not recommended.)
Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France

Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases.

Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries.

As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.


Eligibility Criteria:
Inclusion criteria:

* All patients, whatever age or gender, clinically diagnosed with IRD or with high suspicion for IRDs based on clinical examination and functional tests (such as fundus exam and ERG), regardless of genetic testing
* Patients who attended a consultation at one of the participating centers from SENSGENE network over the inclusion period starting from sites initiation
* Patients who had been prescribed a genetic test for IRD prior to or at the date of inclusion.

Exclusion criteria:

* Patients/Parents/Legally authorized representatives (LAR) opposed to the collection and processing of their medical data/the medical data of their children/the medical data of the person for whom they are LAR;
* Patients who are suffering from any other retinal disorder or optic neuropathy that may clinically or genetically overlap with IRD or non-genetic (phenocopy);
* Patients/parents/Legally authorized representatives (LAR) refusing genetic testing;
* Patients lacking decision-making capacity: Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.
Wellness and Weight Family Group Project

The purpose of the current study is examine the feasibility and efficacy of providing a behavioral family intervention in 30 youth 10 to 17 years of age who are obese and attending a multidisciplinary pediatric obesity clinic and their parents. Participating families will complete assessments consisting of weight status, dietary intake, physical activity, health-related quality of life, psychological functioning, home-food environment, parenting skills, and self-efficacy at pre-treatment (Baseline), post-treatment (Month 3), and 2 month post-treatment follow-up (Month 5). Family attendance data will be collected during the behavioral family intervention and children and parents will complete a treatment satisfaction questionnaire at the post-treatment assessment. Health outcomes (e.g., A1C, glucose) routinely assessed through standard medical care in the multidisciplinary pediatric obesity clinic will be obtained from child medical charts.


Eligibility Criteria:
Inclusion Criteria:

1. child 10 to 17 years of age attending an outpatient pediatric obesity clinic visit
2. child or adolescent is obese (equal to or above the 95th percentile for BMI based on Centers for Disease Control and Prevention (CDC) norms for age and gender)
3. child or adolescent is accompanied by a parent or legal guardian
4. participating child and parent speak and read English
5. family agrees to attend group meetings at a medical clinic over a 3 month period

Exclusion Criteria:

1. participating child or parent, according to parent report, has dietary restriction or medical condition contraindicating mild energy restriction or moderate physical activity (e.g., musculoskeletal, heart, or respiratory condition, uncontrolled blood pressure or exercise induced asthma)
2. child diagnosed according to parent report with pervasive developmental delay (e.g., autistic disorder)
3. child or parent, according to parent report, in commercial weight loss program
4. child or parent currently prescribed medications to impact appetite or weight loss/gain, according to parent report
5. parent and child do not speak and read English
Icotinib as an Adjuvant Therapy for Patients With Stage IIA-IIIA Adenocarcinoma With EGFR Mutation

Adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. This study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage IIA-IIIA adenocarcinoma patients with EGFR mutation. The primary endpoint is disease-free survival.


Eligibility Criteria:
Inclusion Criteria:

* The patients present with operable stage IIA-IIIA (N0-1) lung adenocarcinoma with 19 or 21 exon mutation
* The patients have no history of anti-cancer therapies including chemotherapy, radiation therapy
* The patients' Eastern Cooperative Oncology Group scores are ≤ 0-1
* The patients signed the written informed consent

Exclusion Criteria:

* Patients with unresected tumor
* Wild EGFR type
* Allergic to the study drug
* Patients have severe non-cancerous diseases
* Patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
Ending the Epidemic Interventions in the Dental Setting - UH3

The purpose of this study is to use information technology (IT) to support the efficient delivery of HIV prevention and care best practices in the dental care setting.

