cyrilzakka/clinical-trials huggingface dataset:
The Effect of Physical Therapy on Sexual Function

Sexual function in low back pain and after lumbar surgery has been evaluated in many studies In a few studies, sexual function problems after surgery have also been reported. In the literature, there is no study that investigates the effectiveness of physical therapy on sexual function in patients with low back pain. In this study, the effectiveness of physical therapy on sexual function in patients with low back pain will be evaluated.

63 patients who had chronic low back pain who applied to City Hospital, Physical Medicine and Rehabilitation Department between January 2021 and January 2023 were enrolled in the study. Sexually active patients between the ages of 18 and 60, for whom physical therapy was planned for low-back pain related to lumbar pathologies, were included in the study. Informed consent was obtained from all patients. Exclusion criteria were defined as having contraindications for any physical therapy agents, having cardiovascular, neurological, psychiatric disease, or sexual disorders.

Short Form-12 (SF-12), Oswestry Disability Index (ODI), and Hospital Anxiety and Depression Scale (HAD) were recorded. International Index of Erectile Function (IIEF) and Female Sexual Function Index (FSFI) were utilized to evaluate sexual function

Fifteen sessions of physical therapy were planned for each patient. The physical therapy program included 15 minutes of conventional transcutaneous electrical nerve stimulation, 10 minutes of ultrasound, and 15 minutes of superficial heaters such as hot packs or infrarouge. All patients were evaluated the day before the first physical therapy session, the one-month and three-month after the last physical therapy session.

Eligibility Criteria:
Inclusion Criteria:

* low back pain due to lumbar pathologies
* being sexually active
* have no contraindications for physical therapy agents

Exclusion Criteria:

* known sexual function problems,
* known psychiatric disease and/or are taking antidepressant
* diabetes mellitus,
* cardiovascular disease
* neurological diseases
Combining Manual Soft Tissue Release and Exercise Training in COPD: the Effect on LF, EC, and CAF

The potential effects of combining manual soft tissue release and physical exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with moderate and severe chronic obstructive pulmonary disease were investigated.

Chronic obstructive pulmonary disease (COPD) commonly presents with accessory respiratory muscle tightness and weakness, affecting chest wall compliance and lung elasticity. However, traditional physical therapy interventions, including pursed-lip breathing, sputum clearance techniques, and respiratory muscle training, are often used in treatment guidelines, with few studies focusing on muscle release for the accessory respiratory muscles. Although the effects of manual therapy on lung function and chest tightness in COPD have been demonstrated, the effects of soft tissue release combined with exercise intervention on COPD, including lung function, exercise capacity, and cardiac autonomic function, remain unknown. Therefore, this study proposes a randomized controlled trial to investigate the effects of manual soft tissue release combined with exercise training on lung function, exercise capacity, and cardiac autonomic function in patients with COPD. It is expected that the results of this study will demonstrate that combining manual soft tissue release with exercise training may increase gas exchange in the lungs, reduce respiratory effort, improve co-morbidities, delay disease progression, and enhance patient quality of life and clinical intervention.

Eligibility Criteria:
Inclusion Criteria:

* GOLD grade II\~IV
* Stable condition
* No acute exacerbations in 6 weeks

Exclusion Criteria:

* Acute heart failure and, or arrhythmia
* Pulmonary arterial hypertension
* Skeletal and, or neuromuscular disorders
* Chest surgery
* Untreated or uncontrolled conditions
* Rheumatoid conditions
* Depends on oxygen supply
A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154

Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.

The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Polymyalgia Rheumatica (PMR) and fulfillment of the 2012 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) provisional classification criteria for PMR.
* Must have had at least 2 episodes of unequivocal PMR flare.
* Must be on a stable dose of prednisone.
* Must be willing to follow the protocol-defined glucocorticoid tapering regimen.

Exclusion Criteria:

* Have been treated with a prior TNF antagonist.
* Current use of immunomodulators other than prednisone and hydroxychloroquine.
Anesthesia And Post-operative Mortality After Proximal Femur Fractures

This study evaluates the effect of anesthesia on mortality after surgical repair of proximal femur fracture.

