cyrilzakka/clinical-trials huggingface dataset:
Does Ultrasound Guidance Improve Time to Perform a Spinal or Number of Attempts in Obese Patients?

Spinal anesthesia depends on being able to locate physical landmarks on a patient's body. In obese patients, the commonly used landmarks may be difficult or even impossible to feel. In addition, the spine can be hidden beneath a layer of fatty tissue.

Ultrasound is useful for finding the correct injection site in pregnant patients, but the usefulness of ultrasound has not been adequately evaluated in non-pregnant patients. The potential benefits for obese patients from the use of ultrasound include shortening the duration of the procedure, increasing patient comfort, decreasing the total number of attempts, and aiding in the choice of appropriate needle length for the patient.

The investigators hypothesize that there is no difference in time to perform a spinal anesthetic when landmarking with ultrasound as compared to tactile landmarking in patients with BMI \> 35.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing surgeries amenable to spinal anesthetic
* BMI \>35
* between the ages of 18-85

Exclusion Criteria:

* Patients with known spinal disease or previous spinal surgery
* Pregnant patients
* Patients requiring emergent surgeries
* Patients in positions other than sitting during neuroaxial anesthesia
* Patients with contraindications to neuroaxial anesthesia
Sodium Hyaluronate Injection and Corticosteroids in Trochanteric Bursitis: a Randomized Controlled Study.

Trochanteric pain can be caused by osteoarthritis of the hip, fracture, tendinitis, nerve pathology and trochanteric bursitis. Trochanteric bursitis is often seen at the outpatient clinic and is characterized by chronic lateral hip pain in the vicinity of the trochanter major, overlying the lateral aspect of the hip. When pain is persistent after conventional therapies, anesthetic and corticosteroid (CS) injections can provide short term to intermediate relief of pain, but relapse is common. Only one retrospective study showed the efficacy of intra-bursal trochanteric injections with HA and CS. They concluded that the pain release is significant with large effect sizes for both treatment. However, the efficacy of CS appeared to be short lived and it was shown that the efficacy of HA at 6 and 12 months is significant compared to CS (p\<0.05).

In this study we want to compare the efficacy of corticosteroids and hyaluronic acid in the treatment of trochanteric bursitis.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years and older, but \<75 years;
* VAS for pain \> 30mm;
* Diagnosis of trochanteric bursitis as suggested by Brinks et al with symptoms for more than 3 months (3);
* Failure of conservative therapy of more than one month;
* Written informed consent;
* Available for the duration of the investigation.

Exclusion Criteria:

* Previous surgery in the same region;
* Current other problem(s) in the affected extremity;
* Diabetes mellitus;
* Patient who received a local (CS) injection within 3 months from the baseline visit;
* Allergic or hypersensitive to CS or HA;
* Patients suffering (chronic) low back pain with or without sciatic pain;
* Patients with radiographic signs of moderate or severe hip osteoarthritis (Kellgren and Lawrence \>1);
* Pregnant or lactating, or woman of childbearing potential not willing to use an acceptable method of contraception during the study.
Large Cell Lymphoma Pilot Study III

The main purpose of this study is to find out if it is feasible to deliver a multi-agent chemotherapy regimen which features a shorter, more intensive, immunophenotype-directed approach, and includes an intensification phase with hematopoietic stem cell support for children with large cell lymphoma

Secondary objectives will include documenting the toxicity associated with the treatment regimen, and to estimate the response rates and survival of participants with large cell lymphoma treated on this protocol.

Patients will be treated with induction, consolidation, and maintenance treatment.

Induction

MIED chemotherapy - High dose methotrexate, ifosfamide, etoposide, and dexamethasone for 2 cycles.

High-dose methotrexate 8 gm/m2 on Day 1 with leucovorin rescue Ifosfamide 2 gm/m2/day on days 2-4 (total of 3 days) Etoposide (VP-16) 200 mg/m2/day on Days 2-4 (total of 3 days) Dexamethasone 40 mg/m2/day IV on days 1-4 (given IV or PO daily x 4) Intrathecal MHA, age adjusted dosages.

