cyrilzakka/clinical-trials huggingface dataset:
A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).


Eligibility Criteria:
Inclusion Criteria:

* Men and women between the age of 23 to 70 years old at screening, inclusive
* GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
* No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
* The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
* Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
* Subject had a DXA screening and the results are interpretable according to the study plan.

Exclusion Criteria:

* Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
* Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
* History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
* Signs of intracranial hypertension at screening
* Heart insufficiency, NYHA class \> 2 (Appendix B)
* History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
* History of Acromegaly
Pre-hospital Hypoxemia in Trauma Patients

The intent of this study is to describe the proportion of trauma patients requiring oxygen before hospital arrival, the amount of oxygen they require, and whether or not the oxygen is beneficial to outcomes.

Trauma patients in the United States frequently receive high-flow high-concentration supplemental oxygen in the pre-hospital setting, yet their physiologic need is rarely known. Providing oxygen to everyone regardless of need may seem straightforward, but the practice has extensive implications in logistically challenging areas such as a combat arena or mass casualty event, and is not supported by care guidelines. Indeed, too much oxygen can be harmful for some patients.1, 2 If it is the case, that not all trauma patients require oxygen, this would decrease the logistical burden of providing oxygen in the pre-hospital environment. No study has yet been performed that describes the proportion of patients requiring oxygen, the amount of oxygen they require, and whether or not oxygen is beneficial to outcomes. This prospective observational cohort investigation aims to bridge the knowledge gap surrounding the need and possible benefits or harms arising from oxygen therapy. In our Emergency Medical Services (EMS) systems, the written standard of care is to provide oxygen only to maintain oxygen saturation at 95% or when hemorrhagic shock or traumatic brain injury are suspected.3 We will observe patterns of oxygen treatment and outcome for patients treated according to this written standard of care, and compare this to the treatment and outcomes for patients transported by EMS units who continue their usual practice pattern.

Specifically, we aim to:

1. Identify the proportion of trauma patients who are hypoxemic or who have traumatic brain injury or hemorrhagic shock at the time of initial EMS contact
2. Identify the proportion of trauma patients who develop hypoxemia or hemorrhagic shock while in the pre-hospital setting
3. Identify differences in clinically important outcomes associated with treatments driven by written standard of care compared with the usual practice pattern of EMS units. These outcomes include requirement for advanced airway management, hospital and intensive care unit lengths of stay, and disposition (including in-hospital and 30-day mortality)
4. Determine the amount of oxygen (Liters per minute) required to reverse hypoxemia

Eligibility Criteria:
Inclusion Criteria:

* acute traumatic injury
* transported directly to study hospital
* meets at least one trauma consult/trauma stat criteria

Exclusion Criteria:

* lack of continuous peripheral pulse oximetry data
* age \<18 years
* on prescribed home oxygen therapy prior to trauma
Focused Incentive Spirometry Monitoring to Reduce Postoperative Oxygen Therapy and Respiratory Complications After Bariatric Surgery

Postoperative (PO) hypoventilation, atelectasis and hypoxemia after bariatric surgery are common and multifactorial, contributing to prolonged oxygen (O2) therapy after surgery and even at hospital discharge. Incentive spirometry (IS) is recommended postoperatively but its success in preventing postoperative atelectasis and hypoxemia (POH) heavily depends on patient compliance with IS effort and frequency. The investigators hypothesize that a focused education preoperatively on IS for POH and intensive monitoring of patient compliance with IS therapy in the early postoperative period shortens postoperative oxygen therapy, decreases POH episodes, and improves respiratory outcomes after bariatric surgery, compared to patients receiving standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Patients having planned elective bariatric surgery at University of Colorado Hospital

Exclusion Criteria:

* Emergency procedure
* Oxygen therapy within the previous 30 days
* Smoking within the previous 30 days
* Inability or refusal to provide consent
Prevalence of Chronic Thromboembolic Pulmonary Hypertension After Acute Pulmonary Embolism : (Preva-CTEPH)

The prevalence of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) varies widely (0.4% to 8.8%) in the literature. This large variation could be due to the inclusion of patients with pre-existing CTEPH revealed on the occasion of a recurrence of PE. However, the absence of hemodynamic data when diagnosing PE does not allow to distinguish these patients. A prospective multicentric study involving 146 patients showed that the majority of patients with CTEPH during follow-up had a pulmonary hypertension unknown at the time of PE diagnosis. It is necessary to confirm these results in a broader study.

The aim of this study is to evaluate the cumulative incidence of CTEPH after a PE.

The patients selected in this study are patients with an objectively confirmed PE and previously included since at least 12 months in one of the studies of the INNOVTE network.

