cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)

This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be assessed and compared with that of Yasmin.

The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.

Eligibility Criteria:
Key Inclusion Criteria:

* Sexually active Chinese women, at risk for pregnancy and not planning to use condoms during trial medication use
* Women in need for contraception and willing to use a hormonal contraceptive method for 13 cycles
* Body mass index ≥18 and ≤29 kg/m\^2

Key Exclusion Criteria:

* Contraindications for contraceptive steroids
* Abnormal cervical smear corresponding to indeterminate changes at screening
* Clinically relevant abnormal laboratory result at screening as judged by the investigator.
Host DNA Methylation for Endometrial Cancer Screening

Based on the previous study of NCT04651738, we performed this trial to further confirm the accuracy of host DNA CDO1 and CELF4 methylation for endometrial cancer screening in a multi-center cohort. Thirteen hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA CDO1 and CELF4 methylation, and the results will compared with the endometrial histological pathology, which is achieved after collection of cervical cytology, by surgeries including hysteroscopy, dilation and curettage, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The study will enroll at least 10,000 patients.


Eligibility Criteria:
Inclusion Criteria:

* With uterine and uterine cervix intact
* Aged 18 years or older
* With accessible histological results of endometrium
* Signed an approved informed consents
* With accessible cervical cytology before harvesting endometrial histology

Exclusion Criteria:

* Not meeting all of the inclusion criteria
Pharmacokinetics, Safety, and Tolerability of TR-701 Free Acid (FA) in Elderly Subjects

To compare the pharmacokinetic (PK) profile of TR-700 in elderly subjects versus younger control subjects

This is an open-label Phase 1 study of a single oral tablet of TR-701 FA 200 mg to compare the TR-700 PK profile in elderly subjects (age 65 years and older, with at least 5 subjects 75 years old or older) and younger control subjects (age 18 to 45 years).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects in the following groups: An elderly subject at least 65 years of age. At least 5 subjects must be at least 75 years of age OR A matched-control subject between 18 and 45 years of age, inclusive
* BMI ≥18.0 kg/m2 and ≤35.0 kg/m2

Elderly Group

* Medical history, physical examination, and laboratory results consistent with stable health (as determined by the Investigator)

Control Group

* Medically stable with no clinically significant abnormalities

Exclusion Criteria:

* Significant, uncontrolled, or life-threatening condition or organ or system condition or disease (eg, impaired cognitive status, respiratory insufficiency, advanced malnutrition)
* Positive hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus antibody test result
* Previous inclusion in a TR-701 FA or TR-701 clinical study
* ECG finding of QTc interval \>500 msec, or other clinically significant ECG abnormality at Screening
* Female subjects whom are pregnant, lactating or breastfeeding
Observational Cohort Study on the Use of Parenteral Nutrition and Clinical Outcomes in Adult Critically Ill Patients

The aim of this study is to characterise the use of clinical nutrition support, especially of parenteral nutrition that is administered directly into a vein, in adult patients with critical illness. The study wants to assess nutritional balance (that means the ratio of calories and protein prescribed to calories and protein actually received). Furthermore, it wants to evaluate whether the nutrition received has influence on the patients' clinical outcome, with focus on measures of physical function, such as capability of conducting daily living activities. As the study is "observational", no specific medications or treatments will be provided as part of the study to the patients.

Study patients will be observed during their stay on an intensive care unit, for a maximum duration of 15 days. Furthermore, questions on the well-being of the patients will be asked via telephone interviews 30 and 90 days after their admission to the intensive care unit.

Data of approximately 1250 patients will be collected and evaluated in this study, from approximately 100 hospitals in 11 European countries (Austria, Belgium, Czech Republic, France, Germany, Hungary, Italy, Poland, Spain, Sweden and United Kingdom).


