cyrilzakka/clinical-trials huggingface dataset:
Prevention of Postoperative Pancreatic Fistula by Somatostatin

The purpose of this study is to determine whether somatostatin is more effective that octreotide in the prevention of post-pancreatectomy pancreatic fistula

Prevention of pancreatic fistula remains a major challenge for surgeons, and various technical and pharmacological intervention have been investigated, with conflicting results.

Despite several prospective studies, and metaanalyses, the prophylactic role on pancreatic fistula of octreotide, remains controversial, even if recommended for routine use in patients undergoing pancreatic resection.

In view of recent result, the investigators can hypothesize that higher affinity for somatostatin-receptor lead to stronger pancreatic exocrine secretion inhibition, and better pancreatic fistula prevention.

Consequently, continuous intravenous infusion of somatostatin-14, the natural peptide hormone, associated with 10 to 50 time stronger affinity with all somatostatin receptor, will be associated with a improved pancreatic fistula prevention compared to octreotide.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18 years or greater
* Signed informed consent
* Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy

Exclusion Criteria:

* Patient with radiation therapy
* Patient with neoadjuvant chemotherapy within 4 weeks before surgery
* Pregnancy
* Breastfeeding
* Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the Investigator
* Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to inclusion
* Known hypersensitivity to somatostatin or somatostatin analogues or any component of the somatostatin or octreotide long-acting release (LAR) or s.c. formulations
* Patient previously treated with somatostatin or somatostatin analogues or any component of the somatostatin or octreotide LAR or s.c. formulations
* Patients treated by ciclosporin
* Patient without health insurance or social security
* Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
Plantar Compartment Block in Hallux Valgus Ambulatory Surgery

Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.

Popliteal sciatic nerve block is widely used despite the risk of falling due to prolonged motor blockade.

Plantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.

The purpose of this study is to describe the analgesic effect of the plantar compartment block following hallux valgus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years old
* patient covered by social health insurance
* have signed written informed consent
* scheduled for hallux valgus ambulatory surgery

Exclusion Criteria:

* protected patients or patients incapable of giving written informed consent
* pregnant or breastfeeding woman
* vulnerable adult
* inability to participate in pain scoring scales
* severe coagulopathy
* allergy or contraindications to study drugs
* preopérative gait disorders
* chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by the Cockroft and Gault formula)
* severe chronic liver disease
* chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)
* peripheral neuropathy
* intervention under general anesthesia
The Effects of Jeju Steaming Onion(Oniro) on Reducing Body Fat of Overweight or Obesity Subjects

It is well known that steam onion have benefit effects on controlling the blood sugar, triacylglycerol (TG) and total cholesterol (TC). In this study, the jeju steam onion examined whether it has beneficial effects on reducing body fat of overweight or obesity subjects.

A randomized, double-blind, placebo-controlled clinical trial was conducted to verify the effects of jeju steam onion. Fifty-six healthy male and female subjects aged 20-65 years with normal body weight \[25.0 kg/㎡ ≤ body mass index (BMI) \< 30.0 kg/㎡\] were recruited. The basic framework of the present study was based on a previous study. A 12-week (at each visit; screening, 6-week, 12-week), placebo-controlled, randomized study was conducted with overweight subjects (25.0 kg/㎡ ≤ BMI \< 30 kg/㎡). Subjects participants were divided into two group: either Jeju steaming onion or matching placebo (the baked barley powder). Randomization was achieved by computer generated block randomization (placebo : test = 1 : 1).

