cyrilzakka/clinical-trials huggingface dataset:
Bosentan in Systemic Sclerosis

The effect of bosentan on digital ulcers (DU) was studied in two randomized placebo-controlled trials (RAPIDS-1 and RAPIDS-2). A limitation of these studies was the heterogeneous study population. More importantly, there were no endpoints that assessed changes in vasculopathy and / or perfusion. Laser Doppler imaging has been shown to effectively demonstrate blood flow restrictions in the hands of patients with Systemic Sclerosis (SSc). The relation between blood flow restriction in the hands measured by laser Doppler imaging and the extent of DU disease has not been studied. The current study will attempt to demonstrate this relation. In addition, the impact of bosentan on the blood flow in the hands, in a defined cohort of SSc-DU patients with a history of DU within the past 2 years and a clinically relevant reduction of blood flow in the hands, will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects \> 18 years diagnosed with SSc;
* Reduction of blood flow measured by laser Doppler imaging, of at least 50%, distally to the proximal interphalangeal joint, compared to the healthy volunteers;
* Women of childbearing potential must have a negative pregnancy test and use a reliable form of contraception;
* A history of 1 or more DUs within 2 years prior to inclusion;
* No use of bosentan in the past;
* Subjects willing and able to sign informed consent.

Exclusion Criteria:

* Parenteral prostanoid treatment for DU \< 3 months ago;
* Chronic treatment with PDE-5 inhibitor or ERA;
* History of bosentan use
* Irreversible significant limitation of the hand function, e.g. amputation of more than one finger;
* Other types of system- or connective tissue diseases;
* Significant peripheral (macro-) vascular disease due to e.g. diabetes, hyperlipidemia, uncontrolled systemic hypertension, coagulopathy;
* Any serious medical co morbidity (eg, active malignancy) such that the subjects life expectancy is \< 12 months;
* Known AST and/or ALT elevations higher than 3 times Upper Limit Normal (ULN);
* Moderate to severe liver function disorder;
* Pregnancy or breastfeeding;
* Treatment with Glibenclamide, Fluconazole, Cyclosporin A, Tacrolimus or other calcineurin inhibitors;
* Hypersensitivity for bosentan or one of its components;
* Subjects not able to follow the protocol.
Intermediate Risk Cervical Cancer: Radical Surgery +/- Adjuvant Radiotherapy

The objective of the trial is to evaluate if adjuvant (chemo)radiation is associated with a disease-free survival benefit after radical surgery in patients with intermediate risk cervical cancer. The primary endpoint of the study is the disease-free survival from the day of randomisation. A total of 514 patients are required to achieve 80% power on 5% significance level with non-inferiority margin of 5% to test the difference between the ARMs using Cox proportional hazards model. The maximal tolerated margin for non-inferiority in 2-year DFS is 5% (including expected drop-out rate of 10%).

The role of adjuvant (chemo)radiotherapy in intermediate risk (IR) cervical cancer patients is controversial, supported by single randomised GOG 92 study performed more than 20 years ago. Intermediate-risk group is defined as lymph node negative but with a combination of negative prognostic factors (tumour size \>2 cm, lymphovascular space invasion, deep stromal invasion \>2/3). Recent retrospective studies showed excellent local control in intermediate risk group patients after radical surgery with no additional adjuvant treatment.

CERVANTES trial is designed to bring level A evidence on the role of adjuvant treatment in IR patients in an international, prospective, randomised study. Patients will be registered into the trial before surgery and randomised after the final pathology report has been received into ARM A, with no additional treatment, and ARM B, receiving adjuvant (chemo)radiotherapy. Quality assurance program will be in place for both, radical surgery and adjuvant treatment.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed invasive cervical cancer
* FIGO IB1-IIA
* Squamous cell cancer or HPV-related adenocarcinoma
* Presence of tumour-related risk factors as follows:

