cyrilzakka/clinical-trials huggingface dataset:
Long-term Efficacy of Once Daily Versus Twice Daily Aspirin in High-risk MPN Patients with Aspirin Resistance

Patients with myeloproliferative neoplasm (MPN) could have laboratory aspirin resistance and then increasing dose of aspirin from once daily to twice daily regimen is suggested. However, it is not routinely recommended to perform platelet function testing to determine aspirin resistance in MPN patients. Moreover, it is not known whether increasing dose of aspirin would always correct aspirin resistance and significantly prevent the thrombotic events in MPN patients. Therefore, this study aims to compare the efficacy of once daily versus twice daily aspirin in high-risk MPN patients with aspirin resistance. MPN patients with laboratory aspirin resistance will be included in this prospective randomized study and platelet function testing will be repeated at one and six months later. Clinical thrombosis and side effect from aspirin will be recorded for at least 2 years after intervention.

Inclusion criteria included adult (\>=18 years) Philadelphia-negative MPN patients taking aspirin (81 mg/day). Exclusion criteria included concomitant active cancer, thrombocytopenia (platelet less than 50,000/uL), taking anticoagulant, platelet function test (LTA method) showing no aspirin resistance, active gastric disease, active bleeding. Termination criteria included not taking aspirin regularly, serious side effect from aspirin. Block of four randomization is used. LTA testing is repeated at month 1 and 6 in both arms. PFA200 method is also done at initial enrollment for comparison with LTA method. Follow-up outcome data of clinical thrombosis, bleeding complication and adverse events related with aspirin are collected. Comparative analysis of outcome data is performed between two arms.

Eligibility Criteria:
Inclusion Criteria:

* Philadelphia negative Myeloproliferative neoplasms aged at least 18 years old

Exclusion Criteria:

* Concomitant other active malignancy or cured less than 6 months
* Platelet count less than 50,000/microL
* Receiving anticoagulant
* Active peptic ulcer
* Active bleeding or Planning to undergo procedure/operation with bleeding risk
* No laboratory aspirin resistance with LTA method
Safety and Efficacy of IQP-AK-102 in Reducing Appetite

The individual ingredients in IQP-AK-102 have been widely used. Backed by data from several studies demonstrating their efficacy, we are conducting this study to look into the efficacy and safety of this novel combination of three fibres, in appetite regulation, aiming to reduce the appetite.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years
* 25≤BMI≤35
* Expressed desire for weight loss
* Accustomed to 3 main meals/day
* Generally in good health
* Consistent and stable body weight 3 months prior to study enrolment
* Consistent regular physical activity
* Commitment to avoid the use of other weight loss products during study
* Commitment to adhere to diet and lifestyle recommended for the study

Exclusion Criteria:

* Known sensitivity to the ingredients of the device
* Presence of any active gastrointestinal disease
* Malabsorption disorders
* Pancreatitis
* Stenosis in the GI tract
* Bariatric surgery
* Any other reason deemed suitable for exclusion, per investigator's judgement
Chidamide for Patients With Recurrent and Metastatic Epstein-Barr Virus (EBV)-Associated Solid Tumors

Study of Chidamide as a Single-agent Treatment for Patients With Recurrent and Metastatic Epstein-Barr virus (EBV)-associated Solid Tumors

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide as a single-agent treatment in patients with recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as recurrent and metastatic Epstein-Barr virus (EBV)-associated solid tumors, including nasopharyngeal carcinoma and other solid tumors (Lymphoma excluded). Patients must have failed at least one systemic treatment and been refractory to platinum-containing regimens;
2. At least one measurable lesion according to criteria RECIST v1.1;
3. Age 18-70 years, male or female;
4. ECOG performance status 0-2;
5. Life expectancy no less than 3 months;
6. Adequate hepatic, renal and bone marrow function;
7. History of brain metastasis is eligible, but maintenance of hormone is not required;
8. Contraception during and 4 weeks after the study for patients at child bearing age;
9. Patients have signed the Informed Consent Form.

