cyrilzakka/clinical-trials huggingface dataset:
International COVID-19 Clinical Evaluation Registry -2 (HOPE-2)

PURPOSE. The main objective of the present study is to carefully characterize the clinical profile of individuals with lasting sequelae after a COVID-19 admission.

As secondary objectives, the analysis of the risk-adjusted influence of COVID-19 severity, previous comorbidities and management of patients discharged after COVID-19 will be performed.

DESIGN AND STATISTICAL ANALYSIS Cross-sectional and prospective registry, a real life "all comers" type, with voluntary participation, without specific funding or conflicts of interest.

It is a study initiated by researcher that will have advanced statistical support from the IMAS foundation (Institute for the Improvement of Health Care, Madrid, Spain) and the Cardiovascular Research Foundation (FIC, Madrid, Spain).

International level.

PARTICIPANTS PROTOCOL. The study has been approved by Hospital Clinico San Carlos Ethic´s Committee (21/128-E) and the institutional board of each participating center.

The present study proposes the continuation in time of the work previously carried out in the HOPE registry.

It proposes to select all the patients attended in any health center (with in hospital beds), who have been discharged or have died up to 31st august 2020.

All will be considered eligible with a positive COVID-19 test (any type) or if their attending physicians consider them highly likely to have presented the infection.

Given the anonymous characteristics of the registry and the health alarm situation generated by the virus, in principle, it is not considered necessary to provide written informed consent.


Eligibility Criteria:
Inclusion Criteria:

* Patients discharged (deceased or alive) from any hospital center with a confirmed diagnosis.

Exclusion Criteria:

* There are no exclusion criteria, except for the patient's explicit refusal to participate.
Negative Pressure Wound Therapy: Are All Systems Alike?

Hypotheses: (1)Wound healing during hospital stay will be equal between systems, (2)RNs will perceive the Versatile One (EZCare) system as easier to use, (3)Costs related to dressing changes will be less with Versatile one (EZCare), (4)Hospital length of stay will be equal or shorter with the Versatile One (EzCare) system, (5) Nursing time using Versatile One (EZCare) will be less than or equal to VAC system, (6) Patients will report less pain during dressing changes with Versatile One (EZCare).

This is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using Versatile One (EZCare)versus KCI VAC negative pressure/vacuum systems. Only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adults requiring negative pressure dressings.

Exclusion Criteria:

* Comatose
* Mentally obtunded
* Documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function
* Presence of Manufacturer's contraindications
* Malignancy in wound
* Untreated osteomyelitis
* Unexplored fistula
* Necrotic tissue
* Exposed blood vessels or organs
* Untreated malnutrition.
Cervical Occlusion for the Prevention of Preterm Birth

The aim of this study was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with cervical cerclages.

Cervical weakness and ascending infection have long been considered important causes of preterm birth. Cervical occlusion could theoretically be used for the treatment of cervical weakness and to protect the cervix against infection. A cervical cerclage could be placed to increase the cervical resistance, and occlusion of the external os could be performed to retain the cervical mucus plug thereby preventing infection. The aim of this multicentre, stratified, randomised controlled trial was to evaluate the effect of cervical occlusion versus no cervical occlusion in women with prophylactic and therapeutic cervical cerclages.

Eligibility Criteria:
Inclusion Criteria:

* The physician in charge considered that a cerclage was indicated.
* Gestational age between 12 and 27 completed weeks.
* Previous late mid-trimester miscarriage, or spontaneous preterm labour and delivery before 28 weeks with or without previous cerclages.
* Previous cerclage because of short cervix.
* Confirmed gestational age defined as gestational age estimated by ultrasound at less than or equal to 22+0 weeks, and/or certain last menstrual period.
* Vaginal infection treated before cerclage.
* Ability to read and understand the relevant national language.
* Consent obtained in accordance with specifications of the local research ethics committee.
* 18 years or more of age and legally competent.

Exclusion Criteria:

* Demonstrated cervical infection.
* Obstetrical complications in the current pregnancy.
* Multiple pregnancies.
* History of a significant abruptio placenta in a previous pregnancy.
Balance, Pulmonary Function, and Low Back Pain in Pregnant and Non-pregnant Women

The aims of this study were to investigate balance and pulmonary functions in pregnant and non-pregnant women and to determine their relationship with LBP.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women (in the second and third trimester), non-pregnant women, aged between 18 and 40 years, volunteering to participate in the study

Exclusion Criteria:

* Having a high-risk pregnancy, preeclampsia, multiple pregnancies, gestational diabetes mellitus, hypertension, any physical disability, prior history of surgery related to spine or abdominal, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, fracture history, or those having any exercise program or sportive activity in the last 3 months for pregnant women
* Having any physical disability, spinal or abdominal surgery, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, or fracture history, or those having any exercise program or sportive activity in the last 3 months for non-pregnant women
Iloprost Power 15 in Pulmonary Arterial Hypertension

