cyrilzakka/clinical-trials huggingface dataset:
To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Inhaled AZD8683

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing single doses of AZD8683 administered via inhalation

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of inhaled AZD8683 after Single Ascending Doses administered via Turbuhaler in Healthy Subjects

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures Healthy male subjects aged 18
* 45 years with suitable veins for cannulation or repeated venepuncture
* Male subjects should be willing to use barrier contraception ie, condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product
* Have a body mass index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg inclusive

Exclusion Criteria:

* History or presence of gastrointestinal, pulmonary, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
* Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of the investigational product
* Abnormal vital signs, after 10 minutes supine rest, defined as any of the following:

  * Systolic blood pressure \>140 mm Hg
  * Diastolic blood pressure \>90 mm Hg
  * Heart rate \<40 or \>85 beats per minute Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG. This includes subjects with any of the following:
  * PR(PQ) interval prolongation \>200 ms or dropped beats (single non conducted P-waves) based on screening or Prolonged QTcF \>450 ms or shortened QTcF \<340 ms or family history of long QT syndrome
Clinical Outcome of Dentsply Sirona Profile Implants

This is a retrospective observational study of 50 implants placed between 2013 and 2023 from the same dental implant system (Osseospeed Profile, Dentsply Implants, Mölndal, Sweden).

The aim of this study is to evaluate the cumulative survival, success and complication rates obtained with the use of Osseospeed Profile EV implants in two clinical centres with similar characteristics since its launch on the market in 2013, until today.

All clinical records of patients with this implant system will be collected and the following data will be recorded:

Patient gender Date of placement Dimensions and location of implant(s) placed Type of implantation Design of the implant-supported dental prosthesis, single or partial, screw-retained or cemented Date of last radiographic control Type of biological and/or mechanical complications that occurred In biological complications, presence or absence of inflammatory signs and presence or absence of peri-implant bone loss.

For mechanical complications, screw loosening, porcelain fracture, fracture of the prosthetic abutment or fracture of the implant.

Date of explantation if present

The mean, standard deviation (SD), and percentage will be calculated for all recorded parameters.

A life table will be made with cumulative survival and success rate (CSR), according to Kaplan-Meier analysis. Correlations and regression analysis will be performed to assess the influence of the variables on the outcomes

Conclusions will be drawn based on the results obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have come to private dental clinics with the need to rehabilitate a single edentulous space in the posterior mandibular area.

Exclusion Criteria:

* None
Screening Strategies for People With a High Risk of Anal Cancer

The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among minorities with a high risk of anal cancer and 2) characterize DNA methylation, immunologic response, and social determinants associated with aHSIL.

Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals living with HIV. The study is important because the incidence of anal cancer is particularly high among certain groups; health disparity further contributes to this high risk among minorities. Findings will provide much-needed evidence for anal cancer screening strategies to reduce health disparities, improve screening outcomes, and decrease the incidence of anal cancer among high-risk minorities. The study population includes Black or Latinx, males - men having sex with men (MSM) only - and females with a known history of high-grade lower genital tract neoplasia.

The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants.

Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.

Eligibility Criteria:
Inclusion Criteria:

* 30 years of age and older
* Identifies as Black or Latinx,
* Males (MSM only) and females with a known history of high-grade lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2;
* Women with Human Papillomavirus (HPV) related cervical, vaginal, or vulvar high-grade precancer or cancer

Exclusion Criteria:

* Patients treated for aHSIL less than 6 months before screening,
* History of anal cancer and pregnant women.
Preventing contrAst Induced Nephropathy After TranscathEter Aortic Valve Replacement

Chronic kidney disease (CKD) and (subsequent) acute kidney injury are frequent in patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, these patients are easily hypervolemic and susceptible for cardiac decompensation. Prevention of contrast induced nephropathy (CIN) has not yet been studied in these patients, and evidence on different strategies is urgently needed. The objective of this study is to evaluate the efficacy of 250ml 1.4% sodium bicarbonate versus hypotone saline (0.65% sodiumchloride) hydration prior to TAVI in patients with CKD to prevent CIN.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has provided written informed consent.
2. Patient is undergoing TAVI.
3. Patient has an estimated GFR \<60ml/min/1.73m2.

