cyrilzakka/clinical-trials huggingface dataset:
Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis

The purpose of this study is to assess the effect of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis.

Bronchiectasis is characterized by pathological and irreversible dilation of bronchi caused by the inefficient removal of secretions and microorganisms and the perpetuation of inflammatory processes induced by chronic or recurrent infections, causing more damage to the airways that result in infections, and greater lesion airways and lung parenchyma. Pulmonary rehabilitation in people with bronchiectasis aims to improve exercise capacity, through effects on aerobic capacity and peripheral muscles, and to improve disease control and quality of life. The aim this study is to evaluate the effects of pulmonary rehabilitation on the transport of secretions, inflammation and respiratory resistance, and its repercussions on the quality of life in patients with bronchiectasis. In this study 60 volunteers, of both sexes, aged between 18-60 years, adequate the inclusion criteria, which will be assessed by lung function tests, the saccharin transport time, the inflammatory markers in the airways, the respiratory system resistance and quality of life scales. Volunteers will be randomly divided in pulmonary rehabilitation (PRG) and control groups (CG) that will be subdivided in bronchiectasis and healthy subgroups. In the PRG group they will receive supervised physical training twice a week and will be instructed to adopt a routine of home exercises, while CG will be informed about the benefits of physical activities. All volunteers will be evaluated after 8 weeks of the baseline and at the end of the research. Data evolution will be collected from medical records and notes of the medical team and physical therapy that will follow the routine of these participants

Eligibility Criteria:
Inclusion Criteria:

* clinically stable patients
* both sexes
* aged between 18-60 years
* not due to cystic fibrosis bronchiectasis diagnosis
* non smokers
* no pulmonary disease

Exclusion Criteria:

* asthma or other restrictive conditions
* smokers assets
* decompensated cardiovascular and metabolic diseases, neuromuscular or musculoskeletal that impede the realization of the Protocol.
Fatigue in People With Rheumatoid Arthritis- Randomized Controlled Trial

Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with Rheumatoid Arthritis (RA).

The effect of person-centered physical therapy on fatigue related variables in peoples with Rheumatoid Arthritis- Randomized controlled trial Aim: To study if a person-centered physical therapy intervention program contributes to diminished fatigue in people with RA.

Hypothesis: That the person-centered treatment program diminishes fatigue and its consequences on daily life.

Design: A controlled randomized interventional trial, assessing effectiveness of intervention.

Methods:

Selection: Seventy persons with diagnosis of RA and fatigue over 50 (0-100) will be recruited from the rheumatology clinic at Sahlgrenska University Hospital. Participants are randomized to an intervention group or a waiting list control group.

Intervention: The 12-week intervention period begins with an individual person-centered meeting to develop an individualized feasible self-care plan for the participant with extra focus on health-enhancing physical activity, stress management (relaxation exercise training and modified mindfulness techniques) and balance in daily life. A written consent, aiming to increase coherence, is signed. The participants will be asked to keep a journal about their strategies and reflections. Follow up meetings and contacts will be planned according to personal preferences.

Procedure: The participants are invited to a clinical examination before and after the 12-week intervention and at 6-month follow-up, assessing demographic data, disease activity, inflammation parameters, physical capacity and questionnaires of health status in RA. Primary outcome are questionnaires of single item- and multidimensional fatigue.

Analysis: Effects of the interventions will be analyzed using non-parametric statistics for between-group changes over time. Within-group changes over time will be analyzed for each group.

Expected results. New knowledge of fatigue is of importance for improvement of overall health of people with RA, as fatigue influences all aspects of their life, both private life and employment, thus decreasing the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* aging 20-65 years, disease duration \>3 year, stable pharmacological treatment

Exclusion Criteria:

* Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible.
Efficacy and Tolerance of Therapeutic Apheresis in Paediatric Neurology: a French Multicenter Study

After developing in pediatric hematology and nephrology, therapeutic apheresis is increasingly used in pediatric neurology despite a sparse level of evidence.

There are a few retrospective series with a small number of patients, concerning mainly autoimmune diseases (encephalitis, myasthenia gravis, polyradiculoneuritis).

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.