Consolidation

COPADM chemotherapy for 2 cycles - cyclophosphamide, vincristine, prednisone, adriamycin, high-dose methotrexate

COPAM#1 High dose methotrexate (HD MTX) 5 gm/m2 IV over 4 hours on Day 1 with leucovorin rescue; Doxorubicin 60 mg/m2 IV over 6 hours on Day 2, Vincristine 2.0 mg/m2 (2.0 mg max) Day 1, Cyclophosphamide 500 mg/m2/day (divided every 12 hours) Days 2-4, Prednisone 60 mg/m2 (divided bid) Days 1-5, Intrathecal MHA, age adjusted dosages.

COPADM#2 - like COPADM#1 except: 1. cyclophosphamide dose increased to 1 gm/m2/day divided every 12 hours on Days 2-4, and 2. second dose of vincristine given on Day 6.

DAC chemotherapy x 1 cycle - Dexamethasone, cytarabine, and carboplatin

Carboplatin (AUC of 8) Day 1; Ara-C 2 gm/m2/dose q12 x 2 Day 2 Dexamethasone 40 mg/m2/day Days 1-4; ITMHA dose age adjusted.

Hematopoietic Stem Cell Transplantation - high-dose cyclophosphamide and etoposide

Involved field radiation to the primary tumor will be given over 3-4 weeks. Participants with CNS disease at diagnosis will also receive cranial irradiation.

Maintenance chemotherapy

Vinblastine 6 mg/m2 IV weekly for one year

Eligibility Criteria:
Inclusion Criteria:

* Patient must be previously untreated, except for steroids or emergency radiation therapy.
* Patient must be less than or equal to 18 years of age.
* Patient must have a histologic diagnosis of large cell Non-Hodgkin lymphoma.
* The immunophenotype of tumor cells must be either T-cell or non-B-cell, non-T-cell.

Exclusion Criteria:

* Participants with B-cell immunophenotype NHL.
Adverse Childhood Experiences, Adaptation and Breast Cancer

Adverse Childhood Experiences (ACEs) have long been linked to mental health problems in adulthood. In the case of cancer, no study has considered that such an anteriority could make patients more vulnerable emotionally, even though the presence of reactionary disorders such as stress, anxiety or depression are characteristic of such a pathology. Activated during periods of stress and therefore during the illness, even the attachment system is mobilized and must be considered to allow more understanding of the illness experience. The attachment style can be seen here as an individual dimension that plays a role in the emotional regulation and resilience of patients. It is also particularly solicited during the remission phase, a complex and singular period of cancer disease that confronts patients with an ambivalence of hope and fear. The fear of recurrence is a concern that the cancer may return or progress in the same organ or in another part of the body. This is a determining factor in the occurrence of anxiety-depressive disorders. Finally, several studies have shown a strong association between depression/anxiety and Cancer-Related Fatigue (CRF) after treatment, especially during the remission phase.

ACEs leave physiological and epigenetic impact that can nowadays be easily evaluated, thus providing additional evidence between adversity, physiological and epigenetic vulnerability and the ability to adapt to life's challenges such as cancer. Life history changes are mediated by changes in cellular mechanisms affecting genome expression. It is currently widely demonstrated that ACEs increases epigenetic modifications.

The interest of this project is therefore to highlight the psychological consequences related to the occurrence of cancer in the developmental history (in terms of adversities) of patients who have completed adjuvant chemotherapy for breast cancer, taking into account the patients' previous attachments, resilience, fear of recurrence and perceived fatigue in order to consider their interactions and their effects on their psychological health and ultimately on their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Have had breast cancer
* Be considered in remission
* Be over 18 years of age
* Literate (able to understand the information and complete the questionnaire independently)
* Agree to participate in the project and sign the informed consent form

Exclusion Criteria:

* Be a person subject to a legal protection measure
* Be a protected adult, under guardianship or curators
* Be undergoing oncological treatment
* Have a lack of autonomy making it impossible to complete the questionnaire online
* Have had or have begun psychotherapeutic treatment
To Provide Sildenafil Therapy To Eligible Adult Patients With Pulmonary Arterial Hypertension For 112 Weeks

