cyrilzakka/clinical-trials huggingface dataset:
Single-Cell Map of Immune and Lymphoma Cells in B-cell Non-Hodgkin's Lymphoma

This trial is a translational, prospective, open-label, monocentric research.

The study will be conducted in a population of 60 patients with diffuse large B-cell lymphoma (DLBCL) for whom first-line treatment with R-CHOP is planned as part of their standard of care.

SIMILY program aims at identifying biomarkers and/or molecular signatures related to immuno-phenotypic and -genotypic characteristics of the tumor and immune microenvironment, at the time of diagnosis, during R-CHOP, and at 24 months or time of progression.

Each patient will be followed during 2 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP (treatment by R-CHOP should not have been initiated prior to inclusion in the study)
2. Age 18 to 80 years at the time of study entry
3. Archived initial diagnostic tumor specimen available
4. Life expectancy ≥ 3months
5. ECOG Performance status 0-2
6. FDG-avid disease (for PET monitoring)
7. Signed written informed consent
8. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol
9. Patient affiliated to a Social Health Insurance in France

Exclusion Criteria:

1. Patient pregnant, or breast-feeding
2. Any condition contraindicated with tumor / blood sampling procedures required by the protocol
3. Central Nervous System (CNS) involvement
4. Known history of positive test for Hepatitis B virus or Hepatitis C virus or Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
5. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection and auto immune disorders
6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
8. Current participation in any other therapeutic clinical study
Retrospective Chart Review and Historical Comparison of Capmatinib vs. Standard of Care for German Adult Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring METex14 Mutations

The objective of the study was to compare the therapeutic benefit of capmatinib versus appropriate comparative therapy (ACT) defined by the German HTA agency G-BA for its benefit assessment of capmatinib but also versus the standard of care (SoC) practiced in German routine care. Due to its design as an adjusted, patient-level comparison, the RECAP study addresses the evidence gap due to the single-arm nature of pivotal evidence for capmatinib.

For this purpose, data on patients treated with ACT resp. SoC in German routine care has been collected via a retrospective chart review. This data was then used as an external control for a non-randomized, patient-level adjusted comparison with data from the GEOMETRY mono-1 study of capmatinib (NCT02414139).

Due to the non-interventional nature of this study, the definition of endpoints as primary or secondary was omitted formally.


Eligibility Criteria:
Inclusion criteria

* NSCLC (any histology)

  * METex14 mutation
  * Epidermal Growth Factor Receptor (EGFR) wildtype
  * Anaplastic lymphoma kinase (ALK) rearrangement negative
* Stage IV or Stage IIIB without indication for local therapy
* First or second line of treatment
* Age ≥18 years Exclusion criteria
* Prior treatment with crizotinib, capmatinib, tepotinib or other MET inhibitors
* Carcinomatous meningitis
* Symptomatic brain metastases
* Eastern Cooperative Oncology Group Status (ECOG) \>1
* Uncontrolled, clinically significant heart diseases
* Malignant disease other than NSCLC within the past 3 years
Changes on Pain and Range of Motion by the Use of Kinesio Taping in Subjects With Myofascial Trigger Point

The aim of this study is to demonstrate that the application of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the trigger point pain and an increase of the cervical range of motion in asymptomatic subjects

The use of Kinesio Taping has become very popular for the treatment of many musculoskeletal disorders in recent decades. Of the six variants of application that has the Kinesio Taping, the space correction technique is suggested for pain management. The increased space achieved with this variant decreases the pressure Kinesio Taping by raising the skin directly over the treatment area, reducing chemical irritation receptors and therefore pain. The aim of this study is to demonstrate that the application of this variant of Kinesio Taping on a myofascial trigger point in the trapezius muscle able to cause a decrease of the pain and an increase of the cervical range of motion in asymptomatic subjects. For this, the pressure pain threshold will be measured with a algometer on the trigger point and the range of motion with a cervical goniometer.

Eligibility Criteria:
Inclusion Criteria:

* Agree to participate in the study (signed informed consent)
* Presence of latent myofascial trigger point in upper trapezius.