Exclusion Criteria:

1. Patient has end-stage kidney disease requiring dialysis.
2. Emergent TAVI (planned before next working day).
3. Recent exposure to radiographic contrast agents (within 2 days prior to the TAVI).
4. Allergy to contrast agent.
5. Planned administration of dopamine, mannitol, fenoldopam or N-acetylcysteine during the intended time of the study.
6. Need for continuous hydration therapy (e.g. sepsis).
7. Multiple myeloma.
8. Contra-indication to sodium bicarbonate.
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis

Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.

A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was "failure of treatment" which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours

Exclusion Criteria (prerandomization):

* immunocompromised patients
* pregnant women
* clinical suspicion or CT confirmation of complicated acute diverticulitis
* Karnofsky performance score less than 50%
* allergy to penicillin

Exclusion Criteria (postrandomization):

* withdrawal of the trial
* CT confirmation of complicated acute diverticulitis
* CT not conforming to acute diverticulitis
* CT performed 72 hours after the admission
* adverse reaction to the antibiotic
* bacteriemia
Dysphagia Assessment in Acute Ischemic Stroke Using High-resolution Manometry

Dysphagia occurs relatively commonly in patients with acute stroke, and can lead to aspiration pneumonia and malnutrition. By using the stroke registry of our hospital, we will evaluate the feasibility and usefulness of Dysphagia screening in Acute Stroke using High-resolution impedance manometry (DASH). The hypothesis tested in this study is that high-resolution impedance manometry (HRiM) can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients.

The hypothesis tested in this study was that high-resolution manometry can provide the clinical efficacy to evaluate dysphagia and the diet plan in acute stroke patients. By using of stroke registry of our hospital, we assessed feasibility and usefulness of Dysphagia screening in Acute Stroke using High-resolution impedance manometry in patients with acute stroke.

The registry had the contents of two evaluation steps; the first step was the process to identify the patients with risk of possible aspiration and the second step was for detection of silent aspirators.

Firstly, the patient was interviewed regarding difficulties with food intake, chewing and swallowing, and the neurological signs were confirmed by two independent neurologists. After then, the patients were stratified into three aspiration risk group and controlled by proper diet program. Finally the emergence of aspiration pneumonia was observed.

Eligibility Criteria:
Inclusion Criteria: New stroke lesion should be present in MRI which compatible with clinical history and neurologic examination and patients with onset \<= 48 hours.

Exclusion Criteria:

1. hyperacute stroke receiving thrombolytic therapy
2. symptom onset \> 48 hours
3. patients who died in the incipient stage of acute stroke
4. neurological deterioration (increase in NIHSS ≥ 4)
5. transient ischemic attack
6. history of prior stroke and dysphagia
7. other neurological diseases causing oropharyngeal dysphagia, such as Parkinsonism, dementia, and neuromuscular disorders
8. history of cranial neurosurgery
9. prior or current structural lesions causing oropharyngeal dysphagia,
10. pulmonary diseases such as chronic obstructive pulmonary disease or current pneumonia.
Neuromuscular Electrical Stimulation in Pulmonary Arterial Hypertension

This study aimed to investigate the effects of neuromuscular electrical stimulation on peripheral muscles and other physical and psychosocial variables in patients with pulmonary arterial hypertension. This study was designed as an assessor-blind randomized controlled trial. Thirty-one patients with pulmonary arterial hypertension will be recruited. The participants will randomly divided two parallel groups as treatment and control. For the treatment group, neuromuscular electrical stimulation will be applied to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks. Control group will not be received any additional treatment, just given healthy life recommendations such as walking. The participants will be assessed before and after the treatment by a blind assessor to the group allocation. The outcome measure will be assessments of the upper and lower limb muscle strength, respiratory muscle strength, muscle cross-sectional area and thickness, pulse wave velocity, exercise capacity, walking speed, functional mobility and balance performances, balance confidence, fatigue perceptions, physical activity level, activities of daily living and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Elevated pulmonary artery pressures measured by right heart catheterization
* New York Heart Association class II or III
* Stabile Pulmonary Arterial Hypertension-specific pharmaceutical therapy for 3 months

Exclusion Criteria:

* Orthopaedic problems
* Significant restrictive or obstructive pulmonary disease
* Acute cor pulmonale.
tDCS Plus Physical Therapy for Progressive Supranuclear Palsy

Objective of the study:

To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology

Design:

Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a ten cerebellar tDCS stimulations while the placebo arm will undergo sham stimulation.