The purpose of this study is to provide sildenafil therapy to eligible adult patients with pulmonary arterial hypertension (PAH) and to the patients who completed the A1481142 study for the treatment of PAH in Poland. Only safety and tolerability data will be collected in these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 and over who have any of the following conditions:

   * Idiopathic pulmonary arterial hypertension.
   * PAH associated with connective tissue disease (CTD).
   * PAH with surgical repair, at least 5yrs previously, of atrial septal defect (ASD), ventricular septal defect (VSD) patent ductus arteriosis (PDA) or aorta-pulmonary window.
2. Subjects with a mean pulmonary artery pressure (mPAP) \> 25mmHg and a pulmonary artery wedge pressure (PAWP) \< 15mmHg at rest, assessed via right heart catheterization.
3. Subjects whose baseline 6-min walk test distance was \> 100m and \< 450m.

Exclusion Criteria:

1. PAH secondary to any etiology other than those specified in the inclusion criteria.
2. Subjects with congenital heart disease (other than those specified in the inclusion criteria), PAH due to thrombo-embolism, HIV, chronic obstructive airways disease, congestive heart failure.
3. Subjects whose 6-Minute Walk test might have been limited by conditions other than PAH, associated dyspnea or fatigue.
Nutritional Counseling to Change Eating Behavior, Metabolism and Anthropometry in Adults With Abdominal Obesity

This study evaluates the impact of changes in eating behavior through nutritional counseling, after nine months of intervention, on body composition and metabolism in adult workers with abdominal obesity

This study is a nutritional intervention in voluntary workers with abdominal obesity (waist circumference ≥102cm and ≥88cm). The intervention is divided into two phases: the intensive one has a duration of 6 months and consisted in a 4 face-to-face sessions with 9 online or telephone contacts based on the use of nutritional counseling \[Academy of Nutrition and Dietetics, 2013\] and the second phase: consisted in a 3 months' follow-up with 2 telephone contacts and a final visit face-to-face. The investigators used the Cognitive Behavior Therapy process as a theoretical framework, and also used the intervention comprised sessions designed to promote motivation, social support, self-regulation to promote the eating behavior change process. The participants were measured weight loss, waist circumference, and the lipid profile change, pre-intervention, and after six and nice months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* With abdominal obesity: men with waist circumference (CC) ≥102 cm and women with CC ≥88 cm.
* Literacy.
* Sign the informed consent

Exclusion Criteria:

* Participants with severe alterations of their renal function, hepatic, thyroid and circulatory system (self-reported or found in their laborarotorio analysis)
* Participants with any serious illness, hospitalization in the 6 months prior to the start of the study.
* In nutritional treatment for weight loss in the last three months.
* In psychological and / or psychiatric treatment.
* Depression or anxiety.
* History of bariatric surgery.
* Pregnant or lactating women.
Ambu AuraOnce Versus Ambu AuraGain LM in Children

The investigators test the hypothesis that oropharyngeal leak pressure and fiberoptic position differ between the size 2 LM Ambu AuraOnce and the LM Ambu AuraGain in non-paralyzed anaesthetized pediatric patients.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* age 1 - 16 years
* minor surgery
* extraglottic airway device

Exclusion Criteria:

* age (\<12 months, \>16 years)
* weight (\<12 kg, \>50 kg)
* a known difficult airway
* risk of aspiration
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)

A multicenter study to evaluate the safety and efficacy of ezetimibe/simvastatin versus atorvastatin in elderly patients with high cholesterol at high or moderately high risk for coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a cholesterol level of 130 mg/dL or greater
* Patient is willing to maintain a cholesterol lowering diet for as long as they are in the study
* Patient is at moderate high risk or high risk for coronary heart disease per the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) guidelines

Exclusion Criteria:

* Patient weighs less than 100 lbs
* Patient has an allergy to ezetimibe, simvastatin or atorvastatin
HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor

The HYPNOS study is an acute feasibility study to validate a new device for automatic detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system and it will perform the following tasks:

* Detect apneas and hypopneas in real time, based on physiological signals acquired with a cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))
* Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of mechanoreceptors of the skin close to the mastoid bone

The primary objective is to verify that the PASITHEA system is able to detect apneas and hypopneas reliably.

