cyrilzakka/clinical-trials huggingface dataset:
A Phase I Dose Escalation Trial of PR104 Given Weekly in Subjects With Solid Tumors

The purpose of this study is to determine the side effects and best weekly dose of PR104 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or more
* Histologically confirmed malignancy for which no effective therapy exists
* Measurable or evaluable disease
* ECOG Performance Status of 0 or 1. See Section 15.1 (ECOG performance status) for definition of ECOG Performance Status 0 and 1
* Ability to read, understand and provide written informed consent
* If the subject is on systemic steroids, the dose of steroids must be stable for at least two weeks prior to the first dose of PR-104

Exclusion Criteria:

* Licensed or investigational anti-cancer therapy (including radiotherapy) within four weeks of the baseline disease assessment (within six weeks for nitrosoureas and Mitomycin C). Subjects on androgen deprivation therapy are allowed on study and may continue to receive androgen deprivation therapy while one study
* Prior radiotherapy to more than 25% of bone marrow; prior high-dose chemotherapy (including either myeloablative or non-myeloablative transplants); or prior receipt of more than three chemotherapy regimens
* Absolute neutrophil count of \< 1.5 x 109/L
* Platelet count of \< 100 x 109/L
* Hemoglobin level of \< 90 g/L (or requiring a red blood cell transfusion to maintain hemoglobin \> 90 g/L)
* Serum bilirubin greater than the upper limit of normal
* ALT and AST greater than 2.5 times the upper limit of normal
* Serum creatinine less than 1.5 times upper limit of normal
* Prothrombin time (PT-INR) or activated partial thromboplastin time (APTT) greater than 1.1 times the upper limit of normal range
* Women who are pregnant, breast-feeding or planning to become pregnant during the study
* Men or women of reproductive-potential who are unwilling to use an effective method of contraception during the study and for 30 days following the last dose of study medication. See section 5.11 (Contraceptives) for definition of effective methods of contraception
* Evidence of any other significant medical disorder or laboratory finding that in the opinion of the Investigator compromises the subject's safety during study participation, including uncontrolled infection or infection requiring a concomitant parenteral antibiotic
* Plans for concomitant anti-cancer therapy (excluding androgen deprivation therapy) while on study
* Less than four weeks since major surgery
* Known to be HIV positive, Hepatitis B sAg positive or Hepatitis C positive with abnormal liver function tests
* No known contraindication to single doses of naproxen
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20

A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa


Eligibility Criteria:
Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product

  * Limited mobility and not in the position to attend weekly appointments
  * Limited ability to describe listening impressions/experiences and the use of the hearing aid
  * Inability to produce a reliable hearing test result
  * Massively limited dexterity
  * Known psychological problems
  * Known central hearing disorders
  * colour blinded
Selective Caries vs Stepwise Caries Removal Technique in Deep Carious Lesions

The aim of this clinical study is to compare and evaluate the Success of Selective Caries vs Stepwise Caries Removal Techniques in treatment of dental caries.

The patient will be selected as per the pre-defined eligibility criteria. Written informed consent will be taken from each consenting participant. Initial caries excavation will be done under rubber dam isolation. The patient will then be randomly allocated to two groups: selective removal to soft dentin or stepwise caries removal. Composite restoration with glass ionomer liner will be then placed in both groups. Additional complete caries excavation will be done in the stepwise caries removal group after six months.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient in age range of 18yr-60yr
* Permanent mandibular posterior teeth with deep caries
* Caries extending to \>3/4 of dentin with a layer of sound dentin between pulp and carious tissue as seen on radiograph
* Positive response to cold test and electric pulp test

Exclusion Criteria:

* Any general disease affecting the caries e.g. patient under head and neck radiotherapy
* Patients with immuno-compromised status
* Tooth with fracture line, cracks.
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis

Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis. CSL324 is a novel, recombinant therapy that may treat diseases caused by increased numbers of neutrophils at sites of inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between 18 and 75 years of age, inclusive
* Confirmed clinical diagnosis of moderate to severe HS as per International Hidradenitis Suppurativa Severity Score System (IHS4) guidelines (ie, IHS4 ≥ 4)
* PPP differentiated from other forms of pustulosis
* Psoriasis with a Palmoplantar Pustulosis Psoriasis Area and Severity Index (ppPASI) score of ≥ 12.
* Subjects with HS only: inadequate response to at least a 3-month (90 days) trial of oral antibiotics for treatment of HS
* Subjects with PPP only: confirmed clinical diagnosis of PPP at least 6 months before Screening and inadequate response to topical therapy, phototherapy, and / or previous systemic therapy for the treatment of PPP

