cyrilzakka/clinical-trials huggingface dataset:
Metabolic and Microbial Profiling of Lung Cancer

This pilot study will establish non-invasive sample collections, including breath, saliva, blood and urine pre-surgery and at the participant's one-month post-surgery follow-up visit. Participants with suspected non-small cell lung cancer (NSCLC) stage I-III will be recruited.

Primary Objective

* To evaluate the feasibility of adding non-invasive sample collections in the pre-surgical setting and at the post-surgery follow-up visit.
* To identify and assess metabolic and microbial signatures collected at pre- and post-surgery and determine which are indicative of lung cancer.

Secondary Objective

* To identify signatures which are associated with lung cancer stage.
* To identify signatures which are impacted by patient's pulmonary function status.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients age \>18 years, of all racial and ethnic origins, with suspected nonsmall cell lung cancer stages I, II, and III, as evident through radiographic evidence and felt acceptable to undergo surgical resection.
* Patients who have the ability to understand and the willingness to sign a written consent form.

Exclusion Criteria:

* Patients who are have taken antibiotics within two weeks.
* Patients who are on continuous supplemental oxygen.
* Patients currently undergoing active treatment for other malignancies.
* Subjects who are unable or unwilling to provide consent.
The Influence of High and Low Salt on Exosomes in the Urine

The hypothesis is that changes in the epithelial sodium channel (ENaC) in the kidney is reflected in urinary exosomes and that the amount of ENaC as well as the cleavage degree is upregulated in conditions with low salt.

Methods:

Exosomes will be isolated from spot urine by ultracentrifugation and tested using western blotting. In-house developed antibodies against different parts of the ENaC gamma subunit as well as commercial antibodies will be used. A marker for exosomes will validate the presence of exosomes in the urine.

Power considerations:

In this cross over salt-intervention study with quantification of ENaC the investigators refer to a published study regarding the sodium-chloride co-transporter (NCC) in the kidney, were rats where given aldosterone infusion or a low salt diet. In this study n=6 was sufficient to detect a 2-3 fold change in NCC in urinary exosomes. Furthermore 5 patients with primary aldosteronism had a significant increase in NCC in urinary exosomes (N. Lubbe et al, Hypertension 2012).

On the basis of this the investigators choose to test 10 persons, but are not able to make a regular power calculation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged 20-40
* Body Mass Index (BMI, weight/height\^2) between 18 and 25.

Exclusion Criteria:

* Increased blood pressure (hypertension) or in treatment for high blood pressure
* Diabetes
* Regular medical intake
* Smoking
* Expectation of lacking cooperation or lack of understanding of the experiment
* Clinical relevant organic or systemic disease including malign disease
* Decreased kidney function
Steroid Resistance in Pediatric Immune Thrombocytopenic Purpura

To Predicting steroid resistance on children newly diagnosed with immune thrombocytopenic purpura

Immune thrombocytopenia (ITP, platelet counts \&lt; 100 × 109/L) is the most common acquired childhood bleeding disorder, clinically characterized by a low platelet count in the absence of other thrombocytopenia causes \[1,2\].

The estimated incidence of ITP is 100 cases out of a million people per year; about half of these cases occur in previously healthy children, where it represents the most frequent blood disorder \[3\].

Most children present with a typical history of acute purpura and bruising after a mild viral infection \[4\]. In severe cases, intracranial hemorrhage (the most 0.5% serious complication, but also the rarest occurring in adults), gastrointestinal hemorrhage in 1.5 % of children, and genitourinary hemorrhage may occur \[5\].

The International Working Group on ITP defines ITP according to the following clinical phases \[6\]. These are as follows:

Newly diagnosed ITP is in the first three months post-diagnosis. Persistent ITP is for 3-12 months. Chronic ITP is for \&gt; 12 months. Refractory ITP is the failure to restore count of platelet after splenectomy. For children requiring therapy but without life threatening bleeding, corticosteroids are the recommended first line therapy over IVIG or anti-D \[2\].

Guidelines from the American Society of Hematology recommend a 5-7-day course of prednisone dosed at 2-4 mg/kg/day \[2\]. Seventy-five percent of children respond to steroids, with platelets recovering to hemostatic range by 2-7 days \[7\]. If a more rapid rise in platelets is desired, IV methylprednisolone may be used. Studies comparing outcomes between anti-D versus methylprednisolone \[8\] and comparing methylprednisolone with dexamethasone \[9\] showed similar response rates with minor side effects in all groups.

A study shows that 98% of patients with corticosteroid exposure experienced one or more side events, and 38% of patients need to stop or reduce corticosteroid therapy \[10\].