  1. tumour ≥4 cm OR
  2. tumour\>2 cm \<4 cm AND lymphovascular space invasion OR
  3. tumour \>2 cm \<4 cm AND tumour free distance \<3 mm OR
  4. tumour \>2 cm \<4 cm AND deep stromal invasion (\>2/3)
* No evidence of suspicious pelvic lymph nodes or distant metastases on imaging (by radiological subjective assessment before surgery and negative pelvic LN on final pathology)
* ECOG performance status 0-1
* Deemed suitable and fit for radical surgery followed by adjuvant radiotherapy
* Negative pregnancy test (if applicable)
* Negative HIV test (only performed in high-risk countries or patients who have moved from those countries within the past 10 years)

Exclusion Criteria:

* Adenosquamous cancer or adenocarcinoma unusual type (non-HPV related - such as: mucinous, clear cell, mesonephric) or other rare tumour types (those not listed in the inclusion criteria)
* Inconclusive primary site of disease
* Unequivocally positive lymph node by imaging (by radiological subjective assessment)
* FIGO \<IB1 / \>IIA
* Previous pelvic malignancy
* History of second primary cancer outside pelvis if ≤ 3 years complete clinical remission (CCR)
* Previous pelvic radiotherapy
* Neoadjuvant chemotherapy prior surgical treatment
* Low likelihood of patient compliance to the follow-up
Endophthalmitis After Intravitreal Injection of Antiangiogenic Agents or Corticosteroids, a Cohort Study of the French Population of Patients Who Received Injections Over 9 Years

Intravitreal injections (IVI) of antiangiogenic agents (AA) have revolutionized the management of age-related macular degeneration (AMD) and diabetic macular edema (DME) in particular. Approximately 600,000 AA IVIs are performed each year in France.

Corticosteroid IVIs are an alternative in the treatment of macular edema when it is diabetic or related to venous occlusion, but also due to inflammation.

Endophthalmitis is one of the most feared complications after IVI because of its poor prognosis, despite its low incidence (values found in the literature between 0.01% and 0.08%). IVI practices have evolved over the years based on the recommendations of specialized organizations, with the current recommendation not to use antibiotic prophylaxis.

The purpose of this study is to study the effect of intravitreal injections of anti-angiogenic agents and corticosteroids on the occurrence of endophthalmitis within 28 days following an injection.


Eligibility Criteria:
Inclusion Criteria:

* adult patients within the French population who had an intravitreal injection, identified by CCAM coding BGLB001
* associated with the delivery of an anti-angiogenic agent or a corticosteroid, identified by the corresponding CIP code
* between February 2007 and November 2015

Exclusion Criteria:

* intraocular surgery less than 42 days before the first injection, identified by the CCAM procedure
* risk factors for endogenous endophthalmitis identified in the 42 days preceding an IVI identified by the ICD10 code
Sleep Treatment Education Program for Cancer Survivors: STEP-Together

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a synchronous group session by videoconference.

This single-arm research study of off-treatment cancer survivors with self-reported symptoms of insomnia will test the Sleep Treatment Education Program Together (STEP-Together) intervention which is delivered as a virtual group session.

The research study procedures including screening for eligibility and questionnaires.

Participation in this research study is expected to last about 16 weeks.

It is expected about 90 people will participate in this research study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-89
* History of a cancer diagnosis (except non-melanoma skin cancer) ≥ 6 months prior
* No active cancer therapy (excluding chemoprevention) in the past four months, and no further therapy planned.
* Significant insomnia as evidenced by an Insomnia Severity Index score ≥ 8
* Regular access to the internet
* Able to read and write in English

Exclusion Criteria:

* Usual bedtime does not fall between 5:00 pm and 5:00 am.
* Employment in a position where falling asleep at work could impact public safety (such as air traffic-controller, operating heavy machinery).
* Ever diagnosed with Bipolar Disorder or with Seizure Disorder, currently taking medications to prevent a seizure, or have experienced a seizure in the prior 12 months.
* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently.
Impact of Chemotherapy and Regenerative Markers of Liver Regeneration After Liver Resection for Liver Metastases