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years and ≤95 years, male or female
2. Hospitalised in a medical, surgical, or trauma ICU for at least five consecutive calendar days and either admitted to the ICU during the predefined screening month or admitted to the ICU maximally 4 days before start of the screening month
3. BMI ≥18.5 kg/m2 and ≤45 kg/m2
4. Written informed consent or requirements of local/national ethical committee

Exclusion Criteria:

1. Burn injury
2. Pre-existing neuromuscular or psychiatric disorders that preclude proper assessment of functional status
3. Severe hypoxic brain injury or severe neurological diagnosis (e.g. meningitis, encephalitis, brain trauma, spinal cord injury) at the time of ICU admission that precludes proper assessment of functional status
4. Receiving home parenteral nutrition at the time of ICU admission (e.g. due to short bowel syndrome)
5. Receiving home enteral nutrition (tube feeding) at the time of ICU admission
6. Chronic invasive or chronic non-invasive ventilatory support before ICU admission
7. Patients with a legal representative in place before ICU admission
8. Admission to the ICU for palliative care
9. Previous participation in this study (if the screening month is repeated and a patient is re-admitted to the ICU during the repeated screening month, only ICU data collected for that patient during the original screening month will be included)
10. Concurrent enrolment in a nutrition-related interventional study at the time of screening
An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus

This study will investigate BMS-986165 to assess its effects in participants with systemic lupus erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Systemic lupus erythematosus (SLE) disease diagnosed ≥ 24 weeks before the screening visit
* Meets the Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
* One of the following: elevated antinuclear antibodies (ANA) ≥ 1:80 or positive anti- double-stranded deoxyribonucleic acid (dsDNA) (positive includes indeterminate results) or positive anti-Smith (anti-Sm) as determined by the central laboratory
* Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI-2K score ≥ 4 points with joint involvement and/or rash \[score must be confirmed by Central Review Services (CRS)\]
* Men and women must agree to follow specific methods of contraception, if applicable

Exclusion Criteria:

* Drug-induced SLE, certain other autoimmune diseases, and active, severe lupus nephritis
* SLE overlap syndromes such as scleroderma and mixed connective tissue disease
* Clinically significant abnormalities on chest x-ray or electrocardiogram (ECG)
* History of any significant drug allergy

Other protocol defined inclusion/exclusion criteria apply
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme

RATIONALE: Radioactive drugs such as phosphorus 32 may be able to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of phosphorus 32 in treating patients with glioblastoma multiforme.

OBJECTIVES:

* Determine the dosimetry toxicity of interstitial colloidal phosphorus P32 (C P32) in patients with recurrent or poor prognosis grade 4 astrocytoma.
* Determine the maximum tolerated dose of C P32 administered directly into the tumor of these patients.
* Determine the maximum tolerated fractionated dose of interstitial C P32 in these patients.
* Determine the therapeutic response rate to the acceptable single and fractionated doses of C P32 in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive interstitial colloidal phosphorus P32 (C P32) on day 0. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of C P32 until the maximum tolerated dose (MTD) is determined. The MTD is defined the dose at which 2 of 3 patients experience dose-limiting toxicity.

Patients are followed at 1, 2, 4, 6, 9, 15, and 24 weeks.

PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven grade 4 astrocytoma (glioblastoma)

  * Failed external beam radiotherapy and/or surgery OR
  * Poor prognosis disease
* No clinical evidence of metastatic disease within the CNS other than the primary tumor site
* Stereotactic biopsy or gross total excision with residual tumor
* Lesion 3 to 5 cm in size
* No spinal cord tumor(s)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,000/mm3
* Neutrophil count at least 1,900/mm3
* Platelet count at least 100,000/mm3
* Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

* Not specified

Renal:

* Creatinine no greater than 1.5 mg/dL
* BUN less than 25 mg/dL

Other:

* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics

Surgery:

* See Disease Characteristics
Optimization of Asthma Treatment Through Exhaled NO for Increased Asthma-Related Quality of Life (NOAK)

The purpose of this study is to determine whether use of exhaled NO (nitric oxide) to regulate the anti-inflammatory treatment leads to increased asthma-related quality of life in patients with allergic asthma


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64
* Clinical diagnosis of Asthma
* Glucocorticoid treatment \> 6 months.
* Verified Allergy
* Read and speak Swedish

Exclusion Criteria:

* Smoking
* Current regular treatment with long-acting beta2-agonist
* Treatment with Singulair only or in combination with glucocorticoids
* Taking part in other research study
* Pregnancy or breast-feeding
* Unstable Asthma
Chemoreflex Sensitivity in HFpEF

Patients with heart failure and a preserved left ventricular ejection fraction (HFpEF) almost invariably complain of exertional breathlessness. Abnormal cardiac hemodynamics with pulmonary congestion are believed to trigger dyspnea in this patients. However, some patients may complain of exertional breathlessness which seems to be out of proportion as compared with hemodynamic abnormalities.