This research aims to develop a new prediction model to evaluate whether newly ITP patients are at high-risk of corticosteroid resistance, and help clinicians to choose better therapy so we divide patients to two groups, steroid response and steroid resistance.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed as acute immune thrombocytopenic purpura based on clinical manifestations and laboratory investigations from age of 1 years to age of 18 years.

Gender: both six

Exclusion Criteria:

* children with immune thrombocytopenic purpura below age of 1 years and above 18 years, patient with thrombocytopenic purpura with secondary causes, and chronic ITP
Safety and Tolerability Study of Lu AG06466 in Healthy Young Japanese and Caucasian Participants

The main goal of this study is to evaluate the effect of Lu AG06466 on the body and what the body does to Lu AG06466 after single and multiple doses to healthy Japanese and Caucasian participants.

This sequential study will be divided in two parts, Part A and Part B.

Part A will consist of 3 cohorts (Cohorts A1, A2, and A3) in which participants will be randomized to receive a single dose of Lu AG046466 or a matching placebo orally. After completing the safety review of data from Cohort A1, the study will proceed in Cohorts A2 and A3, with an increased dose of Lu AG046466 or matching placebo being administered to Japanese and Caucasian participants.

Part B dosing will only be initiated after completion of Part A. Part B will consist of 1 cohort (Cohort B1), to which multiple dose of Lu AG046466 or matching placebo will be administered after dose titration.

Eligibility Criteria:
Inclusion Criteria:

* The participant has a BMI ≥18.5 and ≤25 kilograms (kg)/square meter (m\^2) or ≤30 kg/m\^2 for Japanese and Caucasian participants, respectively, and a body weight ≥50 kilograms (kg) at the screening visit and at the baseline visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, electrocardiograms (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Exclusion Criteria:

* The participant has taken disallowed medication \<1 week prior to the first dose of study drug or \<5 half-lives of the disallowed medication as concomitant use prior to the screening visit.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, hematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has had a clinically significant illness \<4 weeks prior to the first dose of study drug.
* The participant has received a SARS-CoV-2 (COVID-19) vaccination \<30 days prior to the first dose of study drug.

Note: Other inclusion and exclusion criteria may apply.
Corneal Changes After Retinal Surgery

The purpose of this study is to evaluate the corneal changes after performing 20 gauge vitrectomy associated with scleral buckling for the treatment of rhegmatogenous retinal detachment.

Patients submitted to 20-gauge vitrectomy associated with scleral buckling were evaluated with corneal topography before surgery and in the 7,30 and 90 days after surgery to asses corneal curvature changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rhegmatogenous retinal detachments

Exclusion Criteria:

* Previous eye surgery
The Therapeutic Effect of Thalidomide in Syringomyelia

Purpose: This phase II clinical trial aims to evaluate the indications, therapeutic effects and side effects of thalidomide in refractory syringomyelia.

Primary outcome measure: The primary endpoint is the change of ASIA at week 12. The clinical efficacy is defined as ASIA increase ≥ 1 at week 12, as compared with that before thalidomide usage.

The pathogenesis of syringomyelia is poorly understood and duraplasty or shunting is not always effective. Although it is generally thought that syringomyelia is simply an accumulation of CSF from the subarachnoid space, the pathogenesis is likely to be more complex and may involve cellular and molecular processes.

The investigators supposed that blood spinal cord barrier(BSCB) might play a key role in the pathogenesis of syringomyelia, especially post-traumatic syringomyelia(PTS), and that thalidomide, as an BSCB protection-related drug, would reduce BSCB damage and protect BSCB in syringomyelia.

Primary objectives: This phase II clinical trial aims to evaluate the indications, therapeutic effects and safety of thalidomide in refractory syringomyelia.

Eligibility Criteria:
Inclusion Criteria:

* Contraindication to duraplasty and shunting treatment due to history or high risk of severe adverse effects,
* or non-effective response to duraplasty and shunting treatment in 12 months prior to study entry.
* Estimated life expectancy must be greater than 12 months.
* Routine laboratory studies: bilirubin \</=1.0 \* upper limits of normal (ULN); aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT)\< 1.0 \* ULN; creatinine \<1.0 \* ULN; white-cell count \>/= 4,000 per cubic millimeter; neutrophils count \>/=1500 per cubic millimeter platelets \>/= 100,000 per cubic millimeter; Hb \>/=110 gram per millilitres; PT, APTT, INR in a normal range.
* Ability to understand and willingness to sign a written informed consent document, or constant caregivers who well understand and willingness to sign a written informed consent document.
* Must be able to swallow tablets

Exclusion Criteria:

