cyrilzakka/clinical-trials huggingface dataset:
Stylet vs No Stylet During EBUS TBNA

This research study compares two ways to biopsy lymph nodes in the chest using endobronchial ultrasound-guided transbronchial needle aspiration" (EBUS-TNBA). During a EBUS-TBNA procedure, the patient is sedated, and a flexible camera and ultrasound probe is inserted through the mouth into the large airways of the chest, allowing us to see (via ultrasound) and biopsy the lymph nodes in the chest.

The purpose of this research study is to determine if the EBUS-TBNA procedure can be made simpler. In today's practice, the biopsy needle has two parts, 1) the needle itself and 2) an inner stylet that runs through the middle of the needle. Because many other biopsy needles (such as the needles used in breast biopsy and different types of lung biopsy needles) do not use an inner stylet, the investigators do not think the use of a stylet is necessary. If this step can be safely eliminated without decreasing the effectiveness of the procedure, this could shorten the procedure (saving time). This study is deigned to formally test the hypothesis that a stylet is not necessary in EBUS-TBNA.


Eligibility Criteria:
Inclusion Criteria:

* All patients \>18 years old and capable of informed consent refereed for EBUS-TBNA at our institution.

Exclusion Criteria:

* Standard contraindications to EBUS (coagulopathy, anti-platlet/anti-coagulant use, clinical instability)
* Pregnant women
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis

The purpose of this study is to determine whether PF-06700841 is safe and effective in the treatment of chronic plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months prior to Baseline/Day 1 (prior to first dose of study drug)
* Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe") at Baseline/Day 1 (prior to first dose of study drug)
* Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at Baseline/Day 1 (prior to first dose of study drug)
* Considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis (either naïve or history of previous treatment)

Exclusion Criteria:

* Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis, with the exception of nail psoriasis which is allowed
* Have evidence of skin conditions (eg, eczema) at the time of screening or baseline visit that would interfere with the evaluation of psoriasis
* Cannot discontinue systemic therapies and/or topical therapies for the treatment of psoriasis and cannot discontinue phototherapy (UVB or PUVA)
* Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).
* Have taken Apremilast (Otezla) within 3 months of first dose of study drug.
* Have undergone treatment with tofacitinib within 3 months of first dose.
A Study of Tirzepatide (LY3298176) Compared With Placebo in Adults With Type 1 Diabetes and Obesity or Overweight

The main purpose of this study is to find out how well and how safely tirzepatide works in adults who have type 1 diabetes and obesity or overweight. Participation in the study will last about 49 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have type 1 diabetes and on insulin treatment for at least one year prior to screening
* Have an HbA1c value of 7.0% to 10.5% inclusive, at screening
* Have a body mass index (BMI) of ≥25 kilograms per square meter (kg/m2) at screening
* Are of stable weight for at least 90 days prior to screening and agree to not start an intensive diet or exercise program during the study

Exclusion Criteria:

* Have experienced two or more events requiring hospitalization due to poor glucose control (hyperglycemia or (diabetic ketoacidosis (DKA)) during the period of 180 days prior to screening and until randomization.
* Have experienced one or more events of severe hypoglycemia during the period of 90 days prior to screening and until randomization.
* Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have had chronic or acute pancreatitis
* Have used any weight loss drugs or alternative remedies, including herbal or nutritional supplements, within 90 days prior to screening
Phase 1 Study of EZN-2968 Weekly in Adult Patients With Advanced Solid Tumors or Lymphoma

This is a Phase 1, open-label, non-randomized, dose-escalation study to determine the maximum tolerated dose (MTD), safety, tolerance, and pharmacologic profile of EZN-2968, a locked nucleic acid antisense oligonucleotide against hypoxia-inducible factor 1α administered as a 2-hour intravenous (i.v.) infusion weekly for 3 weeks per 6-week cycle. In patients treated at a recommended Phase 2 dose of EZN-2968, dose intensification will proceed by maintaining the dose, but gradually increasing the number of doses per 6-week cycle. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.

This is a Phase 1, open-label, non-randomized, dose-escalation study to determine the maximum tolerated dose (MTD), safety, tolerance, and pharmacologic profile of EZN-2968, a locked nucleic acid antisense oligonucleotide against hypoxia-inducible factor 1α (anti-HIF-1α LNA AS ODN) administered as a 2-hour intravenous (i.v.) infusion weekly for 3 weeks per 6-week cycle. In patients treated at a recommended Phase 2 dose of EZN-2968, dose intensification will proceed by maintaining the dose, but gradually increasing the number of doses per 6-week cycle. Up to 3 intensification cohorts will receive the recommended Phase 2 dose of EZN-2968.

