cyrilzakka/clinical-trials huggingface dataset:
CPAP Therapy in Obstructive Sleep Apnea Patients With Pulmonary Hypertension

All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH). These patients seemed to have PH if mPAP ≥25 mmHg . All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of \>70% nights \[380\] obtained from device download with AHI\<5 /hr

Echocardiography:

It was performed initially to diagnose pulmonary hypertension and repeated after three months of CPAP therapy as a follow up . All enrolled patients were subjected to trans-thoracic echocardiography using Ultrasound system (Vivid I, GE Healthcare, Little Chalfont, UK), with a 2.5 MHz transducer. Certain measurements were then used to calculate mPAP.

Patients were considered to have PH if mPAP ≥25 mmHg, and were classified into mild (20-40 mmHg), moderate (41-55 mmHg), and severe (\>55 mmHg) degrees.

Evidence of PH is found by Doppler echocardiography showing an elevated right ventricular systolic pressure (RVSP).


Eligibility Criteria:
Inclusion Criteria:

All patients are newly diagnosed Obstructive Sleep Apnea patients performing full night polysmnographic sleep study, whose echocardiographic findings elucidate presence of pulmonary hypertension(PH).

Exclusion Criteria:

* Patients aged \< 18 years
* Patients with secondary PH, due to pulmonary diseases, or left ventricular heart diseases , or chronic thromboembolic disorders.
* Patients on long term oxygen therapy (LTOT).
* Patients with respiratory neuromuscular weaknesses or chest wall deformities.
* End-organ failure and malignancies
* Obesity hypoventilation syndrome.
Effects of a Structured Occupational Therapy Intervention in an Acute Geriatric Unit

Objectives: To compare the benefits of structured occupational therapy intervention by a single geriatric therapist with the benefits of the conventional treatment model in the functional recovery of patients admitted to an acute geriatric unit.

Design: Non-pharmacological randomised clinical trial. Setting: Acute Geriatric Unit, Albacete, Spain. Participants: The trial included 400 patients admitted consecutively over 6 months to an acute geriatric unit for acute illness or exacerbation of a chronic medical condition. Participants were randomised to the occupational therapy intervention or conventional treatment model group; 198 patients received occupational therapy. All patients completed the study. The mean age was 83.5, and 56.8% were women.

Interventions: Needs assessment, iatrogenic prevention, retraining in basic and instrumental activities of daily living, assessment of need for technical aids, instruction for primary caregiver in patient mobilisation techniques, and structured social and occupational motivation as per protocol in three groups of patients (cardiopulmonary disease, stroke, and other conditions) 5 days a week, 30 to 45 minutes a day over the entire hospital stay.


Eligibility Criteria:
Inclusion Criteria:

* All patients age 65 or older consecutively admitted to the acute geriatric unit at the Complejo Hospitalario Universitario in Albacete, Spain, between November 2002 and June 2003 for an acute medical illness or exacerbation of a previous chronic condition

Exclusion Criteria:

* None
Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs

The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.

Circadin® is a newly developed slow release galenic formulation of melatonin, producing overall levels of melatonin comparable to those observed in a control population, when administered to patients with deficiency in melatonin; thus it deserves more clinical and paraclinical investigations for establishing efficacy in inducing and maintaining sleep and for safety. Since, on the one hand, the endogenous substance melatonin has beneficial effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy.

The aim of this placebo controlled study was to investigate the effect of 2 mg Melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more. Sleep was assessed by means of polysomnography (hypnographic results), all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG), actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female, aged ≥ 55 years, suffering from primary insomnia according to DSM-IV criteria (307.42)

Exclusion Criteria:

* According to DSM-IV, subjects belonging to the following groups are excluded: 780.59; 307.45; 307.47; 780.xx (Appendix 2);
* Use of benzodiazepines or other hypnotics during the preceding 1 month with a frequency of more than 2 times a week and lasting more than 2 weeks;
* Severe neurological, psychiatric or sleep disorders;
* Other serious diseases;
* Taking more than 1/2 l of alcohol, more than 3 cups of coffee or more than 10 cigarettes per day .
* Subjects who need beta blockers as a treatment.
Polymethyl Methacrylate and (PEGT/PBT) Centralizer by the Uncemented BIHAPRO THP

The purpose of this study is to analyse if the alignment of the stem and the number of complications of the new resorbable PEGT/PBT centralizer are comparable to the standard PMMA centralizer during the placement of an uncemented Bihapro hip prosthesis.