Liver is special organ, which can regenerate. On that ability there are many treatment modalities, where liver resection is performed, especially in cancer patients with liver metastases. Liver regeneration provides an opportunity for these patients to undergo multiple treatment regimes and liver resections to achieve curability. There are many factors that impair liver regeneration. One of these factors is chemotherapy. Literature data on impact of chemotherapy to liver regeneration is ambiguous. Therefore we aim to research impact of chemotherapy to liver regeneration.

Liver is the largest parenchymal organ responsible for over 500 different functions in human body, which are detoxification of various toxins, drugs, synthesis of proteins and enzymes, coagulation factors. Liver is special organ, which can regenerate. If 75% of liver is removed it can regenerate to its normal size. Liver volume is very important to liver function, if there is volume insufficiency it could lead to liver failure in addition to other factors that impair liver regeneration. On that regenerative ability there are many treatment modalities, when liver resection is performed, especially in cancer patients with liver metastases. Modern treatment modalities are based on combination of different treatments, surgical and chemotherapeutic. On the other hand, side effects of chemotherapy should not be discarded, which can increase patient morbidity and mortality. Thus, liver regeneration provides an opportunity for these patients to undergo multiple treatment regimes and liver resections to achieve curability. Literature data on impact of chemotherapy to liver regeneration is ambiguous. Therefore we aim to research impact of chemotherapy to liver regeneration.

Eligibility Criteria:
Inclusion Criteria:

• Patients with liver lesions, who are eligible for liver resection

Exclusion Criteria:

* Pregnant women
* Liver resection is not performed
RCT of the Effect of Uvulopalatopharyngoplasty Compared to Expectancy in Patients With Obstructive Sleep Apnea

Hypothesis:Pharyngeal surgery (UPPP) reduces significantly the nightly respiratory breathing pauses (apnoeas-hypopnoeas) and improves the daytime symptoms compared to expectancy for 6 months in patients with OSAS.

Background: Obstructive sleep apnea syndrome (OSAS) is associated with an increased risk of poor sleep quality, excessive daytime sleepiness and prolonged reaction time, which can elevate the risk for traffic accidents. Increased morbidity and three to four times increased mortality in these patients are well documented, mainly in the cardiovascular field. Pharyngeal surgery, i.e. uvulopalatopharyngoplasty (UPPP) opens up the airway and was the predominant treatment for OSAS worldwide before continuous positive airway pressure (CPAP) devices became widely available in the 1990s. Since then, the main treatment for OSAS has been CPAP, but an increasing number of patients are also treated with mandibular retaining device (MRD). UPPP as treatment for OSAS has been performed for 30 years. The evidence-grade for the efficacy has so far been very low, and the side-effects and complication rate has raised the question whether there is a place for surgical treatment of OSAS. However, the compliance for CPAP and dental devices are quite low (50-60%), leaving a lot of patients untreated if surgery is not offered. RCT UPPP is still missing and called for.


Eligibility Criteria:
Inclusion Criteria:

ApnéHypopnéIndex, AHI \>14,9 Daytime sleepiness w Epworth sleepiness scale, ESS\> 7 Sleepy during daytime 3-5 times per week or more BodyMassIndex, BMI \< 36,0 Friedman staging system of tonsil size and tongue: i and II Patients w Friedman stage I and BMI \< 30,0 could be directly included if patient positive and no contra-indications for surgery. All others should be failure of CPAP and MRD before inclusion.

Exclusion Criteria:

Other OSAS treatment during study, i.e., patient is clinically severely deteriorated.

Negative to surgery Night-shift worker Friedman stage III or IV Morbid obesity BMI \>35,9 Severe psychological or neurological disease ASA class \>3 Severe lung- or heart disease (not applicable for hypertension, nor stroke or MI more than after 2 years).