Eligibility Criteria:
Inclusion Criteria:

overweight(WHO) subjects \[25.0 kg/㎡ ≤ body mass index (BMI) \< 30 kg/㎡\]

Exclusion Criteria:

* uncontrolled blood pressure (blood pressure level more than 140/100mmHg)
* fasting blood sugar level more than 126 mg/dl or taking medications (including blood sugar and anti-diabetic drugs)
* history of serious cardiovascular, pulmonary, gastrointestinal, hepatic, renal and/or haematological disease
* taking a weight change medications within 1 month before study
* participation other obese studies within 2 months before study
* having a known allergy to any ingredient in the investigational product
* participation other intervention studies within 1 months before study
* women who are pregnant or desire to become pregnant during the study period
* having any other medical condition which, in the opinion of the investigator, could interfere with participation in the study
CODP Imaging From a Dose Perspective

The noncontrast-enhanced chest computed tomography (CT) is an emerging diagnostical tool in patient with chronic obstructive pulmonary disease (COPD). As shown in previous studies and pointed out by the Fleischner society, an additional scan in expiration reflects the pathophysiology of this complex disease better and extends the clinical information of the CT.

Nevertheless, this scan is leading to an increase in radiation dose. But currently it is unclear if this increased radiation dose is proportional to the additional clinical value when compared to inspiration-only protocols. Therefore, the aim of this study was to compare the organ specific radiation doses of a combined inspiration-expiration CT on a 3rd generation dual-source scanner with noncontrast-enhanced chest CTs of two clinical routine scanners. Therefore, the radiation doses of nearly 2000 chest CTs have been evaluated.


Eligibility Criteria:
Inclusion Criteria:

* noncontrast-enhanced chest CT performed on one of the named devices
* imaging performed between August 2014 and September 2017
* CT protocol used as previously specified

Exclusion Criteria:

-
Digoxin Drug-Drug Interaction With Lurasidone HCl

The objective of this study is to evaluate the pharmacokinetic profile of digoxin when administered alone and when administered with repeated dose of lurasidone 120mg.


Eligibility Criteria:
Inclusion Criteria:

* Male and female 18 to 65 years of age
* BMI \>= 19.5 and \<= 37 kg/m2
* No clinically relevant abnormal laboratory values

Exclusion Criteria:

* History or presence of renal or hepatic insufficiency
* Participated in a clinical trial in the past 30 days
* Use of con meds that prolong the QT/QTc taken within 28 days prior to study drug administration
Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.

The study is conducted to investigate the pharmacokinetics of Doripenem during CVVHDF (Continuous venovenous hemodiafiltration), MARS (Molecular Adsorbent Recirculating System) and intermittent hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Suspected or proven bacterial infection requiring parenteral antibiotic therapy.
* Organ replacement therapy (MARS, CVVHDF or HD)

Exclusion Criteria:

* Known hypersensitivity to doripenem or other carbapenems, or severe hypersensitivity (anaphylactic reaction) to beta-lactam antibacterial agents.
* An expected survival of less than two days.
* Known pregnancy
* Coadministration of valproic acid or probenecid, which cannot be discontinued for the duration of the study
* Doripenem as monotherapy for resistent species or fungal infections.
* Other reasons opposing the study participation on the discretion of the investigators.
Induction of Women With Fear of Labor

The purpose of this study is to evaluate the experience of labor in parous women induced because of fear of labor and, to compare the experience of parous women induced without fear of labor. A comparison with the experience of women delivered with elective cesarean section because of fear of labor is done.

In the induced labors, the induction method is amniotomy. Between groups the experience of delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).

Groups are also compared with regard to time from induction to delivery and rate of operative delivery.

Hypotheses:

* there is no difference in experience of delivery
* there is no difference in time to delivery or rate of operative deliveries


Eligibility Criteria:
Inclusion Criteria:

* parous
* induction or cesarean section
* amniotomy

Exclusion Criteria:

* non proficiency in the Swedish language
ADSTILADRIN Early Utilization and Outcomes in the Real World Setting

Multi-center, prospective non-interventional study to collect data on the early use of Adstiladrin in the US and Israel. Data will be collected from patients and prescribing physicians in a real-world setting


Eligibility Criteria:
Inclusion Criteria:

* Prescribed and scheduled treatment with ADSTILADRIN per physician discretion or received the first instillation of ADSTILADRIN per physician discretion after 5 September 2023 but prior to site activation
* Signed and dated ICF.
* Age 18 years or older at day ICF is signed.

