cyrilzakka/clinical-trials huggingface dataset:
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer

This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.


Eligibility Criteria:
Inclusion Criteria:

1. HER2 positive recurrent or metastasis breast cancer.
2. Patients with measurable disease are eligible.
3. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
4. Adequate organ function.
5. Signed, written inform consent obtained prior to any study procedure.

Exclusion Criteria:

1. History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
2. History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab used in the neo-adjuvant or adjuvant setting.
3. Assessed by the investigator to be unable receive systemic chemotherapy.
4. History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
5. Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Impact of Employee Wellness Programme

The introduction of a wellness programme for workers employed in a clothing factory will improve quality of life, pain, attendance at work and levels of physical activity.

Introduction: The prevalence of health risk behaviours is growing amongst South African employees. Health risk behaviours have been identified as a major contributor to reduced health related quality of life (HRQoL) and the increase prevalence of non-communicable diseases. Worksite wellness programmes promise to promote behaviour changes amongst employees and to improve their HRQoL.

Aims: The aim of this study was to evaluate the short-term efficacy of an employee wellness programme on HRQoL, health behaviour change, levels of self efficacy, pain intensity, body mass index (BMI) and absenteeism amongst clothing and textile manufacturing employees.

Methods: The study was a randomised control trial consisting of 80 participants from three clothing manufacturing companies in South Africa. The experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (CBT) as well as weekly supervised exercise classes over six weeks. The control group received a once-off health promotion talk and various educational pamphlets, with no further intervention. Measurements were recorded at baseline and at six weeks post-intervention. Outcome measures used included the EQ-5D, Brief Pain Inventory-SF, Stanford Exercise Behaviours Scale, Stanford Self-Efficacy Scale, Stanford Self-Rated Health Scale, BMI and absenteeism.

Data Analysis: All the data were analysed with the Statistica-8 software program. Although t-tests are the most commonly used statistical method for evaluating the differences in the means between two groups (e.g. control and experimental), it assumes that the variable is normally distributed. Thus, because the ordinal data were not normally distributed, non-parametric tests were used to evaluate the differences in the medians between the two groups and to determine the level of significance. The Sign test was used in place of the paired t-test to determine the within group changes. The Mann-Whitney U test was used in place of the independent t-test to determine the difference between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* All factory workers who volunteered to take part in the study

Exclusion Criteria:

* Subjects were excluded from the study if they reported uncontrolled diabetes and hypertension, coronary heart disease or any other illness that rendered participation in the exercise component unsafe.
Comparison of Two Chest Radiograph Prescription Strategies in Intensive Care Unit

Current guidelines recommend Routine daily chest radiographs (CXRs) for mechanically ventilated patients in intensive care units (ICUs). However, some ICUs have shifted to an On-demand strategy, in which this CXR is only prescribed if warranted by the patient's status at the morning physical examination. Here the investigators compared Routine and On-demand strategies in 21 French ICUs. The working hypothesis was that CXR prescriptions would fall by at least 20% with the On-demand strategy, with no reduction in quality of care.

Based on a cluster-randomized two-period two-strategies cross-over design, respectively 11 and 10 participating ICUs applied the Routine and On-demand strategies during the first period, each enrolling 20 consecutive patients requiring mechanical ventilation for at least two days. Each ICUs applied then applied the alternative strategy during the second period, again enrolling 20 consecutive patients.

Eligibility Criteria:
Inclusion Criteria:

* All newly admitted adult patients receiving mechanical ventilation at the time of the morning visit-any day during their ICU stay

Exclusion Criteria:

* Patients with mechanical ventilation lasting less than 2 days
Clot Formation and Clot Stability in Patients With Severe Haemophilia A

In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

In the present study we are examining the clot formation and clot stability in patients with severe haemophilia A after they receive recombinat factor VIII and after addition of tranexamic acid. Our hypothesis is that addition of tranexamic increases the clot stability. The perpective of the study is to document whether it is relevant to use traneksamic acid in surgery in patients with severe haemophilia A.

