cyrilzakka/clinical-trials huggingface dataset:
Nasal vs Oral Breathing in Drug Induced Sleep vs Natural Sleep

This project will provide important new information regarding (1) the relationship between route of breathing and airway collapsibility and (2) whether route of breathing during DISE (Drug-Induced Sleep Endoscopy) is representative of natural sleep.

As part of standard of care, a drug-induced sleep endoscopy will be done, where route of breathing will be determined as a percentage of total breaths (during baseline, lateral sleep and maneuver). As part of the research procedure, an in-laboratory Polysomnogram will be conducted as study procedure including a oronasal pressure signal cannula to assess route of breathing.

Eligibility Criteria:
Inclusion Criteria:

* • Adults (≥ 18yrs) that underwent clinical evaluation at the CPAP Alternatives Clinic at Penn Otorhinolaryngology.

  * Must have at least mild OSA (AHI\>5)

Exclusion Criteria:

* • Sleep study with an AHI\<5, \>25% of total events being central or mixed events, or inability to achieve adequate drug-induced sleep.

  * Upper Respiratory Illness at the time of the DISE.
Evaluation of Triathlon - A New Total Knee Prosthesis System - RSA Triathlon Standard vs. Short Keel

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

The objective is to investigate the Clinical, Radiographic, Roentgen Stereophotogrammetric behaviour and patient outcome when using the Triathlon total knee prosthesis in a prospective randomized clinical trial.

The evaluation is carried out by a prospective randomised RSA-study with Triathlon Standard vs. Short Keel.

Eligibility Criteria:
Inclusion Criteria:

1. Patients suffering exclusively from OA, Stage II-V \[Ahlbäck-Traumascore, 1968 391\] will be operated.
2. Patients requiring knee prosthesis, suitable for the use of Duracon and Triathlon knee system
3. Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographical evaluations and the prescribed rehabilitation.
4. Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria:

1. Previous major knee surgery
2. Other significant disabling problems from the muscular-skeletal system than in the knees
3. Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI above 35).
4. Patients with active or suspected infection.
5. Patients with malignancy - active malignancy.
6. Patients with severe osteoporosis, Paget's disease, renal osteodystrophy.
7. Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
8. The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
9. Female patients planning a pregnancy during the course of the study.
10. Patients with systemic or metabolic disorders leading to progressive bone deterioration.
11. Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
12. Patients with other severe concurrent joint involvements, which can affect their outcome.
13. Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
14. Patients under the protection of law (e.g. guardianship).
Investigating the Structured Use of Ultrasound Scanning for Fetal Growth

Fetal growth restriction during pregnancy represents one of the biggest risk factors for stillbirth (Gardosi et al, 2013), with 'about one in three term, normally formed antepartum stillbirths are related to abnormalities of fetal growth' (MBRRACE, 2015).

Therefore, antenatal detection of growth restricted babies is vital in order to be able to monitor and decide the appropriate delivery timing.

However, antenatal detection of SGA babies has been poor, varying greatly across trusts in England in those that calculate their rates (NHS England, 2016). Most trusts do not calculate their detection rates and rates are therefore unknown. It is estimated that routine NHS care detects only 1 in 4 growth restricted babies (Smith, 2015).

Oxford University Hospitals NHS Foundation Trust, in partnership with the Oxford Academic Health Science Network (AHSN) has introduced a clinical care pathway (the Oxford Growth Restriction Pathway (OxGRIP)) designed to increase the rates of detection of these at risk babies. The pathway is intended to increase the identification of babies who are at risk of stillbirth, in order to try to prevent this outcome, whilst making best usage of resources, and restricting inequitable practice and unnecessary obstetric intervention.

It has been developed with reference to a body of research, however, the individual parts of care provided have not been put together in a pathway in this manner before. Therefore it is important to examine whether the pathway meets its goals of improving outcomes for babies in a 'real world' setting.

The principles of the pathway are

1. A universal routine scan at 36 weeks gestation.
2. Additional growth scans at 28 and 32 weeks gestation based on a simplified assessment of risk factors and universal uterine artery Doppler at 20 weeks gestation.
3. Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR).

The clinical data routinely collected as a result of the introduction of the pathway offers a valuable and unique resource in identifying and analysing in the effects of the pathway on its intended outcomes and also in investigating and analysing other maternal, fetal and neonatal complications and outcomes, establishing normal / reference ranges for ultrasound values.

There is no requirement for patient participation in this study. All data collected and analysed is routinely collected clinical data.