Each patient will be evaluated before and after stimulation by PSP-rating scale (PSP-RS), cognitive tests and a battery of gait and movement tests using wearing sensors technology.

Background:

There are no medical effective treatments for progressive supranuclear palsy (PSP). Imaging, neurophysiology and pathology studies suggested cerebellum as possible target of brain stimulation for postural instability using tDCS stimulation

Objective of the study:

To test the efficacy of cerebellar transcranial direct current stimulation (tDCS) associated with physical rehabilitation on postural instability and falls in progressive supranuclear palsy using a double-blind design and wearing sensors technology

Design:

Twenty probable PSP patients with no dementia and still able to walk will be recruited for a randomized double-blind sham-controlled study. Each patient will be hospitalized for a four week physical rehabilitation. In the real-arm, the patients will undergo a 10 days cerebellar tDCS stimulation while the placebo arm will undergo sham stimulation.

cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum for ten days.

Each patient will be evaluated before and after stimulation by berg balance tests (BBS), Tinetti scale, PSP-rating scale (PSP-RS), cognitive assessment and a battery of gait and movement tests using wearing sensors technology.

Sensors assessment:

The following parameters will be evaluated before and after stimulation (real vs sham): The parameter for postural instability defined are:

i) TIME, defined as time without falling ii) The parameter "surface", defined as the sway area iii) Velocity describes the mean velocity of the compensatory movements given in mm/s. iv) Acceleration described as root mean square (RMS), v) Jerk, the time derivate of acceleration, quantifies smoothness of the compensatory movements given in mG/s.

The parameter for gait and turning evaluation during normal walk and timed up and go, defined are: i) stealth length ii) step variability iii) step phases duration iv) gait speed v) turning velocity

Eligibility Criteria:
Inclusion Criteria:

probable PSP diagnosis ability to stand alone without support for at least 5 seconds ability to walk without aid for at least three meters

Exclusion Criteria:

dementia or behavioral alterations contraindications of stimulation
Effects of a Warm-up on Immune Response to Exercise

This randomized cross-over study compares two identical cardiorespiratory exercise bouts, differing only in the inclusion or exclusion of a dynamic period of increasing exercise intensity prior to the exercise bout. Planned comparisons include physiological responses and perceived effort during exercise, leukocyte mobilization, and mood between the two exercise sessions.

Physically active adult men and women are asked to complete three study visits to the laboratory. On Visit 1, participants provide informed consent and are screened for study inclusion criteria: being between 18 and 40 years of age, a non-smoker, not pregnant, free of disease impacting exercise performance or immunity, and performing at least one hour per week of vigorous exercise training (any modality) for at least the prior six months. Participants also complete an incremental submaximal exercise test on a stationary bicycle. The results of this test are used to calculate the resistance corresponding to 80% of estimated maximal heart rate. Participants return within 2-14 days for Visits 2 and 3. These visits consist of 30 min of bicycling at this resistance. One visit included a 10 min dynamic warm-up prior to the exercise bout. Participants were stratified by sex and randomized such that half of the men and women completed the exercise trial with warm-up during Visit 2.

Heart rate, perceived exertion, and wattage are recorded during each minute of the exercise bouts. Participants donate blood before, immediately after, and 1h after each exercise. Blood is analyzed by flow cytometry to characterize leukocyte subsets. After each exercise session, participants complete surveys assessing mood and affect.

Physiological, immunological, and psychological parameters recorded will be compared within participants between the two experimental exercise sessions using appropriate statistical tests. p\<0.05 will be accepted as significant.

Eligibility Criteria:
Inclusion Criteria:

* identifies as exercising 1-3 hours per week or more than 6 hours per week, on average (last 6 months)
* meets American College of Sports Medicine criteria for participation in exercise

Exclusion Criteria:

* underlying medical problems that contraindicate supervised high intensity exercise
* past or present history of autoimmune disease, HIV, hepatitis, stroke, or cardiovascular disease
* chronic/debilitating arthritis
* central or peripheral nervous disorders
* asthma, emphysema, or bronchitis
* bedridden in the past three months
* history of blood clotting disorders
* administration of any medication that might affect physiological response to exercise
* functional or cognitive impairment that would limit exercise performance or prohibit informed consent
* having any common-cold or influenza like symptoms (scratchy throat, runny nose, inflamed sinuses, frequent sneezing or coughing) in the last 2 weeks
* pregnancy
* tobacco use
Distance Education Versus Usual Care Qualification in Asthma Care

The purpose of this study is to evaluate the effectiveness of multifaceted educational interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in teams of the Family Health Strategy and the consequent clinical improvement patients.