Chemoreflex sensitivity accounts for the ventilatory responses to a variety of chemical stimuli, including carbon dioxide produced by the organism during exercise. Chemoreflex sensitivity can be augmented in heart failure with reduced left ventricular ejection fraction, and an increased chemoreflex sensitivity has been linked to symptoms, neurohumoral activation, breathing disturbances, and adverse prognosis.

However, the clinical correlates and implications of chemoreflex sensitivity in HFpEF have not been accurately studied.

We aim to characterize chemoreflex sensitivity in patients with a diagnosis of HFpEF, and to correlate chemoreflex sensitivity with clinical and hemodynamic characteristics.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of symptomatic HFpEF (group 1)
* diagnosis of asymptomatic left ventricular diastolic dysfunction with echocardiographic signs of PH (group 2)
* healthy volunteers (group 3)

Exclusion Criteria:

* breastfeeding or childbearing
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors

The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.

Study scheme

* study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks
* control arm: placebo apply

Outcome measures

* Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk
* vaginal maturation index: at 0 wk and 8 wk
* vaginal pH: at 0 wk and 8 wk

Eligibility Criteria:
Inclusion Criteria:

* breast cancer survivors over 20 years-old
* premenopausal at the time of diagnosis
* treated with operation and chemotherapy
* newly developed dyspareunia after cancer treatment

Exclusion Criteria:

* recent (\< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)
* depression or other psychological problems
* active vaginal infection
* evidence of cancer recurrence
* previously use of lactate-containing lubricants
* other chronic diseases which severely disturb the sexual life
PEEP Setting in COVID19-related ARDS

The best way to titrate positive end-expiratory pressure (PEEP) in patients suffering from acute respiratory distress syndrome is still matter of debate. Electrical impedance tomography (EIT) in a non-invasive technique that could guide PEEP setting based on an optimized ventilation homogeneity.

COVID-19 related ARDS patients admitted to the ICU in March 2021 requiring mechanical ventilation were enrolled. Patients were monitored by an esophageal catheter and a 32-electrode EIT device. Within 48 hours after the start of mechanical ventilation, different levels of PEEP were applied based upon PEEP/ Fraction of inspired oxygen tables, positive end-expiratory transpulmonary (PL)/ FiO2 table, and EIT. Respiratory mechanics variables were recorded.

Eligibility Criteria:
Inclusion Criteria:

* COVID19-related ARDS under invasive mechanical ventilation

Exclusion Criteria:

* none
Study in Healthy Adults to Evaluate Pharmacokinetics, Safety and Tolerability of ABT-450 With Ritonavir

The purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple doses of an experimental hepatitis C virus (HCV) protease inhibitor with ritonavir in healthy volunteers.

This is a multiple ascending dose, non-fasting, open label, randomized study.

Eligibility Criteria:
Inclusion Criteria:

* overall healthy subjects
* non-childbearing potential females included

Exclusion Criteria:

* history of significant sensitivity to any drug
* positive test for HAV IgM, HBsAg, anti-HCV Ab or anti-HIV Ab
* history of gastrointestinal issues or procedures
* history of seizures, diabetes or cancer (except basal cell carcinoma)
* clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder
* use of tobacco or nicotine-containing products within the 6-month period prior to study drug administration
* donation or loss of 550mL or more blood volume or receipt of a transfusion of any blood product within 8 weeks prior to study drug administration
* abnormal screening laboratory results that are considered clinically significant by the investigator
* current enrollment in another clinical study
* previous enrollment in this study
* recent (6-month) history of drug/alcohol abuse that could preclude adherence to the protocol
* pregnant or breastfeeding female
* requirement for any OTC and/or prescription medication, vitamins and/or herbal supplements on a regular basis
Non-interventional Study of Patients With PN NF1 Starting Selumetinib in Russia

The purpose of this study is to evaluate the effectiveness, safety of selumetinib and patient's parameters of symptomatic inoperable PN NF1 in real clinical practice in Russia

This study will be non-interventional retrospective and prospective study. Assessment of parameters will be carried out as if a patient is treated in real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by an investigator 10 clinical sites. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Study population will consist of pediatric patients aged 3 years and older with NF1 and symptomatic inoperable PN who were prescribed with selumetinib

Eligibility Criteria:
Inclusion Criteria:

* NF1 diagnosed (according to the criteria for evaluating NF1),
* Symptomatic inoperable PN,
* Patients receiving therapy with selumetinib. For newly treated patients - registration on the first day of starting treatment with selumetinib,
* Age at starting of selumetinib treatment ≥ 3 to ≤ 18 years old (included in the study or started the therapy at the age of 18 years old),
* Patients whose parents or guardians have signed a consent form.