Patients with symptomatic idiopathic pulmonary arterial hypertension (IPAH), or familial pulmonary arterial hypertension (FPAH) or pulmonary hypertension associated with Human immunodeficiency virus (HIV) or drugs/toxins in New York Heart Association (NYHA) functional class II to IV at baseline, naive to PAH treatment or currently being treated with a stable dose of either bosentan, ambrisentan or sildenafil will be enrolled in the PROWESS 15 study. This randomized, double blind, placebo-controlled, crossover, and single-dose study will determine whether a single inhaled dose of iloprost using the power 15 disc improves exercise capacity compared to placebo in patients with pulmonary arterial hypertension (PAH).


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study mandated procedure,
* Patients with symptomatic idiopathic, or familial pulmonary arterial hypertension or pulmonary hypertension associated with human immunodeficiency virus (HIV) or drugs/toxins in NYHA functional class II to IV.
* Women of childbearing potential must have a negative urine pregnancy test and must use an adequate method of contraception during the study and for 28 days after discontinuation of the study drug.

Exclusion Criteria:

* Pulmonary arterial hypertension related to any condition other than those specified in the inclusion criteria,
* Pulmonary arterial hypertension associated with significant venous or capillary involvement (Pulmonary capillary wedge pressure (PCWP) \> 15 mmHg),
* Known pulmonary veno-occlusive disease, or pulmonary capillary hemangiomatosis,
* Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 65% of predicted value after bronchodilator administration,
* Moderate to severe restrictive lung disease: total lung capacity (TLC) \< 60% of predicted value,
* Pregnant or breast-feeding women,
* Systemic hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg on repeated measurement),
* Systolic blood pressure \< 95 mmHg,
* Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C,
* Chronic renal insufficiency defined by serum creatinine \> 2.5 mg/dL (221 μmol/L) or ongoing dialysis,
* Clinically relevant bleeding disorder or active bleeding,
* For those patients on monotherapy, any contraindication to bosentan, ambrisentan, or sildenafil, according to product label,
* Known hypersensitivity to iloprost or any of its excipients.
European Phase III Study of APD421 in PONV

A comparison of the efficacy of APD421 and placebo in the prevention of PONV in patients at moderate-to-high risk of PONV.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patients undergoing elective surgery (open or laparoscopic technique) under general anaesthesia, expected to last at least one hour from induction of anaesthesia to wound closure and expected to require at least one overnight stay in hospital

Exclusion Criteria:

* Patients scheduled for outpatient/day case surgery
* Patients scheduled to undergo intra-thoracic, transplant or central nervous system surgery
* Patients scheduled to receive only a local anaesthetic/regional neuraxial (intrathecal or epidural) block
* Patients who are expected to remain ventilated for a period after surgery
* Patients who are expected to need a naso- or orogastric tube in situ after surgery is completed
Study of [14C] ABBV-CLS-7262 in Healthy Male Volunteers Following Single Oral Dose Administration

The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-CLS-7262 in healthy, male volunteers following administration of a single oral dose.


Eligibility Criteria:
Inclusion Criteria:

* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
* Body Max Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at screening.

Exclusion Criteria:

* Considering fathering a child or donating sperm during the study and for 94 days after study drug administration, or is unwilling to comply with protocol recommended contraception recommendations.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic, endocrinologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Has had significant exposure to radiation for professional or medical reasons (e.g., serial x-rays or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring), except dental x-rays, within 12 months prior to study drug administration.
Validation of a Surgical Navigation Algorithm During Knee Replacements in Patients With Knee Osteoarthritis

Ganymed Robotics develops a novel solution of surgical navigation to assist surgeons during knee remplacement surgeries. The aim of this study is to train and validate this novel algorithm.

During knee replacement surgery, per-operative images of the patient's knee will be taken. These images will then be compared with the pre-operative CT-scan of the patient using the novel navigation algorithm. The algorithm will be validated based on its ability to correctly compare both modalities (pre-operative and per-operative images).

Eligibility Criteria:
Inclusion Criteria:

* Adults patients who signed the ICF of the study
* Patients suffering from knee osteoarthritis requiring a total knee replacement surgery

Exclusion Criteria:

* Patient under the age 18
* Patient unable to consent to the study or refusing to participate
* Patient with history of knee replacement on the knee that will be operated again
* Patient unable to realize a pre-operative CT-scan
* Patient not covered by French Health insurance or equivalent.
The Impact of Running Therapy on Mental Health of Youth in a Psychiatric Adolescent Department

A randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. The control group will continue the treatment program as usual.

Patients in the inpatient and daycare centers of the psychiatric adolescent department at Ziv Medical Center receive an intensive treatment program including medical management, psychotherapy (individual, groups, and family therapy), and suited educational and other extracurricular recreational activities. Despite growing evidence of the effective influence of aerobic physical activity and running therapy, it is not included in the intensive treatment program, and, as far as we know, it is not included in most psychiatric wards in Israel.

The aim of this study is to assess the effectiveness of combining a group based running therapy as part of the treatment program provided in the inpatient and day care centers of the psychiatric ward.

A randomized controlled trial, whereby the intervention group will participate in a 12-week running program and will also continue their routine treatment program. The control group will continue the treatment program as usual.

Participants will have group running sessions for 1 hour, three times a week, for 12 weeks. Sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. The sessions will be at an open court near the hospital. It will be guided by a team that will address both physical and therapeutic aspects.

The intervention program will include running outside the hospital complex (Safed Stadium) 3 times a week for about an hour each time, for 12 weeks. Participants will be transported to the stadium in an organized manner where the therapeutic running training will be conducted by a team that will include the researcher, running coach, nursing staff and psychology students.

Sessions will include a psycho-educational short explanation, warm-up, main running exercise, relaxation, and a short summing up discussion. At the end of the session, the participants will be driven back to the inpatient ward and day care centers.

Participants from the intervention group will be given specific group running T-shirts. Every week they will be given motivation band bracelets. The control group will be given similar items. Also, both groups will be given running shoes.

Eligibility Criteria:
Inclusion Criteria:

* 12-18-year-olds.
* Expected to be under observation for at least 10 weeks at time of recruitment.
* Consent of the patients and their parents to participate in the randomized control trial

Exclusion Criteria:

* Acute psychosis or manic states
* Acute suicidality
* Extreme physical difficulties
* Anorexia Nervosa
Microembolisation After Carotid Revascularisation

Microembolisation identified on diffusion-weighted magnetic resonance imaging (DW-MRI) is recognized as an important outcome measure for carotid revascularization procedures such as carotid stenting (CAS) or carotid endarterectomy (CEA). In fact, cerebral microembolisation occurring during revascularization procedures is associated with an increased risk of peri- and post-procedural stroke, transient ischemic attack as well as neurocognitive decline. Carotid artery stenting is a less invasive alternative to endarterectomy to treat symptomatic or asymptomatic carotid stenosis. Large randomized clinical trials showed a higher periprocedural risk of non-disabling stroke with CAS and a higher periprocedural risk of myocardial infarction, cranial nerve palsy, and access site hematoma with CEA.

However little is known regarding the correlation between the morphological characteristics of the carotid plaque and the occurrence of microembolisation during the procedure and between microembolisation and midterm cognitive impairment. A few studies suggest that plaque morphology may be an important determinant for the increased risk of microembolisation. These studies however have mainly investigated microembolisation occurring during CAS and exploratory studies comparing the two procedures are still lacking.

The purpose of the present study is to determine the correlation between the morphological characteristics of the carotid plaque and cerebral microembolisation either after carotid stenting or after carotid endarterectomy in patients with symptomatic or asymptomatic carotid disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting a symptomatic (ipsilateral ischemic stroke, TIA located in the carotid artery territory or retinal ischemia) carotid stenosis between 50% and 99% (according to NASCET and ECST criteria)
* Patients presenting an asymptomatic carotid stenosis between 60% and 99% (according to NASCET and ECST criteria) Patients who accept the informed consent

Exclusion Criteria:

* Important neurological deficit with NIHSS \>7 (or severe aphasia) at time of inclusion
* Previous known cognitive impairment
* Pregnancy
* Presence of contraindication based on ground of multidisciplinary team decision:

  * For surgery:

High bifurcation Intracranial extension of the carotid stenosis Patients with tandem lesions High suspicion of severe siphon stenosis Patients with previous irradiation of the cervical region Patients with restenosis after endarterectomy

* For stenting; Excessive arch vessel or carotid artery tortuosity and in particular presence tortuosity ≤90 degrees in the cervical segment Excessive aortic arch plaque burden Patients older than 70 years Unfavourable anatomic disposition as described above Co-morbidities that may preclude the use of a periprocedural dual antiplatelet regime.
* For CT-scan Iodine allergy Renal insufficiency
* For MRI Pacemaker Any other metallic implants Claustrophobia
* For ultrasound Bad quality ultrasound (patient morphology or equipments
The Safety and Effectiveness of Clarithromycin Plus Ethambutol Used With or Without Clofazimine in the Treatment of MAC in Patients With AIDS

PRIMARY: To assess the tolerability of the combination regimen of clarithromycin plus ethambutol with or without clofazimine in patients with disseminated Mycobacterium avium Complex (dMAC).

SECONDARY: To determine the proportion of patients achieving a sterile blood culture along with the time required to achieve it. To determine the duration of bacteriological response, defined as length of time that blood cultures remain sterile.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* History of HIV seropositivity.
* Disseminated MAC.
* Positive blood culture for MAC within 4 weeks prior to study entry.
* Consent of parent or guardian if less than 18 years of age.
* Ability to complete the study.