Exclusion Criteria:

* Treatment with any medications and therapies not permitted during the study.
* History of myeloproliferative disease.
* Malignancy within 5 years at Screening with the exception of nonmelanoma skin cancer, carcinoma in situ, or prostate cancer not requiring treatment.
* Current, or a recent clinically significant history of, uncontrolled renal, hepatic(including currently active hepatitis B virus and / or hepatitis C virus), hematologic, endocrine, pulmonary, psychiatric, or cardiac disease, assessed as potentially having an effect on study outcomes as determined by the Investigator and / or Sponsor.
* Congenital or acquired immunosuppressive condition(s), including human immunodeficiency virus infection.
* Clinical signs of active infection and / or fever \> 38°C during the 7 days before Day 1.
* Clinically significant abnormalities on physical examination, ECG, or laboratory assessments, or neutropenia (defined as absolute neutrophil count \< 2.0 × 109/L) at Screening.
* Subjects with PPP only: concurrent psoriasis vulgaris (not including scaly scalp and / or ears).
* Subjects with HS only: \> 20 draining fistulas."
Erciyes University Faculty of Health Sciences

Sleep disorders are important to place among the symptoms frequently seen in hemodialysis patients. Among sleep disorders, restless legs syndrome is the most common. Restless legs syndrome, seen in patients receiving hemodialysis treatment, causes excessive daytime sleepiness and negatively affects the sleep quality of individuals.


Eligibility Criteria:
Inclusion Criteria:

* Those who are 18 years or older,
* Not pregnant and not planning a pregnancy,
* Having been diagnosed with restless leg syndrome according to the restless leg syndrome diagnostic scale and by a physician,
* Having at least mild restless leg syndrome according to the restless leg syndrome severity rating scale,
* Scoring 11 or above on the Epworth sleepiness scale,
* PSQI score an average of 5 and above,
* Receiving hemodialysis treatment in hemodialysis units for at least 3 months and 3 sessions per week,
* Continuing dialysis treatment in the same institution,
* Able to walk independently,
* No changes in the treatment program before the massage and throughout the research process,
* Not having any allergies to the oils to be used,
* Individuals who can understand and communicate with Turkish will be included in the research

Exclusion Criteria:

* Those who are sensitive and/or have any allergies to the lavender oil to be used,
* Those who have lower leg problems that would prevent them from applying massage to the lower leg area,
* Have a history of mental or physical disability, including peripheral neuropathy, vascular problems in the legs,
* Epilepsy, Alzheimer's, Parkinson's, Multiple Sclerosis, etc. Those with a diagnosed neurological disease such as
* Pre-implemented,
* Those with respiratory system disorders,
* Patients who used other complementary and integrative therapies methods during the study period will be excluded from the study
A Prospective Trial Comparing Transoral Endoscopic Thyroidectomy Vestibular Approach (TOETVA) and Conventional Open Thyroidectomy

To determine if transoral endoscopic thyroidectomy vestibular approach (TOETVA) is a safe and effective procedure compared to traditional open thyroidectomy. Surgical outcomes, patients' satisfaction, voice and swallowing outcomes will be assessed.

This is a prospective case control study involving a total 40 patients, with 20 stratified into the test group receiving surgery under transoral endoscopic thyroidectomy vestibular approach (TOETVA) and 20 patients to the control group under traditional open approach. Subjects will be assigned to either group without randomization. Patients satisfactory score, voice and swallowing quality of life outcomes will be assessed using Voice Handicap Index (VHI) and MD Anderson Dysphagia Inventory (MDADI) outcomes. Surgical outcomes, for instance, lower lip numbness, skin injury, operative time, blood loss, vocal cord paralysis, temporary and permanent hypoparathyroidism will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Benign thyroid nodule less than 4cm
* Suspicious malignant thyroid nodule less than 2cm, suitable for transoral endoscopic surgery

Exclusion Criteria:

* Patients under 18 years old
* Contraindication to general anaesthesia
* Vulnerable population (e.g. Cognitive impairment, pregnant)
* Previous anterior neck surgery
* Previous radiotherapy at the head and neck region
* Malignant thyroid nodule \> 2cm
* Presence of another malignancy, lateral neck, or distant metastasis
* Retrosternal goitre
* Cervical spine disease precluding extension of the neck
* Obesity with BMI \> 35kg/m2
* Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
* Untreated active infection
* Non-correctable coagulopathy
* Emergency surgery
Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction

Studies have demonstrated that the early initiation of ACEI/ARB to patients with acute myocardial infarction is beneficial, especially in patients combined with reduced LVEF or mild-moderate heart failure. Therefore, ACEI/ARB is a traditional treatment for patients post-infarction. Recent clinical trials have demonstrated that Sacubitril/Valsartan is more beneficial than Ramipril to patients post-PCI.Besides, Sacubitril/Valsartan is also effective for essential hypertension.This study aims to assess the effect of Sacubitril/Valsartan on short-term prognosis in hypertensive patients with acute myocardial infarction compared against Valsartan.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with new-onset MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days.
2. Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension.
3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.

