cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of SMART101 in Pediatric and Adult Patients With Hematological Malignancies After T Cell Depleted Allo-HSCT

The purpose of this study is to evaluate the safety and the efficacy of SMART101 (Human T Lymphoid Progenitor (HTLP)) injection to accelerate immune reconstitution after T cell depleted allogeneic hematopoietic stem cell transplantation (HSCT) in adult and pediatric patients with hematological malignancies.


Eligibility Criteria:
Inclusion Criteria:

Group A (adults):

1. Adult patients affected by:

   * Acute leukemia (AML, ALL) defined as:

     * Acute Myeloid Leukemia (AML):

       * High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities
       * Chemo-refractory relapse (MRD+)
       * ≥ CR2
     * Acute Lymphoblastic Leukemia (ALL):

       * Chemo-refractory relapse (MRD+)
       * High risk ALL in CR1; Philadelphia (like) or any poor risk feature
       * ≥ CR2
     * Acute leukemia of ambiguous lineage:

       * ≥ CR1 with a minimal residual disease (MRD) \<5% (flow cytometry, molecular and/or cytogenetics accepted)
   * Myelodysplastic Syndrome (MDS) with least one of the following:

     * Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation.
     * Life-threatening cytopenia.
     * Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype.
     * Therapy related disease or disease evolving from other malignant processes.
2. Patient eligible for a T-depleted allogeneic HSCT
3. Age ≥ 18y and clinical condition compatible with allogeneic stem cell transplantation
4. Karnofsky index ≥ 70% prior to conditioning regimen
5. Patients with normal organ function prior to conditioning regimen

Group B (pediatrics):

1. Pediatric patients affected by acute leukemia defined as:

   * Acute Myeloid Leukemia (AML):

     * High risk AML in CR1; any adverse genetic abnormality, secondary or therapy related AML excluding good risk genetic abnormalities,
     * Chemo-refractory relapse (MRD+)
     * ≥ CR2
   * Acute Lymphoblastic Leukemia (ALL):

     * Chemo-refractory relapse (MRD+)
     * High risk ALL in CR1; Philadelphia (like) or any poor risk feature
     * ≥ CR2
   * Acute leukemia of ambiguous lineage:

     * ≥ CR1 with a minimal residual disease (MRD) \<5% (flow cytometry, molecular and/or cytogenetics accepted)
2. Patient eligible for a T-depleted allogeneic HSCT
3. Age \< 18y at the time of inclusion
4. Absence of a matched sibling donor (MSD)
5. Lansky ≥ 70% / Karnofsky performance status ≥ 70% prior to conditioning regimen
6. Patients with normal organ function prior to conditioning regimen

Exclusion Criteria:

Groups A and B:

1. Use of an HLA matched Cord Blood (8/8 allele matched) or haploidentical donor
2. Prior therapy with allogeneic stem cell transplantation
3. Treatment with another cellular therapy within one month before inclusion
A Study to Evaluate the Efficacy and Safety of Radion™-Pdt in Patients With Oral Precancerous Lesion

A Prospective, Single-Arm, Open-Label, Phase II Study to Evaluate the Efficacy and Safety of Photodynamic Therapy Using Radion™-pdt in Patients with Oral Precancerous Lesion (Oral Verrucous Hyperplasia or Oral Erythroleukoplakia).

This is a single-center, single-arm, open-label study to evaluate the efficacy and safety of topical Radion™-pdt for treatment of patients with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL).

Total duration of the study will be up to 40 weeks (from screening throughout study until completion) as follows:

* Screening (within 2 weeks before dosing)
* Treatment period (up to 14 weeks)
* Safety follow-up period (within 2 weeks after final treatment)
* Follow-up period (final treatment plus 4 weeks, 8 weeks, 16 weeks and 24 weeks respectively) All enrolled patients will receive up to 8 treatments (once every two weeks) during a maximum of 14-week study treatment period. The treated lesion will be clinically evaluated and documented (clinical photograph) at each treatment visit.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥20 years old;
2. Patient with oral verrucous hyperplasia (OVH) or oral erythroleukoplakia (OEL) lesions with histological evidence of oral precancerous lesions. Besides, patients should have at least one lesion whose size should not exceed 4 cm in the greatest diameter and the distance between two lesions should not less than 1 cm.
3. Patient who is willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