Patients who are alive at the time of the selection for the PREVA-CTEPH study are contacted by phone or by mail for inclusion in the prospective interventional part of the PREVA-CTEPH study. Patients who consent to participate to this prospective interventional phase of the PREVA-CTEPH study have dyspnea assessment, EKG, and echocardiography to investigate the diagnosis of CTEPH. Patients with dyspnea (NYHA \>1) and/or a high or intermediate echocardiographic probability of pulmonary hypertension (ESC criteria) have a V/Q lung scan, a right heart catheterization and a pulmonary angiography to objectively confirm the diagnosis of CTEPH according to the current ESC guidelines.

Retrospective phase: All clinical (dyspnea, signs of right ventricular insufficiency...), echocardiographic and imaging (pulmonary angiography, V/Q lung scan) relevant data after the diagnosis of index PE are retrieved from the clinical chart of each patients alive at the time of the selection for the PREVA-CTEPH study and/or with a diagnosis of CTEPH confirmed after the diagnosis of index PE and/or if the patient don't consent to participate to the prospective interventional phase.

For patients died between the inclusion in one of the studies of the INNOVTE network and the time of the selection for the PREVA-CTEPH study, the date and the cause of death are recorded. The same data of the retrospective phase are retrieved.

All cases of CTEPH are adjudicated by an independent committee. In this case, initial Imaging data (CT pulmonary angiography and echocardiography) performed at the time of index PE diagnosis are retrieved for searching previous sign of CTEPH.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Pulmonary embolism objectively confirmed
* Treated during at least 3 months with curative anticoagulant
* Previously included since at least 1 year in one of the studies of the INNOVTE network
* affiliated to the national social security
* after written informed consent

Exclusion Criteria:

* Patients with an objectively confirmed CTEPH before the diagnosis of index PE
* Follow-up impossible
The Effect of Gallstone Characteristics for the Severity of Gallstone Pancreatitis

The purpose of this study was to determine the effect of gallstone characteristics for the severity of acute gallstone pancreatitis (GSP)

The timing of cholecystectomy is closely related to the severity of acute gallstone pancreatitis (GSP). The effect of gallstone characteristics (including stone size, number, etc.) for the severity of GSP are currently unknown.

Eligibility Criteria:
Inclusion Criteria:

* Acute gallstone pancreatitis (GSP) patients.

Exclusion Criteria:

* Pancreatitis with bile duct stones, trauma, drugs, and surgery;
* Recurrent gallstone pancreatitis;
* Combined with other malignant tumors, such as liver cancer, cholangiocarcinoma, pancreatic cancer, gastric cancer, Hematologic tumor, and lymphoma;
* Previous hepatobiliary and pancreatic surgery, Organ transplantation;
* Intestinal obstruction or other obstructive diseases;
* Chronic pancreatitis or pancreatic duct stones;
* Thrombotic disease;
* Alcoholic pancreatitis and hyperlipidemia pancreatitis.
A Study to Assess Efficacy, Safety and Tolerability of the Anti-IL-13 Monoclonal Antibody QAX576 in the Treatment of Perinanal Fistulas in Patients Suffering From Crohn's Disease

Test safety and efficacy and of a novel IL-13 AB in the treatment of perianal fistulas

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria: - diagnosis of Crohn's disease \> 6 month with fistula - at least 1 ineffective fistula treatment in the past

Exclusion criteria: - TNF a antibody treatment failed in the past

- planned surgery
Infrared Transillumination of the Front of the Neck

Infrared light is applied to the front of the neck of patients for awake flexible optical intubation. The infrared light can be detected by the camera at the tip of the flexible video-bronchoscope. The flexible scope is introduced into the trachea with or without the aid of the blinking infra red light and the ease of placement of the flexible scope is studied.

The investigators study patients for anaesthesia who will need endotracheal intubation and in whom the intubation is predicted to become difficult so that an awake flexible-video-scope-guided intubation is chosen.

Infrared light is applied to the front of the neck of patients for awake flexible optical intubation. The infrared light can be detected by the camera at the tip of the flexible video-bronchoscope. The flexible scope is introduced into the trachea with or without the aid of the blinking infra red light and the ease of placement of the flexible scope is studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for awake tracheal intubation over the insertion cord of a flexible video-trachea-bronchoscope.

Exclusion Criteria:

* Age \< 18 years
* Patients at high risk of aspiration of gastric content
* Patients with hypoxia, saturation \< 90 % on ambient air
* Patients with audible stridor at rest
* American Society of Anesthesiology (ASA) physical class \> 3
* contraindication for trans-crico-thyoid-membrane puncture (cancer, infection on the site, severely coagulopathies, inability to identify the crico-thyroid membrane)
Tranexamic Acid vs. Quixil - Reducing Blood Loss in Joint Replacement

We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during hip and knee joint replacements.

