cyrilzakka/clinical-trials huggingface dataset:
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP)

This trial was to determine whether giving low-dose indomethacin to infants weight 500 to 999 grams (approximately 1 to 2 pounds) at birth improves their survival without cerebral palsy or developmental problems at 18 to 22 months of age.

Prophylactic indomethacin reduces patent ductus arteriosus (PDA) and intraventricular hemorrhage in very low birth weight infants. However, the effects of early indomethacin on long-term neurodevelopment remain uncertain. There is also insufficient evidence to rule out serious adverse effects, such as increases in the risk of necrotizing enterocolitis (NEC) and retinopathy of prematurity (ROP). The aim of this trial was to determine if prophylactic administration of indomethacin improves survival without neurosensory impairments in extremely-low-birth-weight infants. Infants (n=1202) with birthweights 500 to 999 grams were randomized between 2 and 6 hours after birth to receive either intravenous indomethacin (0.1 mg/kg) or equal volumes of normal saline placebo, daily for 3 days. The primary outcomes at a corrected age of 18 months was a composite of death, cerebral palsy, cognitive delay, deafness, or blindness. Secondary long-term outcomes were hydrocephalus necessitating the placement of a shunt, seizure disorder, and microcephaly. Secondary short-term outcomes were patent ductus arteriosus, pulmonary hemorrhage, chronic lung disease, cranial ultrasonographic abnormalities, nectrotizing enterocolitis and retinopathy. Infants were evaluated in follow-up at 18-22 months corrected age.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight 500 to 999 grams;
* Postnatal age greater than 2 hours;

Exclusion Criteria:

* Unable to administer study drug within 6 hours of birth;
* Structural heart disease and/or renal disease;
* Dysmorphic features or congenital abnormalities;
* Tocolytic therapy with indomethacin or other prostaglandin inhibitor within 72 hours prior to delivery;
* Overt clinical bleeding from more than one site;
* Platelet count less than 50 x 109/L;
* Hydrops;
* Not considered viable
Expression Pattern of HNRNPH1 and HNRNPK Genes in MPNs

The aim of the study is to evaluate the expression pattern of heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and K (HNRNPK) genes in Myeloproliferative neoplasms as a possible indicator of disease progression and as a potential therapeutic target

Self-renewing Hematopoietic pluripotent stem cells can develop into either myeloid or lymphoid lineages. A diverse range of diseases known as myeloproliferative neoplasms (MPNs) develop due to the aberrant proliferation of one or more terminal myeloid cell lines in the peripheral circulation. MPNs come in four traditional forms: chronic myeloid leukaemia (CML), polycythaemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF). Chronic neutrophilic leukaemia (CNL), chronic eosinophilic leukaemia (CEL), and MPN unclassifiable, were also included in the WHO classification. While PV, ET, and PMF are BCR-ABL1 negative, CML is BCR-ABL1 positive.

In eukaryotic cell's nucleus, many ribonucleoproteins (RNPs) assemble on to recently produced transcripts. The heterogeneous nuclear ribonucleoproteins (hnRNPs) are one type of RNPs. Some hnRNPs are now known to play a role in the development of human hematologic malignancies. Disease research is becoming more interested in how hnRNPs control gene expression. Numerous cancers exhibit changed hnRNPs expression levels, which raises the possibility that they play a part in carcinogenesis.

For instance, leukaemia cells showed downregulation of Heterogeneous nuclear ribonucleoprotein K (HNRNPK). In vivo myeloproliferative neoplasm tumour growth was accelerated by HNRNPK knockdown. On the other hand, A study suggests that HNRNPK overexpression could accelerate CML development and thus a possible indicator of CML progression and a potential therapeutic target might be HNRNPK.

Moreover, one of the earliest RNA-binding proteins (RBPs) to be identified, Heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) contributes to RNA stabilization, RNA editing, and RNA modification. Previous research has demonstrated that high levels of HNRNPH1 expression leads to carcinogenesis by both upregulating the expression of oncogenes and downregulating the expression of tumour suppressor genes such P53, Ron, and BCL-X.

The investigators performed the study with the aim to study the expression level of heterogeneous nuclear ribonucleoprotein H1 (HNRNPH1) and K (HNRNPK) genes and their proteins in MPNs and to investigate the association of HNRNPH1 and HNRNPK with molecular diagnostic tests of MPNs.

Eligibility Criteria:
Inclusion Criteria:

The study will be carried out on patients newly diagnosed with one of the myeloproliferative neoplasms based on WHO Criteria for diagnosis of MPNs whether males or females and of any age.

