cyrilzakka/clinical-trials huggingface dataset:
Hyoscine Butylbromide for Prevention of Bradycardia During Cesarean Section

The aim of this study is to assess the efficacy of Iv hyoscine butylbromide in preventing Bradycardia during cesarean section under spinal anaesthesia with local anaesthetic and morphine.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status class I-II.
* Age: 18 Years to 40 Years.
* Women scheduled for elective Cesarean section under spinal anesthesia.
* indications for CS other than fetal or maternal pathology.

Exclusion Criteria:

* Height \< 150 or \> 180 cm
* Body mass index (BMI) \>35 kg/m2
* Contraindication for central neuraxial block
* Refusal to undergo regional anesthesia
* Known allergy to any of the study drugs,
* Infection at the site of injection,
* Coagulopathy,
* Indication to general anesthesia
* Baseline bradycardia (heart rate \< 60/min), or any cardiovascular disease
* Patients taking β-adrenergic blockers or any drugs that may alter normal response to study drugs.
* Arrhythmia such as atrial fibrillation, supraventricular tachycardia, heart block greater than first degree, left bundle branch block,
* Hypertension (systolic blood pressure more than 140 mm Hg or diastolic blood pressure more than 90 mm Hg), unstable angina or cardiomyopathy,
* Associated medical problem with pregnancy (as hypertension, diabetes mellitus, hepatic impairment or renal impairment)
Feasibility Trial i-Sleep & BioClock Intervention

Students often suffer from sleep problems and circadian rhythm disruptions which affect their mental health and daily functioning. The aim of this project is to develop, implement and evaluate an e-health intervention that targets the biological clock and improves the sleep patterns of university students in order to prevent the development or exacerbation of mental health problems. The investigators will assess the feasibility, usability and acceptability of the intervention in this pilot trial.

The primary objective of this study is to evaluate the e-health modules, in terms of overall acceptability, feasibility, and usability. The secondary objective is to evaluate preliminary effectiveness on the outcomes mentioned below.

Eligibility Criteria:
Inclusion Criteria:

* Being fluent in Dutch and/or English
* Being enrolled as a student (Bachelor, Master or PhD) in one of the seven participating universities (Leiden University, Vrije Universiteit Amsterdam, Utrecht University, Maastricht University, Erasmus University Rotterdam, University of Amsterdam, Inholland University of Applied Sciences)
* Being ≥ 16 years old
* Having self-reported sleep problems; Insomnia Severity Index ≥ 8 (at least subthreshold insomnia)

Exclusion Criteria:

* Current risk for suicidal behaviour
Utrecht COhort for Lung Cancer Outcome Reporting and Trial Inclusion (U-COLOR)

Objective: 1) To collect information on patient characteristics, short- and long-term clinical and patient-reported outcomes; and 2) to create an infrastructure for efficient, fast, and pragmatic randomized evaluation of new interventions.

Study design: Observational, prospective cohort study, according to the 'TwiCs' design.

Study population: All patients with lung cancer referred to the Department of Pulmonology or the Department of Radiotherapy of the UMC Utrecht.

Main study parameters/endpoints: Clinical parameters (performance status, co-morbidity, oncological history, symptoms, imaging, technical and treatment data), clinical endpoints (toxicity, reintervention and survival), and patient-reported outcomes.

The prospective U-COLOR cohort (Utrecht COhort for Lung cancer Outcome Reporting and trial inclusion), aims to:

* Gather data on natural disease progression, treatment response, disease recurrence, complications, quality of life and survival of patients with lung cancer;
* Collect a patient group willing to participate in studies;
* Facilitate multiple, parallel randomized controlled trials within the cohort.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Radiographic and/or histologic proof of lung cancer;
* Referred to Department of Pulmonology or the Department of Radiotherapy for treatment.

Exclusion Criteria:

* Mental disorder or cognitive dysfunction that hinders the patient's ability to understand the informed consent procedure and/or study details;
* Patients with severe psychiatric disorders;
* Inability to understand the Dutch language.
Impact of MK-0518 (Raltegravir) Intensification on HIV-1 Viral Latency in Patients With Previous Complete Viral Suppression

An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir.

While highly active antiretroviral therapy (HAART) reduces plasma HIV-1 levels to below the limits of detection with standard assays, replication-competent virus persist in a stable, latent reservoir in resting CD4+ T cells. So, there is a rapid resumption in plasma viremia when therapy is interrupted.