1. Patients with history of hypersensitivity to any photosensitizer (including 5-aminolevulinic acid HCl or porphyrins), acute or chronic types of porphyria;
2. Record of previous unsuccessful treatment with photodynamic therapy;
3. Patients who have been diagnosed as having oral cancer or carcinoma in situ;
4. Patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, hematological, gastrointestinal or psychiatric disease as determined by the clinical judgment of the investigator;
5. Patients with impaired hepatic function (defined as AST and/or ALT \> 2× the upper limit of normal values), and/or impaired renal function (defined as serum creatinine \> 1.5 mg/dL);
6. Female patient of childbearing potential who:

   * is lactating; or
   * has positive urine pregnancy test at visit -1; or
   * refuses to adopt reliable method of contraception during the study;
7. Patient has received any other investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first photodynamic therapy;
8. Patient has a history of illegal substance abuse, drug addiction or alcoholism within 24 weeks prior to the study.
Ketones in Heart Failure - Effects on Cardiac Efficiency

Ketones may have beneficial effects on myocardial metabolism and hemodynamics. In the present study, healthy test subjects and patients with heart failure with reduced ejections fraction will be investigated in a randomized cross-over design with ketone infusions and placebo. Myocardial efficiency and hemodynamics will be evaluated.

The prevalence of patients with heart failure and reduced ejection fraction (HFrEF) is 1-2%, and the lifetime risk of heart failure at age 55 years is approximately 30%. Despite advances in treatment, hospitalization rate and mortality remains high. It is well known that myocardial metabolism changes during development of HFrEF, and may contribute to contractile dysfunction. However, the myocardium can be considered an omnivore regarding substrate utilization, conferring an important adaptive property. Hence, it metabolizes either glucose, lipids, lactate, amino acids or ketones (3-hydroxybutyrate) depending on substrate availability, hormonal status and cardiac demands. These substrates differ with regard to myocardial energy efficiency (MEE) (cardiac work related to oxygen consumption). Since high MEE is associated with a better prognosis in HFrEF, manipulating substrate uptake could be a new treatment modality in heart failure patients.

Recently, it was shown that the human myocardium increases 3-hydroxybutyrate (3-OHB) metabolism during development of HFrEF. These changes may be beneficial as 3-OHB could increase myocardial efficiency and lower oxidative stress by scavenging free radicals. However, until now this has not been investigated in clinical trials, and the effect of 3-OHB on cardiac function, oxygen consumption and perfusion remains undetermined in HFrEF patients.

In the present study the investigators will evaluate whether elevated circulating 3-OHB affect myocardial oxygen consumption, MEE and perfusion in healthy subjects and patients with HFrEF, and whether 3-OHB affect hemodynamics and contractile function.

10 healthy test subjects and 20 HFrEF patients will be subjected to placebo and 3-OHB infusion in a randomized cross-over design. Acetate-PET, echocardiography and right sided heart catheterization will be applied.

Eligibility Criteria:
Inclusion Criteria:

* For participants with heart failure:
* Symptoms of Heart failure NYHA 2-3
* LVEF\<40%

For all participants:

* Negative HCG for women in the pregnant age

Exclusion Criteria:

* Significant cardiac valve disease
* Signs or history of major myocardial infarction (STEMI) within 3 months
* Other disease or treatment making subject unsuitable for study participation
* Treatment for diabetes or HbA1c level \>7%
Physical Therapy in the Treatment of Carpal Tunnel Syndrome

In the present investigation the pain reduction effects of a physical therapy technique will be compared to those produced by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

The present randomized clinical trial will perform a comparison of the pain reduction effect produced by the application of the median nerve neural mobilization technique (a non pharmaceutical physical therapy treatment), to the pain reduction effect produced by the total absence of treatment in subjects who suffer carpal tunnel syndrome. Functionality of the affected upper limb will be evaluated and compared. Subjects will be invited to participate and randomly allocated to 2 different groups.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings).
* Full understanding of written and spoken Spanish (language).
* Participants must freely consent to participate.
* The presence of positive Phalen an Tinel sings.
* The presence of carpal tunnel syndrome signs and symptoms

Exclusion Criteria:

* The lack to meet inclusion criterions, the presence of cognitive impairment, kinesiophobia
* Tumors
* Cancer
* Upper limb surgery or trauma
* Pregnancy
* Deformities of the (affected) upper limb
* Recent skin injuries or infections (in the affected upper limb)
* Autoimmune inflammatory conditions or flu type symptoms.
* Allergy to gabapentin
* Participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors

The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect tumors and lymph nodes with tumors.

This study will involve patients that are scheduled for routine standard of care surgery. It is a single-arm study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and the ability of MSOT imaging data to correlate with clinical findings identified via pathology.