Exclusion Criteria:

* Other malignancies.
* Patients on chemotherapy or radiotherapy.
* Autoimmune diseases.
Evaluation of a New Bi-Condylar Total Knee Prosthesis (TKP) With All-Ceramic Friction (The Forgotten Knee)

The results of TKP (Total Knee Prosthesis) are satisfactory but do not reach those of THP (Total Hip Prosthesis) in terms of indolence and function. By using an all-ceramic friction torque, identical to that of the hip, the promotor of this Clinical Investigation expects to obtain an improvement in term of indolence, ability to perform heavy activities, knee stability and an improvement in the long-term survival of TKP, while at the same time, a decrease in the rate of re-intervention in young patients.

The aim of this study is to evaluate the all-ceramic knee prosthesis, according to clinical and radiological criteria of usual follow-up of a TKP for knee osteoarthritis, at 12 months.

Evaluation of clinical and radiographic endpoints at 12 months:

- Clinical: functional scores (Oxford and International Knee Society IKS), pain (from 0 to 6, better to worse outcome), knee mobility in flexion and extension (degrees), frontal and sagittal stability (in degrees and mm), joint sounds, Forgotten Joint Score (FJS).

The scores are mostly qualitative and all of them will be globally evaluated by the investigator regarding to the patient status.

-Radiographic: X-rays of the front and profile of the prosthesis, positioning of the implants (angle, axis), existence of borders (bone cement, prosthesis cement), presence of osteolysis or any notable element.

MRI will be performed to evaluate the creation of a specific fibrous tissue around the joint that is expected with a ceramic on ceramic bearing.

Eligibility Criteria:
Inclusion Criteria:

* Previously active adult under 70 years of age with disabling knee osteoarthritis resistant to medical treatments (anti-inflammatories, infiltrations, analgesics), with a frontal deformity \< 10° for a primary implantation
* Written informed consent by the patient
* Patients affiliated to the French social security system

Exclusion Criteria:

* Knee deformity \> 10
* Obesity (BMI \> 30)
* Inflammatory rheumatism
* History of infection
* Poor skin coverage at the knee joint
* Known allergy to the materials used and/or anesthetic used in the surgery
* Repeated falls, major neurological disorders, mental or neuromuscular disorders which can be a source of post-operative complications
* Significant functional deficit of the collateral ligaments
* Positive serum or urine pregnancy test for woman with child bearing potential. Pregnancy or within 48 hours post-partum or breast feeding women
* Phobic patient refusing to have an MRI
* Patient with a contraindication to have an MRI (active medical devices, metal implants, etc.)
* Patient under legal protection
* Patient participating in another Clinical Investigation
* Post fracture osteoarthritis
* Osteoporosis
* Anatomical configuration not allowing the implant to be fixed (depending on size constraints)
* Disabling comorbidity upon any resumption of physical activity
Obsessions and Suicidality in Youth With Bipolar 1 Disorder

Obsessive-compulsive disorder (OCD) is a common co-morbidity with bipolar I disorder, a comorbidity that is known to increase suicide risk. This study aimed to assess the presence of OCD in youth diagnosed with bipolar I disorder \& to evaluate the association between OCD and suicide in the same cohort.

Eighty subjects diagnosed with bipolar I disorder were enrolled in this study, subjects were divided according to the presence or absence of OCD to Group A: Bipolar disorder patients with OCD (n = 26), Group B: Bipolar disorder patients without OCD (n = 54). The following scales were applied: Dimensional Yale-Brown obsessive compulsive scale (DYBOCS)- Beck scale for Suicidal ideations (BSSI) - Hamilton depression rating scale (HDRS) and Young mania rating scale (YMRS).

The results revealed that DYBOCS score of group A was 30.23±0.43, \& of group B was 18.50±1.88 with a significant difference (p\<0.01). There was a significantpositive correlation between BSSI and age, age of onset and YMRS in Group A (p\<0.01).

The study demonstrated that OCD is a common comorbidity in youth with bipolar I disorder and may be associated with a greater risk of suicide than in youth with bipolar I disorder without co-morbid OCD. Furthermore, co-morbidity of OCD with bipolar I disorder in youth may be associated with younger age of onset and more severe symptoms profile.


Eligibility Criteria:
Inclusion Criteria:

- Can read and write, agreed to sign the consent, diagnosed with bipolar I disorder

Exclusion Criteria:

* refused to sign the consent, active manic phase, recent substance use
Simultaneous Fluoroscopic and Endoscopic Examination of the Oropharyngeal Phase of Deglutition

To correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES).

The specific aim of this study is to correlate findings between two commonly-used types of swallowing studies: videofluoroscopy and flexible endoscopic evaluation of swallowing (FEES). Specifically, the timing of swallowing events will be correlated between teh two studies. In addition, the pharyngeal constriction ratio (a validated measure of pharyngeal strength on videofluoroscopy) will be compared with the pharyngeal squeeze maneuver (an assessment of pharyngeal strength on FEES), with the hypothesis that there will be a strong correlation between PCR and pharyngeal squeeze.