The main secondary objective of the study is to assess the effect of kinesthetic stimulation on reducing the number of sleep respiratory disorders.

Another objective of the study is to verify the safety of the PASITHEA system.


Eligibility Criteria:
Inclusion Criteria:

* above 18 years.
* Patient with diagnosed severe obstructive sleep apnea syndrome (AHI \> 30/h and \> 80% of obstructive events diagnosed on polysomnography or polygraphy performed less than 6 months ago )
* Patient free from CPAP treatment or any other SAS treatment for at least 3 months
* Patient with stable psychotropic medication since the diagnostic polysomnography or polygraphy exam
* Patient has signed the informed consent

Exclusion Criteria:

* Patients sleeping less than 4 hours per night
* Patients suffering from respiratory failure or periodic breathing (cheynes stokes)
* Obese patient (BMI\>40kg/m2)
* Diabetic patient with autonomic dysfunction
* Vulnerable patient in accordance with article L1121-6 of CSP
* Patient with progressive malignant pathology
* Patient already involved in another clinical study that could affect the result of this study
* Pregnant patient
A Pilot Study of Buspirone for the Treatment of Anxiety in Youth with Autism Spectrum Disorders

The main objective of this exploratory 8-week pilot study is to evaluate the safety and efficacy of buspirone for the treatment of anxiety in youth (ages 6-17 years) with autism spectrum disorders. The study results will be used to generate hypotheses for a larger randomized-controlled trial with explicit hypotheses and sufficient statistical power.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants between 6 and 17 years of age
* DSM-5 ASD diagnostic criteria as established by clinical diagnostic interview
* Participants with a score of ≥60 or more on the Anxiety/Depression subscale of CBCL
* Subjects can be taking psychotropic medications if they have been on the medication for at least 4 weeks prior to initiating study treatment and if they are on a stable dose, provided the medication is not listed in the Concomitant Medications section of the protocol.

Exclusion Criteria:

* History of active seizure disorder (EEG suggestive of seizure activity and/or history of seizure in last 1 month)
* Subjects with a medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study, including:
* Pregnant or nursing females
* Organic brain disorders
* Uncorrected hypothyroidism or hyperthyroidism
* Clinically significant abnormalities on ECG (e.g., QT prolongation, arrhythmia)
* History of renal or hepatic impairment.
* Clinically unstable psychiatric conditions or judged to be at serious suicidal risk
* Current diagnosis of schizophrenia or bipolar disorder
* History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
* Current treatment with medication with primary central nervous system activity (as specified in the Concomitant Medication section of the protocol)
* A non-responder or history of intolerance to buspirone, after treatment at an adequate dose and duration as determined by the clinician
* Subjects currently taking monoamine oxidase inhibitors (MAOI) and/or CYP3A4 inducers or inhibitors including nefazodone, diltiazem, verapamil, erythromaycin, itraconazole, or rifampin.
Evaluation of Immediate and Medium-term Health- and Work-related Effects Following Inpatient Psychocardiological Rehabilitation

Since May 2019, psychocardiological rehabilitation has been carried out at the Rehabilitation Center Felbring (RFE) in the form of a pilot project. The background is the mutual relationship of psychological and physical morbidity, which is of particular importance in cardiological rehabilitation. The present outcome evaluation study is designed as a quantitative longitudinal study with 4 repeated measures, in which at least 75 rehabilitation patients will be included. Three assessments are conducted at admission and discharge to/from inpatient rehabilitation, and an additional survey will be conducted by mail 6 months after the end of rehabilitation. Effects that become apparent as a result of rehabilitation will be recorded from a patient-centered perspective by means of "patient-reported outcomes". In this way, primarily psychological and work-related changes, but also changes in the physical quality of life are to be mapped, which can be determined immediately after completion of rehabilitation and continue in the medium term up to 6 months later.