This is a prospective randomised controlled trial to compare the benefits of Quixil vs. Tranexamic acid in reducing blood loss.

Both medicines are used for the reduction of blood loss in major joint surgery; previous studies have shown each one to be effective and safe, but they have not been directly compared in this setting.

We will compare the blood loss in each of 3 groups: tranexamic acid used, Quixil used, and control group (neither drug used). Blood loss is to be calculated from height, body weight and difference between pre and post-operation haematocrit.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are to undergo elective hip or knee joint replacement
* Must be cemented arthroplasty
* Must be primary arthroplasty

Exclusion Criteria:

* Uncemented arthroplasty.
* Revision arthroplasty.
* Patients on anticoagulant (warfarin, low molecular weight heparin) or other medication known to affect clotting (except aspirin, which is to be given as part of standard DVT prophylaxis in all cases).
* Other drugs that may affect the activity of the drugs under investigation.
* Allergy to asprin (all patients to receive 150mg aspirin as standard DVT prophylaxis for 6 weeks).
* Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
* Previous reaction or ethical/religious objection to receiving blood products (Quixil contains a derivative of human blood).
* Pregnancy or breastfeeding.
* Patients who have a past medical history of thrombo-embolism at any time.
* Patients who need intravenous fluid administration for greater than 24 hours following operation.
* Patients who need allogenic blood transfusion within study period.
* Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.
177Lu-LNC1011 in Patients with Metastatic Castration-resistant Prostate Cancer

This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts underwent sequential 50% dose escalations until the observation of dose-limiting toxicity (DLT).

\[177Lu\]Lu-LNC1011 is a novel long-circulating PSMA therapeutic probe. This study represents the first human investigation, aiming to explore its maximum tolerated dose (MTD), safety, dosimetry, and initial treatment efficacy in patients with metastatic castration-resistant prostate cancer (mCRPC).This study employed an open-label, non-randomized design, representing the first human trial of its kind. It utilized a standard 3+3 dose-escalation approach, focusing on patients with metastatic castration-resistant prostate cancer, initiating treatment at a dose of 1.85 GBq over a 6-week period. Subsequent cohorts received a dose escalation of 0.925 GBq from the previous cohort.

Eligibility Criteria:
Inclusion Criteria:

* progressive metastatic castration-resistant prostate cancer
* tumors with high PSMA expression confirmed on 68Ga-PSMA PET/CT PSMA expression confirmed on 68Ga-PSMA PET/CT

Exclusion Criteria:

* a serum creatinine level of more than 150 μmol per liter
* a hemoglobin level of less than 10.0 g/dl
* a white-cell count of less than 4.0× 109/L
* a platelet count of less than 100 × 109/L
* a total bilirubin level of more than 3 times the upper limit of the normal range
* a serum albumin level of more than 3.0 g per deciliter
* cardiac insufficiency
A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)

The primary objective of this study is to obtain safety information on the use of sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.


Eligibility Criteria:
Inclusion Criteria:

- Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes

mellitus

- Treating physician must agree to provide information regarding the participants treatment
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)

The purpose of this study is to assess the effect of reducing exposure to allergens in patients with hay fever by means of a nasal filter.


Eligibility Criteria:
Inclusion Criteria:

* History of seasonal allergic rhinitis (SAR) for a minimum of 2 years before study entry. Documented by a positive skin test within 12 months of study enrollment.
* Written informed consent
* Reliable anticonception for fertile women
* Must be able to complete the study
* Forced Expiratory Volume at one second (FEV1) higher than 70 % of predicted value
* Positive grass immunoglobulin-E (IgE) blood sample equal to or higher than 3,50 kU/L

Exclusion Criteria:

* Positive pregnancy test for fertile women
* Asthma unless mild and only occurring in relation to the grass pollen season as assessed by the investigator
* Inadequate washout periods in regards to Environmental Exposure Unit (EEU) appointments (intranasal or systemic corticosteroids (1month), intranasal cromolyn (2 weeks), intranasal or systemic decongestants (3 days), intranasal or systemic antihistamines (3 days), loratadine (10 days))
* Rhinitis medicamentosa
* Use of long acting anti-histamines
* Documented evidence of acute or chronic sinusitis as determined by individual investigator
* FEV1 lower than 70 % of predicted value
* Subjects with perennial allergic rhinitis (PAR) to e.g. house dust mites, cats, dogs moulds unless symptom free
* Allergic rhinitis requiring medication caused by allergens other than grass unless symptom free
* Subjects with nasal conditions likely to affect the outcome of the study in the opinion of the investigator, i.e. anterior nasal septum deviation, nasal septum perforations, nasal polyps, chronic nasal obstruction or other nasal diseases
* Receipt of immunotherapy with grass pollen within the previous 10 years
* Women who are breastfeeding
Influence of Pregnenolone on Exposure Therapy in Obsessive-compulsive Disorder

Characterization of the influence of pregnenolone vs. placebo on subjective distress and autonomic functioning during cognitive-behavioral exposure therapy in patients with obsessive-compulsive disorder.

