cyrilzakka/clinical-trials huggingface dataset:
Study of IW-1701, A Stimulator of Soluble Guanylate Cyclase (sGC), in Patients With Type I or II Achalasia

The objectives of this study are as follows:

In participants with primary Type I or II achalasia, following a single 5-mg dose of olinciguat (IW-1701),

* To assess the safety and tolerability
* To determine the effects on measures of esophageal function by high-resolution impedance manometry (HRIM)
* To determine the pharmacokinetic (PK) parameters


Eligibility Criteria:
Key Inclusion Criteria:

* Patient has a diagnosis of primary Type I or II achalasia.
* Patient has no contraindications to the performance of the baseline and postdose HRIM procedures per Investigator discretion.

Key Exclusion Criteria:

* Patient has had any prior esophageal, periesophageal, or gastric surgery, or treatment with sclerosing agent.
* More than 1 pneumatic dilation procedure to a diameter of \> 2 cm in their lifetime.
* Pneumatic dilation procedure to a diameter of \> 2 cm within 1 year prior to randomization. Prior bougie dilation(s) or pneumatic dilation(s) ≤ 2 cm are allowed.
* Prior esophageal injection of botulinum toxin (Botox) within 6 months prior to randomization or more than 2 esophageal Botox injection procedures in their lifetime.
* Patients with malignant or premalignant esophageal lesions.
* Patient has taken any drug that can affect gastrointestinal (GI) motility in the 72 hours before check-in through discharge from the clinic.

Other inclusion and exclusion criteria specified in the protocol.
Clinical Trial to Evaluate the Effect of a Probiotic in Acne

A 12-week randomized, multicenter and double-blind, placebo-controlled study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.

Acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in westernized populations. Acne pathophysiology is multifactorial and may include alterations of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota. Acne pathology shares features with inflammatory chronic conditions such as metabolic syndrome, obesity or diabetes.

Probiotics are live microorganisms that when administered in adequate amounts confer a health benefit for the host. Probiotics are proposed for the treatment of inflammatory chronic conditions, including dermatological diseases as atopic dermatitis and psoriasis. However, the clinical evidence is limited. Therefore, usefulness of probiotics for acne vulgaris treatment must be ascertained in humans.

This randomized study aims to evaluate the effect of a probiotic on the treatment and clinical and subjective evolution of acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent by the patient (and their legal guardian in case of being under age).
* Age between 12 and 30 years-old.
* AGSS (Acne Global Severity Scale) Score: 2 or higher
* Patients who agree to follow the study's dietary recommendations.

Exclusion Criteria:

* Contraindication of any of the components of the product under study.
* Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
* Consumption of probiotics in the previous 2 months.
* Use of systemic retinoids in the previous 6 months.
Predictive Value of SOFA and APACHE Scores for In-hospital Mortality in COVID-19 ICU Patients

The aim of this study is to evaluate the predictive value for in-hospital mortality of respectively the SOFA and Apache scores in a COVID-19 ICU cohort and to develop a new prediction model for COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.

The coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) emerged in December 2019 and has rapidly spread worldwide. The mortality of critical ill patients with COVID-19 has been reported variously as low as 11% and as high as 61%. The application of scoring systems can facilitate the effective evaluation by physicians to screen severe patients. At present, however, there are no specific scoring systems for the evaluation of COVID-19 patients. Scoring systems such as the Sequential Organ Failure Assessment (SOFA) score can help emergency or critical care physicians for prognosis and predicting mortality. The SOFA score described the condition of multiple organ dysfunction through several parameters, including oxygenation index, mean arterial pressure, Glasgow come scale, creatinine or urine volume, bilirubin, platelets for the respiratory, circulatory, neurological, renal, hepatogenic and coagulation systems respectively. The function of each organ system is scored from 0 to 4, and the individual SOFA scores are summed to a total score. Although SOFA was not initially designed to predict mortality, several studies reveal that SOFA could predict morbidity and mortality in severe ill patients.

Besides the SOFA score, the Acute Physiology and Chronic Health Evaluation (Apache II) scores was designed to measure the severity of disease of patients admitted to the ICU and to predict mortality. The Apache II score is calculated based on physiological measurements such as body temperature, mean arterial pressure, pH, heart and respiratory rate, Glasgow coma scale, oxygenation and blood parameters such as sodium, potassium, creatinine, hematocrit and white blood cell count. Recently, the Apache IV score is developed where additional parameters such as admission information, admission diagnosis and chronic health conditions were take into account.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th October 2020.