Eligibility Criteria:
Inclusion Criteria:

• All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019 with no exclusion criteria

Exclusion Criteria:

* Women who have opted out of research related to pregnancy in this pregnancy whilst receiving care by the OUHFT.
* If intrapartum care takes place outside of the OUHFT.
Hemostatic Measures During Laparoscopic Cystectomy for Endometrioma

laparoscopic excision of ovarian endometriotic cysts is generally recommended because it has been associated with a higher spontaneous conception rate, residual ovarian function after the procedure may be affected


Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years
* unilateral endometriotic cyst

Exclusion Criteria:

anovulatory women women with decreased ovarian reserve women receiving hormonal treatment three months prior to surgery women with any contraindication to laparoscopy women with previous ovarian surgery possible ovarian malignancy.
Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.

The purpose of this study is to evaluate changes in vascular parameters and International Index of Erectile Function (IIEF) scores with the administration of Platelet Rich Plasma (PRP) to participants with Erectile Dysfunction (ED)


Eligibility Criteria:
Inclusion Criteria:

1. Be Male
2. Be 30 to 75 years of age (inclusive).
3. Be able to provide written informed consent.
4. Have a diagnosis of ED due to organic origin for at least 6 months prior to consent.
5. Sexually active in a stable, heterosexual relationship of more than three months duration.
6. IIEF-EF score 11-25 at screening (even if taking a single PDE5).
7. Agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs.
8. Agree to comply with all study related tests/procedures.

Exclusion Criteria:

1. Previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting.
2. Previous history of priapism or penile fracture
3. Abnormal morning serum testosterone level defined as a value lower than 300 ng/dL (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dL (±5%).
4. Current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
5. Psychogenic ED as determined by study investigator.
6. Anatomical (Peyronie's Disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area.
7. Patients using Intra Cavernous Injection (ICI)for management of ED
8. Patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or Parkinson's disease.
9. Have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study.
10. History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
11. Any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. Patients who are currently using Selective Serotonin Reuptake Inhibitor or psychotropic medications.
12. Hemoglobin a1c \>9%.
ALK27-001: A Study of Trospium Inhalation Powder (TrIP)Administered to Subjects With COPD

The purpose of this study was to evaluate the efficacy, safety, and tolerability of single doses of trospium inhalation powder (TrIP) administered to subjects with chronic obstructive pulmonary disease (COPD).

This was a single-center, randomized, double-blind, cross-over, placebo-controlled study. Following screening, each eligible subject was randomized to a dosing sequence. Study subjects received a total of 5 single doses, each separated by a 3- to 14-day washout period. Doses A, B, C, and D were administered in a double-blind fashion, in sequences generated by a 4-period Latin square design. The 4 dosing sequences were: ABCD, BDAC, CADB, and DCBA. Dose E was administered in an open-label fashion as the final dose in each dosing sequence for all subjects.

Subjects reported to the clinic the evening prior to each dose. Protocol assessments were carried out until 24 hours postdose. Pulmonary function testing (via spirometry) was captured at specified timepoints at baseline as well as before and after dosing. Other efficacy and safety outcomes were assessed according to protocol. Blood sampling was performed for assessment of trospium concentrations at specified timepoints.

Eligibility Criteria:
Inclusion Criteria:

* Male or female COPD subjects between the ages of 40 and 80 years
* Body mass index between 18 and 35
* Medically healthy (other than COPD)
* FEV1/FVC less than or equal to 0.70
* Current non-smoker or able to abstain from smoking for at least 8 hours postdose
* Within the previous 6 months, demonstrated improvement in FEV1 (greater than or equal to 10%) 1 hour following administration of ipratropium bromide inhalation (4 puffs)
* Females of childbearing potential must agree to use an acceptable method of contraception for the duration of the study

Exclusion Criteria:

* Asthma in the last 10 years
* Allergic rhinitis, atopy, cystic fibrosis, bronchiectasis, or tuberculosis
* Bladder neck obstruction, including urinary retention or known symptomatic prostatic hypertrophy not controlled with medication
* Narrow angle glaucoma
* Tachyarrhythmia
* Alcohol dependence or illicit drug abuse within the past year
* Using long-term oxygen therapy
* Female subjects who are pregnant or breastfeeding
* Participating in another clinical trial
BFR Training on a Bike to Augment RC Strength, Leg Strength, and VO2 Peak

This study will investigate if subjects who bike at 40% of heart rate reserve (HRR) with blood flow restriction (BFR) applied to bilateral thighs for 10 minutes (at 80% limb occlusion pressure) will experience greater gains in 10 rep max for dominant lower extremity leg press, greater gains in rotator cuff strength (hand held dynamometer testing for supraspinatus and external rotators) and greater gains in VO2 peak.