Exclusion Criteria:

* Currently enrolled in a clinical trial.
* Participants who have previously been treated with ADSTILADRIN in the context of a clinical trial
* Participant is pregnant or breastfeeding.
Reducing Health Problems Associated With Injection Drug Use

The purpose of this study is to develop and test an intervention to reduce bacterial and viral infections among injection drug users.

Injection drug use (IDU) is a major public health problem that is associated with a host of medical complications, including blood-borne viral disease (e.g., HIV, Hepatitis C) and bacterial infections (e.g., skin abscesses, endocarditis), that often result from high-risk drug injection practices. There are no current interventions designed to reduce bacterial infections among IDUs, despite high rates of infection.

The objective of this study is to develop and test the efficacy of a skin and needle hygiene intervention for IDUs to reduce practices associated with bacterial and viral infections. In the first phase of the study, focus group interviews were conducted to determine key areas of emphasis for an intervention with this population. An initial intervention was developed, pilot tested, and refined. The final 2-session intervention combines psychoeducation, skill-building, and motivational interviewing.

Following refinement of the intervention, a small randomized controlled trial (n = 60; 30 in each group) to examine the efficacy of the intervention compared to an assessment-only condition will be conducted. The goals of this two-year study are to: 1) reduce high-risk injection practices among active IDUs that lead to bacterial and viral infections, 2) improve skin and needle cleaning behavioral skills, and 3) increase skin cleaning prior to injection and reduce subcutaneous/intramuscular injection.

In addition to examining these goals over a six-month period, the acceptability and feasibility of the intervention will be examined.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* injection of heroin on at least three different days in the last week
* injection of heroin for at least three months
* visible track marks/puncture wounds from needles
* positive urine screen for heroin

Exclusion Criteria:

* currently exhibiting active psychotic symptoms
* cannot complete study assessments or the intervention
* cannot provide informed consent
* unable to provide names and contact information for at least two verifiable locator persons who will know where to find client
* plans to relocate from area or be jail over next six months
* have been in a Project Safe study in the last year
* report being pregnant or attempting to become pregnant
Outcomes of Different Treatment Options in Chronic Venous Disease

This study aims to describe conservative and invasive treatments for patients with chronic venous disease (CVD) in Belgium, and their association with clinical and patient-reported outcomes during a follow-up of 24 months.

This study is an observational, prospective, multicentre study to assess the effectiveness of conservative and invasive treatments in patients with CVD in Belgium. The inclusion period of the study will last 6 months. Patients will be followed until 2 years after inclusion into the study.

During the inclusion period, after confirmation of eligibility, patients with CVD diagnosed by the General Practitioner (GP) and requiring a treatment will be invited to participate in the study. About 140 GPs across Belgium will be included in the study. During the first visit, a treatment strategy will be proposed to the patient by the GP. The treatment can be conservative or invasive, depending on the severity of the disease. Patients awaiting invasive treatment may receive conservative treatment to alleviate symptoms. The choice of treatment modality is left to the discretion of the treating physician, in agreement with the patient and according to local policies. As this is an observational study, there will be no interference in the choice of treatment, and no restrictions will be imposed.

Eligibility Criteria:
Inclusion Criteria:

\* Patient visiting a GP with complaints related to CVD,

* Patient receiving the diagnosis of CVD from the GP during the V0, according to international guidelines and made on a clinical basis,
* Patient requiring and agreeing to receive conservative or invasive treatment,
* French or Dutch speaking patient,
* Patient signed informed consent and agrees to take part in the study and follow-up.

Exclusion Criteria:

* Patient with coagulation disorders such as thrombophilia and/or taking anticoagulation drugs,
* Pregnant or breastfeeding patient,
* Patient with severe Peripheral Arterial Occlusive Disease (POAD), with Ankle Brachial Index (ABI) \< 0.8,
* Patient with malignancy,
* Patient with neurological disorder or dementia,
* Patients taking regular treatment for CVD 3 months prior to inclusion (except painkillers or anti-inflammatory drugs if taken for reasons other than CVD),
* Patient in any other clinical study for any pharmaceutical product within 4 weeks preceding study inclusion,
* Patient with any comorbidity or situation preventing a follow-up of 2 years.
Correlation Between Trachebroncho Malacia/Hyperdynamic Airway Collapse And Obstructive Sleep Apnea

The investigators hypothesize that there is a strong correlation between OSA and TBM/HDAC. Our hypothesis is based on the similarities in mechanism (airway collapse), symptoms (daytime and nocturnal dyspnea) predisposing conditions (obesity and neuromuscular abnormalities of the chest wall and the diaphragm), and effect of interventions (CPAP and BIPAP) in these diseases.

Tracheobronchomalacia (TBM) and HyperDynamic Airway Collapse (HDAC) are two distinct airway diseases that lead to airway collapse which can in turn lead to the symptoms of dyspnea, cough, and inability to expectorate sputum effectively. TBM entails flaccid tracheal and bronchial cartilages leading to airway collapse, emanating primarily from the anterior wall of the lumen. It is seen in conditions such as Relapsing Polychondritis and saber sheath tracheal deformity. HDAC on the other hand is the hyper-flaccidity of the membranous portion of the tracheobronchial tree leading to airway collapse. This condition is commonly seen with obesity and severe emphysema. TBM and HDAC frequently coexist.

In patients with TBM/HDAC sleep disorders are common. Patients often complain of poor quality sleep, snoring, daytime fatigue, and somnolence. These patients are often diagnosed with Obstructive Sleep Apnea (OSA) upon workup.

Eligibility Criteria:
Inclusion Criteria:

* Females and males ages 18-80 years old
* Able and willing to provide written informed consent
* Existing diagnosis of TBM or HDAC or both
* No pre-existing diagnosis of OSA
* No history of reconstructive surgery of chest wall or diaphragm

Exclusion Criteria:

* Inability to provide informed consent
* Non-English speaking
* Poorly controlled congestive heart failure
* Untreated Insomnia
* Severe Coronary artery disease with active symptoms of angina
* Patient is pregnant, or plans to become pregnant in next 3 months
* Moderate to severe bronchiectasis
* Severe untreated gastroesophageal disease (GERD).
* Moderate to large hiatal hernia deemed to be atleast in part responsible for TBM/HDAC
* Airway obstruction not caused by TBM /HDAC or secondary TBM/HDAC caused by conditions such as Chronic Obstructive Pulmonary Disease (COPD).
* Active or recent (with in last one year) cancer or cancer therapy (chemotherapy, radiation therapy or surgery)
* Inability to properly perform the home sleep test
* Unreliable test data after 2 attempts
* BMI\>45
Combined Chelation Treatment With Deferiprone and Deferoxamine in Thalassemia Major

Thalassemia major is a genetic disorder affecting hemoglobin synthesis, rendering individuals dependent upon lifelong blood transfusions. Consequently, iron overload occurs and patients have shortened life expectancy with the most common cause of death being heart failure. This trial tests whether the combination of traditional therapy (deferoxamine) with a newer drug (deferiprone) will prove more effective in removing cardiac iron than deferoxamine alone.

Thalassemia Major (TM) is a hereditary anemia resulting from a single gene defect that results in abnormal red cell production. The survival of affected individuals is dependent upon lifelong blood transfusions. Unfortunately, this causes total body iron overload, and 50% of the patients in the UK are dead by the age of 35. Approximately 70% of these deaths result from heart failure which results as a consequence of cardiac iron toxicity.

A Cardiovascular Magnetic Resonance (CMR) technique (which exploits the fact that T2\* signal decay relates to tissue iron) developed at the Royal Brompton Hospital provides a non-invasive and reproducible assessment of cardiac iron. CMR therefore provides a very useful method to assess response to new treatments in this condition. Using cardiac T2\* as a primary endpoint, we will investigate whether the oral chelator, deferiprone in combination with traditional treatment (deferoxamine), is superior in removing cardiac iron as compared to deferoxamine alone. This trial will provide the first randomized controlled, double-blinded, evidence for the efficacy of combination treatment in TM.