Exclusion Criteria:

1. Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures;
2. QTc elongation with clinical significance ( male˃ 450ms, female˃ 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
3. pericardial effusion ≥10mm sum of echo-free spaces by echocardiography;
4. Patients have undergone organ transplantation;
5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
6. Patients with active hemorrhage;
7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
8. Patients with active HBV or HCV infection;
9. continuous fever within 14 days prior to enrollment;
10. Had major organ surgery within 6 weeks prior to enrollment;
11. Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum);
12. Patients with mental disorders or those do not have the ability to consent;
13. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
14. Patients who received treatment of HDAC inhibitors;
15. Non-appropriate patients for the trial according to the judgment of the investigators.
Prospective Study of the Perception of Palliative Care by Relatives of Patients Treated in Oncology

The purpose of this study is to evaluate (thanks to analysed interview) the perception of palliative care by relatives of patients treated in oncology.


Eligibility Criteria:
Inclusion Criteria:

* man or woman of age who is a relative of a patient treated in oncology
* subject who signed the informed consent
* subject without any legal protection measure and having health coverage

Exclusion Criteria:

* Relatives of patients already followed in the palliative care departement
* Subjects with cognitive impairment or expression;
* Not french spoken subjects
* Pregnant or breastfeeding women
Internet-delivered Psychodynamic Therapy for Depression and Anxiety Disorders

The overall aim of this study is to develop and test a psychodynamic Internet-delivered psychological treatment for patients with major depression and/or anxiety disorders and compare its efficacy to an active control group.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder, Panic Disorder, Social Anxiety Disorder, Generalized Anxiety disorder, Depressive Disorder NOS or Anxiety Disorder NOS
* 10 or higher on the PHQ-9 or on the GAD-7 at pre-treatment

Exclusion Criteria:

* Primary diagnosis of Obsessive Compulsive Disorder or Post-traumatic Stress Disorder
* Severe psychiatric condition (e.g. psychosis or bipolar disorder)
* Alcohol abuse (more than 16 on the AUDIT)
* Suicidal (measured in diagnostic interview)
* Changed medication during the last three months
Study of Boosted Atazanavir (ATV) Versus Non-boosted ATV in Naive Patients

The purpose of this study is to find out if 300 mg of ATV plus 100 mg of ritonavir (RTV) works as well as 400 mg of ATV alone as part of a regimen with stavudine XR and lamivudine to slow or stop the progression of HIV infection in patients who have never used anti-HIV drugs.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* HIV RNA greater than or equal 200 copies/mL at screening
* 18 years old or older
* Must use barrier contraception
* Women of child-bearing potential must have a negative serum or urine pregnancy test within 72 hours before beginning to take the study medications

Exclusion Criteria:

* Unable or unwilling to use acceptable method of birth control for the entire study period including 8 weeks after the study
* Women using oral contraceptives, pregnant or breastfeeding women
* Women who have a positive pregnancy test on enrollment or before beginning to take the study medications
* People who have a life expectancy of greater than 12 months
* Newly diagnosed HIV-related OI or any medical condition requiring acute therapy at the time of enrollment
* Any antiretroviral therapy within 30 days prior to screening
* Any prior antiretroviral therapy (greater than 30 days of NRTI and/or greater than 7 days of non-nucleoside reverse-transcriptase inhibitor (NNRTI) or protease inhibitor therapies)
* Any of the following conditions: Cushings Syndrome, Gilbert's Syndrome, untreated hypothyroidism or hyperthyroidism, suspected primary (acute) HIV infection, obstructive liver disease, proven or suspected acute hepatitis in the 30 days prior to study entry, Intractable diarrhea (at greater than 6 loose stools per day for at least 78 consecutive days) within 30 days prior to study entry, history of hemophilia, history of acute or chronic pancreatitis, presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease
* Active alcohol or substance abuse
* History or signs and symptoms of bilateral peripheral neuropathy greater than grade 2 at the time of screening
* Previous therapy with myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 3 months of study start or the expected need for such therapy or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4
* Inability to swallow capsules
A Study Comparing the Plasma Drug Exposure of an Oral Dose of Palbociclib (PD-0332991) to an Intravenous Dose of Palbociclib (PD-0332991)

The purpose of this study is to determine approximately what percentage of an orally administered dose of PD-0332991 is absorbed from the gastrointestinal tract into the systemic circulation. This approximation is made by comparing the plasma pharmacokinetics of a 125 mg oral dose of PD-0332991 to the plasma pharmacokinetics of a 50 mg intravenous dose of PD-0332991 administered as a 4-hour infusion.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female of non-childbearing potential between the ages of 18 and 55 years of age.
2. A body mass index (BMI) between 17.5 and 30.5 kg/m2, and a total body weight greater than 50kg (110 lbs)