In addition to cellular reservoir, other pharmacologically privileged areas such as the central nervous system and the genital tract might act as additional sources of residual virus in patients with undetectable levels of plasma HIV-1 RNA. There is great current interest in strategies for depleting and eliminating this reservoir.

The antiviral potency of current regimens emerges as an important determinant of complete viral control. In certain patients, the latent reservoir decay can be hastened with treatment intensification.

An intensification with the HIV-1 integrase inhibitor Raltegravir (RAL) of a stable HAART regimen with persistent HIV-1 viral suppression could increase the slope of decay of the HIV-1 latent reservoir. This could provide further insight into this area, decrease the size of latent reservoir, and translate into clinical benefits for patients being simplified to maintenance monotherapy with RAL or in the HIV-1 rebound kinetics and slope after a programmed treatment interruption.

Eligibility Criteria:
Inclusion Criteria:

1. HIV-1 infected adults (+18 years old).
2. Complete virological suppression (\<50 copies/mL) for += 12 months, including at least 3 times during the last year.
3. Patients on HAART regimen including a PI or an NNRTI and at least two nucleotide inhibitors.
4. Voluntary written informed consent.

Exclusion Criteria:

1. Pregnancy, or fertile women willing to be pregnant.
2. Active substance abuse or major psychiatric disease.
3. Presence of drug-related mutations or any polymorphism or mutation associated to MK-0518 resistance prior to first HAART (only if genotype is available).
Intraoral Device vs Facial Mask for Class III Treatment

The aim of this randomized controlled trail is to compare the efficacy of an intraoral device (the Carriere® Motion 3D™ Class III Appliance) with the facial mask for the early treatemnt of Class III malocclusion. This is a monocentric, parallel, controlled trial with blinded examiner.


Eligibility Criteria:
Inclusion Criteria:

* age between 5 and 8 years
* prepubertal patients (cervical vertebral stage 1 or 2)
* Deciduous, early mixed, and intermediate mixed dentition (the lower deciduous canine should show at least 2/3 of the roots unresorbed)
* Presence of Class III skeletal imbalance (Wits appraisal equal to or smaller than
* 1 mm)

Exclusion Criteria:

* Early root resorption of the lower deciduous canines
* Periodontal disease
* Neurologic diseases
* Nickel allergy
* Patients with cleft lip and palate or craniofacial syndromes
* Patients irradiated in the head and neck area
* Patients who have undergone chemiotherapy or immunosuppresive therapy in the previous 5 years
* Patients unable to be followed for at least 1 year
A Trial Evaluating the Effects of Zoledronic Acid 5 mg Infusion on Bone Mineral Density (BMD) in Postmenopausal Osteoporosis (PMO) Patients Between the Ages of 50 and 65 Years

This study will evaluate the effects of zoledronic acid 5 mg infusion on BMD and biochemical markers of bone in post-menopausal osteoporotic patients aged between 50-65.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal osteoporosis
* Patients who has a low bone mineral density at hip or vertebral
* Patients who has an osteoporotic fracture at hip or vertebra

Exclusion Criteria:

* Hypersensitivity either to the active substance or to any of the excipients or to any biphosphonates.
* Known metabolic bone disease excluding osteoporosis.
* Serious systemic disorder treated with drugs interfering with bone metabolism.
* Significant liver or renal failure
* Pathologic fracture in the examined body area or elsewhere.
* Previous anti-osteoporotic treatment within 12 months or less prior to the recruitment.
* Patients with hypocalcaemia

Other protocol-defined inclusion/exclusion criteria may apply
Single Fraction Intraoperative Radiotherapy

This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Histological proven invasive breast carcinoma ductal, lobular and/or Ductal Carcinoma in situ
* Age \> 40 years
* Karnofsky performance status \> 70%
* Tumor. Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of equal to or less than 2.5 cm
* Nodal Status: preoperatively N0
* Clear surgical margins: R0
* All grades G1 - G3
* Any hormonal receptor and HER-2 status
* Informed consent

Exclusion Criteria:

* Gender: male
* Tumor size: more than 2.5 cm
* Nodal status greater than or equal to N1 pathologically
* Multicentricity
* Previous radiotherapy to the involved breast
* Karnofsky Index \< 70%
* Mixed connective tissue diseases e.g. rheumatoid poly arthritis, thromboangitis obliterans, systemic lupus
* Distant metastases
* Pregnancy in woman of child bearing age
* Unable to provide written consent
Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers

Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor \[PPI\]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy

Exclusion Criteria:

* Previous gastric surgery
* Active bleeding at end of endoscopy (despite hemostatic therapy)
* Recent PPI or H2RA use
The Prediction for Postoperative Pain

If the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

Post-operative pain not only alleviates patient discomfort, but also delays recovery and thus prolongs the hospital stay. There are many ways to control postoperative pain, but analgesic infusion through venous route, patient controlled analgesia (PCA), especially narcotic analgesics, is often used to control the infusion when needed. However, because PCA is based on only age, weight, and underlying diseases, there are limitations in effective analgesia, and excessive sedation due to excessive infusion. Therefore, if the individual patient's pain is assessed and the amount of analgesic needed after surgery is predicted, appropriate injection of pain control and excessive injection of narcotic analgesic can be prevented. The noxious stimuli during surgery may have a negative effect on the healing process and surgical outcome of the wound due to stress reaction and catabolism, secretion of pituitary hormone, activation of the sympathetic nervous system, and immunological changes. Therefore, proper analgesia is needed during general anesthesia. A non-invasive, non-invasive analgesic device is currently available for Surgical pleth index (SPI) to assess the status of intraoperative analgesia. SPI = 100- (0.3 \* heart beat interval + 0.7 \* photoplethysmographic pulse wave amplitude) is automatically and continuously calculated from the waveform of peripheral oxygen saturation.

In the postoperative pain prediction study with SPI, the SPI value at the end of the operation was found to be proportional to the pain in the recovery room. However, only the pain score immediately after the operation was confirmed in these studies. Therefore, investigators try to evaluate the degree of pain during surgery and the amount of analgesic use for management of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

undergoing liver resection (laparoscopic or laparotomy)

Exclusion Criteria:

patients who refused to participate patients who have cardiac arrythmia patients who have allergic history for remifentanil
Evaluation of Human Efficacy of SOD Like Super Drink

To assess the efficacy of SOD like Super Drink on anti-oxidant capacity, immuno regulation and skin for human


Eligibility Criteria:
Inclusion Criteria:

* healthy adults aged between 30-65 years old

Exclusion Criteria:

* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder
* Patients with diseases of the skin, liver, kidney.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure (\> 3 hr/week) in the past 4 weeks.
* Students who are currently taking courses taught by the principal investigator of this trial.
Safety Study of CD-NP in Heart Failure

An open-label study designed to determine the safety, tolerability and pharmacodynamics of CD-NP infusions in heart failure patients.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female ≥18 years of age diagnosed with NYHA class III or IV heart failure in the last six months
* Female patients must be post-menopausal or surgically sterile
* Diagnosed heart failure with left ventricular ejection fraction \<40% obtained within the prior 6 months with at least one symptoms or signs of volume overload

Key Exclusion Criteria:

* Women who are pregnant, breast-feeding or of child-bearing potential
* Clinically unstable patients
* Major surgical procedures within 30 days of entry
* Febrile temp \> 100 degrees F)
* Symptomatic carotid disease, critical carotid stenosis, or stroke within 3 months prior to study entry
* Currently on IV vasoactive support (e.g., heart transplant candidate)
* History of unexplained syncope within the past 3 months
* History of organ transplantation
* Comorbidities such as clinically significant cardiac valvular stenosis, aortic valvular disease, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, infiltrative disease, uncorrected congenital heart disease, acute coronary syndrome, restrictive heart failure, or any other condition which, in the opinion of the Investigator, would prevent a patient's participation in the study.
* Participation in a clinical trial of any investigational therapy or device within 30 days prior to randomization.
* Treatment with nesiritide within 14 days prior to dosing.
* Inability to effectively communicate with study personnel.
Profiling Implantable Cardiac Device Diagnostics Trends During Clinical Events .

The study looks to evaluate the device diagnostic data obtained from (all the Cardiac Rhythm and Heart Failure (CRHF) devices of medtronic having the Cardiac Compass® and OptiVol® diagnostic feature) these devices to identify trends during clinical events that will help early detection and prevention of cardiovascular and other comorbid conditions. (i.e. Heart failure(HF), Atrial Fibrilation,COPD, Renal dysfunction (RD), Diabetes etc.)