Exclusion Criteria:

1. Patients with severe renal dysfunction. (GFR\<60mmol/L).
2. Patients who have recently undergone immunosuppressive therapy.
3. Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan.
4. Patients who are hemodynamically unstable.
5. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %).
6. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
7. Any non-CV condition, such as active malignancy requiring treatment at the time of screening, or severe diseases with a life expectancy of fewer than two years based on the investigator´s clinical judgment.
8. Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.
Creation of an Algorithm for the Personalisation of Pedalling Exercises

The aim of the EXO-MODE project is to develop an innovative algorithm for the personalisation of Concentric and / or Eccentric training programmes adapted to the individual to improve the efficiency and tolerance. This algorithm will make it possible to personalise trainings programmes according to the different profiles of subjects, determined on the basis of their personal characteristics (age, sex, comorbidities), their exercise capacity and muscle performance, their level of motivation and their perception of the workload, and of the principal objective of the training programme. The final goal is to develop a tool to allow elderly populations to exercise more easily and more effectively.


Eligibility Criteria:
Inclusion Criteria:

* Subject able to understand simple instructions and to provide consent
* Men or women aged 18 to 75 years old.
* Subjects who engage in moderate physical activity (Level 1 or 2 defined by the recommendations for the classification of subjects during performance studies) \[2\].

Exclusion Criteria:

* Persons without national health insurance cover,
* Cardio-respiratory failure, coronaropathy, severe obstructive cardiomyopathy,
* Recent history of venous thromboembolism (previous 3 months),
* Any medical disorder that could have a major impact on functional capacities (examples: non-stabilised metabolic disorders, such as progressive renal failure, severe asthenia related to a non-stabilised disease, such as neoplasia, systemic disease...),
* Physical disability affecting the lower limbs or the pelvis that could impair or prevent exercise on a cycle ergometer, whether neurological (central or peripheral), arterial (i particular, arteriopathy of the lower limbs with a systolic index \< 0.6) or orthopaedic (degenerative or inflammatory rheumatism).
* Pregnant or breast-feeding women
Respiratory Muscle Training in Acquired Brain Injury Patients.

Background: Respiratory health problems are one of the main causes of morbidity and mortality in adult people with acquired brain injury (ABI). The influence of respiratory muscle training has not yet been studied in this population group. The objective of the study was to evaluate and compare the efficacy of two protocols with respiratory muscle training, inspiratory muscle training vs expiratory muscle training, to improve respiratory strength and pulmonary function in adults with CP.

Methods: The study is a controlled, randomised, double-blind trial and with allocation concealment. 26 ABI patients will be recruited and randomly distributed in the inspiratory muscle training group (IMT) and the expiratory muscle training group (EMT). Over an 8-week period an IMT or EMT protocol was followed 5 days/week, 5 series of 1-minute with 1-minute rest between them. IMT trained with a load of 50% of the maximum inspiratory pressure (MIP) and EMT with 50% of the maximum expiratory pressure (MEP). Respiratory strength and pulmonary function were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Belong to ASDACE.
* Sign the Informed consent.

Exclusion Criteria:

The presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate \> 150 beats per minute (bpm), systolic blood pressure \> 140 millimeters mercury (mmHg) or diastolic blood pressure \> 90 mmHg).
Recognizing Ventricular Fibrillation From an Area of a Mobile Phone

Recognition of out of hospital cardiac arrest (OHCA) during an emergency call is based on standardized questions concerning the symptoms of OHCA. With this method cardiac arrest is recognized in 50-83% of cases. When the emergency medical dispatcher identifies cardiac arrest during the emergency call the survival of the patient improves. Accurate emergency medical service response is activated promptly and bystander will receive cardiopulmonary resuscitation (CPR) instructions. It has been estimated that proper implementation of CPR instructions will save thousands of lives each year.

