cyrilzakka/clinical-trials huggingface dataset:
RW Effectiveness of Lurbinectedin in Extensive Stage SCLC

LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate effectiveness and safety of lurbinectedin in real-world conditions.

LURBICLIN cohort will describe the demographic and clinical characteristics of patients who received at least one dose of lurbinectedin as part of ATU program. LURBICLIN will evaluate overall survival, real world progression-free survival, best response and duration of treatment in patients with advanced, metastatic Small Cell Lung Cancer (SCLC) who received lurbinectedin as part of the French Early Access Program (ATU). Previous and subsequent treatments (treatment delivered immediately after treatment with lurbinectedin) will be recorded. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed extensive stage Small Cell Lung Cancer
* Patients who were informed about the study and accepted for their data to be collected
* Patients who received at least one dose of treatment with lurbinectedin as part of the French Early Access Program (ATU program).
* Selection period spans from June 2020 until March 2021 for initiation of treatment with lurbinectedin.

Exclusion Criteria:

* Patients enrolled in a clinical trial assessing treatment with lurbinectedin
Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies

This is a first-in-human phase 1 study of SYNCAR-001 + STK-009 in patients with CD19+ hematologic malignancies.

SYNCAR-001 + STK-009 is a 2-component human orthogonal (ho) IL-2 receptor-ligand cell therapy consisting of (1) SYNCAR-001, a CD19-directed chimeric antigen receptor T cell (CAR-T) co-expressing an engineered IL-2 beta receptor (hoRb); and (2) STK-009, an engineered pegylated IL-2 cytokine (hoIL-2) selective for hoRb. The study will follow a 3+3 design during dose escalation. Cohort A will enroll subjects to SYNCAR-001 + STK-009 with lymphodepletion. At Dose Level 3, a separate dose escalation cohort will be introduced to enroll subjects to SYNCAR-001 + STK-009 without lymphodepletion (Cohort B). Subsequent dose expansions will enroll subjects at the RP2D for each cohort.

Eligibility Criteria:
Selected Inclusion Criteria:

1. Histologically confirmed relapsed/refractory hematologic malignancies, including Chronic Lymphocytic Lymphoma (CLL/SLL) and selected Non-Hodgkin's Lymphoma (NHL)
2. Prior or current documentation of CD19 expression or high likelihood of CD19 expression based on disease histology
3. No signs of symptoms of central nervous system (CNS) disease or detectable evidence of CNS or meningeal disease on magnetic resonance imaging (MRI) at the time of screening

Selected Exclusion Criteria:

1. Prior CD19 directed therapy including CD19 CARTs
2. Prior allogeneic hematopoietic stem cell transplant within 6 months of enrollment
3. Prior autologous hematopoietic stem cell transplant within 6 weeks of enrollment.
4. Presence of GVHD
Changes in Spontaneous Ventilation in Response to Changes in Extracorporeal Carbon Dioxide Removal

In physiological conditions, spontaneous ventilation is controlled by blood carbon dioxide (and pH) levels. In healthy animals, extracorporeal carbon dioxide removal leads to hypoventilation or apnea (Kolobow et al., 1977). During acute respiratory insufficiency, extracorporeal carbon dioxide removal may be used to control spontaneous ventilation, limiting risks of lung damage and relieving dyspnea (Crotti et al., 2012). However, little is known about how spontaneous ventilation changes in response to changes in extracorporeal carbon dioxide removal during acute respiratory insufficiency, especially in humans.

Aim of this study is to monitor changes in spontaneous ventilation in awake patients treated with extracorporeal gas exchange support because of acute respiratory insufficiency, in response to changes in extracorporeal carbon dioxide removal.


Eligibility Criteria:
Inclusion Criteria:

* Acute Respiratory Insufficiency
* Extracorporeal gas exchange support
* The patient is spontaneously breathing (including assisted ventilation)

Exclusion Criteria:

- age below 18 yrs
Pyronaridine-artesunate and Artemether-lumefantrine for the Treatment of Paediatric Malaria

The purpose of this study is to determine the efficacy of pyronaridine-artesunate and artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in Kenyan children.