Eligibility Criteria:
Inclusion Criteria: Patients must meet all of the following criteria to be eligible for enrollment into the study.

* Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma (Hodgkin's or non-Hodgkin's)
* Patients who have failed standard therapy and have no known effective therapy available to them
* Patients may have a tumor amenable to biopsy
* Measurable or evaluable disease.
* Age 18 years or older

Exclusion Criteria: Patients meeting any of the following exclusion criteria will not be eligible for enrollment.

* Concurrent serious medical illness
* Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
* Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) before the scheduled administration of EZN-2968. Luteinizing hormone-releasing hormone (LHRH) agonist therapy is permitted for patients with hormone refractory prostate cancer.
EFFECTS OF INFLATTABLE CERVICAL TRACTION COLLAR AS COMPARED TO MANUAL TRACION IN THE MANAGEMENT OF CERVICAL RADICULOPATHY

This study is a randomized control trial and the purpose of this study is to determine the effects of inflatable cervical traction collar as compared to manual traction in the management of cervical radiculopathy.

The purpose of this study is to determine the effects of inflatable cervical traction collar as compared to manual traction in the management of cervical radiculopathy on

1. Pain
2. Functional Disability
3. Range of motion Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Recruited participants will be allocated to either of the groups through a sealed opaque envelope method.

Eligibility Criteria:
Inclusion Criteria:

Adults aged 19-44 years Neck pain \>4 and \<8 on NPRS NDI scoring \<24(moderate disability) Positive Spurling test Positive Distraction Test Active and passive ROM limited/painful towards the side of pain Radiating Symptoms Numbness/paresthesia radiating to upper limb Both genders Positive - Upper Limb Neural Tension Tests (ULNTT) will be included. -

Exclusion Criteria:

Patients having Bilateral radiating sign and symptoms Cervical myelopathy Cervical syringomyelia Rheumatoid arthritis Thoracic outlet syndrome Brachial plexopathy Cervical Rib Vertebrobasilar insufficiency Recent history of fracture, surgery, trauma or whiplash Positive alar ligament stress test Positive sharp purser stress test Cervical instability Cancer, tumor or sudden weight loss.

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Heredity of Retinal Vessel Tortuosity

The purpose of this study is to asses the relative influence of genetic and environmental influence on the tortuosity of retinal arterioles in eyes of 218 healthy Danish twins aged 20-46 years. We expect to find a high heredity for the variation in tortuosity. This knowledge can contribute to the elucidation of the pathology in retinal diseases.

All persons underwent an ophthalmic examination including refraction, slit lamp biomicroscopy and digital fundus photography. Two independent graders (both with an MD degree) made a visual grading of the severity of tortuosity of the retinal arterioles in the fundus images.

Eligibility Criteria:
Inclusion Criteria:

* Samesex twin pairs of self-assessed good health

Exclusion Criteria:

* Diabetes mellitus
* Hypertension
* Thyroid disease
* Cataract or other opacities of the refractive media
* Missing fundus photographs
Oat Breakfast Satiety Study

This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density.

This study is designed to test the hypothesis that on an equivalent calorie basis, oat based breakfast cereals do not provide the same satiety benefit. The study will also demonstrate the satiety comparison of the cereals related to product density. Ninety-six healthy men and women 18 years of age or older will be enrolled into this study and divided into 2 groups of 48 each to investigate the satiety impact of two oat based breakfast cereals compared to the leading ready-to-eat (RTE) oat based breakfast cereal. Each subject will participate in two test sessions (1 test cereal vs the leading RTE cereal). Subjects will come to the Ingestive Behavior Laboratory between 8 and 10 am after having nothing to eat for 10 hours prior to the scheduled visit time and be given one of the three cereals. The second session will be scheduled at least 1 week after the first. Visual analogue scales of hunger, satiety and subjective energy will be completed at baseline, 30, 60, 120, 180, and 240 minutes. Subjects will return on another day separated by at least a week to repeat the breakfast. Area under the curves of appetite and satiety will be compared with a mixed model.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Healthy
* Willing to use an effective contraceptive during the study, if sexually active and capable of bearing children

Exclusion Criteria:

* Women who are pregnant or nursing
* Gain or loss of \> 4kg in the last 3 months.
* Diabetes mellitus (fasting glucose \>126 mg/dL)
* Dietary restraint on the Three Factor Eating Questionnaire score greater than or equal to 14
* Allergy to any of the foods used for the test breakfasts (oats or milk)
Comparative Study of the Hypoxia Measured in FAZA and F-miso PET/CT Scan in Patients With Non-small Cell Lung Cancer

The purpose of the study is to compare the intratumoral biodistribution of FAZA and F-miso in patients with non-small cell lung cancer and correlate the results of PET scans with immunohistochemistry.