The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical record. All images will be obtained pre- and post-surgery in a closed surgical patient. The temperature of the patient's skin will also be measured prior to and after MSOT imaging. MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an identified solid tumor, i.e. breast (Stage I-IV), melanoma (Stage I-IV), HNSCC (Stage I-III), pancreatic (Stage I-III), ovarian (Stage I-IV) that is scheduled for surgical removal of the tumor and completed standard imaging prior to surgery
* Have acceptable hematologic status \[total hemoglobin (tHb) ≥ 10 mg/dL\]
* Patients ≥ 18 yrs of age
* Patient provided a signed and dated informed consent
* Willing to comply with study procedures and be available for the duration of the study
* Ability to understand and the willingness to sign an IRB-approved informed consent document.

Exclusion Criteria:

* Patients with central nervous system tumors
* Patients with a tattoo over the surgical site
* Pregnant women
* Women who are breastfeeding
* Systemic or local infection
* Any systemic anomaly during the pre-op assessment preventing patient participation in the study
* Any febrile illness that precludes or delays participation preoperatively
* Anything that would put the participant at increased risk or preclude compliance with the study
* Patients with Stage IV pancreatic cancer, Stage IV HNSCC are not surgical candidates and therefore excluded from this study
Dietary Nitrate and Erectile Dysfunction

An expanding number of studies suggest a therapeutic role for nitrate and nitrite, most notably in treatment and prevention of cardiovascular disease including ischemia-reperfusion injury and hypertension. The nutritional aspects of these cardioprotective effects are particularly intriguing since nitrate is abundant in our everyday diet. Nitrate improves vascular functions in old adults and improves ischemia reperfusion injury in experimental models.

Whether dietary nitrate improves erectile dysfunction is not known and will be investigated in the present study.


Eligibility Criteria:
Inclusion Criteria:

Patients with erectile Dysfunction (IIEF5: 8-21) PDE-5 Inhibitors Responder Aged 30-80 years

Exclusion Criteria:

* Spinal cord disease
* Insulin dependent Diabetes mellitus
* Prostate cancer after operation, radiotherapy and hormone therapy
* Treatment with NO-Donators or sGC-Activators
* Chronic kidney disease (Stage IV-V)
* Advanced liver dysfunction
QL1706 Plus Chemotherapy±Bevacizumab for the First-Line Treatment of Persistent, Recurrent or Metastatic Cervical Cancer

This study is a randomized, double-blind, placebo-controlled, multicenter phase III clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab; Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Subjects must provide sufficient archival or newly obtained tumor tissue samples to determine PD-L1 expression level to be eligible for screening.During the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and PD- L1 level (CPS \< 1 vs 1 ≤ CPS \< 10 vs CPS ≥ 10) and randomized 1:1 into the experimental or control arm.Experimental: QL1706 + Chemotherapy (Paclitaxel-cisplatin/Carboplatin) ± Bevacizumab;Control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Eligibility Criteria:
Inclusion Criteria:

* The subject fully understood and voluntarily signed the informed consent form.
* Histologically confirmed cervical cancer.
* At least one measurable tumor lesion by CT or MRI according to RECIST 1.1 criteria.
* All subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained FFPE pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Expected survival ≥ 12 weeks.
* Adequate level of vital organ function

Exclusion Criteria:

* Previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-PD-1, PD-L1, CTLA-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-ICOS, CD40, CD137, GITR, OX40 antibodies, etc.), and immune cell therapy; previously received VEGF/VEGFR inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors.
* Systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever \> 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator)
* Within two weeks before randomization, there is a need for systemic use of corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) treatment of the disease; Topical corticosteroids, nasal sprays, and inhaled steroids are allowed. Systemic corticosteroids are permitted for the prevention of contrast allergy。
* Systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization
Effect of Intravenous Vitamin C on Intrapartum Maternal Fever After Epidural Labor Analgesia

This study aims to explore the effect of intravenous vitamin C infusion on intrapartum fever after epidural labor analgesia, to reduce the impact of intrapartum fever on maternal and infant, improve maternal and infant outcomes, and provide a reference for clinical preventive medication.