Eligibility Criteria:
Inclusion Criteria:

* Children between 6 months and 12 years old, with a body weight of ≥5 kg;
* Living in the catchment area of the study (within a radius of \~10 km from St. Jude's Clinic, Mbita, Kenya);
* Having microscopically confirmed P. falciparum mono-infection (asexual parasite density 1,000-200,000 µL-1).

Exclusion Criteria:

* Signs and symptoms of severe malaria (according to WHO criteria for severe malaria, (WHO 2012)) or any other severe illness necessitating parenteral treatment;
* Mixed Plasmodium infection;
* Clinically suspected (oedema, jaundice and/or ascites) or reported hepatic and/or renal impairment (any cause, as reported by parents/guardians and/or evident from medical history);
* Having anaemia with an Hb \<6 g/dL;
* Evidence of severe malnutrition (severe wasting: z-score weight for age \<-3 and severe stunting: z-score height for age \<-3 (WHO 2009b));
* Having received anti-malarial therapy in the previous two weeks;
* Known history of hypersensitivity, allergic or adverse reactions to artesunate, artemether-lumefantrine or other artemisinins;
* Participating in other anti-malarial drug intervention studies;
* Previous participation in the PAAL study, e.g. in the previous transmission season (each individual child can only take part in this study once);
* Not being available for follow-up.
Low-Carbohydrate Diet Intervention on Body Weight

* The primary aim of this study is to determine the adherence of low- carbohydrate among Chinese.
* Then compare the effect of low-carbohydrate and traditional Chinese but restricted-calories diet on weight loss and metabolic traits.

Obesity is a well established risk factor for type 2 diabetes mellitus, hypertension, dyslipidemia and cardiovascular disease. Along with rapid nutritional and lifestyle transition featured as increased energy dense diet intake and reduced physical activity, the prevalence of obesity has reached epidemic level and affected more than 70 million Chinese adults nowadays. Previous studies suggested that low-carbohydrate diet was an effective and safe way to lose weight and had potential benefit on lipids profiles. However, it is still unknown whether this diet can be feasible to control the epidemic of obesity and its related metabolic diseases among Chinese, whose carbohydrate consumption contribute approximately 55% of total energy intake.

Therefore, the aim of this pilot study is to investigate the adherence and effectiveness of two weight-loss diets among Chinese. This will be a randomized, controlled clinical trial. A total of 50 overweight or obese nurse assistants will be randomly assigned to receive a low-carbohydrate diet or a traditional high-carbohydrate Chinese but restricted-calories diet for 12 weeks. The adherence of study protocol and effects of the two diets on body weight, waist circumference, body fat, fasting glucose and lipid profile will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* overweight/obese (BMI ≥24 kg/m2)

Exclusion Criteria:

* Pregnancy or lactation;
* Serum creatinine and blood urea nitrogen level beyond the clinical reference value;
* alanine aminotransferase and aspartate aminotransferase beyond the reference levels;
* Gastrointestinal problems that would prevent them from complying with the specified feeding conditions;
* Received gastrointestinal surgery (except for appendicitis or hernia);
* Severer CVD;
* Active cancer;
* Mental diseases, epilepsia or using anti-depression drugs;
* Participating in other scientific studies within 3 months before the study.
A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
* Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
* dCRT treatment according to regional oncology guidelines for esophageal cancer
* Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
* Adequate hematologic and end-organ function prior to randomization
* Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
* Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Key Exclusion Criteria:

* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
* Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
* Prior allogeneic stem cell or solid organ transplantation
* Active or history of autoimmune disease or immune deficiency
* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
* Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
* Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

The safety, tolerability, pharmacokinetics and pharmacodynamics/efficacy profiles of two different doses of GSK233705 will be compared with 2 active comparators and placebo, all medication delivered via dry powder inhaler.

A multi-centre, randomised, partially blinded, placebo-controlled, three-way crossover, incomplete block design study to investigate the, safety, tolerability, pharmacodynamics/efficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mcg twice daily plus two different doses of GSK233705 (20 and 50 mcg twice daily), compared with placebo, salmeterol 50 mcg twice daily alone, and tiotropium 18 mcg once daily alone, in subjects with chronic obstructive pulmonary disease

Eligibility Criteria:
Inclusion criteria:

* females of non-childbearing potential or postmenopausal;
* history of COPD as defined by ATS/ERS criteria;
* moderate COPD responsive to ipratropium and salbutamol;
* current smoker or ex-smoker.