Multicenter medical data collection :

* Montpellier
* Toulouse
* Bordeaux
* Marseille
* Nancy
* Paris Kremlin Bicêtre
* Paris Robert Debré
* Paris Necker
* Paris Trousseau
* Lyon
* Besançon
* Rennes
* Reims
* Strasbourg
* La Réunion
* Nantes
* Tours

Eligibility Criteria:
Inclusion criteria:

* Children under 18.
* Supported in a participating CHU between 2014 and 2019.
* Having benefited from therapeutic apheresis (plasma exchanges and immunoadsorption) in a neuropediatric indication

Exclusion criteria:

- Family or patient refusal to participate
Usability, Safety and Efficacy of AspivixTM

Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD). Currently, the available instruments are traumatic tenacula, which could cause pain and bleeding and therefore represent an obstacle for certain patients to pursue their medical follow-up.

AspivixTM is a new device, which enables atraumatic traction of the cervix while respecting its specific semi-circular anatomic shape through a system powered by a vacuum chamber.

The aim of our pilot study is to assess the usability, safety and efficacy of the device.

Note: Study is made of 2 phases (pilot phase followed by a comparative phase). Details regarding comparative study is registered separately.


Eligibility Criteria:
Inclusion Criteria:

* Participants older than 18 years
* Participants presenting at the outpatient clinic for Mirena IUD insertion.
* Participants able to provide informed consent as documented by signature with at least 24 hours of reflection time
* Good understanding of written and oral speaking used at the centre where the study will be carried out.

Exclusion Criteria:

* Participants who are contraindicated for the insertion of the IUD Mirena
* Participants under use of excessive alcohol, narcotics or benzodiazepines prior to procedure
* Participants who do not wish to be informed of a chance discovery
* Participant receiving anaesthetics prior to IUD insertion procedure
* Participants on anticoagulant medication
* Participants under use of an analgesic
* Previous cervical operation
* Severe vaginal bleeding
* Participant previously enrolled in this study
* Cervix diameter smaller than 26 mm
* Mullerian anomalies with two cervices
* Nabothian cyst
* Cervical myomas
* Cervical condylomas
* Squamous intraepithelial lesion (Cervical dysplasia)
* Cervical endometriosis
* Cervical tears
* A well exposed cervix and / or well aligned vaginal and cervical canals where no traction is required for IUD insertion
* Other cervical abnormalities (cervical polyp, cervical lesion, or irregularity) which may contraindicate or complicate IUD insertion
* Large ectopy, for which it is not possible to find a suitable location near the ectopy where native tissue is present
* Large scar tissue, for which it is not possible to find a suitable location near the scar where native tissue is present
Safety and Efficacy of AN2728 Topical Ointment, 2% in Children, Adolescents, and Adults (Ages 2 Years and Older) With Atopic Dermatitis

The purpose of this study is to investigate the safety and efficacy of AN2728 Topical Ointment, 2% in children, adolescents, and adults (ages 2 years and older) with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 2 years and older
* Has a clinical diagnosis of AD according to the criteria of Hanifin and Rajka
* Has AD involvement ≥ 5% Treatable %BSA (excluding the scalp)
* Has an ISGA score of Mild (2) or Moderate (3) at Baseline/Day 1
* All female subjects of childbearing potential must use acceptable methods of contraception from the Screening Visit continuously until 30 days after stopping study drug

Exclusion Criteria:

* As determined by the study doctor, a medical history that may interfere with study objectives
* Unstable AD or any consistent requirement for high potency topical corticosteroids
* History of use of biologic therapy (including intravenous immunoglobulin)
* Recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD
* Recent or current participation in another research study
* Females who are breastfeeding, pregnant, or with plans to get pregnant during the participation in the study
* Participation in a previous AN2728 clinical trial
An Intervention to Increase Physical Activity Among African American Women

The purpose of this study is to investigate whether a faith-based curriculum delivered in small groups, and emphasizing goal setting along with mutual responsibility, increases physical activity.

Sedentary lifestyles are common among older adults in the United States, especially among minority women. Regular physical activity in older adults has been shown to prevent falls, maintain functional status, prevent both dementia and osteoporosis, and decrease mortality. A review of the literature has shown that current research approaches using exercise classes as the only means of behavior change are ineffective and do not produce long-term sustainable improvement. This study is testing a culturally appropriate behavior modification intervention using 1) group prayer, 2) the development of social support and mutual responsibility for exercise, and 3) group problem solving activities to increase aerobic and strength-related activities among older African American women.

Participants randomized into the intervention arm receive a 45-minute curriculum session and a 45 minute exercise class, while those randomized into the control arm receive a 45 minute session of interactive lectures on unrelated health topics along with the 45 minute exercise class. The exercise class includes both aerobic exercise and strength training using hand-held weights.