Routine preventative HIV screening in all health care settings is considered a best practice by the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) Ending the Epidemic (ETE) Initiative, the New York State Blueprint to End the AIDS Epidemic. Despite this, many patients are not screened for HIV during routine care, including in dental care settings, resulting in missed opportunities for identifying undiagnosed HIV infections and providing education for pre-exposure prophylaxis (PrEP). This study will use information technology to support the delivery of HIV prevention and care best practices in the dental care setting. Dental residents will receive a Best Practice (BPA) alert whenever they have a patient who should be offered HIV screening. This BPA is linked to an order set to simplify ordering HIV tests and reporting results.

A critical knowledge gap for implementing these ETE activities in the dental setting is whether comprehensive ETE efforts could be integrated into existing dental teams consisting of practitioners, dental assistants and hygienists or require augmentation by a dedicated care navigator. To evaluate these two models, the investigators will conduct a crossover clinical trial in 3 urban general dentistry programs (NYP-Columbia, NYP-Cornell, NYP-Queens) randomized to one of 2 arms: (AB) Standard Dental Care Team model followed by crossover to an Enhanced Dental Care Team model with a Care Navigator, or (BA) Enhanced Dental Care Team model with a Care Navigator followed by crossover to a Standard Dental Care Team model.

Eligibility Criteria:
Inclusion Criteria:

* Member of the Dental Team (Provider, Hygienist, Dental Assistant, Care Navigator) at one of the randomized sites with direct patient contact
* Able to provide written informed consent.

Exclusion Criteria:

- Inability to provide written informed consent.
Study on the Phenotype of Language in Preterm Born Children at 5 Years of Age

In recent years, several studies confirm that some of preterm children have language developmental disabilities, in production, in comprehension, or in written language. These language impairments lead to learning disabilities. There are, however, contradictions concerning the origin and nature of language dysfunctions. Some studies find lexical disorders (number of words used by the child), others preferentially phonological disorders (sounds used in the language), others also disorders of the morphosyntaxe (organization of the sentences) and fragilities that affect pragmatics (understanding situations).

The computer-evaluation of the language is carried out at five and a half year coupled with the medical and neuropsychological examinations. The language assessment lasts 30 to 45 minutes per child. It is carried out using a laptop computer that allows the submission of stimuli and recording of the child's responses. The language evaluation scale is the battery CléA (Pasquet F et al, 2014), standardized reference tool for the realization of a language evaluation. The assessment includes three tests: comprehension of words and phrases, production of words and phrases, and judgment of sentences. Each time, the child sees images and hears words or phrases. Sometimes he has to say what he sees on the computer screen.

As usual, a speech-language assessment is not carried out, routinely, at the age of 5 years in the context of the follow-up of children born very preterm.

The evaluation proposed to the child in this research will be carried out at a significant period of development, before writing. This assessment will not only assess the structure of the child's language, but also determine if there are possible difficulties in learning to read and write.

The expected benefits for the health of the children included in the trial therefore concern the detection or characterization of any developmental fragilities affecting the language. These screenings or characterizations will make it possible to advocate a speech rehabilitation if necessary.


Eligibility Criteria:
Inclusion Criteria:

* Children born very preterm in 2011 in the region of Haute-Normandie in France

Exclusion Criteria:

* None
Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates

Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.

Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.

The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.


Eligibility Criteria:
Inclusion Criteria:

* infants born \< 33 weeks gestation in Nancy and Thionville Maternity Wards
* signed parental consent

Exclusion Criteria:

* immunodeficiency
* vaccine contra-indication
Post-Operative Use of Salt Poor Albumin Solution in Resuscitation of Orthotopic Liver Transplant

The purpose of the study is to examine if outcome after liver transplantation is improved by using albumin infusion post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Canadian Transplant status 1 or 2
* Patients at the Royal Victoria Hospital, Montreal, Canada

Exclusion Criteria:

* Emergency liver transplant (canadian transplant status 3 or 4)
* patients who have received more than 300cc of albumin within 48 hours prior to transplant
* patients who underwent previous solid organ transplant
* multi-organs transplant recipients
* patients who had previous adverse reaction to human albumin solution
* patients who have religious restriction to receiving human blood products.
* patients or surrogate unable to give consent to the study