This is a multi-center, non-randomized, Non-interventional, data collection study with no subject follow-up visits required. Subjects will be enrolled and exited from the study during the same study visit.

The final analysis on the study will occur when 50 clinical events are reported on the study.All Medtronic implantable Cardiac Rhythm and Heart Failure devices with the Cardiac Compass® and OptiVol® feature which are commercially available at the start of the registry or become commercially available during the course of the registry and used within its intended use, may be included in the study.

After obtaining the informed consent patients will be interviewed to complete the "patient interview questionnaire". The study team will review medical records and complete the "Medical Record Review" form as completely as possible. The device will then be interrogated to download the cardiac Compass® report in a "save-to-disk" file and print the cardiac Compass® report for the PI or the designated clinician from the study team for review. The "device interrogation questionnaire" will then be discussed with the patient for specific events identified on the Cardiac Compass® report in order to determine possible explanations and fill out the questionnaire as completely as possible. After collection of all the study related data the patient will be exited on the same visit, so a followup visit is not required in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be greater than 18 years of age.
2. Subject must have an implanted Medtronic CRHF device (with the Optivol® and Cardiac Compass® diagnostics) for at least 1 year.
3. Subjects between 18 years and 62 years of age must have at least 1 clinical event ,such as any major medication change, IV drug therapy, hospitalization, outside home-treatment or any similar event in the past 1 year from the date of enrollment which required a Pharmacologic intervention, associated with any of the following comorbid conditions :

   * Heart failure
   * Chronic Obstructive Pulmonary Disease (COPD)
   * Renal deficiency
   * Atrial fibrillation
   * Diabetes
4. Subjects who are currently hospitalized with an Index clinical event can also be enrolled.
5. If the subject is over 62 years of age then subject can be enrolled in the study without any pre-condition of a clinical event associated with a comorbid condition.

Exclusion Criteria:

* Subject is unwilling or unable to give informed consent
The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation

The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.


Eligibility Criteria:
Inclusion Criteria:

* major depression (mild to moderate)
* fluent in German language

Exclusion Criteria:

* bipolar disorder, psychotic disorder, substance dependence
* cardiovascular disease, severe kidney or liver disease, epilepsy
* change of psychotropic medication intake within the last four weeks
* allergic to capsaicin
* allergic to sesame oil
* students in medicine, pharmacy, or psychology in their third year or older
* completed studies in medicine, pharmacy or psychology
Bariatric Surgery and Pharmacokinetics of Fluoxetine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on fluoxetine are investigated.


Eligibility Criteria:
Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract
Multimodal Ultrasound Diagnosis Characteristics of Bi-rads Class 4 Breast Lesions

Objective: To explore the potential association between the multimodal ultrasound characteristics and pathological classification of BI-RADS category 4 breast lesions, so as to clarify the diagnostic characteristics of multimodal ultrasound in different pathological types BI-RADS category 4 breast lesions.

Materials and methods: Patients who visited in The First Affiliated Hospital of Shandong First Medical University ＆ Shandong Provincial Qianfoshan Hospital were collected. Their general clinical features, information on preoperative ultrasound diagnosis, and postoperative pathologic data were reviewed.


Eligibility Criteria:
Inclusion Criteria:

* Perform ultrasound examination at our hospital before surgery or puncture biopsy; Complete histopathological data; Two ultrasound physicians with more than 5 years of experience in breast ultrasound diagnosis were diagnosed as BI-RADS Class 4 based on preoperative ultrasound images.

Exclusion Criteria:

* Poor image quality; Incomplete clinical data.
Self-management Pessary Project

The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse.

The primary question it aims to answer is:

• how many patients succeed learning self-management if offered a standardized training?

Secondary outcomes are:

* how many patients are willing to learn self-management?
* what patient factors contribute to successfully learning self-management and willingness to self-manage?
* how satisfied are patients with pessary therapy and self-management?
* the occurrence of side-effects
* continuation and quitting of pessary therapy and self-management
* cross-over to surgery
* number of visits to doctor because of pessary therapy
* healthcare costs

Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary).

Researchers will compare the self-managing patient to the non-self-managing patients.


Eligibility Criteria:
Inclusion Criteria:

* fitted a ring, sieve of knob pessary
* above 18 years old
* able to understand patient information

Exclusion Criteria:

* fitted a new pessary to replace an old one (continuing former pessary therapy)
* fitted a new pessary after they experienced adverse effects of a former pessary