Data is collected from pedometers worn by participants, as well as from questionnaires before and after the intervention. Blood pressure, weight, and cholesterol are measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 60 years
* Female
* African American

Exclusion Criteria:

* Use of walker for ambulation
* Positive response on a modified Physical Activity Readiness Questionnaire, indicating potential risk of engaging in activity
* Withdrawal by primary physician
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System

This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation System to eradicate anal HSIL lesions in HIV-negative subjects with intra-anal intraepithelial neoplasia (AIN). The study intervention will demonstrate that a reasonable proportion of subjects will be histologically cleared of their anal HSIL within the ETZ in a tolerable and relatively safe manner


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* HRA 2 to 12 weeks prior to the 0 month RFA visit yielding one or more flat, non-condylomatous biopsy-proven HSILs that are

  1. Located entirely within in the eligible treatment zone
  2. Contiguous with the squamocolumnar junction Eligible treatment zone (ETZ) is defined as

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  1. 3 cm above the dentate line to the anocutaneous line
  2. Half of the anorectal circumference (meaning no more than two contiguous quadrants)
* If female of child-bearing age, negative pregnancy test within 8 weeks of the 0 month RFA visit and declared intent to remain on birth control throughout the trial, or, declaration of infertility defined as subject report of status as post-menopausal or surgically sterile (status post hysterectomy or tubal ligation).
* HIV negative, ELISA/Western blot test obtained within 12 weeks of the 0 month RFA visit

Exclusion Criteria:

1. Any biopsy-proven HSIL entirely outside of the ETZ
2. Any biopsy-proven HSIL partially within the ETZ (for example, an HSIL lesion with extension to the perianal skin)
3. Any condylomas in the eligible treatment zone \> 1/2 cm diameter

   • Note: Condylomas in the eligible treatment zone \< 1/2 cm in diameter must be excised or cauterized (not treated topically or with IRC) before or during Visit 1 (0 month RFA visit)
4. Any anal or rectal pathology requiring treatment including ulcer, fistula, fissure, stenosis or proctitis
5. History of or present anal or rectal cancer
6. History of pelvic radiation therapy
7. History of HPV vaccination or plans to initiate HPV vaccination during the trial
8. History of ablation or resection therapy within the ETZ other than cauterization or excision of condyloma(s)
9. History of topical therapy (Imiquimod, 5-FU) within 6 months prior to the 0 month RFA visit within the ETZ
10. Hemorrhoids \> grade II
11. Fecal incontinence (that the investigator feels may impair healing)
12. Concurrent disease requiring systemic immunosuppression therapy
13. Concurrent malignancy requiring systemic therapy
14. Life expectancy \< 2 years
Device for Breathing Frequency Monitoring in Muscular Dystrophy

Patients at risk of developing respiratory dysfunctions, such as patients with severe forms of muscular dystrophy, need a careful respiratory assessment, and periodic follow-up visits to monitor the progression of the disease. Continuous monitoring of respiratory activity pattern at home could give additional understandings about disease progression, flanking traditional, intermittent, cardiopulmonary evaluations, allowing prompt clinical intervention, and anticipating respiratory dysfunction. The main objective of the present study is thus to investigate the feasibility of using an innovative wearable device for respiratory monitoring, especially breathing frequency variation assessment, in patients with muscular dystrophy. The comparison between the measurements of breathing frequency obtained by using the IMU-based device and by using the reference method provided optimal results, in terms of accuracy errors, correlation and agreement. Participants positively evaluated the device for what concerns ease of use, comfort, usability and wearability. Moreover, preliminary results confirmed that breathing frequency is an interesting breathing parameter to monitor, at the clinic and at home, because it strongly correlates with the main indexes of respiratory function


Eligibility Criteria:
Inclusion criteria:

* documented DMD or LGMD2
* loss of independent ambulation (wheelchair-bound patients)
* ability to understand and follow test instructions and to report pain and discomfort.

Exclusion criteria:

* presence of metal implants and cardiac pacemakers
* relevant concomitant comorbidities (e.g.epilepsy)
* behaviour and/or psychiatric disorders (e.g. emotional problems, anxiety, panic attacks).
Evaluation of the Haemostatic Agent Purabond in ENT TORS

To evaluate the use of Purabond in ENT TORS for diagnostic and therapeutic procedures. Consecutive patients enrolled retrospectively via case note review. Outcome measures - primary and secondary haemorrhage, swallowing outcomes, need for nasogastric tube or tracheostomy, readmission.

