cyrilzakka/clinical-trials huggingface dataset:
The Effects of Provent® on Obstructive Sleep Apnea During Continuous Positive Airway Pressure Therapy Withdrawal

Randomised, placebo-controlled trial of continuous positive airway pressure therapy (CPAP) versus Provent® and Placebo-Provent® to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk.

Randomised, placebo-controlled trial of Provent® versus Placebo-Provent® versus continuous positive airway pressure therapy (CPAP) to define the effects of Provent® on the severity of obstructive sleep apnea, daytime symptoms as well as on measures of cardiovascular risk in patients with obstructive sleep apnea.

Patients successfully treated with CPAP will be randomised to one of three arms for a duration of 2 weeks:

1. Withdraw CPAP and use Provent®
2. Withdraw CPAP and use Placebo-Provent®
3. Continue treatment with CPAP

Eligibility Criteria:
Inclusion criteria:

1. Objectively confirmed obstructive sleep apnoea (at the time of original diagnosis) with an oxygen desaturation index (ODI, \>4% dips) of between 10 and 50/h and an ESS of \>10 (these thresholds will exclude subjects with borderline and very severe forms of OSA in whom there may be a disproportionate treatment effect).
2. Currently \>10/h oxygen desaturations (\>4% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP.
3. Treated with NCPAP for more than 12 months, minimum compliance 4h per night.
4. Current ESS \< 10.
5. Written informed consent.

Exclusion criteria:

1. Previous ventilatory failure (awake resting arterial oxygen saturation \<93% or arterial PCO2 \> 6kPa).
2. Unstable, untreated coronary or peripheral artery disease, severe arterial hypertension (\>180/110mmHg).
3. Previously diagnosed with Cheyne-Stokes breathing.
4. Current professional driver.
5. Any sleep related accident.
6. Age \<20 or \>75 years at trial entry.
7. History of chronic nasal obstruction.
8. Mental or physical disability precluding informed consent or compliance with the protocol .
9. Non-feasible trial follow-up (for example, distance from follow-up centre, physical inability).
GSK2018682 FTIH in Healthy Volunteers

This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.

This protocol describes the first administration of GSK2018682 to humans. The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of GSK2018682. The study will also provide preliminary evidence of the potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte counts.

Eligibility Criteria:
Inclusion Criteria:

* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters significantly outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. Subjects with lymphocyte counts outside the normal range should always be excluded from enrollment
* BMI within the range 19 - 28 kg/m2 (inclusive).

Exclusion Criteria:

* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A positive pre-study drug/alcohol screen.
* A positive test for HIV antibody.
* History of regular alcohol consumption
* Subjects with a history of, or examination suspicious for, skin cancer(s) including melanoma, basal cell or squamous cell carcinoma.
* Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.
* Symptomatic reduction in blood pressure after orthostatic challenge.
* Subjects with resting heart rate less than 45 beats per minute or greater than 90 beats per minute

Other criteria may apply as defined by the clinical protocol.
Impact of IBSR on Postpartum Mothers' Mental Health.

The period of pregnancy, childbirth, and the postpartum phase significantly impacts the mental health of women and their families. Mental health is crucial for overall well-being, quality of life, and is associated with healthcare costs. Therefore, promoting mental health should be a top priority in public health and health promotion efforts.

The Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life.

Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers' mental health.

In recent years, there is growing evidence regarding the effectiveness of population-based mental health promotion interventions. Developing social and emotional skills such as improved self-esteem, sense of control and self-efficacy, self-acceptance, purpose in life, positive relationships with others, problem-solving, and coping skills has been shown to improve mental health and contribute to psychological well-being. According to the International Union for Health Promotion and Education (IUHPE, 2021), interventions to promote mental health can be classified into eight priority areas. The first priority is to promote the mental health of infants and mothers by focusing on social and emotional development and positive mental health in early childhood development services, including prenatal care, home visits, and parenting programs. The healthcare system today faces the challenge of gaining a better understanding of the mechanisms that allow women to develop and maintain positive mental health in the postpartum period and understanding how these mechanisms are sustained over time.

The Inquiry-Based Stress Reduction (IBSR) intervention, developed by Byron Katie ("The Work"), enables participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR involves a contemplative "inquiry" process and a "turnaround," which is a method of experiencing the opposite of what the participant believes. This process equips individuals with skills for self-inquiry and management of stressful thoughts that can be easily integrated into daily life. Based on previous research, we hypothesize that the IBSR intervention can improve postpartum mothers' mental health.