This study will randomize healthy adult subjects to one of two groups: a BFR biking group that performs 10 min of cycling at 40% heart rate reserve (HRR) with bilateral occlusion applied to the proximal thighs (80% LOP) or to a non-biking BFR group perform 10 min of cycling at 40% HRR. After each cycling session subjects will perform 3x15 of the scaption exercise and 3x15 sidelying external rotation with their dominant upper extremity. They will initially start training the shoulder at 30% of 1RM (estimated from an equation formula) for the first 2 weeks followed by increasing training load by 1lbs each exercise every 2 weeks. The training program will last 6 weeks (3x week for 6 weeks, total of 18 sessions).

Pretest and posttests will include: VO2 peak testing on a cycle using Cosmed metabolic cart, hand held dynamometry to measure strength of the supraspinatus and external rotators of the shoulder using traditional manual muscle test positions, and on a separate day 10RM testing on a leg press for the dominant lower extremity.

Eligibility Criteria:
Inclusion Criteria: healthy adults (18 yrs of age and older) -

Exclusion Criteria: no current musculoskeletal symptoms/injuries; no prior lower extremity or shoulder/upper extremity surgery (dominant) during the prior year; no contraindications to BFR training

-
Quality of Life Assessment of Radiotherapy in Recurrent Head and Neck Cancer

The purpose of this study is to examine the uses of a mobile health-based assessment and symptom monitoring platform.

This study will involve patients who have been diagnosed with head and neck or gynecologic cancers and are receiving radiation treatments via the QUAD shot regimen. It is a single arm pilot trial designed to provide information on the ease of use, feasibility, and perceived usefulness of a smartphone application to monitor symptoms and quality of life during cancer treatment, as well as assess barriers to care and perceptions of the smartphone app.

Patients will download the study app onto their personal smartphone, if the phone is compatible with the app, or a study smartphone will be loaned to them. The smartphone app will first ask patients to complete the 15-25 minute baseline survey, followed by one daily brief survey that ask about symptoms, quality of life, and barriers for 75 days. At the end of this period, the smartphone app will prompt the patient to complete a final survey, followed by a brief in-person or telephone interview to assess opinions about the app. Patients' symptoms, treatment effects, medication adherence, pain, quality of life, and general barriers to care will be assessed with questionnaires to measure the impacts of the mobile health-based assessment platform. Results from this study will be for research only and will not impact treatment decisions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Written informed consent and any locally-required authorization obtained from the patients prior to performing any protocol-related procedures, including screening evaluations
* Pathologically (histologically or cytologically) proven diagnosis of cancer of the head and neck (nasopharynx, oral cavity, oropharynx, hypopharynx, larynx, or unknown primary) or Gynecologic cancers (cervical and endometrial)
* Locally recurrent or metastatic HNC or Gyn cancer not deemed amenable to curative-intent salvage therapy, in whom at least six months have passed since their prior RT, if received
* Must have evaluable lesion per RECIST v1.1
* Patients agree to provide their smoking history prior to registration
* ECOG performance status of 0-2

Exclusion Criteria:

* Prior radiotherapy to the region of the study cancer within less than 6 months
* Patients who have received prior radiation therapy and who, in the opinion of the treating radiation oncologist, cannot be reirradiated safely without excess risk of severe toxicity given prior radiation dose to critical structures.
* Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., Ataxia-Telangiectasia, Nijmegen Breakage Syndrome)
* Female patients who are pregnant
A Study to Assess Change in Disease Activity in Adolescents and Adults With Moderate to Severe Prurigo-type Atopic Dermatitis in Japan Who Are Treated With Oral Upadacitinib

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Around one-third of patients with AD have had at least 1 incidence of prurigo nodularis (PN), which is characterized by intense, persistent itchy skin and sometimes pain with burning. In this study, the effectiveness of upadacitinib (UPA) will be assessed in participants with prurigo-type AD in a real world (RW) setting in Japan.

UPA is an approved drug for the treatment of AD. Adults and adolescents who have been diagnosed with prurigo-type AD and prescribed UPA according to the label and practice in Japan will be enrolled in this observational study. The doctor's decision to prescribe UPA will be made prior to and independently of study participation. Approximately 200 participants will be enrolled in the study at 10 sites in Japan.

Participants will receive extended-release oral tablets of UPA once-daily for 48 weeks.

There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic.


