cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Properties of GLPG1690 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

A multicenter randomized, double-blind, parallel group, placebo-controlled, exploratory phase IIa study in subjects with Idiopathic Pulmonary Fibrosis (IPF) to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG1690. Male and female subjects aged 40 years or older will be screened to determine eligibility. The screening period will be up to 4 weeks. At baseline, eligible subjects will be randomized in a 3:1 ratio to GLPG1690 or matching placebo administered for 12 weeks. The subjects will visit the study center at screening, baseline, Weeks 1, 2, 4, 8 and 12 and for a follow-up visit 2 weeks after the last administration of study drug. Planned assessments: Adverse event reporting, clinical laboratory tests, vital signs, physical examination, 12-Lead-ECG, PK blood sampling, biomarker blood/bronchoalveolar lavage fluid (BALF), Spirometry, St George's respiratory questionnaire, high-resolution computed tomography (HRCT).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects able and willing to sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved Informed Consent Form (ICF)
2. Male or female subjects of non-child-bearing potential aged ≥ 40 years
3. Subjects with a chest HRCT performed within 12 months prior to screening
4. Subjects with IPF diagnosed by a multidisciplinary team
5. Subjects with: a. forced vital capacity (FVC) ≥50% predicted of normal AND b. Diffusing capacity for the lungs for carbon monoxide (DLCO) ≥ 30% predicted of normal corrected for hemoglobin
6. Subjects with a forced expiratory volume in 1 second (FEV1)/FVC (Tiffeneau-Pinelli index) ratio ≥ 0.70 (based on pre-bronchodilator spirometry
7. Subjects on stable supportive care
8. Subjects in stable condition

Exclusion Criteria:

1. Subjects with know hypersensitivity to any of the study drug ingredients
2. Subjects with a history of or current immunosuppressive condition
3. Subjects with a history of malignancy within the past 5 years
4. Subjects with clinically significant abnormalities on ECG
5. Subjects with acute IPF exacerbation within 6 weeks prior to screening
6. Subjects with a lower respiratory tract infection requiring antibiotics with 4 weeks prior to screening
7. Smoking within 3 months pre-screening
8. Interstitial lung disease
9. History of lung volume reduction surgery or lung transplant
10. Unstable cardiac or pulmonary disease other than IPF within 6 months prior to screening
11. Subjects with abnormal liver function
12. Subjects with abnormal renal function
Minimally Invasive Simple Hysterectomy in Low Risk Cervical Cancer

The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.The SHAPE trial was designed to answer the clinical question of whether simple hysterectomy could be performed instead of radical hysterectomy in low-risk early stage cervical cancer but not the surgical approach. The favorable oncological outcome observed in SHAPE despite 75% of patients were treated with minimally invasive approach suggests that this approach may be safe. However, the trial was not designed to analyze oncological outcomes from surgical approach.

The Laparoscopic Approach to Cervical Cancer (LACC) Trial showed that minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. Since then, the standard of care in terms of surgical approach to radical hysterectomy has been considered the laparotomy. More recently, the SHAPE trial results were presented showing that in patients with low-risk cervical cancer (defined as FIGO 2018 stage IA2 and IB1 up to 2 cm, with limited stromal invasion: \< 10 mm on LEEP/cone and \< 50% depth on MRI) simple hysterectomy was not inferior to radical hysterectomy for what concerned pelvic recurrence, with less complications and better quality of life. However, SHAPE trial was not designed to assess the surgical approach.

The rationale of the present study is to assess the safety of the minimally invasive surgery approach in patients meeting the SHAPE trial inclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma of uterine cervix
* FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤10mm on conization specimen
* FIGO 2018 stage IA2-IB1 (≤2cm) with depth of infiltration ≤50% at pre-conization MRI-scan or "expert" US-scan.
* Age ≥18 years

Exclusion Criteria:

* Neuroendocrine, clear cell, serous carcinoma
* Depth of infiltration \>10 mm on conization specimen
* Depth of infiltration \>50% at pre-conization imaging
* Cervical tumor \>2 cm
* Diagnosis on inadvertent hysterectomy
* Neoadjuvant chemotherapy
* Previous pelvic radiotherapy
* Pregnant women
* Contraindications to surgery
* Lymph nodes \>15 mm short axis
* Fertility sparing treatment or desire
* Recurrent cervical cancer
* Time between cervical cancer diagnosis and hysterectomy \>4 months if conization with tumor negative margins
* Time between cervical cancer diagnosis and hysterectomy \>3 months if conization with invasive tumor positive margins
A Study of Mycobacterium w Plus Docetaxel for Hormone Refractory Metastatic Prostate Cancer

This study proposed the comparison the overall survival, hematological toxicity, pain reduction score,PSA levels, tumor response, quality of life in two arms of HRPC patients from different parts of India.