Exclusion Criteria:

* Subjects in which not clearly identified myofascial trigger point in the upper trapezius .
* Subjects who suffer or have suffered pathologies of upper limb deformities or orthopedic injuries that can alter static and biomechanics of shoulder and neck.
* Subjects who suffer or have suffered rheumatic or neurological disease or chronic shoulder pain and/or neck
* Subjects diagnosed with fibromyalgia, myelopathy or radiculopathy.
* Subjects suffering from any psychiatric disorder (such as anxiety or depression).
* Subjects who have suffered post-traumatic alteration (whiplash type) or cervical surgery.
* Pregnancy risk of abortion.
* Have used analgesics in the 48 hours before participating in the study
* Subjects presenting any contraindications to the application of Kinesio Taping.
* Know the Kinesio Taping technique applied in the study.
* Be receiving physical therapy for any shoulder or neck pathology.
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0973 in Combination With GDC-0068 When Administered in Participants With Locally Advanced or Metastatic Solid Tumors

This open-label, multicenter, Phase Ib dose-escalation study will evaluate the safety, tolerability and pharmacokinetics of oral dosing of GDC-0973 and GDC-0068 administered in combination in patients with locally advanced or metastatic solid tumors. Cohorts of patients will receive multiple ascending doses of GDC-0973 and GDC-0068. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically documented locally advanced or metastatic solid tumors for which standard therapies either do not exist or have proven ineffective or intolerable
* Evaluable disease or disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST)
* Life expectancy \>/= 12 weeks
* Adequate hematologic and end organ function

Exclusion Criteria:

* History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
* History of prior significant toxicity from another phosphoinositide 3-kinase (PI3K) or Akt pathway or mammalian target of rapamycin (mTOR) inhibitor requiring discontinuation of treatment
* Anti-cancer therapy within 28 days prior to first dose of study drug, except as stated in protocol
* History of type I or type II diabetes mellitus requiring insulin
* Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease)
* Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B or hepatitis C virus
* Active autoimmune disease
* Pregnant or lactating women
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* History of glaucoma
* History of retinal vein occlusion
Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy

Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial

To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.

Eligibility Criteria:
Inclusion Criteria:

* Aged 15 years old or older,
* Diagnosed with Head and Neck cancer
* On treatment of external Radiation therapy

Exclusion Criteria:

* Pregnant
* Previously underwent external Radiation therapy
* Illiterate
Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).


Eligibility Criteria:
Key Inclusion Criteria:

* Participants who have completed study drug treatment in the parent study (VX21-121-105; NCT Number: NCT05422222)

Key Exclusion Criteria:

* Hepatic cirrhosis with portal hypertension, moderate hepatic impairment, or severe hepatic impairment that might pose an additional risk in administering study drug
* History of solid organ, hematological transplantation, or cancer
* History of drug intolerance in the parent study

Other protocol defined Inclusion/Exclusion criteria may apply.
the Effect of High Dose Ascorbic Acid on Critically Ill Patients With ARDS

1. To access role of vitamin C supplementation in ARDS patients on the following:

   Oxidants/ antioxidants imbalance Length of hospital stay Mortality rate Weaning from mechanical ventilator Incidence of adverse drug reaction
2. To access tolerability of vitamin C supplementation in patients with ARDS.

Acute Respiratory distress syndrome (ARDS) is a form of severe hypoxemic respiratory failure due to severe impairment of gas exchange and lung mechanics that is characterized by inflammatory injury to the alveolar capillary barrier, with extravasation of protein-rich edema fluid into the air space. Current ARDS antioxidant treatment strategy, is based upon supportive therapies including low tidal volume ventilation, fluid management, nutritional support and glucocorticoids.

Ascorbic acid or Vitamin C is an important dietary water-soluble antioxidant, it significantly decreases the adverse effects of ROS such as reactive oxygen and nitrogen species that can cause oxidative damage to macromolecules. Recent studies show that high dose of Vitamin C have protective effects against overwhelming oxidative stress due to critical illness. Vitamin C improves immune function and improves tissue perfusion and reduce tissue hypoxia and subsequent organ dysfunction. Also, Ascorbate, the redox form of vitamin C is physiological antioxidant and has bacteriostatic activity Hence the study aims to evaluate the impact of IV Vitamin C in ARDS, as a novel pharmaceutical approach in an attempt to improve the clinical outcome of ARDS patients, decrease other medications toxicities and improve patients' quality of life.

The objective of the current study was to evaluate the efficacy, safety and tolerability of IV Vitamin C administration in addition to conventional therapy in patients with ARDS by assessing the following:

1. Oxidants/ antioxidants imbalance
2. Length of hospital stay
3. Mortality rate
4. Weaning from mechanical ventilator
5. Incidence of adverse drug reaction
6. Serum IL8 levels

8. Serum Vitamin C levels

Eligibility Criteria:
Inclusion Criteria:

1. All ARDS cases presenting to the Chest department ICU within 48 hours of diagnosis
2. who don't have an exclusion criteria will be included.