Exclusion criteria:

* no instable COPD; max 1000 mcg inhaled steroids per day; no B-blockers
A Multiple-Dose Study to Assess the Safety, Tolerability, and Steady State Pharmacokinetics of APD791 in Healthy Volunteers

The APD791-002 study is designed primarily to evaluate the safety, tolerability, and pharmacokinetics of APD791 when administered for 7 days to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women, ages 19-45
* Non smokers

Exclusion Criteria:

* History of a bleeding disorder
* Use of any drug known to have an effect on coagulation or clotting or any anti-platelet therapy within 2 weeks of the screening
* Recently donated blood or had significant blood loss
* Current use of a prescription medication
* Pregnant females
Effects of Muscle Energy Technique With and Without Stationary Cycling on Toe Walking With ASD

In Autism spectrum disorder (ASD) is a developmental disability caused by differences in the brain. People with ASD often have problems with social communication and interaction, and restricted or repetitive behaviors or interests. People with ASD may also have different ways of learning, moving, or paying attention. The Aim of this thesis is Effects of Muscle Energy Technique with and without Stationary Cycling on toe walking children with Autism Spectrum Disorder This study seeks to explore whether the synergistic application of these interventions can provide a more comprehensive and effective approach in managing the debilitating symptoms associated with toe walking in Autistic children.

. The study\&amp;#39;s sample size will be 26 participants. Inclusion criteria for this study will be: Diagnosed Autistic between ages 4-10 years, Diagnosed Autistic Children, Treatment was given to each of the participants for 3 days a week and for 8 weeks. Inclusion criteria were all gender with the age group of 4-10 years, participants diagnosed cases of Autism spectrum disease with Toe Walking and their exclusion criteria were suspected but undiagnosed cases of ASD, the presence of any limb deformities , autistic children with MR, and unwillingness of participant or parents to be a part of the study. An RCT included 26 diagnosed autistic children as per inclusion criteria the subjects were divided into two groups, i.e., group A and B, the group A was given MET with Stationary bicycling whereas Group B was given MET without Stationary Bi-Cycling participants were clinically examined. Dynamometer, foot posture Index, Observational Gait Scale, and Parent report of percentage of time toe walking,

Eligibility Criteria:
Inclusion Criteria:

* Children with diagnosed Autism .
* Aged between 4 to 10 years.
* Autistic children with Toe-Walking
* Regular for follow-up
* Both Gender included

Exclusion Criteria:

* Children with Comorbidities .
* Children with mild cognitive dysfunction
* Children less then 4 year or older than 10 years..
* Autistic Children with limb deformity
* Autistic Children with Mental Retardation.
Risk Factors for Hepatic Inflammation, Fibrosis and Prognosis in Patients With CHB and NAFLD

Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, with the improvement of living standards and changes in lifestyle and dietary habits, non-alcoholic fatty liver disease (NAFLD) has become another important cause of liver cirrhosis and HCC.HBV combined with NAFLD inevitably develops into continuous or intermittent liver inflammation and fibrosis, which greatly increases the risk of cirrhosis, liver cancer and even end-stage liver disease. We aimed to investigate the risk factors and establish diagnostic models for hepatic inflammation, fibrosis in patients with CHB associated NAFLD. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.

Chronic hepatitis B (CHB) affects an estimated 292 million people, and causes approximately 800,000 people deaths per year from liver-related complications including cirrhosis and hepatocellular carcinoma, remaining a major global public health issue.Meanwhile, with the improvement of living standards and changes in lifestyle and dietary habits, non-alcoholic fatty liver disease (NAFLD) has become another important cause of liver cirrhosis and HCC.HBV combined with NAFLD inevitably develops into continuous or intermittent liver inflammation and fibrosis, which greatly increases the risk of cirrhosis, liver cancer and even end-stage liver disease. We aimed to investigate the risk factors and establish diagnostic models of hepatic inflammation and fibrosis in CHB associated NAFLD patients using a multicenter study. In addition, to find risk factors for liver cirrhosis, liver cancer or liver failure in patients with CHB-related NAFLD.

