cyrilzakka/clinical-trials huggingface dataset:
Colchicine in COVID-19: a Pilot Study

This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint.

This is an interventional, pilot, multicenter, randomized, open-label, phase 2 study, enrolling patients with COVID-19 disease. Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care versus current care.

One-month rate of entering the critical stage (either a. Respiratory failure occurs and requires mechanical ventilation; b. Patients combined with other organ failure need ICU monitoring and treatment; c. Death) is the primary endpoint. Secondary objectives are trend of White blood cell count, Change of the "Sequential Organ failure Assessment" (SOFA), Rate of biochemical criterion (CK, ALT,ferritin) recovery, Rate of disease remission and safety of Colchicine.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent for participation in the study
* Virological diagnosis of SARS-CoV-2 infection (real-time PCR)
* Hospitalized due to clinical/instrumental diagnosis of pneumonia
* Oxygen saturation at rest in ambient air ≤94%
* PaO2/FiO2 ratio of 350 to 200

Exclusion Criteria:

* Known hypersensitivity to colchicine or its excipients
* Severe diarrhea
* Patients who cannot take oral therapy
* Pregnant and lactating patients
* Patients with severe cardiac, renal insufficiency (creatinine clearance (CCL) \<30 mL / min)
* Patients with kidney or liver damage \[(AST or ALT\> 5 times the normal limits in International Units (ULN)\]; or are taking CYP3A4 enzyme - P glycoprotein inhibitors.
* Known other clinical condition that contraindicates colchicine and cannot be treated or solved according to the judgement of the clinician
* Neutrophils \<1.000 / mmc
* Platelets \<50.000 / mmc
* Bowel diverticulitis or perforation
* Patients already in ICU or requiring mechanical ventilation
* Patients receiving Tocilizumab
* Patients already enrolled in other clinical trials
Continuous Positive Airway Pressure (CPAP) for Primary Care

The objective of the study is to compare the results of a follow-up and treatment coordinate and interactive program performed by the General Practitioners (GP) for Obstructive Sleep Apnea (OSA) patients treated with positive continuous pressure (CPAP) vs. usual control by sleep specialists from the sleep unit.

METHODOLOGY: DESIGN: Randomized comparative study. It will include patients with diagnosis of severe OSA that should start treatment with CPAP. Participating center is Hospital Universitario Araba in Vitoria-Gasteiz (Spain). These patients will be randomized to two monitoring groups : 1 monitoring in the sleep unit; 2: monitoring in primary care consultations by the General Practitioners (GP), once the OSA diagnosis has been made and it was indicated the treatment with CPAP.

Patients will be carried out in both groups the same follow-up visits in two study arms: basal, 1 month, 3 month and 6 months. PRIMARY OUTCOME: To compare the objective CPAP compliance treatment in the two study groups, so that use \>= 4h/day is defined as good adherence to the treatment. SECONDARY OUTCOMES: 1)To evaluate the level of patient's satisfaction by visual-analogical scales and quality of life tests; 2) to establish the clinical improvement by somnolence and sleep scales; 3) To determine the numbers of CPAP complications, type, severity and duration; 4) To figure-out the level of take care of the CPAP machine, substitutions and complements, assistance and technical incidents; 5) Cost-effectiveness analysis.


Eligibility Criteria:
Inclusion Criteria:

* Men and women over 18 years old.
* Patients with OSA diagnosis performed in the sleep unit
* Written informed consent signed.

Exclusion Criteria:

* Previous CPAP treatment for OSA diagnosis
* Psycho-physical inability to complete questionnaires
* Presence of any previously diagnosed sleep disorders: narcolepsy, insomnia, chronic sleep deprivations, regular use of hypnotic or sedative medications nad restless leg syndrome
* Patients with respiratory diseases (overlap syndrome, hypoventilation, restrictive diseases)
* A medical history that may interfere with the study objectives or, in the opinion of the investigator, compromise the conclusions.
Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease

Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program.
Collaborative Approach to Examining Adversity and Building Resilience Study

To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.

Early-life trauma and related adversities are prevalent and associated with negative health and achievement outcomes. These adverse childhood experiences (ACEs) are especially common in economically disadvantaged and communities of color. While there has been tremendous growth in knowledge about ACEs and their impact on health across the life course, critical gaps persist: 1) Which biologic pathways are most affected by ACEs during early childhood and may help identify those children at greatest risk for future poor health? And, 2) How may child and family resilience be bolstered across the care continuum to mitigate the negative health effects of ACEs? These critical gaps severely limit our ability to effectively identify children at high-risk and to intervene to promote resilience before poor health occurs.

Three previously piloted resilience-promoting, caregiver-child interventions will be examined: primary care-based, group-delivered Resilience Clinic (RC); home-based, dyadic Attachment and Biobehavioral Catch-up (ABC); and primary care-based, dyadic Resiliency Family Program (RFP). Using a randomized wait- list controlled trial design,12 families will be assigned to intervention or enhanced primary care (n=50/arm in each intervention, total n=300). Pre-post intervention health (behavioral, caregiver stress) and biology will be compared between intervention and controls, as well as modifying factors such as setting and delivery method.