Exclusion Criteria:

1. Known allergy to Vitamin C
2. Inability to obtain consent;
3. Age \< 18 years;
4. More than 48 hours since meeting ARDS criteria;
5. Pregnancy or breast feeding,
6. Moribund patient not expected to survive 24 hours;
7. Patients not eligible to CPR
8. Active kidney stone
Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Bronchitis

A multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute bronchitis

The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: Xiyanping injection(andrographolide sulfonate) 10-20ml/d, with 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. Control group: Xiyanping injection simulation(0.9% Sodium Chloride Injection) 10-20ml/d, The treatment method is the same as the experimental group. Treatment cycle: less than 7 days (the longest period of treatment is 7 days, if the clinical symptoms were relieved in the treatment, patients were stoped treatment).

Eligibility Criteria:
Inclusion Criteria:

* 1.18-65 years, males or females;
* 2.patients met the acute bronchitis diagnosis;
* 3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial;
* 4.patients compliance is good, written informed consent was obtained from all participants before the study.

Exclusion Criteria:

* 1.Patients had a history of andrographolide sulfonate or andrographolide allergy.
* 2.pregnancy, lactation, and absence of contraception in women of fertile age.
* 3.Judging by the researchers, Past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases.
* 4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases
* 5.Patients using systemic steroids or other immunosuppressive therapy
* 6.Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases.
* 7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year.
* 8.Patients were participated in any study of drug trials in the last 30 days.
* 9.According to the researchers' judgment, anyone who are not suitable for the study.
Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction

Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.

The goal of this study is to compare a traditional single port expander with a two-port expander for equivalency when used for breast reconstruction following mastectomy. Complication rates that will be tracked include seroma, mastectomy skin flap necrosis, infection, wound dehiscence, need for explantation of the expander. Management of seromas will be compared between the two groups. The investigators hypothesize that the AlloX2 expander will be as effective in achieving the final outcome of completion of the second stage of reconstruction with equal or improved complication rates.

Study Design A prospective 1:1 randomized, single center, open label study will compare the traditional 1- port tissue expander with the AlloX2 2-port expander placed during immediate tissue expander breast reconstruction. Due to the nature of the surgery, the study cannot be blinded. Patients will be followed until completion of expansion and exchange for the permanent implant which typically takes 2 to 3 months. Risks factors that have been previously identified to be associated with increased postoperative complications include smoking, obesity, breast size, diabetes, radiation therapy, and expander fill volume will be identified. The final outcome is completion of expansion and exchange to permanent implant.

Standard operative procedure and postoperative care will be done. Both groups will have the same two external drains placed which is standard operative procedure. Complications will be noted at each postoperative clinic visit and entered into a database. Complication rates will be compared between the two groups and associations with risk factors will be analyzed. There will be no cross-over into the other group in case of reconstructive failure. Treatment failures will be treated in the same fashion in the two groups.

Eligibility Criteria:
Inclusion Criteria:

* patient agrees to immediate tissue expander breast reconstruction
* a suitable patient for tissue expander reconstruction

Exclusion Criteria:

* not a surgical candidate for immediate breast reconstruction
* age less than 18
* patient declines tissue expander reconstruction
* patient anticipated to need radiation therapy postoperatively
Preventing Learning Problems in Young Children: A Public Health and Physician-Based Outreach

This study will evaluate a program to prevent learning problems in children. The program is an inexpensive public health outreach program designed for families living in poverty and is administered through pediatricians' offices and clinics.

This study will assess the effectiveness of a low-intensity, low-cost, preventive intervention to reduce developmental delay and learning problems in young children. The goal is to improve home caregiving environment factors that are often suboptimal in families living in poverty; these families are often subject to social, economic, and medical risk factors. The intervention is based on a public health/primary care partnership and combines mailed parent-completed Ages \& Stages Questionnaires (ASQ), a monthly mailed age-paced parenting newsletter (Building Blocks) and corresponding developmental toys (BB), and a Reach Out and Read (ROR) physician-based distribution of children's books.

Families of 4- to 7-month-old children attending a participating pediatric clinic will be randomized to either an ASQ/BB+ROR group, an ROR-only group, or a no intervention control group. Outcomes measures will be obtained at 15, 24, 36, and 48 months of age and include measures of the home environment, parenting and parent-child interaction, child language and mental development measures, and rates of referral to Early Intervention programs. Baseline and ongoing demographic information and psychosocial and biological risk factors will also be gathered to see how they relate to child and family outcomes and to determine whether certain subgroups of families are more likely to benefit from the intervention than others.