Eligibility Criteria:
Inclusion Criteria:

1.18 years or older 2. Positive hepatitis B surface antigen (HBsAg) for at least 6 months and without other viral co-infection at baseline 2.NAFLD diagnosed by imaging liver biopsy, and/or blood testing/predictive indices

Exclusion Criteria:

1. Other chronic liver diseases, such as alcoholic liver disease, other viral hepatitis, drug-induced liver injury;
2. HCC or other malignancies before liver biopsy;
Effect of PEEP on Lung Recruitment and Homogeneity Over Time in Moderate to Severe ARDS

This study evaluates the effect of airway pressure release ventilation (APRV) on lung homogeneity and recruitment in patients with moderate to severe acute respiratory distress syndrome (ARDS).

It will do this by comparing the homogeneity of ventilation and recruitment prior to a patient being ventilated on APRV, and at 30, 60 and 120 minutes after starting APRV.

Ventilator-induced lung injury (VILI) is a well-recognised problem of ventilation in patients with ARDS, and is currently treated with lung-protective ventilation, which limits tidal volumes and airway pressures by applying higher levels of positive-end expiratory pressure (PEEP). However, it is not known whether higher levels of PEEP increases recruitment and homogeneity of ventilation within the lungs.

APRV is a mode of inverse ventilation, where high levels of PEEP are maintained with brief releases of pressure, and has been proposed as an appropriate method of ventilation in patients with ARDS.

This study will assess homogeneity of ventilation and recruitment in 15 patients before APRV is started, and 30, 60 and 120 mins after commencing APRV. It will do this using Electrical Impedance Tomography (EIT), nitrogen wash in/wash out technique, and lung strain.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and \< 80 years

  * Weight \> 35 Kg and BMI \< 40
  * Informed consent according to local regulations
  * Hemoglobin ≥ 70 g/dl
  * Haemodynamically stable \> 4 hours
  * Moderate to severe ARDS (PaO2/FIO2 \< 26.6 kPa with positive end-expiratory pressure (PEEP) \> 5 cmH2O) as per Berlin definition of ARDS

Exclusion Criteria:

* Expected survival \< 72 hours

  * Suspected pregnancy (negative pregnancy test required for women of child-bearing potential)
  * Open abdomen
  * Documented or suspected raised intracranial pressure
  * Active air leak (pneumothorax, pneumomediastinum, subcutaneous emphysema)
  * Morbid obesity BMI \> 40
  * Recent \< 1 week cardiac or thoracic surgery
  * Unstable thorax and sternum with paradoxical chest wall movement
  * Severe Chronic Respiratory Disease (COPD) - GOLD 3 or 4 emphysema with bullae
  * Severe smoking (\> 40 pack-year history)
  * Liver Failure: Child-Pugh Class C
  * Massive ascites
  * Lung fibrosis
  * Severe cardiac disease (one of the following): New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachyarrhythmias
  * Sickle cell disease
The Safety and Effectiveness of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs

To evaluate the safety and antiretroviral activity of saquinavir soft gelatin capsule formulation (SQV-SGC) in combination with other antiretroviral drugs.

All patients receive SQV as monotherapy or in combination with other antiretroviral drugs chosen by the investigator and patient. (This study provides only SQV.) Patients may not choose another protease inhibitor (PI) as part of their combination therapy; furthermore, patients taking PIs other than SQV must undergo a 5-day washout period before study-drug administration. Patients are monitored for adverse events and changes in routine laboratory tests, plasma viral load, and CD4+ T cell levels. Outcomes are analyzed by stratifying patients according to CD4+ T cell levels and prior history with protease inhibitors.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

Antiretroviral treatments other than PIs.

Patients must have:

* HIV infection.
* No prior experience with PIs. (Note:
* At least 75 percent of patients must be naive to PIs.)

Exclusion Criteria

Concurrent Medication:

Excluded:

PIs other than SQV.

Prior Medication:

Excluded:

Any PIs (see note in General Criteria--Inclusion).
Study of Oral Edaravone in Healthy Adult Males

To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males


Eligibility Criteria:
Inclusion Criteria:

Additional screening criteria check may apply for qualification:

* Healthy adult male volunteers
* Japanese or Caucasian
* Subjects aged between 20 and 45 years at the time of informed consent
* Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

* Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study
* Body mass index (BMI) of \<18.0 or \>30.0, or body weight of \<50 kg (BMI formula: body weight \[kg\]/height \[m\]2, rounded to one decimal place)
* Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs
* Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration
* Subjects who have previously received edaravone
* Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent