cyrilzakka/clinical-trials huggingface dataset:
Ultrasound Airway Examination as a Tool for Detection of Difficult Intubation in Adult Patients

the goal of the observational study to measure the effectiveness of neck ultrasound in prediction of difficult intubation in adult patients

All participant undergoing elective surgery under general anesthesia will go a detailed preoperative sonographic assessment by the anesthesiologist who has experience in airway ultrasound for measurement of Hyomental distance, thyrohyoid distance, thyroid cricoid, anterior soft tissue thickness at levels of hyoid bone, cricoid cartilage and vocal cord and all measurement will be measured in neutral and sniffing position.

after induction of general anesthesia intubation will done by macintosh laryngoscope and degree of difficulty of intubation will be measured by cormack-lehane classification without any external manipulation

Eligibility Criteria:
Inclusion Criteria:

* Adult patients above18 years old
* Both sex
* Requiring general anesthesia with endotracheal intubation

Exclusion Criteria:

* Emergency surgery,
* patients with limited mouth, head or neck movement,
* patients with temporomandibular joint impairment,
* fracture or tumors of mandible,
* patients requiring awake intubation,
* uncooperative patients,
* any cervical spine limitation movement
* neck swelling or tumor
* Prominent teeth deformities.
Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting

Clinical trials organization in several neuromuscular disorders (NMD) has some specific issues. Nonambulant status and difficulties with transportation are among them. Moreover a lot of patients with NMD have so poor condition that even short transportation is able to worse it. Such situation forces researchers to limit a region of recruitment for clinical trials and to exclude from trials more severe subgroup of patients, which cause additional issues especially for rare diseases.

The purpose of this study is to prove hypothesis about possibility to reliably monitor patient condition remotely, without trial site visiting. Visit-free study design is potentially able to widen eligible patient population and to decrease patient dropout rate as well as burden of numerous assessments. Meanwhile assessment frequency could be increased enabling monitoring of short fluctuations in patients' condition.

Spinal muscular atrophy (SMA) is a rare neuromuscular condition to which all mentioned above issues are completely applicable. Direct current stimulation (DCS) of neural structures is well studied and safe intervention, however, its effects on SMA patients' strength and durability has not been reported for today. The investigators suppose that investigation of DCS action in SMA patient population is an adequate model for visit-free design feasibility, reliability and sensitivity evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* 5q SMA confirmed by molecular testing

Exclusion Criteria:

* Need for ventilation
* Hypersensitivity (pain or allergic reaction) to current stimulation
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Columbia

This is a Columbian, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects will provide their Informed Consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected both retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

• To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To identify adherence subject profiling
* To assess the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above, below or within normal ranges)

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to Summary of Product Characteristic (SmPC)
* Over the age of \>2 years
* Under \<18 years of age, or over 18 without fusion of growth plates
* Parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the SmPC
* Use of an investigational drug or participation in another interventional clinical study
Trial of Antihypertensive Intervention Management

The objective of the Trial of Antihypertensive Intervention Management (TAIM) was to determine the efficacy of dietary management and/or drug therapy, namely thiazide-like diuretics or a beta-blocker, in the control of mild hypertension. Additionally, the Continuation of the Trial of Antihypertensive Intervention Management (COTAIM) tested the effects of long-term weight reduction, and sodium/potassium changes added to weight reduction, as well as the original drug treatment, on the failure rate of blood pressure control.

BACKGROUND:

The Trial of Antihypertensive Intervention Management was an extension of the NHLBI-supported Dietary Intervention Study of Hypertension (DISH) which concluded in March 1984 and showed that either weight reduction or sodium restriction diets reduced relapse rates of hypertensives who had received long-term drug treatment and then been withdrawn from drugs. TAIM was initiated in April 1984 and continued for four years at three centers and added to DISH the art of evaluating combined drug and dietary treatments. COTAIM was continued at three clinical sites in July 1988. Analysis of COTAIM results continued through November 1994 under grant R01HL40072.

DESIGN NARRATIVE:

TAIM patients were randomly assigned to one of three diets and to one of three drug regimens. The dietary interventions consisted of a weight loss program, sodium reduction with increased potassium intake, or no change in diet. The drug regimen consisted of a beta-blocker (atenolol), a thiazide-like diuretic (chlorthalidone), or placebo. The major endpoint was change in diastolic blood pressure after six months of intervention. Individuals who did not reach goal blood pressure after six months received additional drugs. Other endpoints included total risk factor score change, psychological function, and lifestyle change.

COTAIM consisted of two studies with a total of 600 subjects. COTAIM I compared the TAIM weight loss group to a randomly selected half of the usual diet group. The primary endpoint of COTAIM I was the degree of control of blood pressure on initial TAIM therapy between TAIM baseline and the end of COTAIM, a five year period.

COTAIM II added a weight loss regimen both to the sodium restriction/potassium supplementation groups and to the other half of the usual diet group. The primary outcome was control of blood pressure on initial TAIM therapy between COTAIM baseline and the end of COTAIM, a two-year period.

Eligibility Criteria:
Men and women, ages 21 to 65, with mild hypertension in the range of 90 to 100 mm Hg diastolic blood pressure.

Subjects were obese (110-150 percent of ideal weight).
Expanded Access Protocol of 68Ga-PSMA-11 for PET Imaging

To provide expanded access to 68Ga-PSMA-11 PET imaging for eligible participants to detect and localize prostate cancer for initial and subsequent treatment strategy.

Prostate-specific membrane antigen (PSMA) targeted Positron Emission Tomography (PET) imaging has been embraced enthusiastically worldwide. Given the unmet clinical need for accurately diagnosing and staging prostate cancer and the encouraging results of 68Ga-PSMA-11 PET worldwide, University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) conducted pivotal registration trials to assess 68Ga-PSMA-11's safety and efficacy profile in detecting prostate cancer in adult patients. To gap the unmet clinical need of 68Ga-PSMA-11 PET during the period prior to FDA approval, UCLA Nuclear Medicine offers expanded access of this investigational PET drug to eligible participants.

Eligibility Criteria:
Biochemical recurrent (i. Inclusion/Exclusion) and preprostatectomy (ii. Inclusion/Exclusion) staging patients will be eligible for the expanded access protocol. In order to be eligible to participate in this study, an individual must meet the following criteria:

Biochemical Recurrence Population:

i. Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma.
* Rising prostatic specific antigen(PSA) after definitive therapy with prostatectomy or radiation therapy.

  * Post radical prostatectomy (RP)
  * PSA equals to or greater than 0.2 ng/mL measured more than 6weeks after RP
  * Post-radiation therapy -ASTRO-Phoenix consensus definition
  * Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group (ECOG)/ World Health Organization (WHO) equivalent).
* Age \> 18.
* Ability to understand a written informed consent document, and the willingness to sign it.

  i. Exclusion Criteria:
* Concomitant investigational therapy.
* Known inability to lie flat, remain still or tolerate a PET scan.
* Patient undergoing active treatment for non-prostate malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.

Preprostatectomy Staging Population:

ii. Inclusion criteria:

* Biopsy proven prostate adenocarcinoma.
* Considered for prostatectomy with lymph node dissection.
* Intermediate to high-risk disease (as determined by elevated PSA \[PSA\>10\], T-stage \[T2b or greater\], Gleason score \[Gleason score \> 6\] or other risk factors).
* Able to provide written consent.
* Karnofsky performance status of ≥50 (or ECOG/WHO equivalent).

ii. Exclusion criteria:

* Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam.
* Neoadjuvant chemotherapy, radiation therapy or any definitive local therapy prior to prostatectomy including focal ablation techniques (HiFu).
Elonva in Combination With Hp-FSH Versus Elonva With Low Dose hCG

The study compares in a randomized controlled way two stimulation methods. One of these stimulation methods implements a new insight in ovarian follicular growth. If this novel method of stimulation proves to be as efficient as the classical stimulation protocols, there might be a dramatic reduction of the costs of the medical therapy in IVF, thus reducing also the overall IVf costs significantly.


Eligibility Criteria:
Inclusion Criteria:

* IVF/ICSI patients
* Cycle 1, 2, 3, 4

Exclusion Criteria:

* PCOS
* Endocrinological diseases
Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder

Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder.

Objectives: The primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. The primary outcome is pain measured through the Visual Analogue Scale (VAS) over a follow up period of 6 months.

Methods: This is a prospective randomized clinical trial that will be conducted between February 2021 and January 2022. Patients will be randomly allocated into two groups. Group I will receive paravertebral block guided by a nerve stimulator. Group II patients will receive suprascapular nerve block. Patients will be followed up at week 1, month 1, month 3 and month 6.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* presenting with frozen shoulder and were unresponsive to conservative therapy

Exclusion Criteria:

* Complete rotator cuff tear
* Osteoarthritis
* Calcified tendinitis
* History of shoulder joint injury
* Cervical radiculopathy
* Bleeding disorder
* Active infection
* Allergy to Bupivacaine
* Diabetes Mellitus
Identification of Tongue Involvement in Late-Onset Pompe Disease

This purpose of this study is to determine if tongue strength and tongue ultrasound measurements differentiates patients with untreated late-onset Pompe Disease (LOPD) from patients with acquires/hereditary myopathies or neuropathies. It is hypothesized that abnormalities in tongue function and structure in patients with LOPD may be useful in discriminating this condition from others that have similar presentations.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 12 years
* confirmed diagnosis of LOPD and naïve to enzyme-replacement therapy (ERT)
* acquired/hereditary myopathy (e.g., dermatomyositis, polymyositis, inclusion body myositis, limb-girdle muscular dystrophy, distal myopathy, myotonic muscular dystrophy, and other myopathy)
* neuropathy (e.g., peripheral neuropathy, cranial neuropathy, autonomic neuropathy, focal neuropathy)

Exclusion Criteria:

* current use, history within the past two years of use, or eligible but declined use of Lumizyme® enzyme replacement therapy (applicable to LOPD group)
* history of stroke, Parkinson's disease, oculopharyngeal muscular dystrophy, head and neck cancer or radiation treatment to head/neck, or other conditions that commonly affect lingual strength
* inability to follow directions for study participation
A 3-day Course for CFS/ME

Chronic fatigue syndrome/Myalgic encephalomyelitis (CFS/ME) can be a serious and disabling condition with a heavy symptom burden and low function. Work disability is common, and social life dramatically affected. CFS/ME is a challenging health problem as well as a societal problem.

In recent years, a doubling of the number of patients with a CFS/ME diagnoses has been reported in Norway. The patient group represents a challenge for the health care system, the municipality, and the Norwegian Labour and Welfare Organization (NAV). According to new figures, the NAV pays 100 million Norwegian Kroner (NOK) each month in permanently incapacitated expenses for people with CFS/ME. Municipalities have expenses in form of care, rehabilitation and other measures.

There is a lack of effective treatment for CFS/ME. Evidence-based knowledge is highly needed.

If the 3-day course shows promising effects, this could have positive consequences for patients, relatives and health personnel, but also financially for the society and the municipality.

This is a randomized controlled trial (RCT) to investigate potential effects (positive and negative) of a 3-day course with follow-up for 100 adults with CFS/ME.

The 3-day course used in this trial is named the Lightning Process (LP). The course is built on the LP manual (Parker, 2013) and includes stress theory, Positive Psychology and knowledge about regulating thoughts, feelings and behavior, and through that positively influencing physiology.

Positive and negative effects of the course on symptoms, disability and quality of life will be investigated, and a long-term follow-up of work participation conducted.

Any adverse events experienced during or after the 3-day course will be handled according to protocol.

Eligibility Criteria:
Inclusion Criteria:

* CFS/ME diagnosis based on the Canada Consensus Criteria.
* At least 50% out of school/work.
* Readiness to change (corresponding to the preparation phase in transtheoretical model)
* Has given informed consent.

Exclusion Criteria:

* Assessed by a General Practitioner (GP):
* Underlying physical illness or mental disorder that may explain the symptoms.
* Suicide risk/previous suicide attempts.
* Pregnancy.
* Bedridden and in need of continuous care.
* Insufficient Norwegian speaking or writing skills to participate in the 3-day course and fill out questionnaires.
Prognostic Value of TIL in Nasopharyngeal Carcinoma

Our center plans to conduct a prospective, multicenter, observational study aimed at observing the percentage of TIL infiltration calculated using deep learning methods based on digital pathological images, and analyzing its prognostic significance in nasopharyngeal carcinoma, in order to help guide personalized treatment.