Eligibility Criteria:
Inclusion Criteria:

* Severe haemophilia A
* Above 17 years old
* Thrombocyt count above 100 x 109/l within the past two years

Exclusion Criteria:

* Received recombinant factor VIII with in the past 3 days
* Inhibitor against recombinant factor VIII
* HIV-positive
* Ongoing treatment for hepatitis C
* Known kidney disease
* Allergy against Tranexamic acid
* Not able to give informed consent
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants

The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants. Also, to assess the safety and tolerability of a single dose of E7090 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

1. Non-smoking, healthy males, age greater than or equal to (\>=) 35 years and less than or equal to (\<=) 55 years old at the time of informed consent
2. Body Mass Index (BMI) of \>=18 to \<=32 kilogram per square meter (kg/m\^2) at Screening
3. Provide written informed consent
4. Willing and able to comply with all aspects of the protocol
5. History of a minimum of 1 bowel movement per day

Exclusion Criteria:

1. Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)
2. Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090
3. Participant has had exposure to significant diagnostic or therapeutic radiation (example: serial x-ray, computed tomography scan, barium meal) or has current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
4. Participant has the following ocular disorders:

   1. Any previous history or current evidence of corneal disorder
   2. Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)
5. Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)
6. Participants has a known history of food allergies or significant seasonal or perennial allergy
7. Participants is known to be human immunodeficiency virus positive at Screening
8. Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening
9. Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)
10. Participant received blood products within 2 months prior to Day -1, or donation of blood within 3 months prior to Screening, donation of plasma within 2 weeks prior to Screening, or donation of platelets from 6 weeks prior to Screening
Incorporating Healthy Living Strategies to Aid in Recovery After Acute Pulmonary Embolism

The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.


Eligibility Criteria:
Inclusion Criteria:

1. English speaking (\>18 years old). Daily messages will be sent in English.
2. Acute PE with at least one of the following:

   1. any right ventricular enlargement or dysfunction on echocardiogram;
   2. CT Angiogram reporting any right ventricular enlargement; or
   3. elevated cardiac biomarker (NT-pro BNP or troponin above baseline). Criteria for enrollment will be included on source document.
3. Rate controlled atrial arrythmias (resting heart rate \<110 beats/m) are eligible for enrollment. This includes atrial fibrillations. This is standard of care management for atrial fibrillation.
4. Subjects do need to take prescribed anticoagulation.

Exclusion Criteria:

1. Pregnancy.
2. Cardiac Effort \>3.5 beats/m during 6MWT.
3. Resting tachycardia \>110 beats/m at hospital discharge.
4. Chronic Thromboembolic Pulmonary Hypertension
5. Systolic blood pressure \>180 mmHg at hospital discharge.
6. Inability to walk.
7. Estimated prognosis \<12 months at the time of discharge due to underlying co-morbidities (e.g., cancer).
8. Advanced neurologic disease and would not be able to comply with the messages.
9. Lack of access to email or text messaging 10. Inability or unwillingness to follow daily instructions.
Prone Positioning for Brain-injured Patients With Severe ARDS (ProBrain)

Prone position (PP) is a key component to treat hypoxemia in patients with severe acute respiratory distress syndrome (ARDS). However, most studies evaluating PP effects in patients with ARDS exclude those with brain-injuries without providing any medical evidence. This prospectice observational study aimed to investigate if prone positioning leads to significant modification of cerebral perfusion in brain-injured patients with ARDS.


Eligibility Criteria:
Inclusion Criteria:

* adult's patients suffering from brain injuries
* patients neurologically monitored with TCD
* patients requiring prone position for severe ARDS

Exclusion Criteria:

* pregnant women
* patients with contrindication to prone position
Comparison of Two Analgesic Pretreatment Techniques Before Spinal Needle Insertion for Pain Reduction and Maternal Satisfaction Level Assessment in Women Undergoing LSCS.

Nowadays lower segment cesarean sections are preferably carried out under regional anesthesia due to multiple advantages.

Local infiltration of lidocaine or any other anesthetic is used before lumber puncture in many centers to reduce needle stick pain.

EMLA (eutectic mixture of local anesthetic) cream is the combination of lidocaine and prilocaine which have been effectively used in few studies to reduce needle prick pain.

We would like to see which analgesic pretreatment is superior in terms of reducing pain of spinal needle insertion and have better maternal satisfaction levels.