Exclusion Criteria:

* Patients currently participating in an interventional study/clinical trial,
* Patients are excluded if there is evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy,
* Patients who receive other antitumor treatment options on optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer. If the patient on selumetinib treatment develop optic nerve glioma, malignant glioma, malignant tumor of the peripheral nerve sheath, or other cancer, he can continue selumetinib therapy +\\- other treatment options on physician decision,
* Female patients above 12 age who are pregnant /plan to become pregnant or at breast feeding.
Safety and Tolerability of the Ketogenic Diet in Amyotrophic Lateral Sclerosis (ALS)

This research is being done to see if the ketogenic diet (which is high in fat and low in carbohydrates) is safe and tolerable in amyotrophic lateral sclerosis (ALS) patients who are fed through a gastrostomy tube. This is not a study to see if ketogenic diets are effective in the treatment of ALS.


Eligibility Criteria:
Inclusion Criteria:

1. Familial or sporadic ALS diagnosed as probable, laboratory-supported probable or definite according to the World Federation of Neurology El Escorial criteria
2. Age 18 or older
3. Capable of providing informed consent and complying with trial procedures
4. Gastrostomy tube in place for the prior month
5. Appel ALS score less than 100
6. Able to stand on a scale with assistance
7. For patients with Appel ALS scores greater than 80, availability of caregiver who is willing and able to:

   * Prepare, administer and log tube feeds
   * Check and log gastric residuals
   * Assist with weighing subject at home if necessary
8. Willing to chart food intake during the six-month study
9. Patients either not taking Riluzole (Rilutek) or Minocycline or on a stable dose of these for 30 days
10. Not taking Coenzyme Q10 or on a stable dose and brand for 30 days
11. Absence of exclusion criteria

Exclusion Criteria:

1. Forced vital capacity \<50% of predicted
2. Dependence on mechanical ventilation for more than 12 hours per day
3. Exposure to any experimental agent within 30 days of onset of this protocol
4. Women who are pregnant or planning to become pregnant
5. Women of childbearing potential not practicing contraception
6. Enrollment in another research study within 30 days of or during this trial
7. Mini-Mental State Exam (MMSE) score \<20
8. Patients with symptomatic cardiac disease or hypercholesterolemia
9. Patients with myocardial infarction within 6 months of this trial
10. Renal dysfunction defined as BUN and creatinine \>2XULN
11. Known mitochondrial disease
12. BMI\<18.5
13. Prior use of a 4:1 ketogenic diet or Atkins diet within 1 month of this trial
14. Impaired liver function, defined as AST or ALT of 3 X ULN
15. Patients who have a pacemaker or other internal electronic medical device
C752 for Refractory/Relapsed B Cell Non-Hodgkin Lymphoma

It is a single-arm, open-label clinical study to assess the safety and efficacy of the C752 CAR-T Cells for patients with CD19+ refractory/relapsed B cell non-Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent in accordance with federal, local, and institutional guidelines, Males and females ≥18 years of age at the time of consent
* Documented diagnosis of Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
* Have progression by least one systemic treatment and no available standard of care treatment.
* At least one measurable lesion by Lugano 2014
* Expected survival ≥ 12 weeks
* Have an ECOG performance status of 0 or 1
* Adequate organ function
* Screening test indicates histopathological CD19 + if the subject received CD19-targeted therapy
* Women of childbearing age must have a negative pregnancy test, and agree to take effective contraception during the trial

Exclusion Criteria:

* Treatment with any prior HSCT, gene therapy product, cell therapy product ect.
* Central nervous system involvement
* HBV/HCV
* HIV infection
* Concurrent use of systemic steroids or immunosuppression
* Uncontrolled active infection
* Wash-out period of from the last anti-cancer treatment
* Active second malignancy
* Have not recovered from the effects of previous therapy
* Have psychological or physical conditions that do not permit compliance with the protocol
* Pregnant or nursing (lactating) women