Prostate Cancer is a common health issue facing men worldwide in most of the patients cancer will shrink with hormonal therapy. In some cases cancer returns or continues to grow despite very low levels of circulating male hormones, which is called Androgen-Independent Prostate Cancer (AIPC) or Hormone Refractory Prostate Cancer (HRPC). Mycobacterium w is known to share multiple antigen including PSA. It administration is associated with antigen specific generation of cell mediated immunity. Docetaxel is found to useful in management of metastatic hormone refractory prostate cancer, which is associated with improved survival, tumor progression free survival with reduction in pain, serum PSA and improvement in quality of life. Cyclophosphamide 300mg/sq.m will be used to eliminate T-regulatory cell responsible immuno suppression. The vaccine Mycobacterium w will be administered on a day following cyclophosphamide. For better initiation of immune responses Docetaxel will be given seven days following first dose of Mycobacterium w.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate with clinical or radiologic evidence of metastatic disease.
* Disease progression during antiandrogen therapy, having surgical or medical castration status.
* Karnofsky Performance Status 50-100
* Normal cardiac function
* Life expectancy at least 24 weeks.
* Laboratory criteria for eligibility will include
* A neutrophil count of at least 1500 per cubic millimeter
* A hemoglobin level of at least 9 gm%
* A platelet count of at least 1000,000 per cubic millimeter.
* A total bilirubin not grater than 1.5 times the upper limit of the normal range for each institution.
* Serum creatinine levels not more than 1.5 times the upper limit of the normal range
* Written informed consent

Exclusion Criteria:

* Prior treatment with cytotoxic agents or radioisotopes
* Estrogen use for at least three months
* History of another cancer within the preceding five years (except basal or squamous-cell skin cancer)
* Brain or leptomeningeal metastases
* Symptomatic peripheral neuropathy of grade 2 or higher
* Uncontrolled intercurrent illness that would limit compliance with study requirements
Oxygen Insufflation Via Flexible Scope

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

The investigators will study to what extent insufflation of oxygen via the suction channel of a flexible bronchoscope can help with making access from the mouth to the trachea easier when there is blood or secretions in the way. We provide the oxygen-flow from the circle-system of an anaesthesia-machine and in this way we can limit the pressure to 30 and 40 cm H2O which are relatively safe pressure-levels. The endoscopy is performed on a plastic manikin and artificial sputum mixed with artificial blood is used. The procedure will be performed by 64 anaesthetists that will be randomised to use either oxygen-insufflation or not. The setup is cross-randomised so that each participant will perform two attempts, one with insufflation and one without. The procedures will be video-taped and evaluated by a blinded observer regarding a) success/failure of advancing the scope to the mid trachea under vision, b) the duration of the procedure. Additionally, subjective scores regarding the benefit of using insufflation will be obtained

Eligibility Criteria:
Inclusion Criteria:

Anesthesiologists attending the airway course "Airwaymanagement for Anaesthesiologists"

-

Exclusion Criteria:

* non acceptance of participation
iFR Pressure Wires in Assessment of the Provisional Side-branch Intervention Strategy for Bifurcation Lesions

Even in the era of drug-eluting stents, bifurcation lesions remain one of the most challenging lesion subsets in coronary intervention practice. This study was performed to evaluate the functional outcomes of pressure wires (IFR)-guided jailed side-branch intervention strategy.

Fractional flow reserve (FFR) measurements require minimal and constant microvascular resistance which is routinely achieved by intravenous adenosine infusion. Adenosine-induced hyperemia establishes an optimal vascular environment for FFR measurement. However, breathlessness and chest tightness are common adverse events during adenosine infusion and severe asthma occurs occasionally. The Introduction of an adenosine-independent index (instantaneous wave-free ratio \[iFR\]) into clinical practice offered easier and hyperemia-free method for lesion assessment.

Physiological changes and clinical evaluation of iFR warrants further research. Therefore, the investigators conducted this study to evaluate the functional aspects of iFR-guided provisional jailed side-branch intervention strategy and compare clinical endpoints to conventional non-iFR-guided operations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute coronary syndrome
* Jailed side-branch of a vessel size \> 2 mm
* Vessel length \> 40 mm
* Lesion length \< 10 mm by visual estimation

Exclusion Criteria:

* Significant stenosis in the left main coronary artery or the main branch proximal to the stented segment
* Totally occluded bifurcation lesions
* Primary myocardial disease
* Serum creatinine level of ≥ 2.
Counseling Intervention in Hereditary Hemorrhagic Telangiectasia in the COVID Era.