Eligibility Criteria:
Inclusion Criteria:

* Mothers up to two years after giving birth, between the ages of 18 and 45 (at the time of birth), without a history of mental disorders or illnesses

Exclusion Criteria:

* Mothers with a history of illness or mental disorders
* mothers who have passed more than two years since their last birth
Study of Troxatyl™ Administered by Continuous Infusion to Subjects With Solid Tumors

This is a phase I, single-arm, open-label, single-center study to establish the recommended infusion schedule for Troxatyl™ administered as a continuous infusion for 2-5 days to subjects with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced solid malignancy refractory to prior therapy and unlikely to benefit from known therapies (e.g., chemotherapy, radiation therapy, and surgery).
* Diagnosis confirmed histologically or cytologically.
* Subjects may have received prior cancer therapy (including surgery, radiotherapy, chemotherapy, and hormonal therapy), but must have completed all therapies at least 30 days prior to study drug administration (42 days for nitrosourea or mitomycin).
* Subjects must have recovered from the toxic effects associated with prior treatment.
* Subjects must have an Eastern Cooperative Oncology Group performance status of ≤ 2 and an estimated life expectancy of at least 12 weeks.
* Subjects must have adequate organ and immune function as indicated by standard laboratory tests.
* The subject must understand, be able, willing, and likely to fully comply with study procedures, including scheduled follow-up, and restrictions.
* The subject must give written, personally signed and dated, informed consent to participate in the study before implementing any study related procedures.

Exclusion Criteria:

* Previously documented brain metastases.
* Active and uncontrolled infection.
* Subjects with uncontrolled medical problems, unrelated to the malignancy, or of sufficient severity that in the opinion of the investigator, impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment.
* Neurological or psychiatric disorders that would interfere with consent or study follow-up.
* Prior treatment with more than 6 courses of alkylating agent-containing chemotherapy (except low-dose cisplatin) or more than 4 courses of carboplatin, radiation therapy to \> 25% of hematopoietic reserves or two or more courses of mitomycin C or nitrosourea.
* Known or suspected intolerance or hypersensitivity to the study materials \[or closely related compounds\] or any of their stated ingredients.
* History of alcohol or other substance abuse within the last year.
* Use of another investigational agent or participation in a clinical trial within 30 days prior to enrollment.
* Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening must be excluded.
* Subjects that have previously been enrolled into this study and subsequently withdrawn must also be excluded.
An Evaluation of Patient Reported Outcomes and Clinical Outcomes

This extension study is being conducted to assess the following objectives through 12 months post-cardiac surgery:

* Patient reported outcomes (PRO), using the EQ-5D questionnaire
* Clinical outcomes


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have completed the REN-007 study to be eligible to participate in the Extension Study.

Exclusion Criteria:

* Subjects who did not complete the REN-007 study are not eligible to participate in the Extension Study.
* Female subjects who become pregnant during the REN-007 study are not eligible to participate in the Extension Study.
Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's Disease

This randomized study was designed to evaluate the efficacy and safety of IPu-infused liatermin (15mg/putamen/day) compared with placebo in subjects with symptomatic, levodopa-response Parkinson's disease. This study consisted of a 90-day evaluation period followed by implantation of the IPu delivery system and then a 6-month double-blind treatment period.


Eligibility Criteria:
Inclusion Criteria: - Diagnosis of bilateral, idiopathic Parkinson's disease
Multicenter Performance Study of TriQuik Invitro Diagnostic Device

This prospective and historical clinical study is designed to test the performance of the Genlantis TriQuik test kit (Cassette). The primary goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to the same patient's medical history.

Previous tests were performed on serum and whole blood specimens. A total of 607 serum specimens1 were collected for evaluation and comparison of the performance of the TriQuik Hepatitis B Surface Antigen (HBsAg) Test with a licensed commercial HBsAg EIA. 84 of 85 positive serum samples testing by the licensed commercial HBsAg EIA were reactive with TriQuik HBsAg Test and 520 of 522 negative samples testing by the licensed commercial HBsAg EIA were tested negative with TriQuik HBsAg Test.

Study Objective To demonstrate clinical performance of the TriQuik Invitro Diagnostic device.

Measurement Methodology Whole blood samples are collected by fingerstick. Samples should be tested immediately.

Using the supplied sample dropper, transfer specimen blood drop into the sample well. Wait 20-30 seconds. Add two drops of the supplied assay buffer (\~90µL) to the same sample well Read result in 20 mins.

Primary end points will determine how accurate these tests are (p\<=0.02) by analyzing for:

Diagnostic Sensitivity; TP / (TP + FN) The ability of the test to correctly identify those patients with the disease Diagnostic Specificity; TN / (TN + FP) The ability of the test to correctly identify those patients who are truly free of the specific disease Positive Predictive Value: TP / (TP+ FP) The probability that subjects with a positive test truly have the disease. Negative Predictive Value: TN / (FN + TN) The probability that subjects with a negative test truly don't have the disease.