* Evidence of tumor metastasis, recurrence, or invasion;
* History of psychiatric diseases ;
* History of seizures;
* History of arteriosclerotic cardiovascular diseases (ASCVD), e.g. stroke, myocardial infaction, unstable angina, within 6 months;
* New York Heart Association Grade II or greater congestive heart failure;
* Serious and inadequately controlled cardiac arrhythmia;
* Significant vascular disease, e.g. moderate or severe carotid stenosis, aortic aneurysm, history of aortic dissection;
* Severe infection;
* History of allergy to relevant drugs;
* Pregnancy, lactation, or fertility program in the following 12 months;
* History or current diagnosis of peripheral nerve disease;
* Abnormal in liver and renal function;
* Active tuberculosis;
* Transplanted organs;
* Human immunodeficiency virus;
* Participation in other experimental studies.
Geisinger Education Intervention Study in Obesity Protocol

Overweight and obesity has become an epidemic which warrants more aggressive treatment. However, few primary care physicians (PCPs) address this issue or do not possess adequate education regarding treatment modalities such as nutrition counseling or bariatric surgery. The primary goal of this study will be to determine whether the referrals for weight management can be influenced through obesity education.

Evaluation of educational interventions focusing on the treatment of obesity will include in person CME sessions, interactive game/virtual patient computer software and two 30 minute DVD/Web-based CME opportunities that the physicians can review at their leisure. These educational interventions were not completed as part of this research.

A control group will be comprised of those healthcare professionals who did not complete the CME survey.

Completion of the post education survey would be completed even if there was no study. The reward given to PCP's (free enrollment in CME session and either lab coat or $40 CME credit) was given for clinical purposes only and not for research. The study consists of the collection of PCP referral rates prior to the educational opportunity and then after the CME looking for a change to referral rates.

In June of 2009, an Obesity Educational Intervention Summit was attended by PCPs. This research seeks approval to perform data pulls consisting of referrals from their practice to the GI/Nutrition Clinic for potential bariatric surgery evaluation.

The information to be collected regarding the primary care providers' referral rates will be collected by a CDIS data pull by a data broker. The biostatistician will link survey responses to referral patterns and education type and will be true, only individual to have access to direct identifiers and in turn will provide PI and study team with de-identified summary data.

Eligibility Criteria:
Inclusion Criteria:

Geisinger General Internal and Family Medicine PCPs (include physician, physical assistants and CRNP):

* PCP must be active between May 2008 - May 2009
* Average patient age between 30-60 (no individual patients will be identified using personal identification)
* Minimum of 100 patients assigned to PC

Exclusion Criteria:

* PCPs from clinics/departments other than General Internal Medicine or Family Medicine will be excluded from the analysis
14/21 Diet-walking in the Park

The scientific literature shows a quantitative relationship between diet combined with physical activity as a long term weight reduction modality and an important factor in weight maintenance.

Primary assumption - the 14/21 diet will have an impact on BMI values, and their long-term maintenance.

Secondary assumption - the 14/21 diet will have a positive impact on anthropomorphic and biochemical markers, on blood pressure, resting heart rate, RMR, and life quality.

An interventional part for a duration of 56 days and a follow-up period including monitoring of different parameters. Follow up session are set to 3, 6, 12 and 24 months from the end of the interventional period.

Participants will be recruited in several rounds, each including up to 25 participants. Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.

The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group.During the intervention period subjects will meet for walking. In addition, 30 minutes of aerobic exercise will be recommended 3 times/week.

Eligibility Criteria:
Inclusion Criteria:

Hebrew speaking 25\<BMI\<30 18 years old or older signed an informed consent

Exclusion Criteria:

Subjects who have a physical disability preventing them from exercise, Subjects who are pregnant or lactating, Subjects who are currently involved in another lifestyle intervention program, Subjects who had undergone bariatric surgery in the past, Subjects with: cancer, liver/kidney disease, organ transplantation, alcohol/drug addiction, Subjects that have cognitive deterioration or psychosis, vegetarians who does't eat fish/sea food or vegans

-
The Application of Comprehensive Prevention and Treatment Strategy of Placenta Accreta Spectrum Disorders

Placenta accreta spectrum (PAS) disorders are pathological attachment of the placenta to myometrium, where trophoblastic cells invade the uterine placental interface. PAS can lead to severe postpartum hemorrhage or even maternal death. Prenatal diagnosis of PAS is essential for optimal obstetric management to improve the pregnancy outcomes. However, in some low resource regions in China, less than 20% PAS are detected before delivery.

To explore the feasibility and universality of the bundled prevention and treatment strategy for placenta accreta spectrum disorders in different levels of medical institutions, and to investigate its effectiveness in improving the specialized disease management capabilities of medical institutions at all levels. We will conduct a regional, cluster-randomized trial to assess a multicomponent PAS management strategy to improve the prepartum detection rate of PAS.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who have regular prenatal examination at the research hospitals
* Pregnant women diagnosed with PAS before or after delivery

Exclusion Criteria:

* Pregnant women who have never been diagnosed with placental implantation disease throughout the pregnancy
* Pregnant women who were lost to follow-up during the study period
Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients

The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food.