Exclusion Criteria:

1. Any condition which could possibly affect drug absorption.
2. Pregnancy or actively nursing females, or females of childbearing potential.
3. A positive urine drug screen.
Minocycline to Prevent Acute Kidney Injury After Cardiac Surgery

This study proposes to investigate whether treatment with minocycline pre-operatively in patients with mild to moderate chronic kidney disease undergoing cardiac surgery will reduce the occurence of kidney injury.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* planned CABG or valvular surgery with cardiopulmonary bypass
* Serum creatinine available (within 30 days)
* Estimated GFR 15-90ml/min using the abbreviated MDRD formula (CKD stages 2-4)

Exclusion Criteria:

* Emergent or urgent surgery (to be performed within the next 36 hours)
* End stage renal disease, or GFR \< 15ml/min (CKD stage 5)
* Estimated GFR\>90ml/min (CKD stage 1 or no CKD)
* Ongoing infection by positive blood, urine or sputum cultures or pneumonia on CXR
* Allergy to minocycline or tetracyclines
* inability to take oral medications
* use of preoperative vasopressor agents at therapeutic doses
* Pregnant or lactating females
* Advanced liver disease by history or exam(cirrhosis, ascitis, jaundice)
* Rising creatinine meeting the definition of acute kidney injury prior to surgery
* Neurologic signs or symptoms or history of increased intracranial pressure
* current participation in another research study involving an investigational drug or device
Clinical Trials to Assess the Efficacy and Safety of HLIM

The purpose of this study is to assess the efficacy and safety of HLIM

A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 75
* Weight more than 11.5 kg

Exclusion Criteria:

* Has a history of hypersensitivity to IP ingredients
* Hypertension or Diabetes
* Smoking more than 20 pack-years
Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike

The investigators are testing whether a single session online intervention for self-dislike decreases:

1. Fear of self-compassion from immediate pre to immediate post intervention
2. Self-hatred immediate pre to 1 month post-intervention
3. Individual depression symptoms immediate pre to 1 month post-intervention more than a placebo online single session intervention encouraging the disclosure of feelings in college students.

   The investigators will also explicitly test whether the following variables are predictors, of at least the smallest variance predicted of interest, of response to treatment vs. placebo on self-hatred:
4. Pre intervention self-hatred score
5. Screening positive for clinical depression based on self-report
6. Immediate pre to post-intervention reduction in fear of self-compassion
7. The investigators will also assess whether any of the variance shared between the treatment and changes in individual depression symptoms immediately pre Intervention to 1 month post-intervention is statistically mediated by change in self-hatred from immediate pre intervention to 1 month post intervention


Eligibility Criteria:
Inclusion Criteria:

Participant is a current college student at the time of study enrollment

Participant has not previously taken part in the study

Participant speaks English well enough to complete online intervention activities, which are available in English only

Participant is comfortable with completing online surveys and programs

Participant is at least 18 years of age.

Exclusion Criteria:

The investigators will exclude participants 3 SDs above/below the mean completion time for the study or exit the study prior to randomization for our listed analyses.

The investigators will also test whether there's any association between how quickly participants are responding to questions and the variability in their responses. If there is a response time frame (i.e., a series of questions that require answers where timing is measured) where there is a linear relationship between response time and response variability, the investigators may exclude those participants, as response time and response variability should be uncorrelated and a linear association can indicate random responding. This time frame can be identified visually on a graph, and sensitivity tests can be conducted to determine if slight variations on the visual interpretation affect substantive results.

The investigators will exclude participants who respond with either copy/pasted responses from text earlier in the intervention (e.g. Copy and pasting only text from a previous testimonial slide) to any of free response questions.

The investigators will exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of 5 words or fewer to writing prompts that ask for at least 1 sentence or more.
Acupuncture and Hot Flashes

Methods: 103 participants, after being randomized to medical versus sham acupuncture received bi-weekly treatments for 5 weeks, after a baseline assessment week. They were then followed for an additional 7 weeks. Participants completed daily hot flash questionnaires, which formed the basis for analysis.