OBJECTIVES: To compare the pain reduction and maternal satisfaction levels of two analgesic pretreatment modalities on pain reduction of spinal needle insertion i.e. 2% lidocaine infiltration and EMLA in patients undergoing elective LSCS.

Hypothesis: Analgesic pre-treatment with EMLA is superior to local skin infiltration with lidocaine

Eligibility Criteria:
Inclusion Criteria:

* All adult women undergoing elective LSCS under spinal anesthesia

Exclusion Criteria:

* BMI of more than 35 kg/m2
* Contraindication to spinal anesthesia
* Spinal deformity
* Refusal of regional anesthesia
* Patients with a history of back surgery
* confirmed allergy to local anesthetics
* More than three attempts of needle insertion for inducing spinal anesthesia
Dose-response of Anteroposterior Mobilizations in Weight Bearing Talus Dorsiflexion

Ankle mobility limitations are common in older adults. A possible treatment to restore joint mobility is manual therapy based on mobilization techniques, in this case, applied on the ankle joint. Previous research had proposed different treatment volumes (one to twelve sessions), but shown a different and non-consistent degree of effectiveness according to such factor. Therefore, this work aims to determine the dose-response relationship of manual therapy (talus mobilizations) on ankle range of motion in the older adult.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling older adults.
* Limited ankle mobility (\< 35 degrees).
* Over 60 years.

Exclusion Criteria:

* Not willing to participate or signing a consent form
* Lower limb injury in the three months prior to the study (ex. sprain)
* Diagnosed condition that may influence mobility assessments (i.e. stroke)
StereoEEG Motor Neuronal Potentials Decoding

The goals of this study are (1) to evaluate the rate of stereoEEG brain-computer interface (BCI) classification accuracy and (2) to collect the dataset of neuronal signals recorded from stereoEEG electrodes during motor performance, motor imagery or brain-computer interface control. The study enrolls hospitalised patients suffering from resistant epilepsy with already implanted intracranial stereoEEG electrodes for medical reasons (i.e. for preoperative localization of the epileptogenic foci). The number and location of electrodes are determined solely for the clinical purposes of stereoEEG monitoring and are not related to the protocol of the current study.

After obtaining informed consent to participate in the study, each patient will participate in one experimental session lasting no more than 60 minutes, recording brain signals associated with hand movement, motor imagery, and BCI control. All tasks and instructions presented during the study session are not pro-epileptogenic and cannot provoke an epileptic attack. The experiments will take place in the patient's room, without interruption of observation by the department's medical staff.

The data recorded in this study will be used to improve or develop new algorithms for decoding motor signals from deep brain structures for their potential use in invasive BCIs.


Eligibility Criteria:
Inclusion Criteria:

* male and female patients who have had stereoEEG electrodes implanted for medical reasons;
* voluntary informed consent to participate in the study;
* age from 18 to 70 years.

Exclusion Criteria:

* patient refusal to participate in the study;
* cognitive impairment that prevents following the study instructions;
* severe visual impairment that does not allow viewing visual instructions on a computer screen;
* upper limb paresis or other motor disorders;
* pain in the hand of any etiology;
* any acute diseases, exacerbation of chronic diseases, acute life-threatening conditions;
* occurrence of an epileptic attack during the experiment.
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects


Eligibility Criteria:
Inclusion Criteria:

* Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.
* Between 18 - 55 years old.
* Male of Caucasian ethnic origin.
* Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.

Exclusion Criteria:

* High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
* Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).
* Family history of long QT syndrome, hypokalaemia or Torsades de Pointes
* Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness
* Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer

Patients with cervix cancer usually require external radiation given to the whole pelvis then an internal radiation boost, also called brachytherapy, to treat any remaining tumour. Standard brachytherapy has been used successfully for many years, but does not take into account differences in the shape of the tumour or normal structures between patients. This study aims to implement individualized -optimized- brachytherapy, based on international recommendations. MR scanning with the intra-uterine applicator in place allows improved identification of residual tumour and normal structures, allowing brachytherapy to be individualized for each patient with the aim to reduce side-effects and improve outcome. Additionally, repeating MR scans during brachytherapy treatment will allow further assessment on motion of the applicator during treatment and the effect on radiation dose. Sexual health assessments aim to identify the relationship between sexual health and treatment effects.