For a correct placement and early fixation of an uncemented hip prosthesis, a centralizer is used. Normally, the centralizer is made of PMMA, the same material as bone cement. When a revision is needed, PMMA is difficult to remove, which is one of the reason not to use a cemented hip prosthesis. With a PMMA centralizer, still PMMA will remain in the bone and needs to be removed in case of a revision. PEGT/PBT is a reabsorbable material, which gives stability during the first month after the placement of the hip prosthesis. However, PEGT/PBT is reabsorped afterwards and, therefore, will not interfere with a revision procedure.

The goal of this study is to analyse if the PEGT/PBT is as safe as PMMA in terms of alignment, direct postoperative complications and clinical results.

Therefore, 100 patients indicated for a cementless Bihapro hip prosthesis which have signed an informed consent are included and randomised over the used centralizers using a weighted randomisation method. All patients will be treated equally. The patients are examined preoperatively, 1 day, 6 weeks, 3, 6, 12, 24 en 48 months postoperatively using an X-ray, the Harris hip score and a patient questionnaire, the Womac and SF36.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Diagnosis: Osteoarthritis
* Indicated for a primary hip prosthesis

Exclusion Criteria:

* Previous hip surgery
* No informed consent
* Active infection in hip
* Immature skeleton
* Rheumatoid arthritis, M. Paget
The Effectiveness of the Push-Pull-Hold Program on Improving Self-Care in Patients With Heart Failure

This study is a randomized controlled trial that tests the effectiveness of a novel intervention called the Push-Pull-Hold program on improving self-care in patients with heart failure. This intervention was developed based on our previous quantitative and qualitative findings and existing psychological concepts. Results would inform current understanding of the intention-behavior link in self-care and inform future policy and intervention development to improve patient and caregiver outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with chronic heart failure for at least 1 month
* More than 21 years old
* Able to read and understand English or Chinese

Exclusion Criteria:

* Dependent on caregivers
* Awaiting implantable devices or surgery
* Pregnant
Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Subjects will attend a total of 5 to 9 visits, depending on whether one eye or both eyes are implanted. The second eye surgery, if applicable, will occur 1 to 30 days after the first eye surgery. Total individual duration of participation will be up to 4 months, including an up to 2-month preoperative period.

This study will be conducted in Japan.

Eligibility Criteria:
Key Inclusion Criteria:

* Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
* Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Irregular corneal astigmatism.
* History of anterior segment, posterior segment, or optic nerve pathology.
* History of previous intraocular or corneal (refractive or trauma related) surgery.
* Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and laser assisted in situ keratomileusis (LASIK).
* Other protocol-defined exclusion criteria may apply.
Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery

Patients at high risk of preterm birth are hospitalized with an high stress for their child's future. In order to better prepare the patient to a possible preterm delivery we use to propose her a visit of the neonatology unit. However, as a result of their obstetrical condition and of the pediatric staff disponibility, this visit is not always possible. Virtual Reality (VR) is well known to provide an immersive experience while staying in a unique place. Our project is to propose a virtual visit of the delivery room, neonatology unit and intensive care unit to all hospitalized patients at risk of preterm delivery in order to prepare and decompress them.

Most of the future parents are unprepared to outcomes of their premature child and the neonatology unit visit has a demonstrated anxiolytic effect on them (decrease of 6.7 points on the State Trait Anxiety Inventory-form Y scale (STAI-Y1)) unfortunately, as a result of their obstetrical condition and of the pediatric staff disponibility, the visit of the neonatology unit is not always possible in time.

Furthermore VR is known to be an immersive experience wich had already proved its comforting interest during delivery or to prepare patient to a planned caesarean.

In this study we propose to all hospitalized and high risk of delivery early patients a virtual visit of the neonatology unit from their sit in the calm space of their room. If the patient doesn't tolerate or has some VR contraindication : a virtual visit is possible on digital tablet. The visit is presented after the foetal lung maturation by 48h of Betamethasone. Patients complete a STAI-Y-A survey before and after the experience and a Simulator Sickness Questionnaire (SSQ) questionary to evaluate their tolerance. All medical informations can be found in the medical record.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient
* Patient with high risk of preterm delivery
* \> 24 Week of Gestation (WG) et ≤ 34 WG
* Patient who received corticosteroids for fetal lung maturation in the previous 24h
* Patient \> 18 years old

Exclusion Criteria:

* Patient no speak french
* no read french
* \> 34 WG
* Guardianship, curatorship, or under the protection of a conservator
* Foetus vital prognosis engaged
* Medical contraindication to virtual reality: Epilepsy, bipolarity, severe motion sickness ( evaluated by the patient herself : history of nausea, sweat, emesis during car, boat or airplane transportation ... +/- preventive therapy)
Clinical Evaluation of NIR (Non-Invasive Infrared) Thermometer Performance

The study is conducted in order to evaluate the performance of the NIT thrmometer by comparing the predictive measurement to equilibrium measurement and to make a final tuning to the thermometer algorithm.