The aim of the study is to compare the biodistribution of the two tracers specific for hypoxia in patients with non-small cell lung cancer.

Two PET scans will be performed with FAZA and F-Miso tracers. The time between these twi PET scans will be 24 hours.

another 24 hours after the late PET scan, the surgery will be done and a piece of tumor will be collected.

Piece of tumor will be analysed by immunohistochemistry for hypoxia markers.

The results of immunohistochemistry will be correlated with the biodistribution of the two tracers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* More than 18 years old
* Patient with non-small cell lung cancer (histologically proved)
* PS inferior or equal to 1 (good general state)
* Patient must have surgery for their non-small cell lung cancer
* Stage of tumor Superior or equal to 2a without metastasis
* Tumoral fixation with 18-FDG-PET superior to mediastinal background noise
* Written inform consent

Exclusion Criteria:

* Histology other than primitive non-small cell lung cancer
* In situ form at the histological study
* Patient without evaluable target
* No fixation on the pretherapeutic FDG-PET scan
* PS Superior or equal to 2
* neoplastic disease (less than 2 years or progressive)
* Pregnant woman or child-bearing
* Patient Under guardianship or curators
Study to Evaluate the Efficacy and Safety of Hyoscine Butylbromide Tablets for the Treatment of Occasional or Recurrent Episodes of Gastric or Intestinal Spasm-like Pain or Discomfort

In contrast with Hyoscine Butylbromide Capsule 10mg, Study is to evaluate the efficacy and safety of Hyoscine Butylbromide tablets 10 mg (20mg, 3 times daily, orally) over a period of 3 days for the treatment of occasional or recurrent episodes of self-reported gastric or intestinal spasm-like pain or discomfort


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent given by the patient
2. Male and female patients aging from 18 to 70
3. Subjects with occasional or recurrent episodes of gastric or intestinal spasm-like pain, or discomfort, such as occur e.g. in irritable bowel syndrome, which has been present for at least 3 months
4. The pain intensity score upon screening is at least 4 cm in VAS score

Exclusion Criteria:

1. Patients with the following concomitant disease were not eligible for enrolment

   * Painful gastric or intestinal spasm of organic origin such as Crohn's disease, ulcerative colitis, lactose intolerance, gastritis, ulcer. Exception: diverticulitis and mild gastritis if dominant symptom was cramp pain, but ineligible if heartburn or reflux were dominant symptoms
   * Pain related with malignancy
   * Patients with other severe pain states of organic origin
   * Mechanical stenosis of the gastrointestinal tract, megacolon
   * Urinary retention associated with mechanical stenosis of urinary tract
   * Narrow-angled glaucoma
   * Tachyarrhythmia
   * Myasthenia gravis
   * Meulengracht-Gilbert syndrome
   * Known depression or known mental illness, anxiety disturbance
2. Frequent vomiting that might have prevented adequate absorption of the active ingredient after the film-coated tablet was taken
3. Patients taking the following concomitant medication are not eligible for enrolment

   * Analgesics
   * Spasmolytics
   * Anticholinergics
   * Affecting gastrointestinal motility, such as propantheline metoclopramide, cisapride, loperamide, diphenoxylate, opioid analgesics, antacids and other ulcer treatment
   * Regular administration of laxatives
   * Narcotics
   * Antidepressant treatment or treatment with psychoactive drugs
4. Pregnancy and/or lactation or planned pregnancy
5. Known hypersensitivity to N-butylscopolammonium bromide
6. Alcohol or drug abuse
7. Simultaneous participating in another clinical trial, or discontinuing from another clinical trial before randomization (administration of study medication); moreover, in the case of screening failure or premature discontinuing from the trial, repeated enrolment is forbidden
8. Unwilling to or unable to complete the entire trial procedure according to the protocol
9. In investigator's opinion, the patient was not proper for the trial
Parenteral Artesunate Compared to Quinine as a Cause of Late Anaemia in African Children With Malaria

Delayed anaemia has been reported in European travellers with malaria cured by artesunate. Although no deaths related to this delayed anaemia have been reported so far, blood transfusion has been necessary in some affected patients. Recent observations suggest that this episodes of anaemia also occurs in endemic countries. The aim of this trial is to assess the incidence of late onset anaemia after treatment with intravenous artesunate compared to intravenous quinine, to identify patients at risk and to clarify the causes of this delayed anaemia.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 6 months and ≤ 14 years
* Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum or mixed with non-falciparum species
* Asexual P. falciparum parasitaemia ≥ 100,000/uL and ≤500,000/uL
* Haemoglobin ≥5.0 g/dL
* Parents/guardians agree to hospitalize the child for the length of treatment (3 days) and bring the patient for planned follow-up visits at day 7, 14, 21, 28, 35, 42
* Signed consent from the guardian/parents