Pre-treatment: Prior to examination under anaesthesia and placement of the intra-uterine applicator, in addition to standard assessment of treatment toxicity, the patient may complete an optional Sexual Health assessment taking approximately 15 minutes. Following standard insertion of the intra-uterine applicator under general anaesthetic and planning MRI scan, there is an optional additional MRI scan taking an extra 30 minutes This extra scan will not affect the commencement of treatment planning as images from the planning scan will be transferred to the treatment planning system as soon as they are obtained. From the MRi planning scan, target and specific normal structures are contoured. An individual BT plan will be derived based on a standard plan to deliver dose within specified dose volume constraints.

During treatment: During inpatient BT optional MRI scans, each taking 15 minutes will be obtained in the period between treatment pulses once during each 24 hours of admission. The information from the additional MRI scans will not be used to alter or influence treatment.

Follow-up: Standard follow-up procedures will be followed, with the optional addition of the Sexual Health evaluation at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* ECOG performance status 0-2
* Histological confirmed carcinoma cervix
* Decision to treat with EBRT (+/- concurrent chemotherapy), and PDR BT
* Ability to comply with study protocol
* Patient informed consent

Exclusion Criteria:

* Unable to or unwilling to give informed consent
* Not suitable for intra-uterine brachytherapy
* Previous treatment for pelvic malignancy
* Previous pelvic radiotherapy
* Serious claustrophobia
* Previous history of metallic injury to the eye
* Non-removable implants contraindicated for MRI
* Cardiac pacemaker
* Other contraindication to MRI -Pregnancy, lactation or child-bearing potential without adequate contraception -
Opium Tincture Against Chronic Diarrhea - Patients

The purpose of this study is to investigate the mechanistic anti-propulsive effects of opium tincture on the gastrointestinal tract of a cohort of patients with chronic diarrhea

Opium tincture is used a symptomatic drug against chronic diarrhea even though no clinical studies have investigated the effect on gastrointestinal function. With this randomized, double-blind, placebo-controlled cross-over trial in 16 patients with chronic diarrhea, we wish to provide evidence-based insights into the effects of opium tincture on gastrointestinal function. Additionally, effects on the central nervous system will be investigated a tertiary aim.

Eligibility Criteria:
Inclusion Criteria:

* • Signed informed consent before any study specific procedures

  * Able to read and understand Danish
  * Male or female with an age of 20 years or more
  * The researcher believes that the participant understands what the study entails, are capable of following instructions, can attend when needed, and are expected to complete the study.
  * The investigator will ensure that fertile female participants have a negative pregnancy test before each treatment visit and use contraception during the entity of the study.
  * Specific underlying pathophysiology has been identified, but targeted treatment (e.g. antibiotics or bile acid sequestrants) and treatment with loperamide has failed.

OR

* No specific underlying pathophysiology has been identified and treatment with loperamide has failed.
* At least 6 months post-surgery in the gastrointestinal tract
* No sign of cancer at standard clinical follow-up
* Chronic diarrhea defined as at least 3 daily bowel movements for the last week

Exclusion Criteria:

* • Known allergy towards pharmaceutical compounds similar to Dropizol.

  * Participation in other studies within 14 days of first visit (1 year if opioids involved).
  * Expected need of medical/surgical treatment during the study
  * History of psychiatric illness (e.g. mental retardation, schizophrenia, major depression)
  * History of substance abuse (e.g. alcohol, THC, benzodiazepine, central stimulants and/or opioids)
  * Family history of substance abuse
  * Known major stenosis of the intestines
  * Known severe decreased renal function (defined as eGFR below 30)
  * Known severe decreased hepatic function (defined as Child-Pugh class B or higher)
  * Treatment with MAO- inhibitors during the entity of the study
  * Severe COPD or acute severe asthma (defined as FEV1 below 50 % or acute ongoing exacerbation)
  * Known cor pulmonale
  * Female participants that are lactating
  * Medicine known to affect gastrointestinal motility must not be initiated during the entity of the study
  * Treatment with opium tincture during the last month