NOTE:

* Patients with active opportunistic infections other than dMAC are permitted if dosage and clinical parameters have been stable for 4 weeks prior to enrollment.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Active therapy with carbamazepine or theophylline, unless investigator agrees to carefully monitor blood levels.
* Active therapy with investigational drugs other than treatment for HIV disease, except with approval of the sponsor.
* Concomitant terfenadine (Seldane or Seldane-D) or astemizole (Hismanal).
* Amikacin.
* Azithromycin.
* Capreomycin.
* Ciprofloxacin.
* Cycloserine.
* Ethionamide.
* Gentamicin.
* Kanamycin.
* Levofloxacin.
* Lomefloxacin.
* Ofloxacin.
* Rifampin.
* Rifabutin.
* Sparfloxacin.
* Streptomycin.
* Any other aminoglycosides, quinolones, and macrolides.

Patients with the following prior conditions are excluded:

History of allergy or hypersensitivity to macrolides, ethambutol, or clofazimine.

Prior Medication:

Excluded:

* Other antimycobacterials, including aminoglycosides, ansamycin (rifabutin), other macrolides (such as clindamycin), quinolones, and rifampin, between screening and study entry.
* Clarithromycin or azithromycin as prophylaxis or treatment (for any cause) for more than 14 days cumulative within the past 2 months.
Protocolized Reduction of Non-resuscitation Fluids vs Usual Care in Septic Shock Feasibility Trial

The objectives of this feasibility trial are to assess the efficacy and feasibility of methods and procedures of a protocol purposed to compare a reduction of administration of non-resuscitation fluids to usual care in patients with septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years of age)
* Septic shock according to the Sepsis 3 criteria: suspected or confirmed infection AND infusion of vasopressor/inotrope to maintain mean arterial pressure of 65 mmHg or above despite adequate fluid resuscitation AND lactate of 2 mmol/L or above at any time following ICU admission when there was a simultaneous need for vasopressor/inotrope.
* Inclusion within 12 hours after ICU admission.

Exclusion Criteria:

* Confirmed or suspected pregnancy
Resistive Exercise for Arthritic Cartilage Health (REACH)

Female subjects over the age of 40 will be recruited and randomised into a progressive resistance training (PRT) or sham-exercise group. The PRT group will train at 80% of their peak strength, using Keiser pneumatic resistance machines, and progress approximately 3% per session. Strength will be re-assessed fortnightly. Exercises will target muscles around the hip and knee. The sham-exercise group will train on the same equipment as the PRT group except hip adduction, but without added resistance or progression. Both groups will train 3 days per week for roughly 45 minutes for 6 months.

It is hypothesised that high intensity PRT will decelerate the tibial and femoral cartilage degeneration in the knee affected most by OA.

Primary Outcome:

Articular cartilage morphology following 6 months high intensity progressive resistance training

Secondary Outcomes:

Muscle and fat cross-sectional area (CSA) (pre and post) Muscle strength, power, endurance, and contraction velocity (pre, 3 months, \& post) Medications (pre, 3 months, \& post) Body composition (pre, 3 months, \& post) Balance; Physical function (pre, 3 months, \& post) Questionnaires (pre, 3 months, \& post)

* Habitual exercise (PASE) -WOMAC index (pain, stiffness and functional ability)
* Depressive symptoms (Depression Scale) -Quality of life (SF36)
* Confidence performing physical activity (Ewart) -Demographics


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged over 40 years old
* Primary Osteoarthritis in at least one knee using standard criteria of the American College of Rheumatology (ACR) criteria for classification of clinical osteoarthritis
* Ambulatory without human assistance
* Willingness to be randomised to experiential or control group
* Ability to attend scheduled exercise and testing sessions

Exclusion Criteria:

* Regular exercise of any kind over the past 3 months (\>1dpw).
* Secondary osteoarthritis (traumatic or post-surgical), rheumatic disease, gouty or septic arthritis, Paget's disease, pseudogout, major congenital abnormalities, hemochromatosis, Wilson's disease and other rare forms of arthritis
* Joint injury, injection or surgery within the past 6 months or knee joint replacement
* Contraindications to MRI/Exercise
Procalcitonin Use in Pneumonia Patients in the Critical Care Setting

The goal of the study is to determine the impact of procalcitonin (PCT)-guided therapy on duration of antibiotic therapy in critical care unit (CCU) patients with suspected pneumonia at Mayo Clinic Health System Eau Claire.


Eligibility Criteria:
Inclusion criteria:

* 18 years old
* admitted to critical care unit
* placed on pneumonia protocol

Exclusion criteria:

* patients who received outpatient antibiotic therapy within previous 21 days