If the ECG could be recorded by the mobile phone, transmitted during the emergency call to the dispatch centre and analysed there with the software of a semi-automated external defibrillator(AED), the recognition of cardiac arrest could be more accurate.

The aim of this study is to examine, if AED, with minimal size electrodes within an area of a mobile phone, is able to recognize reliably ventricular fibrillation (VF), the rhythm with the best prognosis in OHCA.

Dysrhythmia patients who need an implantable cardioverter defibrillator(ICD) or patients with an already implanted ICD which function needs to be revised will be recruited into this study. Our hypothesis is that the ECG and VF is recordable in 100% of cases with a semi-automatic defibrillator. In sample size calculations we compared this 100% recognition to the present situation with 80% recognition of cardiac arrest in emergency medical communication centre during emergency call. According to the power calculation of 1-sided binomial test with risk level 0.05 and power of 95 %, 22 observations is needed to detect difference between expected full successes (99 %) from the previous 80 % of successes in recognition.

Eligibility Criteria:
Inclusion Criteria:

* age over 18
* ventricular fibrillation will be induced during the implantation or revision of ICD
* patient's informed consent

Exclusion Criteria:

* ventricular fibrillation will not be induced during the implantation or revision of ICD
KineSpring® System Patient Preference Study

The primary objectives of the survey are to obtain patient preference information that can be useful during the benefit-risk assessment of the KineSpring System.

Well-established, quantitative research methods were employed to understand the relative importance of effectiveness, safety, and other characteristics of orthopedic surgical treatments and develop a benefit-risk model to inform regulatory decision making.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 25 - 80 years
* Diagnosed with osteoarthritis in the knee
* Experience pain in the knee of greater than or equal to a "4" on a "0 - 10" scale, where 0 means not at all painful and 10 means extremely painful
* Experience knee pain at least once a week
* Previously failed non-surgical treatments for knee OA pain
* Pass a security screen

Exclusion Criteria:

* Do not suffer or has not been diagnosed with knee osteoarthritis
* Has had knee surgical intervention involving an implant or a prosthesis (i.e. total knee replacement, unicompartmental knee arthroplasty, high tibial osteotomy)
Couples' QOL in Metastatic Breast Cancer

The primary objectives of this study are to adapt and evaluate a sexual quality of life intervention in women with metastatic breast cancer and their partners.


Eligibility Criteria:
Inclusion Criteria:

* Patient is female
* Patient is at least 18 years old
* Patient has a diagnosis of metastatic (stage IV) breast cancer
* Patient has a partner or spouse who is at least 18 years old
* Patient lives with a romantic partner (same or opposite sex) for at least 6 months
* Patient scores 3 or above on Patient Care Monitor sexual concerns item (range: 0-10)

Exclusion Criteria:

* Patient or partner is not able to speak and read English
* Patient or partner has a hearing impairment
* Patient or partner medically unable to participate as judged by physician/in medical record or by self-report
* Patient and partner do not have reliable telephone access
* Patient has overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, physician or referring source, or self-report
* Patient past or current history of any cancer other than non-melanoma skin cancer or breast cancer
* Patient is currently participating in couple/marital therapy
* Patient is currently pregnant
Hospitalisations of Teenagers and Young Adulthoods in Mayotte After Consumption of an Illegal Drug Called " Chimique ", Which Substances Are Incriminated ? : HOMACHI

The study aims (i) to identify which substances leading to hospitalizations at Mayotte are also called "chimique" and (ii) to correlate these substances with clinical pictures in order to favor a better approach of the treatments.

The CEIP-A of Bordeaux (in charge of French overseas departments) has been commissioned by the MILD\&CA in 2015 to reinforce the links between local caregivers and the addictoviligance's inquieries. In particular, the CEIP-A has been alerted about a drug called " chimique " in Mayotte, leading to many hospitalizations. Most of the patients are less than 18 year old or are young adulthoods. For all patients who have agreed to participate in this study, the remainder of the blood sample will be reused for a drop of blood on blotting paper; the remainder of the remainder will be stored in the heparinized tube. Medical data collected in the emergency department will also be collected. All the data will be analyzed by the pharmacology and toxicology laboratory of the Bordeaux University Hospital

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in the Emergency Department of the Mayotte Hospital Center after taking a chemical or other psychoactive substance and for whom a blood test is required;
* Age ≥ 14 years.

Exclusion Criteria:

* Patient without parental authority for minor patients aged 14yrs; Patient not included in the exception article 59 of the law of January 6th, 1978 modified for patient aged 15yrs and older