Eligibility Criteria:
Inclusion Criteria:

* Beta thalassemia major
* Maintaining pre-transfusion hemoglobin of 9 g/dL
* Myocardial T2\* between 8 and 20 ms
* Ability to give informed consent
* Male or female
* Age \>18 years
* Any ejection fraction
* Confirmation of effective contraception throughout the trial (both men and women)

Exclusion Criteria:

* Implant incompatible with MR (magnetic resonance), such as pacemaker, claustrophobia, or other condition making CMR impossible or inadvisable
* Neutropenia within 12 months (ANC \<1.5 x10\^9/L), unless normal at screening
* Thrombocytopenia within 12 months (\<50 x10\^9/L), unless normal at screening
* Liver enzymes \> 3 times upper limit of normal
* Patients who have previously received deferiprone for a total of more than 6 months over the last 5 years.
* Patients with a previous reaction to deferiprone
Physiological Responses to Laparoscopic Sleeve Gastrectomy: Focusing on Ghrelin

Our hypothesis is that decreased concentration of ghrelin after LSG is important for the decreased appetite and food intake postoperatively. We therefore expect infusion of ghrelin will increase an ad libitum food intake after LSG. We also expect that a decreased postprandial concentration of ghrelin after LSG play a role for increased insulin secretion and decreased postprandial plasma glucose concentrations after surgery.

Laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG) are to bariatric procedure. After both procedures, a changed secretion of hormones from the gastrointestinal tract is believed to affect appetite and glucose metabolism. Studies have shown that after LRYGB, there is a significant increased secretion of GLP-1 and PYY. In contrast, a decreased secretion of ghrelin is a characteristic finding after LSG opposite post-LRYGB, where secretion of ghrelin is reported to be increased, decreased or unchanged. Ghrelin is primarily secreted from the gastric mucosa in the fasting state and decreases in response to food intake. Ghrelin stimulates food intake through appetite-regulating centers in the hypothalamus. Administration of exogenous ghrelin has been reported to stimulate appetite. In addition, ghrelin has recently been suggested also to affect glucose metabolism by inhibition of glucose-stimulated insulin secretion. Therefore the markedly decreased secretion of ghrelin could be of particular important for the decreased appetite and improved glucose tolerance seen after LSG.

Eligibility Criteria:
Inclusion Criteria:

* The Danish national inclusion criteria for bariatric surgery
* Signed written informed consent
* Fasting plasma glucose \<6.1 mmol/l

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Hemoglobin \<6.5 mM
* Newly emerged serious disease
Parent-Child Early Approaches to Raising Language Skills (PEARLS) Intervention

The purpose of this research study is to develop and evaluate a parent training program, which aims to improve language. The study is being conducted to see if teaching parents positive parenting techniques and behavior strategies will improve the rate of language development in children with cochlear implants when compared to standard speech therapy (e.g., auditory-verbal therapy).


Eligibility Criteria:
Inclusion Criteria:

1. children who are severely to profoundly deaf and a cochlear implant candidate,
2. children who are 12 to 48 months,
3. English or Spanish as primary language spoken at home,
4. families educating their children in spoken language,
5. children who pass the cognitive screening, scoring 75 or above on the screening measure

Exclusion Criteria:

1. parents who do not consent to being videotaped,
2. children with moderate to severe developmental delays (as assessed using the Battelle Developmental Inventory (BDI-2) 2nd Edition for children ages 0 to 24 months or the Leiter International Performance Scale-Revised),
3. children with significant syndromes (e.g., CHARGE, autism, cerebral palsy) or severe brain abnormalities,
4. families who do not receive their auditory-verbal therapy from University of Miami (UM). Further, children who have already completed the BDI-2 within the past year as part of their Early Steps (Florida Early Intervention) program will not have it re-administered.