Patients will receive either a subarachnoid block or a combination of peripheral nerve blocks and light general anesthesia (PNB/GA).

The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid free light anesthesia may have more favourable outcomes.

Both groups will be followed up for assessment of post-operative morbidity and mortality.

Proximal femur fracture is one of the most common causes of admission in emergency departments. Mortality is high among these patients and is reported to range from 10% at 30 days, up to 32% at one-year post-operative.

Several strategies to reduce mortality have been used, but mortality rate has plateaued since 1998. Attempts to show benefit from regional or general anesthesia have shown inconsistent results. New techniques with peripheral nerve blocks have been used, but their effect on mortality when used as major anesthesia component have not been studied.

The investigators hypothesise that smaller physiologic impact of peripheral nerve blocks associated to light general anesthesia may improve survival rates and reduce short term delirium after proximal femur fracture surgery. Recovery of quality of life will also be assessed.

Patients will be randomized into two groups, being allocated for a subarachnoid anesthesia or a combination of peripheral nerve blocks and light general anesthesia.

Patients will be followed up for short-term post-operative complications such as incidence of delirium, recovery of quality of life and survival up to one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted wiht a diagnosis of proximal femur fracture (ICD-9 codes 820.0 to 820.9) and submitted to surgical internal fixation of femur or hip prosthesis (ICD-9 codes 7935, 8151 and 8152)

Exclusion Criteria:

* Multiple fractures; polytrauma, active malignancy, ASA(American Society of Anesthesia) status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known allergies to local anesthetics, contra-indication to general or regional anesthesia
Assessment of Netosis During COVID-19, Under Treatment With Anakinra, an Interleukin-1 Receptor Antagonist

During their activation in response to an infectious stimulus or during chronic inflammatory processes, blood and tissue neutrophils modify their functional phenotype and produce numerous toxic mediators. In particular, they rapidly release chromatin filaments covered with numerous granular and cytoplasmic components called "Neutrophil Extracellular Traps" (NETs). This phenomenon, called netosis, has been implicated in many diseases, in particular in viral infections during which this response can be useful for the anti-infectious response at the initial phase, then deleterious when it becomes toxic. for the tissue environment. This has been shown in particular during post-pneumonia acute respiratory distress syndrome.

The intensity of netosis is therefore an early factor in activating neutrophils and inflammation. Given the major biological signs of inflammation observed in patients with COVID-19 as soon as they enter the hospital \[C-Reactive protein (CRP), Interleukin-6 (IL-6), D-dimers, etc.), it seems particularly interesting to better document this inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years
* Patients hospitalized within the Paris Saint-Joseph Hospital Group for whom the diagnosis of COVID-19 has been established on the basis of a PCR positive for SARS-CoV 19 using a nasal swab and/or a typical chest CT scan
* Patients with a severe or aggravating form of COVID-19, based on an oxygen saturation ≤93% under 6 l/min of nasal oxygen or a saturation ≤93% under 4 l/min oxygen with a decrease in saturation of at least 3% during the last 24 hours, in ambient air
* Patients treated with Anakinra
* Patients for whom IL-6 assays have been performed
* French speaking patients

Exclusion Criteria:

-
Study of a Non-invasive Glucose Measuring Device

This explorative clinical investigation has been launched to collect spectral Raman data paired with validated glucose reference values in persons with diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject ≥18 years.
2. Subject with type 2 diabetes.
3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Individual treated with intensified insulin treatment.
2. Sodium, Potassium. Creatinine, eGFR, and ALAT (more than three times the upper limit of normal range).
3. Clinically relevant anaemia or thrombocytopenia.
4. Infection with hepatitis B, C or HIV (if subject participates in subprotocol 1).
5. Intake of anticoagulant medication (with the exception of acetylsalicylic acid, ASS 100).
6. For female subjects: Pregnancy or breastfeeding or lack of a negative pregnancy test (except in case of menopause, sterilization, or hysterectomy).
7. Subjects not able to understand and read local language.
8. Cognitive impairment, or in investigator's opinion, subject is not able to follow instructions provided and as specified in the clinical investigation plan (CIP).
9. Subject not able to hold hand/arm steady (including tremors and Parkinson's Disease).
10. Skin changes, tattoos, or diseases on right thenar (measurement site).
11. Reduced circulation in right hand evaluated by Allen's test.
12. Known allergy to medical grade alcohol.
13. Haemodialysis.
14. Topical administration of glucocorticoids at the right hand for the past 7 days or during the study period.
15. Any disorder, which in the investigator's opinion, might jeopardise subject's safety or compliance with the CIP.
16. Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g., mental, or visual incapacity, language barriers, alcohol or drug abuse.
17. Dependency from the sponsor or the clinical investigator (e.g., co-workers of the sponsor, the study site, and/ or their families).
18. Subjects currently participating in another study.
Open Label Study Investigating Safety and Efficacy of NPL2009 50 mg - 150 mg on Prepulse Inhibition Tests and Continuous Performance Tasks, Adults With Fragile X Syndrome