Eligibility Criteria:
Inclusion Criteria:

* Children 0-18 years old, with or without fever that arrive at the unit of emergency medicine in Schneider medical center.
* An informed Consent was signed by the patient or his guardian.

Exclusion Criteria:

* The medical stuff decides that the patient can't participate.
A Study of Glipizide to Treat High Blood Sugar in People With Pancreatic Cancer

The purpose of this study is to find out how effective and safe glipizide is for lowering blood sugar in people with pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

Cohort 1

* Age ≥18 years
* Biopsy-proven PDAC
* Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
* Willing and able to comply with the requirements of the protocol
* Willing to use their bluetooth-enabled wifi or cellular mobile device
* Hemoglobin A1c (HbA1c) \&gt;8%, or fructosamine \&gt;325 mg/dL, or random glucose \&gt;200 mg/dL, or strong clinical suspicion that patient has hyperglycemia, making it reasonable to expect their mean daily glucose is ≥183 mg/dL
* Eastern Cooperative Oncology Group performance status ≤2
* BMI \&lt;30 kg/m2

Cohort 2a

* Age ≥18 years
* Biopsy-proven PDAC
* Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic pancreatic cancer)
* Clinical diagnosis of diabetes mellitus
* Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period from which data were recorded in the electronic medical record (in this retrospective study patients need not be under active care at the time the research is conducted)
* At least 1 electronic prescription for a sulfonylurea (glipizide, glimepiride, or glyburide) or metformin
* Three-month baseline period before metformin or sulfonylurea initiation in which the participant does not receive either drug class or insulin
* Body weight recorded within 3 months before start of metformin or a sulfonylurea

Cohort 2b

* Age ≥18 years
* Biopsy-proven PDAC
* Radiological evidence and clinical assessment that patient has active disease (local, locally advanced, or metastatic)
* Active care at MSK (defined as at least 1 physician or APP encounter every 3 months) for PDAC during the period of data collection
* Apparent current use based on chart review of metformin (but not sulfonylurea); sulfonylurea (but not metformin); or neither drug

Exclusion Criteria:

Cohort 1

* Use during the past month of any antidiabetic medication other than metformin at home (sporadic use \[fewer than 1 of 7 days during the past month\] is permitted)
* Changes in metformin dose in the past month
* History of sulfonylurea intolerance or allergy
* History of severe hypoglycemia (hypoglycemia requiring emergency medical assistance, emergency room or urgent care visit, or hospital admission)
* AST or ALT \&gt;3 x upper limit of normal
* Glomerular filtration rate \&lt;30 mL/min/1.73m2
* Daily chronic use of any dose of corticosteroids (as distinct from intermittent exposure to steroids as part of cyclic chemotherapy)
* Inability to wear CGM

Cohort 2a

* Greater than trace ascites documented on imaging or physical exam

Cohort 2b

* Greater than trace ascites documented on imaging or physical exam
Juno Perth Clinical Trial

This study is to evaluate the efficacy of a new therapy (Automatic Expiratory Positive Airway Pressure with intelligent Volume Assured Pressure Support (AutoEPAP iVAPS)) designed to treat respiratory insufficiency, respiratory failure and/or nocturnal hypoventilation with upper airway obstruction. The study will be performed in two phases: In a sleep unit and in the home environment. The new therapy will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (iVAPS)".

Phase I: AutoEPAP iVAPS will be compared against two existing ventilator therapies: "Spontaneous Timed (ST) mode" and "Intelligent Volume Assured Pressure Support (Fixed EPAP iVAPS)" in current NIV users with respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD),Obesity Hypoventilation Syndrome (OHS) or Neuromuscular Disease (NMD). Patients will spend a total of 3 nights in the sleep laboratory in the three modes described above. The apnoea-hypopnoea index will be the primary outcome measure.

Phase II: AutoEPAP iVAPS will be compared to ST mode over a period of 7 nights in the patients' home. The mean EPAP setting of each device will be the primary outcome measure.