Eligibility Criteria:
Inclusion Criteria:

* complaints of dysphagia
* scheduled to undergo videofluoroscopy
* able to tolerate both videofluoroscopic evaluation of swallowing and FEES

Exclusion Criteria:

* age less than 18
* contraindications to videofluoroscopy (reaction to barium, possible pregnancy)
* contraindications to FEES (bilateral obstructing nasal pathology or nasopharyngeal stenosis)
* specific/vulnerable populations (children, mentally handicapped, pregnant women, fetuses, prisoners, cognitive impairment, life-threatening disease, social or economic disadvantage)
Efficacy of Kinesio Taping in Musculoskeletal Neck Pain

The aim of this study is to compare efficacy of Kinesio taping against a conventional tape in a patient with cervical musculoskeletal pain. For this, a double-blind controlled clinical trial be carried out in patients with musculoskeletal neck pain.

During the months of May to July 2021, a research assistant will contact potential participants who will be invited to participate in this study. Once they agree to participate, it will schedule for a face-to-face consultation at the university, where the main researcher will inform the study participants. Once the information sheet and informed consent will be a sign, an investigator will carry out the measurements of the variables for initial data collection in the first session. In another room, an expertise physiotherapist with experience in applying Kinesio taping will perform interventions on patients on the same day as the initial evaluation. It this way, the investigator that will assess outcomes will be blind to the treatment that each patient will receive.

At the second consultation, 4 days after the first, the same physiotherapist who applied the bandage will remove it from the patients who received it and any remains of the bandage on the skin were cleaned. For patients in the control group (nothing apply), it will be the same protocol to alter, not the double-blind. The principal investigator will perform the evaluations and data collection without knowing the intervention the patient will receive.

In a third consultation, as a follow-up (30 days after the second consultation), the collection of the same measurements and clinical variables from the patients who completed the process will repeat by the same investigator that did the outcomes' assessment.

Eligibility Criteria:
Inclusion Criteria:

* Presence of myofascial pain syndrome (MPS) and myofascial trigger point (MTP) in the upper trapezius muscle, according to the diagnostic criteria proposed by the American Academy of Pain Medicine(2) and the scientific community (3) a) tender point on palpation, with or without referred pain b) patient recognizes pain during tender point palpation c) at least three of the following: muscle stiffness or muscle spasm, limited range of motion in an associated joint, increase of pain with stress, palpation of tight band and / or nodule, associated with a tender point
* understand written Spanish.

Exclusion Criteria:

* Neck pain of traumatic origin, due to recent surgery or causing radiculopathy
* Have been diagnosed with chronic pathology, as well as neoplastic or suspicion of it
* Have received some type of pharmacological or non-pharmacological analgesic treatment in the last 30 days.
* Pregnant or menstrual women
Effects of Metabolic Testing Data and Education on Attitudes and Beliefs Related to Carbohydrate Intake in Adolescent Female Athletes

Many studies have consistently shown that females across sports under consume carbohydrate. Registered dietitians working with athletes have also reported female athletes chronically under consume carbohydrate. The primary objective of this study is to compare the effectiveness of education versus education plus interpreted individual metabolic (exercise) testing results to change attitudes and beliefs of female athletes regarding carbohydrate intake. The secondary objective is to assess the effectiveness of the education alone on attitudes and beliefs towards consuming carbohydrate in female athletes.

The study hypothesis is that education alone will not significantly impact attitudes and beliefs, and that metabolic testing and the interpretation of the individual results will alter attitudes and beliefs toward carbohydrate intake.


Eligibility Criteria:
Inclusion Criteria:

1. Females aged between the ages of 13-19 years old
2. Non-smoker
3. Currently enrolled in an IMG Academy sport
4. Willing to fast overnight (10 hours) prior to testing (for metabolic testing group).
5. Understand the protocol and be able to give verbal and written informed consent for participation as well as obtain parental consent if \<18 years of age.
6. Must be fluent in English reading, writing, and speaking.
7. You are not employed by, or have a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If you are unsure if a company would be considered a competitor to Gatorade, let the study investigator know the name of the other company and the nature of your relationship to that company before you sign the informed consent
8. If subject has asthma, they may still participate in but will be required to bring their prescribed inhaler if placed in the metabolic testing group

Exclusion Criteria:

1. Expulsion from school for any reason
2. Leaving the IMG sports team
3. Pregnant or planning to become pregnant
4. Participated in any other clinical trial in the past 30 day
5. Participated in any PepsiCo trial in the past 6 months
6. Physical injury that would prevent participation in exercise group
Study to Assess the Management of Synthetic Disease-modifying Antirheumatic Drug (DMARD) at the Onset of Adverse Events, Intolerance or Lack of Efficacy in Rheumatoid Arthritis (RA)

The purpose of this study is to find patterns in the use of non-biological DMARDs as the initial treatment of RA and how adverse events (AEs), intolerance or lack of efficacy may impact therapeutic decisions in real life in the Spanish Andalusian region.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes ≥ 18 years.
* Patients diagnosed with RA (according to the American College of Rheumatology (ACR) 2010 criteria) between January 2008 and December 2012 and who have initiated treatment with at least one synthetic DMARD during that period.
* Patients who have given written informed consent for their data to be collected and reviewed.