This is an open label exploratory study to investigate the safety and effects of a single dose of NPL-2009(50 mg - 150 mg) on Prepulse Inhibition (PPI) Tests and Continuous Performance Tasks (CPT) in adults with Fragile X Syndrome


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18 to 45 years of age.
* Diagnosis of Fragile X Syndrome.
* Females must demonstrate a negative pregnancy test at screening.
* Females of child-bearing potential must be using a medically accepted means of contraception or must remain abstinent for the duration of the study.
* Each Legally Authorised Representative (LAR, usually parent or caregiver) must have a level of understanding sufficient to provide written informed consent to all required study tests and procedures.
* Each patient must consent/assent (depending on center-specific procedures) to all required study tests and procedures.
* Permitted concomitant medications must be stable for at least 6 weeks prior to enrollment. The following concomitant medications are permitted: psychostimulants, SSRIs, atypical antipsychotics, anticonvulsants which do not have liver inducing effects, clonidine.
* Each patient must be able to swallow the capsules (2, 3 or 4) to be provided in the study.

Exclusion Criteria:

* Current treatment with anticonvulsants known to induce liver enzymes e.g. depakote
* Current treatment with N-methyl-D-aspartate (NMDA) antagonists
* Current treatment with tricyclic antidepressants
* Current treatment with typical antipsychotics
* Current treatment with lithium
* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behavioural therapy within 6 weeks prior to enrolment.
* History of, or current cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
* History of, or current cerebrovascular disease or brain trauma.
* History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
* History of, or current malignancy.
* Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the Investigator.
* Current major depressive disorder (patients must be free of the disorder for 3 months prior to enrolment).
* Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the Investigator.
* Tourette's Disorder.
* Female patients who are either pregnant or nursing.
* Current drug abuse or dependence disorder or dependency in the 3 months prior to enrolment.
* Clinically significant abnormalities in safety laboratory tests, vital signs or EKG, as measured at screening
* Patients with significant hearing and/or visual impairments that may affect their ability to complete the test procedures
* Enrollment in another clinical trial within the previous 30 days
Tailored Intervention to Improve Patient Adherence to Secondary Stroke Prevention Medication

Patient suffering a Transient Ischemic Attack (TIA) or stroke are subsequently at high risk of a new stroke, however, poor adherence to secondary prevention medications occurs frequently within this patient group. The purpose of this study is to evaluate whether a complex tailored pharmacist intervention will lead to increased adherence to secondary stroke prevention medications and less new stroke events when compared to a usual care group. Interventions focus on motivational interviewing, medication review and telephone follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years or older
* Patient admitted or receiving ambulatory treatment for an acute transient ischemic attack or ischemic stroke which has occurred within the previous 30 days.
* The patient or a carer usually dispenses the patient's medications
* Written consent

Exclusion Criteria:

* Cognitive or physical impairment that would preclude comprehension of a conversation
* Terminal illness
* Lives in a care home or an institution
* Receives dose dispensed medicine from a pharmacy
* Medicine is dispensed by a nurse in the patient's home
* Correctional mental health patients
Clinical and Physiological Assessment of a Nearly Ultra-protective Lung Ventilation Strategy: A Quasi-experimental Preliminary Study in ARDS Patients