Cluster-randomized trial with follow-up of 6 months. The aim of this study is to determine whether multifaceted interventions performed at a distance for the care of asthma symptoms reduce overhead, improve asthma control and qualify the care provided to patients.

Eligibility Criteria:
Inclusion Criteria:

* Practice:Participate in the Telessaúde/RS. Minimal staff consisting of a general practitioner, nurse, nurse and community health agents (CHA), ability to give at least ten patients diagnosed with asthma, located in a municipality to make available for free inhaled medication (short-acting bronchodilators and corticosteroids ) for the treatment of asthma and willingness to participate in the study.
* Patients: 5 to 45 years with a diagnosis of asthma made by a physician and register at least one consultation for asthma or an asthma-related hospitalization during the year preceding the beginning of the study.

Exclusion Criteria:

* Patients with other chronic diseases with pulmonary complications such as tuberculosis, cancer and cystic fibrosis or those with severe mental illness
Abiraterone-Rechallenge Study for CRPC Patients

To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone.

To assess activity of abiraterone-re-challenge in patients with advanced prostate cancer and prior response to abiraterone. CRPC patients with prior response to abiraterone (confirmed PSA Response) and progression can be re-challenged with abiraterone. Patients may have received treatment with docetaxel, enzalutamide and radium-223.

Eligibility Criteria:
Inclusion Criteria:

1. Written prostate cancer.
2. Adult patients with histological or cytological diagnosis of adenocarcinoma of the prostate.
3. Men with castration-resistant metastatic decline maintained for at least 3 weeks as per PCWG2 criteria).
4. Confirmed biochemical response to prior abiraterone acetate (≥50% PSA Informed Consent (including consent for biomarker studies including the fresh tumour biopsies)
5. Progressive disease according to PCWG2 criteria during prior therapy with standard dose of abiraterone acetate (confirmed increase of PSA ≥25% over nadir) or soft-tissue or bone progression. Patients that have stopped abiraterone acetate for reasons other than progression are not eligible.
6. Documented progression of disease by any of the criteria listed here:

   * PSA
   * Soft tissue
   * Bone scan all as per PCWG2 criteria
7. Patients may have received treatment with docetaxel, enzalutamide or radium-223
8. PSA of ≥10ug/l
9. ECOG performance status 0 - 2
10. At least 3 months (90 days) since stop of prior abiraterone acetate.

Exclusion Criteria:

1. Major surgery within 28 days weeks prior to start of treatment
2. Prior treatment with cabazitaxel or the CYP-17 inhibitor TAK-700/orteronel
3. Any concurrent treatment or prior treatment with an investigational drug within 28 days prior to start of treatment.
4. Known brain or leptomeningeal disease
5. Concurrent use of steroids other than prednisone \>10mg/d
6. Inadequate bone marrow and organ function as evidenced by:

   Platelet count \<75 x 10 G/L ASAT and/or ALAT ≥ 2.5 x ULN Total bilirubin ≥ 1.5 x ULN (≥ 2.0 x ULN for patients with Gilbert's disease) Hypokalaemia despite adequate supplementation Creatinine Clearance \<30ml/min
7. Uncontrolled hypertension or cardiac failure or LVEF \<50%

creatinine clearance is to be calculated by using the formula of Cockcroft-Gault in appendix 4 of the protocol
Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis

The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.

Methods: The relationship between relevant biomarkers and stratified diagnosis was analyzed by collecting laboratory and etiological examinations of patients with severe pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* Meets the diagnostic criteria for severe pneumonia；
* Age≥18 years old and \< 80 years old；
* Willing to sign informed consent for the course of the study；

Exclusion Criteria:

* Patients with intracranial hypertension, acute coronary syndrome, pleural fistula, pneumothorax, or subcutaneous emphysema;
* Pregnant and lactating patients;
* Severely hemodynamically unstable (an increase in vasopressors by more than 30% in the first 6 hours, or norepinephrine \>0.5mg/kg/min);
* Those who do not consent to participate in this study；