Exclusion Criteria:

-
The Effect of Continuous Pulse Oximetry Monitoring and Early Intervention Using Wearable Device on the Incidence of Postoperative Hypoxemia

Vital signs of postoperative patient are monitored intensively in post-anesthesia care unit or intensive care unit, but the frequency of surveillance decreases in typical surgical wards. The continuous pulse oximetry in surgical wards is known to be useful in detection and prevention of hypoxemia, reducing complications caused by postoperative respiratory depression. However, continuous monitoring is not conducted, due to shortage of equipment and personnel. Recently, wearable device for measuring pulse oxygen saturation, which is inexpensive, applicable to patients with mobility, and can be monitored continuously through wireless connection, has been supplied. In this study, the investigators evaluate the effect of continuous monitoring of oxygen saturation with wireless device(MASIMO Radius-7) on postoperative patients who are transferred to general wards, and evaluate the effect of early intervention in reducing the event of hypoxemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing noncardiac surgery under general anesthesia
* American Society of Anesthesiologists (ASA) physical status class I-III

Exclusion Criteria:

* Patients refusing to participate in the study
* Patients under emergency surgery
* Patients who wearable device is not applicable
* Patients scheduled to be transferred to intensive care unit
* Patients scheduled to receive oxygen supplementation in surgical ward
* Patients scheduled to undergo continuous pulse oximetry monitoring
Comparing Carbon Ion Therapy, Surgery, and Proton Therapy for Management of Pelvic Sarcomas Involving the Bone

This study compares carbon ion therapy, surgery, and proton therapy to determine if one has better disease control and fewer side effects. There are three types of radiation treatment used for pelvic bone sarcomas: surgery with or without photon/proton therapy, proton therapy alone, and carbon ion therapy alone. The purpose of this study is to compare quality of life among patients treated for pelvic bone sarcomas across the world, and to determine if carbon ion therapy improves quality of life compared to surgery and disease control compared with proton therapy.

PRIMARY OBJECTIVES:

I. Demonstrate whether carbon ion therapy provides improved patient reported health related quality of life (PRO-HRQOL) outcomes and less significant toxicities compared with surgery.

II. Demonstrate whether carbon ion therapy provides improved local control versus proton therapy.

OUTLINE:

Patients complete quality of life questionnaires over 20 minutes at baseline (before any therapy), 2-4 and 5-9 months after completion of therapy, and then annually for up to 5 years. Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Males and females \>= 15 years of age
* Newly diagnosed, histologic confirmation of pelvic chordoma, chondrosarcoma, osteosarcoma, Ewing sarcoma with bone involvement, rhabdomyosarcoma (RMS) with bone involvement or non-RMS soft tissue sarcoma with bone involvement
* No evidence of distant sarcoma metastases as determined by clinical examination and any form of imaging
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 2
* Patients capable of childbearing must agree to use adequate contraception
* Ability to complete questionnaire(s) by themselves or with assistance
* Ability to provide written informed consent
* Chemotherapy per institutional guidelines is allowed

Exclusion Criteria:

* Patients receiving palliative treatment
* Recurrent disease
* Males and females \< 15 years of age
* Previous radiation therapy to the site of the sarcoma or area surrounding it such that it would be partially or completely encompassed by the radiation volume needed to treat the current sarcoma. In other words, treatment on this study would require re-irradiation of tissues
* Patients with distant sarcoma metastases
* Benign pelvic bone histologies
* Any of the following:

  * Pregnant women
  * Nursing women
  * Men or women of childbearing potential who are unwilling to employ adequate contraception
A Study to Evaluate and Compare the Efficacy of Two Facial Creams on Moderately to Severely Photodamaged Skin

The objective of this study is to evaluate the efficacy of a retinol alternative-containing facial cream in improving skin texture, radiance/brightness, and the appearance of fine lines, wrinkles, uneven skin tone, and dark spots, with a positive control of a retinol-containing cream.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type I, II, III, or IV
* Final review of eligibility (Visit 2): Exhibits moderate to severe (score of 4-7 on a 0-9-point scale) overall photodamage on her face, as evaluated by the PI at Visit 2
* Final review of eligibility (Visit 2): Has a score of at least 4-7 (moderate to severe, on a 0-9-point scale) on at least 3 of the 5 following clinical grading parameters on her face, as evaluated by the PI at Visit 2:

  i. Global fine lines ii. Wrinkles (under-eye and/or crow's feet) iii. Tactile surface roughness iv. Overall unevenness of skin tone v. Lack of radiance/brightness vi. Lack of skin firmness (look and/or feel)
* Generally in good health
* Able to read, write, speak, and understand English
* Individual has signed the Consent for Photograph Release and ICD including Health Insurance Portability and Accountability Act disclosure
* Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

* Has known allergies or adverse reactions to common topical skincare products or ingredients in the investigational study materials
* Has a pre-existing or dormant facial dermatologic condition that, in the PI or designee's opinion, may confound the study results or otherwise be inappropriate for study participation (e.g., severe acne, acne conglobata, psoriasis, rosacea, rashes, eczema, atopic dermatitis, skin cancer, many and/or severe excoriations, observable suntan/sunburn, scars, nevi, tattoo, excessive hair, etc.)
* Has self-perceived very sensitive skin
* Has self-reported Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication.
* Is taking a medication/using a product that would mask an Adverse Event or confound the study results
* Is self-reported to be pregnant, lactating, or planning to become pregnant during the study or within 30 days of study completion
* Has a history of or a concurrent health/other condition/situation which, in the opinion of the PI, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study
* Has a surgery and/or invasive medical procedure planned during the study
* Is simultaneously participating in any other study or has participated in any study within 30 days prior to Visit 1
* Is an employee/contractor or immediate family member of the PI, Study Site, or Sponsor
Music Interventions During Wide-Awake Hand Surgery

The purpose of this study is to examine if patients have a lower anxiety level during wide awake hand surgery while listening to their choice of music vs standardized relaxation music. Patients who are planning to undergo wide awake (local anesthetic only hand surgery) and agree to participate will be randomized to either a music intervention where they listen to their choice of music genre or standardized relaxation music during their time in the operating room. 170 participants will be enrolled and can expect to be on study for 2 weeks.

Music has been shown to decrease anxiety and pain during surgery. Wide awake local anesthesia no tourniquet (WALANT) surgery on the hand is gaining popularity due to efficiency, cost savings and patient safety.

Despite the popularity of WALANT, it still can be anxiety producing even for patients who choose to proceed with surgery without sedation. Music has been shown to decrease anxiety during surgery, but patients' music choices vary widely. The frequency (Hz) of the music intervention has been shown to impact pain reduction, and patient choice of music has been shown to increase sense of control which can decrease anxiety. No study has evaluated the intraoperative effect of patient choice of music vs standardized relaxation music on intraoperative anxiety.

The primary objective of this research is to compare the effect of patient music choice vs standardized relaxation music played during surgery on anxiety levels in patients undergoing WALANT hand surgery. The investigators hypothesize that standardized relaxation music will result in reduced anxiety compared to patient's choice of music.

Eligibility Criteria:
Inclusion Criteria:

* Adult (18 years of age or older) patients
* Undergoing Wide Awake Local Anesthesia No Tourniquet (WALANT) hand surgery

Exclusion Criteria:

* Patients under the age of 18
* Patients unable to consent for themselves
* Patients unwilling to consent
* Non-English speaking patients
* Patients with significant hearing impairment not able to be corrected with assistive devices
Iressa in the Treatment of Brain Metastases From Non Small Cell Lung Cancer

The aim of the study is to determine if Iressa is effective in the treatment of Brain metastases from NCSLC


Eligibility Criteria:
Inclusion Criteria:

* Radiologically confirmed brain metastases from Non Small Cell Lung Cancer
* No symptoms due to brain metastases
* No previous radiotherapy treatment for the Brain metastases

Exclusion Criteria:

* No prior chemotherapy
* No other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
* Any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
Two Regimens of IVIG in the Treatment of Newly Diagnosed ITP in Children

To compare the efficacy of two different dosage regimens of intravenous immune globulin (IVIG) in the treatment of children with newly diagnosed immune thrombocytopenia, and to reduce related adverse reactions and economic burdens on the premise of ensuring the remission rate


Eligibility Criteria:
Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria:

1. Meet the diagnostic criteria of ITP and be diagnosed for the first time without treatment
2. Age \> 28 days and ≤ 14 years old
3. PLT\<20×109/L
4. Have signed the informed consent

Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study:

1. Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and glucocorticoid therapy
2. Received glucocorticoid or IVIG therapy within 6 months
3. Weight \> 40kg
4. Menstrual female patients
5. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases
6. Patients who have received radiotherapy and chemotherapy
7. There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results -
Usability, Acceptability, and Safety of Virtual Reality-based Cognitive Intervention

This study aims to determine feasibility, acceptability, and usability, and to assess the safety of using a virtual reality-based software called ''ReCognitionVR'' in healthy volunteers.