An estimated 200 patients are to be enrolled as follows:

150 with a documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable.

HbsAg patients need to have a HbsAg on file \< 2 years. HIV and HCV patients only need one antibody test in their medical chart.

50 with no documented medical history of HIV, HBV or HCV and are considered normal.

Male or female subjects, ages ≥18 years.

Eligibility Criteria:
Inclusion Criteria:

* a documented medical history of HIV, HBV or HCV. A combination of 2 or 3 conditions is acceptable.

  * HbsAg patients need to have a HbsAg on file \< 2 years.
  * HIV and HCV patients only need one antibody test in their medical chart.
* no documented medical history of HIV, HBV or HCV and are considered normal.
* Male or female subjects, ages ≥18 years.
* Signed informed consent provided by an authorized subject representative (based on local Institutional Review Board (IRB)/ethics panel requirements).

Exclusion Criteria:

Any other condition or prior therapy, which, in the opinion of the investigator, would make the subject unsuitable for this study.

Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days before randomization.

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The Effects of Early Mobilization in Stroke Patients on Functional Status, Psychological Distress, and Quality of Life

This study aims to investigate the effects of an early mobilization intervention in improving functional status, psychological distress, and quality of life in stroke patients. We hypothesize that this intervention method can significantly alleviate patient anxiety and depression, thereby promoting functional recovery and enhancing overall quality of life. Through this research, we hope to provide stroke patients with more effective exercise programs to help them regain health and well-being.

This study employs an experimental design conducted on patients in the stroke unit of the hospital who are over 20 years old and have either ischemic or hemorrhagic stroke with stable vital signs post-stroke onset, limb muscle strength greater than 3 points, and good communication skills in Chinese and Taiwanese, or they can read Chinese. Eligible participants are divided into an experimental group and a control group. All participants receive standard stroke unit care, while the intervention group additionally undergoes a 3-day activity protocol. The primary outcomes are assessed at baseline and at 1, 4, and 12 weeks post-stroke. Finally, the study analyzes the effect of early intervention on improving the prognosis of stroke patients.

The data collected in this study, whether in paper form or electronically, will be documented on a computer. After completing the research report, any recordings and paper documents will be destroyed. Once the data is documented, identifiable patient information will be removed, and each record will be assigned a unique code, making individual data unidentifiable.

Eligibility Criteria:
Inclusion Criteria:

* Must be over 20 years old.
* Patients diagnosed with infarct or hemorrhagic stroke 24 to 72 hours later. -Patients with stable vital signs, systolic blood pressure between 140- 220mmHg, heartbeat 40-130bpm, blood oxygen \>92%.
* The muscle strength of the limbs is greater than 3 points.
* Can communicate in Chinese and Taiwanese.

Exclusion Criteria:

* Patients with severe mental illness, critically ill patients and cognitive dysfunction.
* Surgery patients, aphasia patients.
* NIHSS greater than 16 points for severe stroke
Way to Be Active 2 (Lotteries)

Employers are increasingly looking for opportunities to motivate sedentary employees to become more physically active. Workplace walking programs have had mixed success and typically show most improvement among participants that are already fairly active at a baseline. The goal of this study is to determine whether a financial incentive program can motivate sedentary employees to increase the number of steps they walk per day to meet a minimum threshold.

Our primary outcome measure is the proportion of days a minimum activity of 7000 steps or more is achieved. We will assess outcomes each week for 3 months using incentives followed by 3 months of follow-up without incentives. Secondary outcomes will include the average steps walked per day.


Eligibility Criteria:
Inclusion Criteria:

* 1. We will use a minimum age of 18 to ensure all individuals are legally able to consent.
* 2. Participant will need an iPhone or Android smartphone to be able to use the Moves App for tracking steps

Exclusion Criteria:

* Conditions that would make participation infeasible: 1a. Inability to consent 1b. Illiteracy and/or inability to speak, read, and write English 1c. Participation in another research study 2. Conditions that would make participation unsafe: 2a. Current treatment for drug or alcohol use 2b. Consumption of at least 5 alcoholic drinks per day 2c. Myocardial infarction or stroke within the past 6 months 2d. Current addiction to prescription medicines or street drugs 2e. Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia) 2f. Pregnant or currently breastfeeding 2g. Metastatic cancer 2h. Unstable medical conditions that would likely prevent the participant from completing the study
Retrograde Application of Bone Marrow Aspirate Concentrate

The aim of our prospective randomised study is to assess the efficacy of the retrograde application of non-selected bone marrow autologous cells concentrate (BMAC) in patients with heart failure with reduced ejection fraction of left ventricle (HFREF) of ischemic aetiology. The evaluated preparation is concentrated BMAC, obtained using Harvest SmartPReP2 technology.