Eligibility Criteria:
Inclusion Criteria

* Subject has ability to provide written informed consent
* Subject aged ≥18 years old
* Subject has a diagnosis of COPD, OHS or NMD with sleep hypoventilation (historical PtCO2 increase overnight ≥ 10mmHg) and/or daytime hypercapnia (\>45 mmHg)
* Subject is currently using non-invasive ventilation for ≥ 3 months
* Subject with an AHI ≥ 5 hr. (as documented in diagnostic or pressure determination sleep study report)

Exclusion Criteria

* Subjects not compliant on NIV (ie. \< 4 hr/night)
* Subjects with severe asthma
* Subjects who are pregnant
* Subjects on oxygen therapy (ie. \>4 L/min)
* Subjects with a tracheostomy
* Subjects who are acutely ill, medically complicated or who are medically unstable
* Subjects in whom PAP therapy is otherwise medically contraindicated
* Subjects who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
* Subjects with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome.
* Subjects who require ventilatory support during wakefulness
* Subjects with the following pre-existing conditions: severe bullous lung disease, recurrent pneumothorax or pneumomediastinum, low blood pressure, cerebrospinal fluid leak, recent cranial surgery or trauma.
* Subjects with severe developmental delay and who will not be able to follow tasks as instructed in the protocol.
* Subjects who the investigator believes are unsuitable for inclusion because either:

  * they do not comprehend English
  * they are unable or unwilling to provide written informed consent
  * they are physically unable to comply with the protocol
  * they are unsuitable to participate in the trial for any other reason in the opinion of the investigator
Leukemia Inhibitory Factor Level in Intrauterine Growth Restriction Neonates

To see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses

During embryonic development, there are several cytokines such as: LIF (Leukemia inhibitory factor), ciliary neurotrophic factor (CNTF), epidermal growth factor family (EGF), neuregulin 1 (NRG1) and transforming growth factor β (TGFβ) that were found are associated with neurogenesis and differentiation of brain cells .

LIF is a cytokine that is essential for the development of the central nervous system, and has recently been shown in rats that maternal LIF stimulates placental ACTH that in turn promotes secretion of fetal LIF from nRBC , which in turn promotes brain development of the fetus Other studies on IUGR (Intra Uterine Growth Restriction) have shown that IUGR fetuses have more CP (Cerebral palsy) than those who were AGA (Average for Gestational Age) The hypothesis is that LIF is related to the proper development of the nervous system in the fetus and by testing cord blood of embryos IUGR and the placenta we will find changes in LIF and ACTH compared with AGA fetuses level.

Studies have also shown a relationship between CP and IUGR, but the mechanism for this relationship is unclear.

The purpose of our research is to see if there is a relationship between the level of LIF in IUGR fetuses and compared to the level of LIF in AGA fetuses, in one of two ways:

* Changes in the secretion of ACTH in placenta
* Changes in levels of LIF in the umbilical cord blood

Eligibility Criteria:
Inclusion Criteria:

* Women that the Fetal weight estimate puts the fetus bellow the 10th percentile and those that the fetal weight estimate are between 20th and 80th percentiles

Exclusion Criteria:

* Women who do not agree
* known Genetic diseases of abnormalities in the fetus
A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy

To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

To evaluate safety and efficacy of Tri-Luma® cream as an adjunctive treatment to cryotherapy when used in the pre- and post-procedure phases for the treatment of solar lentigines on the back of the hands and in the prevention of post-inflammatory hyperpigmentation after cryotherapy.

The study has 13 weeks for each subject. Five visits will take place: at Baseline, week 2, 5, 9 and 13 after the cryotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Subject agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol;
* Female and male subjects;
* Phototype II to IV;
* Subjects aged between 40 and 65 years;
* Subjects presenting at least 5 lesions of solar lentigines at the back hands with al least 3mm of diameter
* History of post-inflammatory hyperpigmentation on body or face
* Medical history and physical examination which, based on the investigator's opinion, do not prevent the subject from taking part in the study or from making use of the products under investigation;
* Subjects of childbearing age should present a negative urine pregnancy test at baseline and should be using a highly effective contraceptive method during all study;
* Availability of the subject throughout the study;
* Subject agreeing not to undergo other cosmetic or dermatological procedures during the participation in the study;
* Subjects with sufficient schooling and knowledge to enable them to cooperate to the degree required by the protocol.

Exclusion Criteria:

* Pregnant women or women intending to become pregnant in the following 5 months after screening;
* Lactation period;
* Subjects participating in other clinical trials;
* Any prior cosmetic procedures, including fillers, or scars that may interfere with the study results;
* Subjects with neoplastic, muscular or neurological diseases;
* Subjects with inflammation or active infection in the area to be studied;
* Subjects with a history of adverse effects, such as sensitivity to the components of any of the study drug formula,
* Subjects with a history of non-adherence to medical treatment or showing unwillingness to adhere to the study protocol;
* Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.