Eligibility Criteria:
Participants eligible for this study were females aged 45 to 59 with a reported average of ¡Ý 5 hot flashes a day
Short-term Effects of Sound-bed Music Therapy in Healthy Caregivers of a Hospital Oncology Ward (MTO_03)

The purpose of this study is to determine the effects of live sound-bed music on physiological and psychological parameters in staff of a hospital oncology ward.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent of the participant
* affiliation to the staff of the hospital oncology ward

Exclusion Criteria:

* insufficient knowledge of the German language
* alcohol, caffeine or nicotine less than 3 hours before the beginning
Effects of Graptopetalum Paraguayense E. Walther on the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome

Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. The purposes of this study are going to investigate the effects of Graptopetalum paraguayense E. Walther on the oxidative stress, antioxidant enzyme activity and inflammation in subjects with metabolic syndromerelation. The investigators will recruit MS patients(n=50)and the inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007). The MS subjects are randomly assigned to placebo(n=25) and Graptopetalum paraguayense E. Walther supplements(n=25)groups. Hopefully, the results of this study could provide the information of Graptopetalum paraguayense E. Walther supplements to what has been know in MS subjects.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria of MS in adult are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007), if subjects had 3 of the following 5 characteristics: (1) abdominal obesity (waist circumference \>= 90 cm in men and \>= 80 cm in women), (2) impaired fasting glucose ( \>= 5.6 mmol/L), (3) hypertriglyceridemia ( \>= 1.7 mmol/L), (4) low HDL-C (\< 1.0 mmol/L in men and \< 1.3 mmol/L in women), and (5) increased blood pressure (SBP \>= 130 mmHg and DBP \>= 85 mmHg). Subjects using antidiabetic or antihypertensive or lipid-lowering medications were considered to have elevated fasting blood glucose or elevated blood pressures or dyslipidemia, respectively.

Exclusion Criteria:

* Subjects with liver, renal diseases, undergoing statin therapy, pregnancy women, and taking antioxidant vitamins supplements were excluded.
Use of Platelet Rich Plasma (PRP) for Improving Thin Endometrium

Platelets rich plasma is simple source of growth factors and cytokines that can regulate endometrial growth for subgroup of thin endometrium women. It is an autologous source of this enhancing factors; therefore, there os no risk of using it within the same participant.


Eligibility Criteria:
Inclusion Criteria:

* women with thin endometrium

Exclusion Criteria:

* serum positive hepatitis B and C women
Pilot Trial of an Online Personalised Normative Feedback Intervention to Reduce Drinking

Unhealthy alcohol consumption is common in the UK and causes tremendous harm to the individual, as well as harm to others. A significant gap in providing alcohol support is that most people with unhealthy alcohol consumption will never receive advice to cut down on their drinking. However, many are interested in self-directed interventions to help them evaluate their drinking and to motivate reductions in alcohol use. One such promising intervention uses online personalised normative feedback (PNF) which compares a person's drinking with others in the general population of the same age and sex. PNF interventions are thought to work because many people with unhealthy alcohol consumption overestimate how much others drink. Multiple trials have demonstrated that providing PNF to people with unhealthy consumption reduces their alcohol use . While several UK websites do provide feedback on assessment of risk (e.g., Down Your Drink introductory section, Alcohol Change UK), there appears to be no online intervention that provides PNF for unhealthy alcohol consumption.

The major objective of this pilot project is to conduct a two-arm, parallel group randomised controlled trial (RCT) in which 1,318 participants recruited from the Prolific website who have identified themselves as drinking 14 or more units per week are randomly assigned to one of two groups - a) those who are offered a PNF report, and b) those in a no intervention comparator group. Participants in the comparator group will not be provided any intervention materials but will instead be given a list of the different components of the PNF feedback and will be asked to think about how useful they would find each of them. Follow-up assessment will occur at 1 and 6 months post-randomisation. The project is described as a pilot because it is a preliminary evaluation of the PNF intervention in a UK context.


Eligibility Criteria:
Inclusion Criteria:

Typically consume 14+ standard UK alcohol units per week Willingness to complete a 6-month follow-up survey 18 years of age or older
Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria

The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).

Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
* Have adequate venous access for program sample collections as judged by the Investigator for study sample collections

Exclusion Criteria:

* Previously or currently participating in a givosiran clinical trial
* Has any of the following laboratory parameter assessments at Screening:

  1. Alanine aminotransferase (ALT) \>2×ULN
  2. Total bilirubin \>1.5×ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is \<2×ULN
  3. Estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73 m2
* On an active liver transplantation waiting list