Eligibility Criteria:
Inclusion Criteria

* Attend participating pediatric clinic (serving poor, largely black, and Hispanic communities)
* Family with child 4 to 7 months of age at enrollment
* English- or Spanish-speaking

Exclusion Criteria

* Developmental delay
* Eligible for Early Intervention program
Observational Study of Outcomes After EchoMark and EchoSure-based Free Flap Monitoring

The purpose of this study is to evaluate the performance of the EchoMark and EchoSure as an ultrasound-based method of monitoring the viability of free flaps and patency of at-risk vessels.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients presenting for microvascular tissue transfer procedures where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
* Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
* Women of childbearing potential have a negative pregnancy test

Exclusion Criteria:

* Age \<18 years old
* Patient unable to sign informed consent
* Patient participating in another investigational device or pharmacological study
* Prisoner or patient from vulnerable populations as defined in 45 CFR 46.
A Single Center Pilot Study to Assess the Intra-observer Reliability of Measuring Muscle Strength Using a Hand Held Dynamometer in Children and Adults With Neurofibromatosis Type 1 (NF1) and Type 2 (NF2)

Patients with clinically confirmed neurofibromatosis type 1 (NF1) or neurofibromatosis type 2 (NF2) or a known neurofibromatosis (NF) mutation aged 5 years and above will be eligible to participate and will be recruited from the neurofibromatosis clinic. Given the need for identifying measures that can reliably and sensitively measure focal muscle weakness and allow for measuring muscle strength as a functional outcome in therapeutic clinical trials in NF, this pilot study will assess the reliability of measuring muscle strength in NF1 and NF2 using a hand-held dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* For cohort 1:

  * Patients must have clinically confirmed NF1 using the NIH consensus criteria or a known NF1 mutation
  * Ages 5 years and above
  * \< 5/5 strength on Manual Muscle Testing (MMT) testing in at least one muscle group tested on the day of enrollment
  * Able to follow instructions and cooperate with exam to assess strength
* For Cohort 2

  * Patients must have clinically (NIH or Manchester criteria) or genetically confirmed diagnosis of NF2
  * Ages 5 years and above
  * \< 5/5 strength on MMT testing in at least one muscle group tested on the day of enrollment
  * Able to follow instructions and cooperate with exam to assess strength

Exclusion Criteria:

* No orthopedic procedure or other major surgery that could influence extremity strength in past 6 months
* No tibial dysplasia
Pilot Study of Positive-End Expiratory Pressure in Acute Respiratory Distress Syndrome

Randomized controlled pilot trial in 70 patients with Acute Respiratory Distress Syndrome (ARDS) ventilated with low tidal volumes and limitation on airway pressure at 35 centimeters of water (cmH2O), to compare two different methods of selecting the level of Positive End-Expiratory Pressure (PEEP) to be applied: according to fraction of inspired oxygen (FiO2) needed or individualized according to the best compliance. Primary objective was evolution of arterial oxygenation during the 28 days. Secondary objectives were to measure its effects on hemodynamic parameters, 28-day mortality, number of ventilator-free days at day 28, Intensive Care Unit (ICU) and hospital stay, number of multiple-organ dysfunction-free days and a multivariate analysis of 28 day-mortality.

In patients with Acute Respiratory Distress Syndrome the use of Positive End-Expiratory Pressure (PEEP) avoids atelectrauma, improves gas exchange and induces alveolar recruitment.Although it has side effects as inducing alveolar overdistension and circulatory depression.

There are several methods to determine the level of PEEP to be applied. We conducted a study to test the hypothesis that an individualized level of PEEP, set et the best compliance, when compared with a fixed level according to the fraction of inspired oxygen applied, improves oxygenation and reduces mortality rate at 28 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Acute Respiratory Distress Syndrome (ARDS) according to the American-European Consensus Conference definition, after 24 hours under mechanical ventilation.

Exclusion Criteria:

* Younger than 18-year-old
* Pregnancy
* Neuromuscular diseases
* Intracranial hypertension. Head trauma
* Left ventricular dysfunction
* Mechanical ventilation for more than 72 hours
* Previous barotrauma
* Patients with terminal stage of an illness and high risk of mortality within 90 days
* Patients who refused to consent to the study