Insufficient knowledge in Swedish language (important for filling in questionnaires) Dangerous in traffic while driving Severe nasal congestion (can be included after successful treatment) Previous tonsillectomy

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Pulmonary Disease in Patients Undergoing Hematopoietic Stem Cell Transplantation

This will be a retrospective study and analysis of subjects who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.

This study will determine factors influencing pulmonary disease and associated treatment strategies.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who have undergone a hematopoietic stem transplant (either at OSUMC or external location) and were seen at OSUMC at any time between 01Jan2000 and 30Jun2011.
* Age \> 18 years

Exclusion Criteria:

* Age \<18 years
* Prisoners
Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery

The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.

This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:

Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.

Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients aging 16 years and above
* Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital

Exclusion Criteria:

* Patients with history of motion sickness
* Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting
* Patients with any type of allergy to metoclopramide or ondansetron
* Patients refusing to be part of the study (refusal to sign consent)
* Patients on previous treatment by opioids
Pharmacokinetics of Efavirenz in HIV-1 Infected Subjects With Hepatic Impairment

The purpose of the study was to assess the steady-state pharmacokinetics (PK) of efavirenz (EFV) in human immunodeficiency virus type 1 (HIV-1) infected subjects on stable antiretroviral regimens containing EFV, and having selected degrees of hepatic impairment or normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infection with or without Hepatitis B or C infection
* Stable antiretroviral regimen containing efavirenz and nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) for at least 1 month
* Mild, moderate or severe hepatic impairment with hepatic cirrhosis

Exclusion Criteria:

* Acute flare of hepatitis
* Positive pregnancy test for a female
* Significant acute medical illness in past 2 months
* Use of agents known to significantly affect liver metabolism
* Change in medications to treat a chronic disease in the past 2 months
Perceptions, Representations and Experiences of Septic Isolation of Hospitalized Patients for COVID-19 Infection

The aim of this study is to analyze the perceptions, representations and experiences of septic isolation of patients hospitalized for COVID-19 infection.

This analysis could lead to better understanding and communication between the medical profession and patients in septic isolation in hospital. It would also provide patient-specific responses to their expectations, as to their families.

SARS-Cov2 is a new virus responsible for the COVID-19 pandemic. For the first time, it was observed in Wuhan, China in December 2019. For this previously unknown contagious disease, which can cause severe respiratory infections, isolation precautions in hospitals and public places are one of the cornerstones for fighting this pandemic.

Hospital isolation precautions have been present since the 19th century as a means to control the spread of infections. Septic isolation includes contact isolation, droplets and air. Isolation precautions must be prescribed by a physician. To our knowledge, there are few studies about the impact of septic isolation on hospitalized patients at both the psychological level and the relationship with doctors.

This study could enable a better understanding and communication between the medical profession and patients in septic isolation during hospitalization. It could also provide patient-specific responses to their expectations.

Eligibility Criteria:
Inclusion Criteria:

* Major patients
* Living in metropolitan France during the SARS-CoV2 pandemic
* Being or having been hospitalized in isolation contact and droplet for a COVID-19 infection (proven or suspected)
* Being in the process of leaving hospital
* Ready for No Opposition for Participation in the Protocol

Exclusion Criteria:

* Patients under guardianship or curatorship
* Patients unable to give free and informed consent;
* Patients under safeguarding justice
* Hospitalized patients on oxygen therapy with speech dyspnea
A Study of Atropine Sulfate in Healthy Chinese Volunteers

To evaluate the systemic pharmacokinetics and the safety of atropine sulfate eye drops in healthy volunteers.

This is a randomized, open-label, phase I clinical study evaluating the systemic pharmacokinetics and safety of atropine sulfate eye drops in healthy Chinese volunteers.Three concentrations will be investigated, each concentration group must contain both male and female subjects, and each subject receives only one concentration of atropine sulfate eye drop in this study.

The three treatment arms are:

Atropine sulfate dose A (low concentration)

Atropine sulfate dose B (medium concentration)

Atropine sulfate dose C (high concentration)

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subject is a male or female Chinese with his/her biological parents and grandparents are of Chinese ethnicity, aged 18-45 (including cut-off value) at screening;
2. Subject with a body mass index (BMI) between 19.0-26.0kg/m2 (including cut-off value), male weight ≥50.0kg, female weight ≥45.0kg at screening and D0;
3. Subject is in good health, as determined by the investigator, based on medical history, no findings of clinical significant abnormalities at physical examination, vital signs, electrocardiogram and clinical laboratory tests at screening and D0;

Exclusion Criteria:

1. Subject with any eye with corrected visual acuity \<1.0, clinically significant abnormal intraocular pressure, slit lamp and fundus examination.
2. Subject with history of eye diseases, including the history of internal eye surgery or laser surgery.
3. Subject with clinically significant history of the central nervous system, mental, cardiovascular, kidney, liver, respiratory, metabolic, and musculoskeletal system diseases etc., which may endanger the safety of the subject or affect the results of the study, as judged by the investigator.
4. Subject with clinically significant history of allergies, such as drug allergies, especially those who are allergic to any component of atropine sulfate eye drops.
5. On average, subject smokes more than 5 cigarettes per day or that who ex-smokes less than 3 months.
6. Subject has used any topical or systemic antimuscarinic/anticholinergic drugs (e.g., atropine, 1-hyoscyamine, tropicamide, chlorpheniramine, diphenhydramine, oxytropine, cyclic antidepressants, etc.) within 3 weeks before screening.
7. Subject has used any local or systemic drugs (including any prescription or over-the-counter drugs) within 2 weeks before screening.
8. Subject has participated in interventional clinical trials within 3 months before screening.
9. Subject who has worn contact lenses or cosmetic contact lenses within 1 weeks before screening.
10. Subject who is pregnant or breastfeeding.
11. The investigator believes that the subject is not suitable to participate in the trial.
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation

Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.

MydCombi is approved for inducing mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. The approved dose is 1 metered spray to the cornea of each eye to be dilated to be repeated after 5 minutes. This study will define the dilation of the pupil with ½ of the approved dose - a single metered spray to the cornea of each eye.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide signed written consent prior to participation in any study-related procedures.
* Ability to return for the study treatment visit.
* Photopic screening pupil diameter ≤ 3.5 mm in each eye.
* Females not of childbearing potential or negative pregnancy test

Exclusion Criteria:

* Pregnant or Lactating
* Clinically significant abnormalities of the eye
* Active eye disease
* Using medication that can effect pupil dilation
Comprehensive Screening for Women at High Genetic Risk for Developing Breast Cancer

To screen women who are high risk for breast cancer with breast MRI, mammogram and random periareolar fine needle aspiration.

General Purpose: The purpose of our protocol is develop a comprehensive screening protocol for women at high risk for developing breast cancer in the hopes of detecting breast cancer or it's precursor lesions at the earliest possible stage and reducing breast cancer mortality.

The following are our specific goals in this endeavor;

1. To assess the sensitivity and specificity of MRI in breast cancer detection in women at high risk compared to mammography
2. To assess the ability of random periareolar fine needle aspiration to detect abnormal ductal cells and to correlate these results with MRI and mammogram findings
3. To assess appropriate screening intervals for BRCA1/2 mutation carriers and women with a \>10% risk of developing breast cancer in ten years The following aims will be outlined in detail under methodology.

Eligibility Criteria:
Inclusion Criteria:Subjects must be female, between the ages of 25 and 65, or ten years younger than the youngest breast cancer diagnosed in the family, or have no mutation identified but have a greater than 10% risk of developing breast cancer in ten years (based on the Claus Model).

May have had previous breast or ovarian cancer, but must be at least one year out from treatment of a Stage 1 or early 2 cancer.