The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Both groups need to register their dietary intake in a period of 14 days and will be weighed three times during the intervention. At the end of the intervention they need to fill out a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* patients with leukemia, lymphoma or other malignant hematological disease
* adults
* be able to talk and understand danish
* be able to eat both solid and liquid food

Exclusion Criteria:

* not able to cooperate
* need for total tube or parenteral nutrition
* need for dialysis
Postoperative Hip Bracing After Hip Arthroscopy

Hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS) involves reshaping of the osseous sources of impingement ("osteoplasty") and treatment of impingement-associated labral tears with labral repair. Postoperative hip braces are advocated to decrease postoperative pain by offloading hip musculature. However there are no studies looking at efficacy of hip braces after hip arthroscopy, and on average 50% of high-volume hip arthroscopists use bracing. The objective of this study is to use a randomized controlled trial to test the cited benefits of postoperative hip bracing on short term patient reported pain scores, validated hip-specific pain scores, and physical exam findings of hip flexor tendonitis.

Hip arthroscopy for treatment of femoroacetabular impingement syndrome (FAIS) involves reshaping of the osseous sources of impingement ("osteoplasty") and treatment of impingement-associated labral tears with labral repair. The hip joint is subluxated with traction to accomplish this procedure. The diagnoses of FAIS and the incidence of hip arthroscopy have both increased dramatically in the last 20 years in the US -- in a recent study using IBM Marketscan to evaluate rates of hip arthroscopic treatment of FAIS, the investigators found this incidence doubled from 1.2 to 2.1 per 100,000 person-years in just a 3-year period. Despite the increasing incidence of hip arthroscopy in the US, on a recent review the investigators have found few evidence-based studies on postoperative care. A particular area of debate is the use of postoperative hip braces. Postoperative hip braces are advocated to decrease postoperative pain by offloading hip musculature. They may also prevent overuse of the hip flexors by supporting the hip during gait. However there are no studies looking at efficacy of hip braces after hip arthroscopy, and on average 50% of high-volume hip arthroscopists use bracing. The utility of bracing is important because hip braces are expensive (averaging $350-$600): if there are over 7000 hip arthroscopies performed nationwide and 50% of surgeons use hip braces, this amounts to over $2,000,000. The investigator's overall objective is to use a randomized controlled trial to test the cited benefits of postoperative hip bracing on short term patient reported pain scores, validated hip-specific pain scores, and physical exam findings of hip flexor tendonitis.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 14-60 on date of surgery
* Patient seen at the institution for the study
* Patient scheduled to undergo arthroscopic osteoplasty and labral repair for femoroacetabular impingement syndrome.

Exclusion Criteria:

* Any patient anyone who cannot follow up in person in clinic for the 6-week postoperative visit.
* Non-English speaking patients (due to limited validation of the patient reported outcome measures in non-English speaking populations).
Transverse Myelitis Related to SARS-CoV-2 Vaccines

Few patients receiving SARS-CoV-2 vaccines may experience rare but serious adverse events such as transverse myelitis (TM). Today, data about TM are scarce.

The objective was to investigate reports of TM adverse events related to SARS-CoV-2 vaccines labelled by FDA and EMA, including ChAdOx1nCov-19 (Oxford-AstraZeneca), BNT162b2 (Pfizer/BioNTech), mRNA-1273 (Moderna) and Ad26.COV2.S (Janssen/Johnson \& Johnson) and using the World Health Organization's (WHO) pharmacovigilance database: VigiBase.

Here, investigators use the World Health Organization's (WHO) database of individual safety case reports, to identify cases of TM related to SARS-CoV-2 vaccines.

Eligibility Criteria:
Inclusion Criteria:

- case reported in the World Health Organization (WHO) database (VigiBase) of individual safety case reports at the time of the extraction,

Exclusion Criteria:

* chronology not compatible between the SARS-CoV-2 vaccine adminisration and onset of TM.
* vaccines non-labelled by FDA/EMA (data cutoff december 10, 2021)
A Phase II Study in Patients With Alopecia Areata

This is a global Phase 2 study to evaluate the safety and effectiveness of an investigational study drug (called SHR0302) in adults with moderate to severe alopecia areata.

The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 3 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18-65 years of age (both inclusive), at the time of informed consent;
* Must have moderate to severe alopecia areata.

Exclusion Criteria:

* Other types of alopecia or other diseases that can cause hair loss
* Other scalp diseases that could interfere with assessment of hair loss/regrowth
* Any previous use of any Janus kinase (JAK) inhibitor