Parturients who request pain relief would receive epidural labor analgesia after the obstetrician and anesthesiologist jointly evaluated and approved. The epidural catheter was inserted at the intervertebral space of either L2-3 or L3-4. 5 ml 1.5% chloroprocaine (with 1:200,000 epinephrine) as a test was delivered to parturients via the catheter. Then parturients would be observed for 5 min whether there were adverse reactions and then were given an initial dose of 10 ml ropivacaine 0.08% with sufentanil 0.3 µg/ml. After that, a patient-controlled epidural analgesia (PCEA) pump (240ml 0.08% ropivacaine with sufentanil 0.3 µg/ml) would be attached to the catheter. The pump would be set to administer an 8 ml bolus every 20 minutes and a 2 ml patient-controlled bolus with the same interval. Subsequently, trained nursing staff would take charge of the parturients and inform the obstetrician. The basic condition of parturients was monitored during the whole process. After that, parturients in each group will be administered vitamin C intravenously except the group for placebo-controlled.

Eligibility Criteria:
Inclusion Criteria:

* single-fetus, head position, and full-term vaginal delivery receiving epidural labor analgesia.

Exclusion Criteria:

* have a fever before epidural analgesia, acute infection on admission, incomplete baseline data, fatal fetal malformations or comorbidities, duration from admission to delivery of more than 72 hours or less than 3 hours, or an American Society of Anesthesiologists (ASA) classification of ≥ Ⅲ.
A Comparison of Survey Methodologies to Elicit Sensitive Information From Adolescents in Urban India

The goal of this study is to use three different survey methodologies to evaluate whether adolescents report on their knowledge, attitudes and behaviors on sexual and reproductive health issues differently based on the manner in which questions are asked.

Specific Aims and Research Questions Aim 1: To compare adolescents' levels of reporting of their own reproductive health knowledge, attitudes and behaviors using three survey methodologies: (1) Face-to-face interview (2) Audio-CASI (Computer Assisted Self Interview) and (3) a culturally appropriate interactive methodology.

The following hypothesis will be tested:

• Overall, adolescents will be more likely to divulge their own reproductive knowledge, attitudes and behaviors with Audio-CASI and the interactive method as compared to face-to-face interviews. Levels of knowledge, attitudes and behaviors will vary by education, age and gender.

Aim 2: To compare respondents' levels of comfort, accuracy and honesty with the survey methodologies (i.e. face to face, audio-CASI and interactive methodology) to their reporting of knowledge, attitudes and behaviors related to sexual and reproductive health.

Eligibility Criteria:
Inclusion Criteria:

Unmarried male and female adolescents in the age group 15-19 in pre-identified slums in Delhi, India

Exclusion Criteria:

-
Neurorehabilitation Impact on Neurocognitive Impairments in Cerebellar Lesions

Depending on their localization, cerebellar lesions cause various pronounced cognitive and/or affective dysfunctions, which are causally related to the involvement of cerebellar structures in neuronal networks for higher-order processing of cognitive and emotional items in the association areas of the cerebral cortex. For further investigation, event-related potential (ERP) analyses will be performed to record and visualize specific signals in the surface EEG, which should provide information about the course of treatment of neurorehabilitation with respect to a close correlation and thus predictive power to functional recovery that occurred as a result of cerebellar injury. With EEG parameters and clinical examination findings including neuropsychology, the functions for four thematically distributed domains (affective: prosody; cognitive: abstraction, linguistic and formal incongruence) will be recorded and evaluated over a four-week structured neurorehabilitation with an average therapy volume.

Cerebellar damage causes various cognitive and affective dysfunctions to varying degrees depending on its location, with cognitive abnormalities seen primarily in the posterior lobes, whereas disorders of affect modulation are seen more frequently in lesions of the vermis. Causally, cerebellar structures are thought to be involved in neuronal networks distributed primarily within temporal, parietal, and frontal association cortices for higher-order processing of cognitive and emotional items. Based on the evidence to date, cerebellar areas appear to be involved at the level of congruent and incongruent associations with different temporal binding of the cerebral networks responsible for them. For further investigation, event-related potential (ERP) analyses will be performed to capture and represent temporal signal dynamics in surface EEG, which will be used to calculate predictive values for the quality and extent of neurorehabilitation applications for functional recovery and thus clinical outcome via neurophysiological markers. In addition to clinical scales and neuropsychological investigations, the processing of four thematically distributed (prosody, abstraction, linguistic and formal incongruence) trials at the beginning and after about four weeks of a structured neurorehabilitation with a therapy volume of at least 20 hours per week of physical and occupational therapy as well as computer-assisted exercises, in their temporal and topographical characteristics of neurophysiologically tangible functional disorders and their dynamics in the course of treatment will be investigated via the derivation of ERP.

Eligibility Criteria:
Inclusion Criteria:

* active group: patients with a cerebrovascular lesion within the cerebellum
* comparator group: patients with a cerebrovascular lesion supratentorial

Exclusion Criteria:

* any kind of history in neurological or psychiatric disorders