Eligibility Criteria:
Inclusion Criteria:

1. Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative exclusion criteria - have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)
2. Attachment and Biobehavioral Catch-up (ABC) Program

   * Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
   * Child: 2 to 4 years, PEARLS score \> 1
3. Resilience Clinic

   * Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking
   * Child: 2 to 5 years, PEARLS score \> 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff
4. HEROES Family Program

   * Caregiver: 18 years old and older, primary caregiver, ACE score \> 2 if child PEARLS score = 0, English or Spanish speaking
   * Child: 2 to 5 years, PEARLS score \> 1

Exclusion Criteria:

1. Caregiver: active suicidality, other psychiatric issues
2. Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly with routine vaccines in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month-old infants (42 to 98 days)
* Available for the entire study period (14 months)

Exclusion Criteria:

* Previous vaccination with pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib vaccines
* A previous anaphylactic reaction to any vaccine or vaccine-related component.
Effectiveness and Tolerability of аgomelatine in the Treatment of Patients With Depression After SARS-CoV-2 (TELESPHOR)

This is a multi-centre, observational, non-interventional study, which will prospectively collect clinical and socio-demographic data from patients with depression occurred after COVID 19 in real clinical settings during 8 weeks of treatment.

10 clinics and 10 of psychiatrists and neurologists across the country will participate in the study and it is estimated that each investigating physician will enroll 10 patients.

A patient with depression occurred within 3 month period after onset of confirmed COVID 19 infection who has already been recommended to initiate antidepressive treatment with agomelatine will be asked to provide a consent to participate in the study and in case of consent is positive the patient will be invited for 3 more visits starting from the date of the inclusion in the study according to clinical practice. Therefore clinical parameters needed for describing effectiveness and tolerability of agomelatine treatment will be prospectively collected at each of these visits. Antidepressive treatment of enrolled outpatients can be modified by investigating psychiatrist or neurologist at any time of the observation if required.

Following visits are planned:

1. Inclusion Visit 0 (V0) - inclusion in the study
2. Follow up Visits 1-2 (V1-V2) - visits at week 2 and week 4 after V0.
3. Final Visit 3 (V3) - visit at week 8 after V0.

Eligibility Criteria:
Inclusion Criteria:

* Obtained signed informed consent from the patient.
* Age of 18-65 years old.
* Out-patient with confirmed COVID 19 infection within 3 months period before the date of inclusion.
* Confirmed depression with total HAMD-17 score of 8-24 required treatment with antidepressive medicines.
* Decision to administer agomelatine preceeds the decision to include a patient in the study.

Exclusion Criteria:

* Current participation in any clinical trial or during 30 day period from inclusion visit.
* Suicide risk (accoding clinical evaluation of investigator).
* Psychotics symptoms (according clinical evaluation of investigator).
* Schizophrenia, schizo-affective disorders, organic damages of CNS, dementia, epilepsy, multiple sclerosis, Parkinson disease, Alzeimert disease, Bipolar disorders.
* Alcohol abuse or drug addiction in anamnesis.
* Severe or decompensated somatic or neurological disorders.
* MAO inhibitors during last 2 weeks.
* Treatment by others psychotropic products (antipsychotics, anxiolitics etc.).
* Any contraindications to agomelatine in accordance to the local SmPC.
* Patients with severe/decompensated psychiatric, somatic or neurological disorders.
* Patients with any sign of liver failure (increase of transaminase up to 3 times higher), which needs to stop treatment with agomelatine.
* Patients who participate in any clinical trial or survey.
Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.

Sixty volunteers with functional GI disorders (Functional dyspepsia according to Rome-III criteria) will be recruited for a randomised, double-blind, placebo-controlled, two-arm parallel study in which the effect upon the gastrointestinal function of a probiotic mix containing bifidobacteria and lactobacilli (manufactured by Biopolis SL) will be compared with placebo (maltodextrin). The study design includes a 4 week run-in period, in which the volunteers will not consume any probiotics/prebiotics, followed by a 4 weeks intervention period (a daily capsule of placebo or probiotic) and an 8 weeks washout period. At the beginning/end of each period questionnaires in gastrointestinal function, dyspepsia related symptoms and diet will be carried out. A serum sample will be taken for cytokine levels determination. A faecal sample will be taken for 16S microbial population profiling and for determining the faecal levels of Bifidobacterium, Bacteriodes, Faecalibacterium, Akkermansia, Lactobacillus and Blautia by qPCR and the concentration of the main bacterial metabolites; acetate, propionate and butyrate by gas-chromatography.

Eligibility Criteria:
Inclusion Criteria:

* Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria

Exclusion Criteria:

* Celiac disease or other organic GI disease
* Orthorexia nervosa or other eating disorders
* Special dietary patterns (vegans, vegetarians, macrobiotic, exclusion diets, etc.)
* Extreme BMI (\<18,8 or \> 39,9)
* Metabolic disorders
* Positive Helicobacter pylori test
* Congenital IgA deficiency
* Lactose malabsorption/intolerance
* SIBO
* Diabetes
* Scleroderma, CREST, lupus or other connective tissue diseases
* Previous GI surgery or neoplastic disease
* Treatment with non steroidal anti-inflammatory drugs and/or acetyl salicylic acid.
* Pregnancy
* Menopause
Comutti - A Research Project Dedicated to Finding Smart Ways of Using Technology for a Better Tomorrow for Everyone, Everywhere.