Transoral robotic surgery (TORS) has been increasingly utilised in ear, nose and throat (ENT) Surgery over the past 20 years offering unprecedented 3-dimensional (3-D) views and enabling access to traditionally 'difficult-to-reach' tumours. It is now becoming a viable first line treatment option for oropharyngeal squamous cell carcinoma (OPSCC) compared to chemoradiotherapy. One of the main concerns is serious haemorrhage that can lead to death. PuraBond® (also known as PuraStat ®; 3D Matrix Ltd, Tokyo, Japan), which consists of the RADA16 family of synthetic peptides. PuraBond® is a self-assembling viscous solution that once applied on the surgical bed, it forms a transparent hydrogel 3-D matrix to achieve local haemostasis. Its transparent nature allows visualisation of the surgical field, permitting real-time assessment of intraoperative haemostasis. There are some studies demonstrating that it can promote healing. We aimed to assess the effect of Purabond in ENT TORS for diagnostic and therapeutic procedures such as oropharyngectomy and tongue base mucosectomy. Patients were enrolled from a single tertiary university hospital trust in the United Kingdom (University Hospitals Birmingham National Health Service Foundation Trust). Case notes for all patients were analysed retrospectively. Data extracted included patient demographics (age, sex, smoking history), procedure details (date, indication for surgery and type of TORS procedure) and tumour details (histopathology including p16 status and stage). The primary outcome measure was post-operative haemorrhage rate (primary; within 24 hours of surgery, and secondary; between 1-30 days post-surgery). Secondary outcome measures included, length of hospital stay (LOS), post-operative swallowing complications, in particular whether feeding tube insertion or tracheostomy was performed either prior to or within 30 days of surgery, hospital re- readmission rate within 30 days of surgery, and surgeon-reported ease of PuraBond® application. Descriptive statistical analysis was undertaken where applicable (mean, median, standard deviation) using Microsoft Excel® version 16.31.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients undergoing ENT transoral robotic surgery (TORS) with Purabond application between August 2021 - May 2022 at a single centre teaching university hospital NHS trust

Exclusion Criteria:

* Purabond not applied
* incomplete case notes
Nosocomial Pneumonia With Suspected Or Proven Methicillin-Resistant Staphylococcus Aureus (MRSA)

To determine if linezolid is superior to vancomycin in the treatment of nosocomial (acquired in the hospital) pneumonia due to Methicillin Resistant Staphylococcus Aureus (MRSA) in adult subjects. Subjects entered in to the study will have proven healthcare-associated methicillin-resistant Staphylococcus aureus pneumonia which will be treated with either linezolid or vancomycin.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male and female subjects with clinically documented nosocomial pneumonia proven to be due to methicillin-resistant staphylococcus aureus.
* Chest X-ray at baseline/screen or within 48 hours of treatment consistent with the diagnosis of pneumonia.
* Suitable sputum specimen defined as having less than 10 squamous epithelial cells and greater or equal 25 leukocytes or have a culture taken by an invasive technique within 24 hours of study entry.

Exclusion Criteria:

* Subjects who were treated with a previous antibiotic with MRSA activity (other than linezolid or vancomycin) for more than 48 hours, unless documented to be a treatment failure (72 hours of treatment and not responding).
* Subjects with severe neutropenia (\<500 cells/mm3)
* Subjects with hypersensitivity to oxazolidinones or vancomycin.
A Randomized, Double-blind, Placebo Controlled Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy (Carboplatin- Etoposide) in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of HLX10+ Chemotherapy vs placebo+Chemotherapy in Previously Untreated Patients with Extensive Stage Small Cell Lung Cancer.

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (HLX10 arm): HLX10 + chemotherapy (Carboplatin-Etoposide) ; Arm B (placebo arm): Placebo + chemotherapy (Carboplatin-Etoposide); The three stratification factors for randomization include: PD-L1 expression level (negative, positive, not available), Brain metastasis (yes versus no), Age (≥ 65 years versus \< 65 years)


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
* No prior systemic therapy for ES-SCLC
* Major organs are functioning well
* Participant must keep contraception

Exclusion Criteria:

* Histologically or cytologically confirmed mixed SCLC.
* Known history of severe allergy to any monoclonal antibody.
* Known hypersensitivity to carboplatin or etoposide.
* Pregnant or breastfeeding females.
* Patients with a known history of psychotropic drug abuse or drug addiction.
* Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.