Eligibility Criteria:
Inclusion Criteria:

Cardiovascular disease and increased psychological distress due to one of the following mental health diagnoses (according to ICD-10):

* Depressive Episode
* Recurrent depressive disorder
* Phobic disorders
* Anxiety disorders (incl. panic disorder)
* Acute stress reaction
* Post-traumatic stress disorder
* Adjustment disorders
* Other reactions to severe stress
* Psychological or behavioral factors that play a significant role in the etiology of physical illnesses

Exclusion Criteria:

* Acute danger to self or others
* Acute mental disorders, the extent and/or instability of which does not allow participation in rehabilitation
* High degree of neurocognitive deficits
* Highly degraded communication skills
The Use of Surfactant in Lung Transplantation: A Randomized Control Pilot Study

1. Working Hypothesis:

   The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.
2. Aims of the Study:

The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.

Background: Lung transplantation induces surfactant dysfunction that may be a contributing factor for primary graft dysfunction (PGD) and graft failure. Animal studies and limited human reports suggest that surfactant administration may prevent primary graft dysfunction.

Working hypothesis and aims:

The purpose of the trial is to study the effect of exogenous calf surfactant (calfactant) on the prevention of primary graft failure due to ischemic-reperfusion lung injury in lung transplant patients.

Methods: The trial is an open randomized controlled prospective study. Patient population: 42 patients eligible for lung transplant according to hospital criteria.

Study medication: Calfactant intratracheal suspension -an extract of natural surfactant from calf lungs, which includes phospholipids, neutral lipids and surfactant-associated proteins B and C (SP-B and SP-C).

Study design: Patients randomized to receive calfactant will have the drug administered through a fiberoptic bronchoscope distributing the drug evenly across the lung immediately after connection. The other patient will not have any administration to avoid any excessive flushing. When 2 lungs will be used from the same donor for 2 recipients one patient receiving one lung will be treated with calfactant while the other patient receiving the other lung will not be treated and serve as the control. Otherwise lungs will be treated with surfactant in every other case.

Expected results: We expect surfactant instillation during lung transplantation to improve oxygenation, prevent primary graft dysfunction, make intubation time shorter and to enhance early post transplantation recovery. In a pilot study that we already performed results are encouraging.

Importance: PGD could cause substantial morbidity and mortality among transplanted patients. In a pilot study we already found that surfactant instillation during lung transplantation improves oxygenation, prevents primary graft dysfunction, shortens intubation time and ICU stay. We believe that surfactant treatment enhances early post transplantation recovery, and may also be cost effective by shortening expensive ICU stay.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for lung transplantation

Exclusion Criteria:

* Differential diagnosis of PGD
* Pulmonary Edema
* Stenosis or thrombosis of pulmonary artery/vein anastomosis
Efficacy of 25% Trichloroacetic Acid Peel Versus 30% Salicylic Acid Peel in Mild to Moderate Acne Vulgaris

To compare the efficacy of 25% trichloroacetic acid peel versus 30% salicylic acid peel in mild to moderate acne vulgaris.

Study Design: Randomized Control Trial. Place And Duration of Study: Department of Dermatology, CMH Abbottabad from 01 Jun 2022 to 30th Nov, 2022.

Methodology: A total of 60 patients presented with mild or moderate acne vulgaris were randomized into two groups comprising 30 patients in each group and treated with either the TCA peel or the SA peel at 2-week intervals for 12 weeks. Patients in Group A were treated with 25% TCA peel whereas patients in Group B were treated with 30% SA peel. At the end of therapy after 12 weeks, evaluation of active acne was done by individual lesion counts (comedones, papules and pustules) and calculation of the Michaelsson acne score (MAS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with mild or moderate facial acne vulgaris presented in dermatology opd

Exclusion Criteria:

* Patients with grade III or IV acne vulgaris
* patients taking any acne medications or had taken oral or topical medications in the past 4 weeks
* pregnant female patients or nursing a baby
* patients with known hypersensitivity to the formulations used in the study or a history of photosensitivity
* hypertrophic scars, keloidal tendency, active or recurrent herpes simplex infection
* active dermatosis
* unrealistic expectations