cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients

This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.

This multicenter, double-blind, randomized controlled trial will evaluate the clinical outcomes of DAPT de-escalation at 1 month compared to 12 months, in patients who have undergone PCI with drug-eluting stent (DES) implantation. The study aims to optimize post-PCI treatment duration while reducing associated risks such as bleeding complications. Intravascular ultrasound (IVUS) will be used to guide stent placement and optimize results, especially in high-risk, complex cases.

Participants will be randomly assigned to two groups:

1. One month of DAPT, followed by monotherapy with a P2Y12 inhibitor.
2. Standard 12 months of DAPT. Patients will be followed for 12 months after the intervention to track cardiovascular events, bleeding complications, and overall safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
* Patients with the following clinical indications for PCI:

  * Unstable Angina: Prolonged chest pain at rest, new-onset angina within the past 2 months, or increasing frequency/severity of angina attacks.
  * Acute Myocardial Infarction (MI): With or without ST-elevation.
  * Chronic Coronary Syndrome: Requiring coronary revascularization.
* Patients who agree to participate and provide informed consent.

Exclusion Criteria:

* Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
* Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.
* Coronary Artery Bypass Graft Surgery: History of CABG surgery.
* Planned Surgery: Patients who have surgeries planned within the next 12 months.
* Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² or patients on dialysis.
* Chronic Anticoagulation Therapy: Patients requiring chronic oral anticoagulation (e.g., warfarin, DOACs) beyond DAPT.
* Thrombocytopenia: Platelet count less than 100,000/mm³.
* Contraindications to Antiplatelet Therapy: Allergy or intolerance to aspirin or P2Y12 inhibitors.
* Liver Disease: Patients with cirrhosis or significant liver dysfunction.
* Limited Life Expectancy: Patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
* Other Medical Conditions: Any condition that might interfere with adherence to the study protocol or follow-up schedule.
Metabolic Changes in Hypothyroid Patients

Hypothyroidism is a frequent condition in danish women, but often overlooked. Along with fatigue one of the main symptoms is weight gain as a result to significantly decreased energy expenditure.

This study was undertaken to elucidate changes in glucose, lipid and amino acid turnover in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed hypothyroidism with tsh over 40 mU/L, etiology chronic autoimmune thyroiditis
* Healthy controls matched regarding sex, age and body mass index

Exclusion Criteria:

* Pregnancy, breastfeeding
6MWT With and Without Walker

Elderly subjects repeated 6MWT with or without walker


Eligibility Criteria:
Inclusion Criteria:

* clinically stable
* aged over 65 years
* could walk
* did not use walker frames in routine

Exclusion Criteria:

* criteria outlined in the European respiratory society/American thoracic society technical standard related to 6MWT
* impaired cognitive function
Characterization and Epigenetics of Post-Partum Preeclampsia

This study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.

Preeclampsia (PEC) is a heterogeneous disease that complicates 5-8% of pregnancies. Approximately 10% of PEC patients will present with post-partum PEC without having developed the syndrome during the pregnancy (PP-PEC). Management of post-partum preeclampsia (PP-PEC) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. The pathogenesis and clinical characteristics of PP-PEC are understudied and poorly understood. Identifying clinical risk factors and biomarkers of PP-PEC would help to identify women at risk.

Eligibility Criteria:
Inclusion Criteria:

* Post partum pre-eclampsia

Matching based on:

* maternal age (years +/-3)
* BMI (+/-5 points)
* Ethnicity
* Mode of delivery
* Gestational age at delivery (+/7 days)
* Smoking status

Exclusion Criteria:

* Intrapartum pre-eclampsia
An Islamic Psychospiritual-Acceptance and Commitment-based Prevention Program for At-risk Young Adults in the COVID-19 Pandemic

The COVID-19 pandemic has increased mental health concerns worldwide, and young adults are at higher risk of experiencing increased psychological distress due to the pandemic. University students face compounding stressors during the pandemic, such as online and remote learning, economic insecurity, and uncertain career prospects. This study aims to evaluate the effectiveness of an online modular prevention program featuring integrated elements of Acceptance and Commitment Therapy (ACT) and Islamic spirituality in reducing the psychological distress and increasing the psychological flexibility, self-compassion, and resilience of Muslim university students in Malaysia.


Eligibility Criteria:
Inclusion Criteria:

* Undergraduate or postgraduate student enrolled in a Malaysian university
* aged 18-29 years old
* Obtained moderate and above levels in either one of the stress, anxiety, and depression subscales of the DASS-21 pre-intervention assessment
* Muslim
* Owns a gadget with Internet access
* Can read and understand English

Exclusion Criteria:

* Those with previous experience with a modular ACT-based treatment with Islamic elements
* Those with past or present diagnosis of mental/neurological disorder
* Those reporting active suicidality
* Those involved in any other form of psychological treatment (ie. psychotherapy, pharmacotherapy)
The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safeyt Profile of Test Product Compared to Reference Product Will be Assessed.

To evaluate and compare the relative bioavailability and therefore the bioequivalence of Vildagliptin Tablets 50 mg of AET Laboratories Private Limited, India, with GALVUS® 50 mg Tablets of Novartis Europharm Limited, United Kingdom, in normal, healthy, adult, male human subjects under fasting conditions and to evaluate the safety and tolerability of Vildagliptin Tablets 50 mg in normal, healthy, adult, male human subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

1. Male subjects aged between 18 and 45 years (both inclusive).
2. Subjects' weight within the normal range according to normal values for the Body Mass Index (18.5 to 30 kg/m2) with minimum of 50 kg weight.
3. Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within clinically acceptable normal range.
4. Subjects having clinically acceptable 12-lead electrocardiogram (ECG).
5. Subjects having clinically acceptable chest X-Ray.
6. Subjects having negative urine screen for drugs of abuse (including amphetamines, barbiturates, benzodiazepines, marijuana, cocaine and morphine).
7. Subjects having negative alcohol breath test.
8. Subjects willing to adhere to the protocol requirements and to provide written informed consent.
9. No history or presence of smoking.
10. No history or presence of alcoholism and drug of abuse.

Exclusion Criteria:

1. Hypersensitivity to Vildagliptin or related class of drugs.
2. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
3. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month of the study starting.
4. History or presence of asthma, urticaria or other significant allergic reactions.
5. History or presence of significant gastric and/or duodenal ulceration.
6. History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumor.
7. History or presence of cancer.
8. Difficulty with donating blood.
9. Difficulty in swallowing solids like tablets or capsules.
10. Use of any prescribed or OTC medication during last two weeks prior to Dosing in Period 01.
11. Major illness during 3 months before screening.
12. Participation in a drug research study within past 3 months.
13. Donation of blood in the past 3 months before screening.
14. Positive screening test for any one or more: HIV, Hepatitis B and Hepatitis C.
15. History or presence of significant easy bruising or bleeding.
16. History or presence of significant recent trauma.
17. Subjects who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
Intervention for Improving Psychological Distress in Dialysis

To explore whether it is feasible to recruit and retain haemodialysis patients into a randomised controlled trial of online cognitive-behavioural therapy to manage distress


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or over and receive hospital haemodialysis three-times weekly
2. Presence of mild to moderately severe depressive symptoms (based on PHQ-9 scores of 5 to 19 in range; a self-report measure of depression) and/or presence of mild to moderate anxiety symptoms (based on GAD-7 scores of 5-14)
3. Speak English sufficiently well to engage with screening tools
4. Have a basic understanding of how to use the Internet and an email address
5. Have a minimum dialysis vintage of ≥3 months (electronic patient record)

Exclusion Criteria:

1. Hospitalised at the time of assessment or within 1 month prior to the assessment
2. Currently receiving active treatment for depression and/or anxiety. We consider active treatment to be any current psychological treatments (talking therapies) or receipt of a new anti-depressant and/or anti-anxiety medication. A medication is considered new if it is commenced three months prior to the completion of the depression and anxiety screening questionnaire
3. Severe mental health disorders, for example, psychosis, bi-polar disorder
4. Active suicidal thoughts-any participant that scores greater than one on the depression PHQ-9 item "Thoughts that you would be better off dead, or of hurting yourself" will be excluded from the study.
5. Evidence of addiction to alcohol or drugs
A Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin in Subjects With Community-acquired Pneumonia

The purpose of this study is to assess if a therapy with oral and intravenous moxifloxacin is as effective as a therapy with intravenous ceftriaxone + intravenous azithromycin followed by oral amoxicilline/clavulanate and oral clarithromycin in the treatment of community-acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized non-ICU patients (age, \>= 18 years)
* Clinical signs and symptoms of CAP, with PSI score IV or V
* Radiologically confirmed evidence of a new and/or progressive infiltrate(s)
* Requirement for initial parenteral therapy
* At least 2 of the following conditions:

  * Productive or non productive cough with or without purulent or mucosus or mucopurulent sputum
  * Dyspnea and/or tachypnea (respiratory rate of \> 20 breaths/min)
  * Rigors and/or chills
  * Pleuritic chest pain
  * Auscultatory findings of rales and/or crackles on pulmonary examination and/or evidence of pulmonary consolidation
  * Fever (an oral temperature of \>= 38 °C, a rectal temperature of \>= 39 °C, or a tympanic temperature of \>= 38.5 °C) or hypothermia (rectal or core temperature of \< 35 °C), and a WBC count of \>= 10,000 cells/mm3 or \>= 15% immature neutrophils bands; regardless of peripheral WBC count) or leukopenia (total WBC count of \< 4500 cells/mm3)
* Written informed consent

Exclusion Criteria:

* PSI Class I-III and V with need for ICU admission
* Hospitalization for \> 48 hours before developing pneumonia, or discharge from hospital \< 30 days prior. Note: patients currently residing in residential long-term facilities can be enrolled in the study
Impact of Production Pressure in the Block Room on Patient Safety

This randomized, single blinded simulation based study investigates the impact that production pressure can have on the safety of patients undergoing regional anesthesia. We created a high fidelity scenario where anesthesiologists and trainees were to perform a single shot infraclavicular ultrasound guided block. Participants were randomly assigned to the intervention or control group. Participants assigned to the intervention group were exposed to various production pressure generating interventions. The goal of this study was to look at the impact of production pressure on patient safety by scoring anesthesiologists' and trainees' performance and examining the differences between the two groups.

Sample size:

To our knowledge, no studies were performed to evaluate the impact of production pressure on anesthesiologists nor on how to emulate production pressure in a simulated environment. Although it is known that production pressure affects negatively healthcare workers' performance, it remains difficult to predict its impact on a scoring system such as the RAPS assessment tool. Therefore, we used a convenience sample based on the number of residents and staffs anesthesiologists who agreed to participate. Using the t value and the degrees-of-freedom of the unpaired t-test, the investigators calculated the effect size (r) to characterize the magnitude of the effect and evaluate if the sample size is enough to answer the research hypothesis. An r value of around 0.2 was considered a "weak" effect, 0.5 "medium", and 0.8 "strong". We intend to recruit between 10 to 20 participants in each group.

Scenario:

Participants were asked to obtain consent and perform a single shot infraclavicular ultrasound guided block on a 50 year old woman with mild COPD. The simulation took place in situ in a regional anesthesia block room. Upon entering the room, the anesthesiology evaluation was already completed. A CAE infraclavicular block simulator was installed on a simulated patient. A simulated anesthesiology nurse was also present to assist only. All preparation steps and safety measures had to be initiated by the participant. Participants in the intervention group were exposed to 4 standardized pre-recorded audio interventions, encouraging them to proceed faster. The choice of these interventions was based on articles and surveys detailing the common sources of production pressure for the anesthesiologist.

Data collection:

Performances were filmed in order to be reviewed by three regional anesthesia experts. Participants were then asked to fulfill a questionnaire in another room. This form included a validated task load index grid (NASA) to quantify the amount of stress experienced, demographic data and a realism score.

Eligibility Criteria:
Inclusion Criteria:

* To be a certified anesthesiologist or anesthesiology resident
* To have performed at least 10 regional anesthesia techniques including 5 infraclavicular blocks
* To consent to the study

Exclusion Criteria:

- To refuse to participate
Study to Assess the Effects of High Protein Diet in Obesity, the LOWER Study

This program is carried out in a dedicated outpatient-clinic in the city of Hengelo for the evaluation and treatment of subjects with obesity. The program puts emphasis on intervention with appropriate diet and physical exercise, and supports the patients in achieving long-term behaviour changes. Interventions which are compared are normal vs high protein/low carb diets.

Assessment focuses on the effect of the specific diets on weight reduction after 3 months, and weight maintenance after 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Obesity with BMI \> 27 kg/m2

Exclusion Criteria:

* Recent loss of body weight (\>10%)
* Underlying malignancy, HIV infection, psychiatric disease
* Pregnancy or breast feeding
Retinal Microvasculature by Optical Coherence Tomography Angiography During Integrating Physical Activity in Diabetic Subjects.

Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.

Recently, it has been proven that the parameters measured by Optical Coherence Tomography (OCT) Angiography: the vascular density of the macular retinal capillary plexi and the foveolar avascular zone, can be modified after a high-intensity sports training program in healthy subjects.

the team wants to study the evolution of the macular, in type 2 diabetic subjects, before and after a stay in a care structure dedicated to the multidisciplinary and integrative management (nutrition, physical activity, therapeutic education) of a duration of 3 weeks.

The prevention of vascular and neurological complications in diabetic subjects represents a major public health issue. Diabetic retinopathy is a common condition of diabetes and can lead to blindness, making it one of the most feared complications of diabetes.

Diabetes management is global and aims at a stable glycemic balance putting the patient out of the micro and macrovascular complications linked to this pathology. It involves modifying the lifestyle of patients with the practice of appropriate physical activity, balancing daily food intake, not necessarily by taking insulin-sensitizing or hypoglycemic drug treatment, but also by management of other risk factors related to complications: dyslipidemia, weight, smoking, arterial blood pressure balance.

The use of Optical Coherence Tomography Angiography allow the evaluation of the microvasculature of the macula.

Diabetic macular edema is the leading cause of vision loss in type 2 diabetic subjects mainly due to dysfunction of the macular microvasculature.

Macular analysis via Optical Coherence Tomography Angiography can quickly and non-invasively predict the risk of occurrence of Diabetic macular edema and therefore that of a decrease in acuity and visual impairment.

Eligibility Criteria:
Inclusion Criteria:

* Patient for whom a 3-week multidisciplinary and integrative program was offered in a diabetology unit
* Patient having given his consent
* Patient affiliated to a social security scheme or equivalent
* Patient with type 2 diabetes

Exclusion Criteria:

* History of exudative or tractional retinal detachment
* Intraocular foreign body
* History of endophthalmitis
* History of inflammatory disease of the retina
* History of chorioretinitis
* Patient with age-related macular degeneration
* Patients with type 1 diabetes or secondary diabetes
* Uncontrolled hypertension does not define Systolic arterial pressure (SAP) \> 180 mmHg or Diastolic arterial pressure (DAP) \> 110 mmHg
* Patient who has already received intravitreal injections of anti-angiogenic molecules.
* Pregnant or breastfeeding patient at the time of the study
* Persons under a legal protection regime for adults (safeguard of justice, guardianship, curatorship, institutionalized, or under mandate for future protection)
Rapid Intravenous Infusion of Velaglucerase Alfa (VPRIV) in Treatment-naive Patients With Type 1 Gaucher Disease

During the past two years, the investigator has performed succsefully an IIR wherein patients with GD, previously treated with velaglucerase alfa ERT were gradually switched to a 10 minutes (rapid) administration of the same ERT. The success was expressed as safety (no clinically meaningful AEs, no antibodies detected, home therapy), efficacy ("lack of deterioration") and patients' satisfaction. The latter was based not just on specific questionnaires and analog scales, but particularly by the patients' sharing the experience with other patients and consequently repeated requests by many to switch to a rapid administration of their ERT.

Therefore, the investigator is hereby proposing to investigate the safety and efficacy of a 10 minutes administration of velaglucerase alfa in a cohort of treatment-naive patients.

The current VPRIV label is restricted to a dosage of 60 units/kg body weight every other week (60 units/kg EOW) - this dose will be used throughout the study period. The enzyme will be provided by Shire, which will also provide a research grant for the conduction of the trial.

Protocol:

Study Design: This will be a single-center, open-label trial to assess the safety and efficacy of rapid administration of velaglucerase alfa (VPRIV) to treatment-naive patients with type I Gaucher disease. The first six infusions will be administered in the hospital: the first three infusions within 60, 30 and 20 minutes each, with the beginning of a 10 minutes administration from infusion #4. Following the three uneventful administration of the 10 minutes in the hospital, the bi-weekly ERT will continue as home therapy, as outlined in the protocol. The duration of the study will be 12 months, with an extension pending positive results.

Number of Patients: 15. The first ten patients will be adults, and then children will be allowed to enroll in the trial.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years or older for the first ten adult patients; 6 years or older for the last five patients.

  * Confirmed enzymatic diagnosis of Gaucher disease with a defined genotype and elevated biomarker LysoGb1, performed at CentoGene using DBS methodology.
  * Indications for ERT will be guided by fulfilling the MOH criteria.
  * Female patients of child-bearing potential who agree to use a medically acceptable method of contraception.
  * Patients who have not received ERT or SRT in the past or Patients who have not received ERT or SRT in the past 12 months and have a negative anti-glucocerebrosidase antibody

Exclusion Criteria:

* Currently taking another experimental drug for any condition

  * Presence of neurologic signs and symptoms characteristic of Type 2 or Type 3 Gaucher disease
  * Pregnant or nursing
  * Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the study.