Our assumption is that non-selected BMAC administrations will lead to improvements in the left ventricular ejection fraction (LV EF), the left ventricular end-systolic and end-diastolic diameters and volumes (measured with magnetic resonance imaging) compared to standard heart failure therapy.

Furthermore, it will be associated with improved exercise tolerance in the six-minute corridor walk test and an improvement in the life quality of patients without increasing the incidence of severe ventricular arrythmias.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic heart failure and left ventricular ejection fraction ≤ 40% with coronary artery disease and with symptoms of heart failure in the NYHA class ≥ 3 on standard heart failure therapy for 3 months and in a stabilised state for at least 1 month
* Age ≥18 years
* Informed, written consent by the patient
* Ability to comply fully with the study protocol
* Negative pregnancy test (and effective contraception) in women with childbearing potential

Exclusion Criteria:

* Previous bone marrow disease (especially myelodysplastic syndrome or non-Hodgkin's lymphoma)
* Acute myocardial infarction ˂ 1 week
* Active infection or antibiotics treatment ˂ 1 week
* Previous malingant ventricular arrhythmias without cardioverter-defibrilator (ICD) implantation
* Anemia (HTC≤28%), leukocythosis (≥ 14.000/mm3) or thrombocytopenia (≤50.000/mm3)
* Previous bleeding diathesis
* Need for hematopoietic growth factor treatment (e.g. erythropoetin, G-CSF)
* Impossibility of aspiration 240ml of bone marrow
* Hepathopathy or cirrhosis (bilirubin, ALT or AST ≥ 2,5x upper limit of normal)
* Terminal renal insufficiency or haemodyalysis
* Uncontrolled hypertension
* Need for high dose (\> 7.5mg/day) corticotherapy within the next 6 months
* Inability to stop anticoagulation therapy (\>72 hours) before bone marrow aspiration
* Known malignancies requiring actino or chemotherapy, or previous actinotherapy
* Patients with a BMI \>40
* Known allergy to contrast agents
* Other comorbidities with a life expectancy of 6 months
Pain Relief Study of Ultrasound Guided Transverse Abdominis Plane(TAP)Block

The purpose of this study is to determine if injecting a local anesthetic, or numbing medication, above each hip will decrease the amount of narcotic pain medicine that is typically required by a patient after a cesarean delivery. Ultrasound pictures will be used to guide placement of this injection. Either ropivicaine (a type of numbing medication called a local anesthetic) or a placebo (saline) will be injected. For 24 hours, you will be given a button to press when you have pain. When the button is pressed, you will be given a small amount of pain medication called hydromorphone through your IV. You will also be given a pain medication called ketorolac through your IV every 8 hours for 24 hours after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or over
* ASA class 1 , 2 or 3
* BMI greater than 30 kg/m2 (as recorded at the patient's last clinic appointment or as measured on the day of delivery)
* Scheduled for cesarean section via Pfannenstiel incision (with or without a tubal ligation)
* 150 cm or taller
* Informed consent obtained

Exclusion Criteria:

* ASA class 4
* Age under 18
* Relevant drug allergy
* Contraindication to spinal anesthesia
* Height \< 150 cm
* Patient receiving medical therapies considered to result in a tolerance to opioids
* Any other major surgical procedure performed other than cesarean delivery with or without tubal ligation
* Patient with relevant contraindications to ketorolac, such as history of gastrointestinal bleeding or impaired renal function
* Patient refusal
NeoAdjuvant Chemotherapy Followed by Radical Hysterectomy (OP) Versus Primary Chemo-RADiation in Cervical Cancer FIGO Stage IB2 and IIB

Randomized comparison of neoadjuvant chemotherapy followed by radical hysterectomy with pelvic ± para-aortic lymphonodectomy (LNE) versus primary cisplatin-based chemo-radiation in patients with cervical cancer FIGO IB2 and IIB.

The optimal treatment for patients with cervical cancer on FIGO stage IB2 and IIB is controversial. There is no randomized comparison of a dose-dense NACT (TP or TIP-schedule) followed by hysterectomy and LNE (investigational Arm A) versus primary chemo-radiation (standard arm B). Primary endpoint is the DFS at 5 years, secondary endpoints local control at 5 years, OS at 5 years, QOL, questionnaires on sexual activity/QOL.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* cervical cancer FIGO IB2, IIB,
* squamous cell, adeno or adenosquamous cell carcinoma
* informed consent

Exclusion Criteria:

* small cell/neuroendocrine component
* previous radiation, previous cancer
* pregnancy
* HIV
* severe co-morbidities