Exclusion Criteria:

* Body weight ≤ 5 kg
* Severe malaria or signs of severe malaria as defined by WHO Guidelines 2013
* History of hypersensitivity or contraindication to quinine or artesunate
* A clear history of adequate antimalarial treatment in the preceding 24 hours with drugs expected to be effective
* Presence of intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the patient treatment or results of the study
* Participation in another clinical trial
Maternal Oxygen Supplementation for Intrauterine Resuscitation

More than 80% of the 3 million women who labor and deliver each year in the United States undergo continuous electronic fetal monitoring (EFM) during labor in order to fetal hypoxia and prevent the transition to acidemia, expedited operative delivery, and/or neonatal morbidity. Category II EFM is the most commonly observed group of fetal heart rate features in labor. One common response to Category II EFM is maternal oxygen (O2) supplementation. The theoretic rationale for O2 administration is that it increases O2 transfer to a hypoxic fetus. There are conflicting national guidelines regarding O2 administration - the American College of Obstetricians and Gynecologists suggest O2 is ineffective, whereas the Association of Women's Health, Obstetric, and Neonatal Nurses recommend continued use given lack of definitive data on safety and efficacy. A recent national survey of nearly 600 Labor \& Delivery providers in February 2022 revealed that 49% still use O2 . Thus, there remains equipoise on the topic and high-quality data on the safety of intrapartum O2 is needed. None of the trials to date have studied the effect of intrapartum O2 on important clinical measures of neonatal or maternal morbidity. This safety data is imperative because the field of obstetrics must hold supplemental O2 to the same rigorous standards applied to any drug used in pregnancy. Without data on these definitive outcomes, it will be challenging to implement evidence-based recommendations for supplemental O2 use on Labor \& Delivery. The investigators will conduct a large, multicenter, randomized noninferiority trial of O2 supplementation versus room air in patients with Category II EFM in labor.


Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Gestational age\>=37 weeks
* Spontaneous labor or induction of labor
* English or spanish speaking
* Planned continuous fetal monitoring

Exclusion Criteria:

* Preterm gestation
* Major fetal anomaly
* Multiple gestation
* Category III fetal monitoring at time of admission
* Maternal hypoxia \<95%
* Planned or scheduled cesarean delivery Excluded from randomization if receiving nitrous oxide for analgesia at time of randomization.
Mechanism of Thrombocytopenia in Infants

This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.

Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.

Eligibility Criteria:
Inclusion Criteria:

* Infants who are less than 34 weeks gestation
* Infants born to mothers with preeclampsia
* Infants who are born small for gestational age whose mother did not have preeclampsia

Exclusion Criteria:

* Infants who are greater than 34 weeks gestation
* Infants with known congenital anomalies or known congenital infections
The Link Between Anemia and Deficits in Memory and Attention in Individuals With Sickle Cell Disease

Sickle cell disease is an inherited blood disorder that affects red blood cells (RBCs). People with sickle cell disease frequently experience anemia, or a low number of RBCs. RBCs are responsible for carrying oxygen to the brain and other body tissues that need oxygen to function properly. The purpose of this study is to determine what changes, which were possibly caused by anemia, exist in the brains of individuals with sickle cell disease.

The role of RBCs is to carry oxygen from the lungs to the brain and other body tissues. Individuals with anemia have unusually low numbers of RBCs. They also often have difficulty concentrating and remembering information, which is likely caused by a reduced oxygen supply to the brain. Previous research has shown that correcting anemia in patients without sickle cell disease improved their memory and attention. The purpose of this study is to examine any abnormal changes in the brains of individuals with sickle cell disease and to determine whether these changes are related to reduced memory and attention capabilities.

Participants will attend one study visit. During this visit, a brain magnetic resonance image (MRI) will be performed while participants complete neuropsychological tests that measure memory, attention, and organizational ability. There will be no follow-up visits.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sickle cell disease

Exclusion Criteria:

* Pregnancy
* Claustrophobia
* Mass lesion (e.g., meningioma, cyst, or spinal block)
* Need for life support constant monitoring
* Any unstable condition that is likely to require resuscitation
* Presence of a pacemaker or other iron-containing magnetic substances in the body