Eligibility Criteria:
Inclusion Criteria：

* Histopathology confirms nasopharyngeal carcinoma;
* At the initial treatment, there was no evidence of distant metastasis, and the staging was II-III (AJCC 9th);
* Age range of 18-70 years old, KPS ≥ 80 points;
* Having good organ function; The following conditions must be met: Hematology: White blood cell count\>3.0 × 109/L; Absolute neutrophil count (ANC)\>1.5 × 109/L; Hb\>90g/L； Platelets\>100 × 109/L; Albumin ≥ 3g/dL Liver function: Bilirubin ≤ 1.5 times the upper limit of normal (ULN), AST and ALT ≤ 3 times ULN, and alkaline phosphatase (ALP) ≤ 3 times ULN • International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; • Renal function: Serum creatinine ≤ 1.5 times ULN or creatinine clearance rate ≥ 60mL/min.
* Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests, and other research procedures;
* Willing to comply with arrangements during the research period and cannot participate in any other clinical studies related to drugs and medical devices;
* Patients sign a formal informed consent form to indicate that they understand that this study complies with hospital policies.
* Sufficient tissue stored in wax blocks suitable for scientific research use.

Exclusion Criteria:

* Merge with other malignant tumors
* Individuals with a history of severe immediate hypersensitivity to any medication used in this study
* No capacity for civil conduct or limited capacity for civil conduct;
* Abuse of drugs or alcohol addiction, patients with physical or mental illnesses, and those deemed by the researchers to have a complete or thorough understanding of the possible complications of this study;
* Other serious acute or chronic medical conditions (including immune-mediated colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illnesses (including dementia and epilepsy, recent, past year, or active suicidal ideation or behavior) that may increase the risks associated with the study protocol treatment, or may interfere with the interpretation of study results and (based on the researcher's judgment) make patients unsuitable for participation in this study, or laboratory test abnormalities;
* Previously diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases;
* Pregnant or lactating female patients, male or female patients who have fertility but are unwilling or unable to use contraception for at least one year throughout the study period and after the end of the treatment plan.
SARS-CoV-2 and Acetylsalicylic Acid (SARA)

SARS-CoV-2 infection in pregnancy is associated with an increased risk of adverse maternal and perinatal outcomes. One explanation is that the infection might increase the existing pregnancy-associated prothrombotic status, leading to a higher risk of placental and vascular complications. Administration of low-dose acetylsalicylic acid (LDASA) has shown to improve maternal and perinatal outcomes in women at high-risk of endothelial and placental complications. However, there are no data on the effect of LDASA in preventing complications in SARS-CoV-2- infected pregnant women. To reduce SARS-CoV-2- related complications in a highly vulnerable group to the infection, we will carry out this randomized, double-blind, placebo-controlled multicentre trial in 400 SARS-CoV-2-infected pregnant women. The study main objective is to evaluate the efficacy and safety of LDASA administered up to 36 weeks of gestation in SARS-CoV-2-infected pregnant women in reducing the incidence of adverse maternal and perinatal outcomes. Pregnant women tested positive up to 32 weeks of gestation with a SARS-CoV-2 rapid antigen or PCR test and agreeing to participate, will be randomised 1:1 to receive daily LDASA (125 mg) or placebo up to 36 weeks of gestation and be followed-up until delivery.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women up to 32 weeks of gestational age
* Aged 18 years or older\*
* Willing to deliver at the recruitment health facilities

  * In Mozambique, in case of age below 18 years, the participant will be asked for the assent and the informed consent will be given by the legal tutor in accordance with the national regulations.

Exclusion Criteria:

* On regular ASA treatment for pre-eclampsia prevention
* On long-term non-steroidal anti-inflammatory medication
* Bleeding disorders, mainly haemophilia, hypoprothrombinaemia orVon Willebrand's disease
* History of hypersensitivity to ASA or to any of the excipients of the investigational product.
* History of peptic ulceration, including active, chronic or recurrent gastroduodenal ulcer; recurrent gastric discomfort History of gastric bleeding or perforation after treatment with aspirin or other non-steroidal anti-inflammatory drugs
* Inability to cooperate with the requirements of the study
* Severe COVID-19 disease (with any of the following: respiratory rate \> 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
* Treatment resistant hyperemesis gravidarum
* Hypersensitivity to nonsteroidal anti-inflammatory drugs or to tartrazine (cross-reaction) or to any of the excipients used in its composition.
* Asthma.
* Severe renal or hepatic insufficiency.
* Nasal polyps associated with asthma that are induced or exacerbated by aspirin.
* Severe COVID-19 disease (with any of the following: respiratory rate \> 30 breaths/min; severe respiratory distress; SpO2 ≤ 93% on room air; acute respiratory distress syndrome; sepsis with acute organ dysfunction).
* Treatment resistant hyperemesis gravidarum