Virtual reality (VR) imitates reality by creating an artificial 3-D environment using computing technology or software. Using this software with a headset, a virtual environment is created, which cognitively stimulates the user's brain to think they are in an artificial world. Creating a virtual environment allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled virtual environment. VR strengthens the brain's ability to focus, learn, and retain experience. VR for attention deficit disorders has been reported to have promising results. This trial aims to follow in similar footsteps using the gamification of exercises for cognitive stimulation in healthy volunteers to record outcomes and perform usability testing. These exercise "games" allow users to focus and pay attention to the game while helping reorient and cognitively stimulate the user's brain. The games are built with increasing difficulty and complexity of user demand and output. A novel, 3D-simulated software platform prototype called ''ReCognitionVR'' was developed to provide VR-based cognitive exercises to healthy participants for testing.

The premise of this trial is that VR-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. The system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed- environment with music.

According to our institutional review board recommendations, this pilot study will be conducted in two steps on two different cohorts which are as follows:

In the first step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercises will be evaluated on elderly healthy subjects. This study's results will inform the design of a second-step pilot study.

In the second step, the usability, acceptability, and safety of ReCognitionVR-based cognitive exercise will be evaluated for elderly surgical patients who are at high risk for the development of delirium.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35 years or ≥60 years
* Healthy volunteers who meet one of the following criteria according to their self-reported medical history:

  1. American Society of Anesthesiologists (ASA) 1: A normal healthy patient. Example: Fit, nonobese (BMI under 30), a nonsmoking patient with good exercise tolerance.
  2. ASA 2: A patient with mild systemic disease. Example: Patient with no functional limitations and a well-controlled disease (eg, treated hypertension, obesity with BMI under 35, frequent social drinker, but is nonsmoking).

Exclusion Criteria:

* Age \<18 years; 36-59 years
* Person with active psychiatric disorders, especially schizophrenia
* Person who is deaf or blind
MEMORA-Caregiver : Risk Factors of Caregiver Burden Among Patients With Neurocognitive Disorders or Subjective Cognitive Complaint

The investigators will investigate which patients' characteristics are associated with caregivers burden and its evolution for outpatients visiting a memory clinic, in particular how functional autonomy, behavioral and psychological symptoms as well as patients comorbidities can influence caregiver burden.

The study will be conducted among outpatients with progressive cognitive complaint followed in a Memory Clinic and their primary caregiver. The investigators hypothesis that caregivers experience a higher burden due to disease symptoms such as impairment of functional autonomy, behavioral and cognitive impairment, whatever the aetiology of the cognitive decline.


Eligibility Criteria:
Inclusion Criteria:

* patients with a cognitive complaint, either expressed by the patient or one of their relatives,
* patients at any stage of disease (cognitive complaint, mild cognitive impairment (MCI) or dementia),
* patients living in the community,
* patients having an informal caregiver who will complete the questionnaire to assess the caregiver burden.

Exclusion Criteria:

-
Rapid Urinary Tract Infection Diagnosis and Real-time Antimicrobial Stewardship Decision Support

The study aims to assess the accuracy and impact of rapid diagnosis and rapid diagnosis decision support on different aspects of antibiotic consumption when implemented alone or together.

This interventional study in two centers compares two groups with each other and with a pre-intervention control group. In group 1 rapid techniques for handling urine cultures will be the only intervention. In group 2 rapid diagnostics will be supplemented with real-time antimicrobial stewardship decision support (RADS). In each center two departments will be involved.

Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination and screened for inclusion in the interventional study.

In one of the centers, rapid techniques will be coupled to real-time antimicrobial stewardship decision support (RADS). RADS will be given by telephone to a designated clinician with the aim of:

1. Switch to active treatment if non-working empirical treatment
2. De-escalate broad spectrum empiric treatment when feasible
3. Promote early intravenous to per oral switch
4. Shorten treatment duration

Eligibility Criteria:
Inclusion Criteria:

* Urine sample present at the laboratory weekdays
* At least 11 ml of urine in sample
* Admitted to surgical or medical ward.
* Urine sample taken on admission to hospital.
* Rapid diagnostics suggesting mono microbial growth of \> 100.000 microbes/ml urine.
* Clinical and laboratory signs/symptoms of urinary tract infection at time of sample delivery.

Exclusion Criteria:

* Other simultaneous infections that warrant systemic antimicrobial therapy or surgery.