Main out-come parameters:

Inter-session habituation as per SUD (100 mm VAS), Y-BOCS

Secondary out-come parameter:

HF/LF of HRV, Salivary epinephrine

Eligibility Criteria:
Inclusion Criteria:

-OCD according to DSM-IV criteria.

Exclusion Criteria:

* Acute suicidality
* psychotic disorders,
* bipolar disorder
* substance dependency
* organic brain disorder
* pregnancy
* lactation
* tuberculosis
* gastric/duodenal ulcer
* diabetes mellitus
* acute inflammation
* autoimmune disorders
* arterial hypertension
* therapy with glucocorticoids (up to 4 weeks ago)
Platelet-Rich Fibrin in the Healing of Regional and Free Flaps

Determine if the use of platelet-rich fibrin (PRF) versus historical treatment methods improves the post-operative management of healing complications from flap donor sites.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had surgery involving a microvascular free flap or a myocutaneous regional flap for head and neck reconstruction who develop one of the following donor site complications: wound dehiscence, wound margin breakdown or contraction resulting in healing by secondary intention, myocutaneous fistula formation, or incomplete coverage of the donor site by a skin graft placed in the operating room.

Exclusion Criteria:

* Patients under 18 years of age
* Patient's unable to participate in blood draw either due to medical compromise, inability to tolerate the procedure, or inability of the physician to successfully draw the blood at the time of appointment.
Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.

This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.

An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.

Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study.

Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task.

Four important features of the COGNISION(TM) will be investigated:

1. Patient tolerance
2. Ease of use
3. Data quality
4. Network architecture

Eligibility Criteria:
Inclusion Criteria for AD:

* Age 60 to 85
* Mild to moderate diagnosis of Alzhiemer's disease

Inclusion Criteria for Control:

* Age 60 to 85
* Cognitively healthy with no complaints

Exclusion Criteria:

* Subjects with advanced AD and severe impairment (CDR \> 2, MMSE less than 15)
* Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia)
* Subjects with life threatening illnesses and subjects with significant hearing or visual impairments
* Subjects with a current prescription for psychoactive pharmaceuticals
Efficacy and Safety of Diclofenac DDEA 2.32 % in Patient Suffering From Knee Osteoarthritis (OA)

This study will evaluate the efficacy and safety of diclofenac DDEA 2.32 % in patient suffering from knee osteoarthritis (OA).


Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female ≥ 50 years old; 2. Symptomatic OA of one or both knees, according to ACR criteria, diagnosed at least 6 months previously; 3. Pain in either knee originates in the knee (not referred pain from other sites, such as hip or back) and no other cause of pain than knee OA; 4. Have used oral NSAIDs or COXIBs for the knee OA pain (including aspirin if ≥ 500 mg and used in this indication), at least one dose per day, for not less than 10 days out of the 14 days preceding the screening visit and also within the 24 hours preceding the screening visit; 5. Be able to tolerate rescue medication with only 500 mg paracetamol (APAP) taken in doses of 1-2 tablets up to a maximum of 6 tablets (3 grams) per day for the duration of the study

Exclusion Criteria:

- 1. Partial or total replacement of either knee joint, past or planned/expected during study duration.

2. OA of the knee due to other underlying conditions, such as gout, chondrocalcinosis, hemochromatosis, joint infections, neuropathia, or severe traumatic joint damage (however, common risk factors, such as obesity and past meniscectomy or ligament rupture and repair, are allowed); 3. History of systemic inflammatory (autoimmune) disease (rheumatoid arthritis, systemic psoriasis, systemic lupus erythematosus, systemic sclerosis, etc.) or laboratory values indicative of such disease with subsequent diagnosis by a physician; 4. Fibromyalgia within the previous year; 5. Allergy or asthma to diclofenac, APAP, aspirin, other NSAIDs or any of the ingredients in the gel (i.e. isopropyl alcohol, propylene glycol, or butylhydroxytoluene), or any other contraindication for the study drug or the rescue medication