Eligibility Criteria:
Inclusion Criteria:

* Physician confirmed diagnosis of moderate to severe atopic dermatitis (AD) at baseline
* AD symptom onset \> 1 year prior to baseline
* Initiation of UPA treatment for AD is indicated and prescribed per the label in Japan
* Worst Pruritus Numerical Rating Scale (WP-NRS) ≥ 4 at baseline
* Presence of palpable prurigo nodules at baseline

Exclusion Criteria:

* Prior treatment with UPA
* Contraindications to UPA
* Chronic pruritus resulting from another condition (e.g., neuropathic disorders) than AD, prurigo nodularis (PN)
* PN caused by medication, metal allergy, infection, insect bite
* Current participation in interventional research
Combined Use of Contact Aspiration and the Stent Retriever Technique Versus Stent Retriever Alone for Recanalisation in Acute Cerebral Infarction

Mechanical thrombectomy (MT) with a stent retriever (SR) device is now the standard intervention in ischemic stroke with large vessel occlusion. Favorable outcome is strongly associated with the successful reperfusion status. New device of MT such as contact aspiration seems promising to increase reperfusion status and clinical outcome.

The main hypothesis is to show the superiority of combining the use of contact aspiration with a stent retriever compared to a stent retriever alone in treatment of acute stroke due to proximal arterial occlusion.

The primary endpoint is the rate of perfect reperfusion score at the end of the endovascular procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and older (i.e., candidates must have had their 18th birthday)
* Groin puncture carried out within 8 hours of first symptoms
* Neuroimaging demonstrates large vessel proximal occlusion (distal ICA through MCA bifurcation, M1 or M2)
* Consenting requirements met according to French laws.
* With or without intravenous thrombolysis

Exclusion Criteria:

* Absence of large vessel occlusion on non-invasive imaging
* Known or suspected pre-existing (chronic) large vessel occlusion in the symptomatic territory
* Suspected pregnancy; if, a woman is of childbearing potential, a urine or serum beta human chorionic gonadotropin (betaHCG) test is positive.
* Severe contrast medium allergy or absolute contraindication to iodinated agents.
* Patient has severe or fatal comorbidities that will likely prevent improvement or follow-up or that will render the procedure unlikely to benefit the patient.
* Acute ischemic stroke involving posterior circulation (vertebrobasilar occlusion)
* Angiographic evidence of carotid dissection or tandem cervical occlusion or stenosis requiring treatment.
* Patients benefiting from a legal protection
* Non-membership of a national insurance scheme
* Opposition of the patient or (in case of inclusion as a matter of urgency) of the trustworthy person
Use of HA 330-II for Hemofiltration in Patients With ALF as a Bridge to Liver Transplantation .

ALF (ALF) is defined by three criteria: (1) rapid development of hepatocellular dysfunction (jaundice, coagulopathy), (2) hepatic encephalopathy, and (3) absence of a prior history of liver disease.

Interval between onset of acute hepatic injury (jaundice) and onset of liver failure (encephalopathy with or without coagulopathy) in such patients (icterus-encephalopathy interval; IEI) has been described to be between 4 weeks (Indian definition) to 24 weeks (AASLD-ALF study group). Further, due to the diverse natural course, ALF has been sub-classified as hyperacute (IEI ≤ 7 day), acute (IEI ≤ 4 weeks) and sub-acute ALF (IEI ≥ 5 week to ≤12 weeks) by British authors.

Since the 1960s, Liver Transplantation (LT) has emerged as a cornerstone intervention to cure liver failure. Mortality in patients with liver failure who cannot be rescued with Liver Transplantation remains high despite improvements in supportive care.

Artificial Liver Support System (ALSS) in ALF aim to remove excess inflammatory cytokines and attenuate inflammatory response, to remove albumin-bound and water-soluble toxins, to restore and preserve hepatic function and mitigate or limit the progression of multiorgan failure while hepatic recovery or liver transplant occurs. ALSS may also provide benefit in instances where LT is contraindicated.

The following beneficial effects have been documented with ALSS in ALF patients: improvement of jaundice, amelioration of hemodynamic instability, improvement of hepatic encephalopathy, SOFA score and survival.

HA 330-II is a broad-spectrum adsorbent made of neutral macroporous resin, removes toxins such as Inflammatory mediators (IL-1, IL-6, IL-8 \& TNF-α) along with hepatic toxins such as phenol, mercaptan, aromatic amino acids, false neurotransmitters and indirectly ammonia by improving liver function recovery. However, this indirect ammonia removal with HA 330-II is insignificant. By removing excess inflammatory cytokines and attenuating uncontrolled immune response, HA 330-II prevents worsening of encephalopathy, improves liver function recovery and improves prognosis.

Eligibility Criteria:
Inclusion Criteria:

• Acute Liver Failure patients with SIRS and Hepatic Encephalopathy, without hyperbilirubinemia.

Exclusion Criteria:

* Patients with age less than 18 years or more than 65 years
* Extremely moribund patients with an expected life expectancy of less than 24 hours or with poor prognosis
* With poor blood clotting function and PTA \<30%.
* Active Bleed
* Chronic heart, lung or kidney disease
* Malignant tumors including liver cancer
* Past history of organ transplantation