Exclusion Criteria:

* Patients who are already participating in a clinical trial/s at the moment of participation in this study.
* Patients with whom it is suspected there will be insufficient information to complete the study objectives.
Pediatric Source Control for Hazardous Particulate Exposure in Aerosol Generating Procedures

There are two purposes of this study. The first purpose is to determine the exposure seen by medical providers (e.g. anesthesiologists, surgeons, and nurses) to infectious and smoke particulates generated during anesthesia-related aerosol generating medical procedures (AGMPs) and pediatric otolaryngologic surgeries (with and without an intubated airway). The second goal of this study is to apply a local exhaust ventilation system (LEVS) to re-evaluate the exposure seen by the same medical providers during the same AGMPs and surgeries.

Prior to the patient entering the OR, particle counters (Digital PM2.5 Air Quality detector, ExGizmo, China) will ensure that the OR air quality has undergone the appropriate airflow exchanges and thus will all read 0.

Measurements will be taken every 30 seconds. A research assistant in the periphery of the OR will observe and record the following events: patient entrance into the OR, initiation of mask induction, intubation, rotation of OR table for surgery, initiation of surgery, completion of surgery, rotation of OR back to anesthesia, extubation, and patient departure from the OR. The particle counters will be positioned accordingly: 1) at the level of the patient's head, 2) at the level of the anesthesiologist/surgeon performing the AGMPs, 3) to the right of the patient, 4) to the left of the patient, 5) at the anesthesia workstation, and 6) at the circulating nurse's computer in the corner of the room. The particle counters will continue with measurements until the patient exits the OR. For patients randomized to the LEVS group, active suction will be provided through the use of a closed biohazardous smoke evacuation system (Neptune 3, Stryker, Michigan, USA) equipped with an internal high efficiency particulate air (HEPA) filter capable of capturing aerosolized particles as small as 0.1 mm with 99.99% efficiency via suction power up to 25 cubic feet per minute air exchange. The active suction will be positioned near the patient's airway without interfering with the AGMP, and across from the location of the anesthesiologist or surgeon performing the AGMP such that no HCW is positioned between the patient's airway and the suction device.

Eligibility Criteria:
Inclusion Criteria:

* children receiving anesthesia-related aerosol generating medical procedures

Exclusion Criteria:

* patients with positive COVID symptoms
* positive preoperative COVID testing
Role of Inflammation in Vascular Phenotype Associated with E-cigarette Use

The use of electronic nicotine delivery systems, or e-cigarettes - colloquially referred to as "vaping" - in the United States has increased exponentially since their introduction to the US market in 2007. Prevalence of ever and current e-cigarette use is highest among teenagers and young adults with 16-28% of this population having reported vaping. While the majority of e-cigarette users are current tobacco smokers, 32.5% of current e-cigarette users are never- or former-smokers, representing a growing population of young adults who exclusively vape. While e-cigarettes have been marketed as a safer alternative to tobacco cigarettes, clinical studies examining these claims are limited. Cardiovascular disease (CVD) is the primary cause of premature death among tobacco cigarette smokers and reductions in vascular endothelial function, a significant predictor of future CVD, are detectible in otherwise healthy young adults who smoke. Despite the explosion in e-cigarette use among young adults, the health effects - especially the effects on mechanisms of vascular function - of these devices remain relatively unexplored. The purpose of this study is to directly asses the mechanistic role of inflammation in this dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 24 years of age
* no history of e-cigarette use (control) OR current with 6 months or more history of e-cigarette use (chronic use).

Exclusion Criteria:

* tobacco cigarette use (current or history of)
* use of stimulant drugs
* skin diseases
* cardiovascular disease
* diagnosed or suspected hepatic or metabolic disease including diabetes
* statin or other cholesterol-lowering medication
* antihypertensive medication
* current pregnancy or breastfeeding
* blood pressure greater than or equal to 140mmHg systolic and/or greater than or equal to 90mmHg diastolic
* allergy to materials used during the experiment
* known allergies to salsalate or other study drugs
A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety

This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit 2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 \[telephone visit\]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.

See approved Package Insert for Adverse Event information.

Eligibility Criteria:
Inclusion Criteria:

* Currently being treated with conventional alprazolam

Exclusion Criteria:

* Dose of greater than 10 mg