The goal of this interventional study is to determine the incidence of depression, anxiety, sleep disturbances and resilience in a sample of subjects affected by Hereditary Hemorrhagic Telangiectasia. The study is declined through the evaluation of some outcome parameters at the time of enrollment (T0), during the counseling intervention (T1 and T2) and at the end (T3) of the subjects who will have carried out an individual counseling intervention.


Eligibility Criteria:
Inclusion Criteria:

Recruited subjects have a diagnosis of Hereditary Hemorrhagic Telangiectasia and are 18 years of age or older.

Exclusion Criteria:

Previous or current intellectual disability and a diagnosis of psychiatric disorders in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.
A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of moderate to severe (Part A) or mild to moderate (Part B) UC for ≥3 months prior to baseline.
* Active disease beyond the rectum (\>15 cm of active disease from the anal verge at the screening endoscopy).

Part A (moderate to severe): Must have a 5 to 9 score on the modified mayo score, including an endoscopy subscore of at least 2. Part B (mild to moderate): Participants with mMS of 4 to 6, ES of ≥2 and RB score of ≥1

* Must have inadequate response to, loss of response to, or intolerance to at least one conventional therapy for UC.
* Total body weight \>40 kg (88.2 lb).

Exclusion Criteria:

* Presence of indeterminate; microscopic; ischemic; infectious; radiation colitis; diverticular disease; Crohn's disease; colonic stricture; colonic obstruction/ resection; presence of cancer.
* History of bowel surgery within 6 months prior to baseline.
* History of significant trauma or major surgery within 4 weeks of screening or considered in imminent need of surgery or with elective surgery scheduled to occur during the study.
* Presence of clinical signs of fulminant colitis or toxic megacolon, primary sclerosing cholangitis and evidence of colonic dysplasia, adenomas or neoplasia.
* Clinically significant infections within 6 months of baseline
Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation therapy by pharmacist intervention compared to enhanced usual care in participants with unrecognized AF and/or known AF but not taking blood thinners.

Background:

AF is the most common arrhythmia and the leading cause of stroke. Despite robust evidence oral anticoagulation (OAC) therapy is effective and safe for stroke prevention in patients with AF; there is a lack of real-world application. Alternative strategies to deliver stroke prevention therapy need to be explored. Although pharmacists' prescribing of antihypertensive and lipid lowering drug therapy has been shown to increase adherence to guideline-based targets and warfarin management improve control of international normalized ratios in anticoagulation clinics, the role of pharmacist initiation of OAC therapy compared to usual care in AF patients for stroke prevention in a community setting is unclear.

In this study, the investigators will screen participants presenting to community pharmacies to identify participants with unrecognized AF and/or known AF but not taking blood thinners or not on optimal OAC therapy and randomize care to either the pharmacist or enhanced usual care (family physician notification by pharmacist).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years with one additional stroke risk factor (hypertension, diabetes, heart failure history of or left ventricular ejection fraction \<0.40), previous stroke or transient ischemic attack).
* Atrial fibrillation and not on oral anticoagulation (OAC) therapy but eligible
* Atrial fibrillation on sub-optimal OAC

Exclusion Criteria:

* Uncontrolled hypertension (defined as average SBP ≥ 160 mmHg \[2 readings taken at time of screening\]).
* End stage renal disease (CrCl \< 15 ml/min)
* Valvular Heart Disease including those with prosthetic valve, mitral stenosis (moderate to severe) or valve repair.
* Excess alcohol intake (males: ≥ 28 units/week, females: ≥ 21 units/week. One unit of alcohol = 8 oz beer, 1 oz hard liquor or 4 oz wine).
* Intracranial bleed at any point.
* History of "Major Bleeding" at any point (defined as overt bleeding at a critical site including intracranial, intraspinal, intraocular, pericardial, or retroperitoneal; or bleed requiring hospitalization).
* Foreshortened life-expectancy or severe comorbidities precluding study follow-up period
* Unable to read/understand English
* Severe cognitive impairment (defined as score ≥ 5 on the Short Portable Mental Status Questionnaire)
Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec

Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.

People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.

Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.