This study aims to determine whether a protective mechanical ventilator strategy generates a reduction in the Bohr´s dead space in patients with moderate or severe acute respiratory distress syndrome (ARDS). Commonly used ventilatory strategies in the clinical practice were applied sequentially to assess their impact. Data obtained from volumetric capnography will be recorded after each ventilatory strategy is applied

Protective mechanical ventilation strategies are currently the cornerstone of treatment for patients undergoing mechanical ventilatory support. Among them, we can mention the reduction in tidal volume, the reduction in driving pressure, the PEEP setting, and the respiratory rate reduction. All of these strategies are aimed at preventing ventilator-induced lung injury. Few clinical studies have evaluated the effects of protective mechanical ventilation strategies on dead-space. This study was designed to evaluate dead space and alveolar ventilation with a sequence of protective ventilatory strategies, keeping PEEP levels constant. The ventilatory strategy was developed to reduce tidal volume, set an end-inspiratory pause, and reduce the frequencies of lung tissue impact.

Baseline:

All the patients kept the variables under study constant for 60 minutes. Each of the participants was studied for a period of 150 minutes. PEEP programming was set with transpulmonary end-expiratory pressures to maintain between 0 and 5 cmH2O and was remained constant throughout the study.

Protocol design:

Baseline: Vt 7 ml/kg/PBW Phase I: Vt 6 ml/kg/PBW. Phase II: Vt 5 ml/kg/PBW. Phase III: end-inspiratory pause prolongation until achieving I:E ratio equal to 1, maintaining a constant Vt level (5 ml/kg/PBW) Phase IV: Respiratory rate reduction by 20% of basal conditions, maintaining constant VT level (5 ml/kg/PBW).

After 30 minutes of continuous monitoring, minute ventilation, mechanical power, variables obtained by volumetric capnography, and arterial blood gases were recorded in each study phase.

This study will be performed in the Intensive Care Unit of a University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* The requirement of invasive mechanical ventilation for more than 4 hours and less than 72 hours
* Severe hypoxemia (PAFI \< 200) secondary to ARDS

Exclusion Criteria:

* Heart failure stage IV
* Chronic obstructive pulmonary disease (COPD) on home oxygen
* Bronchopulmonary fistula
* Hypovolemic Shock with active hemorrhage
* Gastrointestinal bleeding
* Oesophageal Varices
* Nasopharynx surgery, recent oesophageal or gastric surgery
* Massive Pulmonary Thromboembolism
* Catastrophic respiratory failure requiring urgent extracorporeal life support
* Respiratory acidosis. Hydrogen potential (pH) is less than 7.20 and PaCO2 higher than 60 mmHg at baseline.
The Effect of Intravenous Lidocaine on Pain After Tonsillectomy

This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy.

A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation.

Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.

Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Tonsillectomy

Exclusion Criteria:

* mental change
* allergy to local anesthetics
Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. The overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.

Breast cancer is a major life event. A patient's experience of breast cancer may depend heavily on her intimate partner. However, both patients and partners may experience depressed mood or other psychosocial adjustment problems. Individual and relationship factors, such as the couple's joint efforts to deal with the cancer experience, are likely to contribute to their psychosocial adjustment. More knowledge is needed on the adjustment problems patients and partners experience and how they deal with them.

The study investigates the following research questions:

* Which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory?
* To what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa?
* Which factors are associated with psychosocial adjustment problems?
* How do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner?

A prospective, population-based cohort will be established of women diagnosed with breast cancer in Denmark and their partners. The study combines questionnaire data and data from nationwide clinical and administrative registries.

An invitation letter and study material will be sent to patients by mail. Patients will be asked to invite their partner to participate in the study. Only couples in which both the patient and the partner wish to participate will be asked to complete the questionnaire at 5 and 12 months of follow-up.

Up to 3000 couples (3000 patients and 3000 partners) will be asked to participate in the study during the one year inclusion period.

Eligibility Criteria:
Inclusion Criteria:

* For patients: being a female patient diagnosed with primary breast cancer within the last four months
* For patients: cohabiting with a male partner/spouse
* For partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months

Exclusion Criteria:

* For patients: previous diagnosis of breast cancer or breast cancer relapse