According to World Health Organization, worldwide one in 160 children has an ASD. About around 25% to 30% of children are unable to use verbal language to communicate (non-verbal ASD) or are minimally verbal, i.e., use fewer than 10 words (mv-ASD). The ability to communicate is a crucial life skill, and difficulties with communication can have a range of negative consequences such as poorer quality of life and behavioural difficulties. Communication interventions generally aim to improve children's ability to communicate either through speech or by supplementing speech with other means (e.g., sign language, pictures, or AAC - Advanced Augmented Communication tools). Individuals with non- verbal ASD or mv-ASD often communicate with people through vocalizations that in some cases have a self-consistent phonetic association to concepts (e.g., "ba" to mean "bathroom") or are onomatopoeic expressions (e.g., "woof" to refer to a dog). In most cases vocalizations sound arbitrary; even if they vary in tone, pitch, and duration depending it is extremely difficult to interpret the intended message or the individual's emotional or physical state they would convey, creating a barrier between the persons with ASD and the rest of the world that originate stress and frustration. Only caregivers who have long term acquaintance with the subjects are able to decode such wordless sounds and assign them to unique meanings.

This project aims at defining algorithms, methods, and technologies to identify the communicative intent of vocal expressions generated by children with mv-ASD, and to create tools that help people who are not familiar with the subjects to understand these individuals during spontaneous conversations.


Eligibility Criteria:
Inclusion Criteria:

* having a clinical diagnosis of autism spectrum disorder according to DSM-5 criteria
* use fewer than 10 words

Exclusion Criteria:

* using any stimulant or non-stimulant medication affecting the central nervous system
* having an identified genetic disorder
* having vision or hearing problems
* suffering from chronic or acute medical illness
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery

The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.

Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>= 18 years old
* Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy
* Provide written informed consent

Exclusion Criteria:

* Poor (English) language comprehension
* Minimally invasive valve surgery
* Off-pump procedures
* Emergency operations
* Known history of increased bleeding disorder
* Thromboembolic disease
* Allergy to tranexamic acid
* Severe renal impairment (eGFR \<30 mL/min/1.73m2 )
Pain Control for Intrauterine Device Placement Using Paracervical Block

Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.

Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement. Studies to evaluate effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed.

Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women
* English or Spanish speaking
* Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).

Exclusion Criteria:

* Pregnancy
* Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis)
* If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs
* Misoprostol administration within 24 hours of enrollment
* History of prior IUD insertion
* Known contraindications to IUD
Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?

Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.

Women attending the antenatal clinic with a viable singleton pregnancy below 14 weeks were randomized to receive routine counselling by their obstetrician or the intervention, where they watched a 16-minute educational video on aneuploidy screening before their consult. The primary outcome, rate of informed choice, was assessed using an adapted multidimensional measure of informed choice (MMIC) questionnaire, where informed choice was defined as good knowledge and value-consistent behaviour. Secondary outcomes included informed choice with deliberation, decisional conflict and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* aged 21 years or older
* English speaking
* had a viable singleton pregnancy below 14 weeks gestation

Exclusion Criteria:

* women who had any prior discussion with a clinician regarding aneuploidy screening for their current pregnancy
First In Human Study of CX-2051 in Advanced Solid Tumors

The purpose of this first-in-human study, CTMX-2051-101, is to characterize the safety, tolerability, and antitumor activity of CX-2051 in adult participants with advanced solid tumors.

The study is comprised of 2 parts. Part 1 involves CX-2051 dose escalation to identify the maximum tolerated dose (MTD) of CX-2051. Part 2 (dose expansion) will further assess safety and tolerability as well as preliminarily assess antitumor activity of CX-2051 in indication-specific expansion cohorts.

Eligibility Criteria:
Inclusion Criteria:

* Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Measurable disease per RECIST v1.1
* Consent to fresh biopsy or if medically contraindicated, recent (within 6 months) archival tumor tissue
* Additional inclusion criteria may apply

Exclusion Criteria:

* Recent history (within last 2 years) of localized cancers that are not related to the current cancer being treated
* Known active central nervous system (CNS) involvement by malignancy
* Systemic anticancer treatment, radiotherapy, or investigational agent(s) within 14 days prior to C1D1
* Previous treatment with antibody-drug conjugates (ADCs) with Topo-I inhibitor payload
* Major surgery (requiring general anesthesia) within 4 weeks prior to C1D1
* Elevated baseline laboratory values
* Serious concurrent illness
* Pregnant or breast feeding
* Additional exclusion criteria may apply
Brain Health in Midlife

The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.


Eligibility Criteria:
Inclusion Criteria:

* Participated in the ADORE trial ( R01 HD083292)

Exclusion Criteria:

* History of seizures or Epilepsy
* Pregnant at screening
* Ineligible to complete MRI due to metal in the body