Eligibility Criteria:
Inclusion Criteria:

* People with T1D ≥18 years at the moment of switch to Insulin Degludec
* Diagnosed with T1D ≥2 years before switch to Insulin Degludec
* On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec
* ≥6 months use of Insulin Degludec at moment of datacollection
* Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec

Exclusion Criteria:

* People with T1D \<18 years at the moment of switch to Insulin Degludec
* People without T1D or with T1D \<2 years before switch to Insulin Degludec
* Women with T1D who are pregnant or planning pregnancy during -12 and +12 months
* Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months
* Start to use non-insulin antidiabetic agents between -12 and +12 months
* Having received treatment with oral or injectable corticosteroids during -12 and +12 months
* Undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months
* \<6 months use of Insulin Degludec at moment of datacollection
* Not using continuous glucose monitoring or \<2 years before switch to Insulin Degludec
Assessing of Artificial Intelligence-based Software Platform for Diabetic Retinopathy Screening

To examine the potential for the detection of diabetic retinopathy (DR) using the artificial intelligence (AI)-based software platform Retina-AI.

Operator took fundus images with a non-mydriatic fundus camera as per the Retina-AI CheckEye imaging protocol (an optic disc centered image and a fovea centered image for each eye).Thereafter, operator uploaded fundus images in the AI system for processing by the neural network.

Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of diabetes mellitus by definition.
2. Understanding of the Study and willingness and ability to sign informed consent
3. Patient age 18 or above
4. Diagnostic for diabetes: 4a) Type 1 diabetes of a lest 5 years of evolution; or 4b) Type 2 diabetes

Exclusion Criteria:

-1. Patients under 18 years of age; 2. Failure to give informed consent; 3. Presence of retinal diseases - acquired disease: age-related macular degeneration (AMD), occlusion of retinal vessels (ORV), etc.; birth defects: coloboma of choroid or optic nerve disc, etc.; hereditary diseases: retinitis pigmentosa, angioid streaks of the retina, etc.

4. A patient who has already undergone treatment (surgery, laser, etc.) for any disease of the retina: age-related macular degeneration (AMD), retinal vascular occlusion (ARV), etc. These patients should be excluded or allocated to a separate group.
Bifurcation Coronary Lesion 0-0-1

Research Involving Human Persons (RIHP 3) focusing on the treatment of type 0-0-1 bifurcation lesions in routine practice. Multicenter Study.

To retrieve and analyze the details of different angioplasty techniques used in this type of bifurcation lesion (Medina 0-0-1) in order to describe current practice and search for predictors of clinical events.

The primary objective of the trial is to estimate the frequency of Major Adverse Cardiac Events (MACE), including cardiac death, myocardial infarction within the territory of the treated lesion, and revascularization of the target lesion in a representative population of patients treated by coronary angioplasty of type 0-0-1 bifurcation lesions.

The sample size will be determined by the number of angioplasties of type 0-0-1 bifurcation lesions performed at each center between 2016 and 2022.

Since the trial is observational in nature and there are no previously published studies, the sample size cannot be calculated based on the desired precision of the estimation.

Furthermore, the purpose of the study is also to assess the techniques used to treat this type of coronary bifurcation and to highlight any differences between different centers and with other types of coronary bifurcation lesions described in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and older,
* Who underwent angioplasty for a coronary bifurcation lesion of type 0-0-1 between 2016 and 2022.

Exclusion Criteria:

- Opposing the collection and processing of necessary data and refusing additional telephone follow-up
Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).

The purpose of this study is to:

* assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease;
* explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer;
* identify dose(s) that will be studied in subsequent trials.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of CF
* FEV1 greater than or equal to 75% of predicted normal for age, gender, and height
* oxyhemoglobin saturation greater than or equal to 90%
* clinically stable

Exclusion Criteria:

* abnormal renal or liver function
* clinically significant findings atypical for moderate cystic fibrosis
A Phase I, Open Interaction Study Between GLPG1837 and Midazolam in Healthy Male Subjects

This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG1837 on the single dose pharmacokinetic profile of midazolam administered in fed healthy male subjects. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG1837 and on Day 12 co-administered with GLPG1837, after multiple oral doses of GLPG1837 (daily for 10 days, from Day 2 until Day 11).

Also, the safety and tolerability of multiple oral doses of GLPG1837 co-administered with midazolam in healthy male subjects will be evaluated.

A first dose group of 12 subjects will receive a total daily dose of 500 mg (250 mg b.i.d.) GLPG1837 and a second dose group of 12 subjects will receive a total daily dose of 1000 mg (500 mg b.i.d.) GLPG1837.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking