cyrilzakka/clinical-trials huggingface dataset:
Backtracking Leukemia-Typical Somatic Mutations in Cord Blood

A comprehensive mechanistic and epidemiological study to obtain banked cord blood samples from consecutive childhood leukemia patients enrolled in the COG Project:EveryChild (APEC14B1) study. Will attempt to backtrack the initiating genomic alteration identified in the matched diagnostic leukemia sample and molecularly characterize pre-leukemic cells. The ultimate goal of this research is to pinpoint the cell of origin of leukemogenic alterations formed in utero, elucidating the etiology of these initiating mutations (as opposed to frank leukemia), and devising a test for circulating pre-leukemia that can be applied on a population-wide basis.

OBJECTIVES:

Primary Aim 1: To obtain stored cord blood and dried bloodspots of pediatric leukemia patients in Project:EveryChild.

Secondary Aim 2: To conduct preliminary backtracking and characterization of ALL- and AML-typical somatic mutations in cord blood and dried bloodspots.

OUTLINE:

Accrue patients with ALL and AML who indicate having banked cord blood at birth through the APEC14B1 intake questionnaire

Eligibility Criteria:
Inclusion Criteria:

* The patient must have a diagnosis of acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML).
* Stored diagnostic pre-treatment samples corresponding to the patient's original diagnosis of leukemia must be available for request from either the COG Biopathology Center or a treating institution
* The patient must be enrolled on APEC14B1 with consent to future contact and indicate that cord blood was stored at birth in the APEC14B1 registry intake data.
* The patient must also have been registered with COG by a North American (limited to the U.S. and Canada) member institution.
* ≤ 25 years old at the time of original diagnosis with ALL or AML
* The patient must be able to understand written and spoken English or Spanish
* All patients must provide their consent/assent, as appropriate, and for patients under the age of majority at least one parent or legal guardian must provide consent as well
* All institutional, FDA, and NCI requirements for human studies must be met

Exclusion Criteria:

* Patients who responded that cord blood was not stored at birth are excluded. Patients without stored diagnostic, pre-treatment leukemia samples at either the COG Biopathology Center or their treating institution are excluded.
Endocervical Lidocaine Spray for Pain Control During Office Hysteroscopy

lidocaine spray is used endocervical before office hysteroscopy to reduce the pain

5 sprays of Lidocaine is applied 3 minutes before office hysteroscopy

Eligibility Criteria:
Inclusion Criteria:

Patients indicated for diagnostic hysteroscopy for infertility or AUB. Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)

Exclusion Criteria:

Contraindication to office hysteroscopy Neurological disorders affecting the evaluation of pain. Previous cervical surgery.
Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression

The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:

* How the two formulations compare in terms of their effectiveness in treating TRD.
* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.

Participants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.

The TREK study is a randomized, prospective, rater blinded (primary outcome raters), parallel group, comparative effectiveness trial of racemic ketamine and Spravato®, comparing their effectiveness, acceptability, safety, effects on quality of life (QOL), function and cost effectiveness after 4 weeks - 6 months of treatment in people with TRD.

Participants will be recruited from clinics/hospitals that are providing racemic ketamine and Spravato® treatment services for TRD. Participants will be referred, treated and followed up as per the clinic's normal clinical practice. Participants who consent to participate in this research study will undergo other processes in addition to the standard treatment procedures provided by their clinic:

* Randomisation to receive racemic ketamine or Spravato®.
* Completion of questionnaires to measure treatment effects on mood, acceptability, safety, quality of life and function and cost effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)
* Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD
* Aged ≥18 years
* Written informed consent for research study obtained

Exclusion Criteria:

* Not able to give informed consent
* Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments
* Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales
Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals

This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained from the subject.
* Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
* Male and female healthcare professionals aged ≥18 years from selected hospitals.
* Healthcare professionals in frequent contact with patients in the hospitals.
* Agreeing for collection of a blood sample for the study.

Exclusion Criteria:

• Medical students working as healthcare professionals.
Neoadjuvant Propanolol in Breast Cancer

This trial is a Phase II study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .

* Patients will be recruited from the Garbar Breast Care Center and University Medical Center following diagnosis of invasive breast cancer by breast biopsy.
* The sympatholytic nonselective beta blocker propranolol will be administered to all participants in a non-randomized manner at an equal dose of 1.5 mg/kg/day.
* Following surgical resection of the tumor , the primary endpoint of this study is quantified by comparing the proliferative index of the tumor before propranolol administration (quantified using the initial tumor biopsy) and after 3 weeks of propranolol (quantified using the surgically resected tumor).
* Additional molecular analyses and evaluation of safety and toxicity will also be performed to better understand the effects of this treatment on breast cancers and patient adherence to the drug.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18- 65
* diagnosis of stage I-III breast cancer , confirmed by a core biopsy
* Planning to undergo definitive surgery including mastectomy or breast conserving surgery
* Systolic blood pressure must be \>100 mmHg but no more than 140 mmHg and/or diastolic \> 60 mmHg and no more than 95 mmHg.
* normal baseline EKG

Exclusion criteria:

* Pregnancy; potential subjects of female bearing age will have to complete a pregnancy test during screening to ensure that they are not pregnant. Potential patients who are post-menopausal must have confirmed one year without menstrual cycle.
* Free of major medical illnesses including:
* Uncontrolled Diabetes (HbA1c of ≤ 8 if previously tested)
* Uncontrolled hypertension: BP \>systolic 140/ diastolic \> 95
* Cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, any cardiac arrhythmia/bradycardia) with the exception of the diagnosed cancer.
* Histories of asthma, bronchospastic disease, or obstructive pulmonary disease
* Previously diagnosed thyrotoxicosis
* Severe allergic reactions to medications which are included in the beta blocker family
* Previously or currently treated with a beta adrenergic receptor antagonist
* Patients with locally advanced or inflammatory breast cancer not amenable to surgical resection
* Patients taking any of the following medications will be excluded:

  * Drugs that are categorized as digitalis glycosides, beta-blockers and calcium channel blockers, ACE inhibitors and alpha blockers
  * Amiodarone
  * Cimetidine
  * Ciprofloxacin
  * Delavudin
  * Dobutamine
  * Ethanol
  * Fluconazole
  * Fluoxetine
  * Fluvoxamine
  * Haloperidol
  * Imipramine
  * Isoniazid
  * Isoproterenol
  * Luvoxamine
  * Paroxetine
  * Phenytoin
  * Phenobarbital.
  * Propafenone.
  * Quinidine
  * Reserpine
  * Rifampin
  * Ritonavir
  * Rizatriptan.
  * Tenioposide
  * Theophylline
  * Thyroxine
  * Tolbutamide.
  * Warfarin
  * Zileuton
  * Zolmitriptan
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease

Approximately 90 patients, aged 50 to 80 years, with a diagnosis of early Alzheimer's disease will take part in this research study. This study will be conducted in the US. There will be 3 treatment groups: 2 Active doses and 1 group will receive placebo completely by chance. Patients, caregiver, Sponsor, nor study staff will know which treatment is assigned. There are 3 periods in this study: Screening to confirm suitability, Treatment to receive study medication, and Follow-up to check overall health post-participation

This is a randomized, placebo-controlled, double-blind, parallel-group study that will assess the safety, tolerability, and potential efficacy of Trappsol Cyclo in patients with EAD as defined according to the FDA Guidance for Industry on Early Alzheimer's Disease: Developing Drugs for Treatment. The study will enroll approximately 90 (30 patients/treatment arm) male and female patients aged 50 to 80 years at Screening with characteristic pathophysiologic changes of AD who meet National Institute on Aging-Alzheimer's Association (NIA-AA) criteria for either AD with MCI or mild AD collectively known as EAD (Stages 3 and 4). Enrolled patients must have evidence of progressive cognitive decline in the last year as determined by serial cognitive test scores, if available, or patient or informant/caregiver/study partner (hereafter called caregiver) report as documented by the Investigator

Eligibility Criteria:
Inclusion Criteria:

* MCI due to AD (Stage 3)
* MMSE-2:SV score 20 and 28 at both Screening (V1) and Baseline (V2) with no more than a 3 point change between visits
* Positive PrecivityAD blood test biomarker for AD with high APS (58-100) Locally or centrally read MRI of ARIA

Exclusion Criteria:

* Clinically significant renal disease
* Evidence of a neurodegenerative disease other than AD Severe hypothyroidism
* Abnormally low levels of serum Vitamin B12
* Lacks visual, auditory acuity and/or language abilities adequate to perform cognitive assessments
Efficacy of Hydroxycinnamates and Beta-glucans as a Dietary Tool Against Obesity (OBHEALTH)

The study aimed at assessing the effect of a decaffeinated green coffee extract, rich in hydroxycinnamates, oat beta-glucans or the combination of both bioactive compounds on overweight/obese subjects with hyperglycemia.

In a randomized, crossover, blind, three-arm study, volunteers consumed twice a day a nutraceutical providing 5 g/d beta-glucan (BG), 600 mg/d green coffee polyphenols (GC) or a combination of both (5 g/d BG + 600 mg/d GC). Each intervention stage lasted 8 weeks and was followed by a 4-week wash-out.

Blood, urine and fecal samples were obtained at the beginning and end of each intervention stage. Blood pressure, oral glucose tolerance test (OGTT) and body composition (body weight, anthropometry, bioimpedance) were measured at each control visit. Physical activity was controlled by accelerometry (1 week during each intervention stage). Energy expenditure was measured by calorimetry. Food intake was monitored by 3-d food records. Satiety was determined by subjective (VAS) and objective (weighting consumed food) records after consuming the nutraceutical during each intervention stage.

In a subset of volunteers (9), a pharmacokinetic study was performed to assess bioavailability and metabolism of polyphenols at the beginning and end of each intervention (GC and GC+BG only). In these volunteers, blood was taken at different times during 24 h; urine samples were also collected at different intervals during 24 h, and feces were obtained at 0 and 24 h approximately after consuming the nutraceuticals containing GC. A targeted metabolomic analysis was carried out in these samples. In these volunteers, incretins and hormones were also determined in blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Men and women, with BMI between 25-35 kg/m2
* Fasting blood glucose between 6,11-6,94 mmol/L (110-125 mg/dL) and/or
* Blood glucose between 7,77-11,04 mmol/L (140-199 mg/dL) 2 h after an oral glucose overload

Exclusion Criteria:

* Having other chronic pathologies different from overweight/obesity and prediabetes.
* On prescription drugs, hormones or dietary supplements (e.g. dietary fibre, pollen, vitamin complexes, etc.)
* Vegetarian
* Smoking
* Known hypersensibility/allergy to any of the tests products
* Pregnant women
* On dietary regimen or physical training to lose weight
The Effect of Auricular Press Needle on Visual Analogue Scale (VAS) and Short Form (SF-12) Scores in Chronic Pain With Depression Symptoms

Chronic pain is a medical and social problem that can significantly impact the quality of life. Chronic pain is an important risk factor in the development of depression. It is shown by the significantly higher prevalence of depression in individuals who experience chronic pain (20-80%). Apart from that, chronic pain and depression also have a close relationship in the development of disease and mutually influence the severity of each condition.

To reduce the cost of pain management from a pharmacological perspective and its use in the long term, it is necessary to consider other non-pharmacological treatment methods that have good therapeutic effects with minimal side effects. Acupuncture has become a non-pharmacological therapy option that has proven its effectiveness and safety in treating chronic pain in depressed patients. Previous literature has reported the effectiveness of acupuncture therapy, especially auricular acupuncture in treating pain. Auricular acupuncture therapy using press needles is quite easy to apply, fast, and can provide continuous stimulation with minimal side effects.

This study aimed to assess the effectiveness of the auricular needle press in chronic pain with depressive symptoms. This study was a double-blinded randomized clinical trial and was carried out on outpatients at Dr. Cipto Mangunkusumo National General Hospital Jakarta and Soerojo Hospital Magelang. This is also a collaborative study between the medical acupuncture department and the psychiatry department.

This study includes 60 participants who will be randomly allocated into 2 groups, the press needle and sham press needle groups. The press needles will be placed at 6 auricular points bilaterally, which are MA-TF1 Shenmen, MA-IC7 Heart, and MA-IT1 Cingulate gyrus.

The outcomes that will be assessed in this study are pain intensity using the visual analog scale (VAS) and quality of life using the short form-12 (SF-12) as well as time-to-event achievement in the form of a decrease in the VAS score \>= 14 mm.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 18-59 years.
* Subjects who experience chronic pain with symptoms of depression.
* Subjects with VAS \>= 30 mm and \< 70 mm from 100 mm during activity (daily activities or light exercise).
* Duration of pain \> 3 months.
* Patient Health Questionnaire-9 Items (PHQ-9) score 5-19 on a scale of 0-27.
* Willing to take part in this study until completion and sign the informed consent.

Exclusion Criteria:

* Pain caused by malignancy.
* Patients diagnosed with major depression, depressive symptoms accompanied by psychotic symptoms, and depressive symptoms with antidepressant therapy.
* Patients with medical emergencies or pregnancy.
* Infection, scar tissue, or malignancy at the acupuncture area.
* Anatomical abnormalities in the ear shape.
* Having hypersensitivity reaction to previous acupuncture therapy (metal allergy, atopy, keloid, or other skin hypersensitivity).
* Patients with cognitive impairment or impaired consciousness.
Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg

The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study
SPICE UP MyPlate - Strategy for Promoting Intake of Delicious Healthful Dietary Patterns Based on MyPlate: a Pilot Study

The aim is to conduct a pilot study to assess the feasibility, acceptability and potential effectiveness of culinary focused nutrition education to promote increased adherence to the Dietary Guidelines for Americans compared to standard low-intensity care.

This is a 15-week, 2-arm randomized controlled pilot trial. In a 1:1 ratio, participants will be randomized to the intervention arm or the control arm. The intervention group will receive a 12-week culinary focused nutrition education program. The control group will receive standard low-intensity care (i.e., printed healthy eating material). Outcome measures will be assessed at baseline and 15 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 31-59 years
* Involved in meal cooking at home and consumes a home cooked meal ≥ 1 time per week
* Individuals taking medications for blood pressure, lipid or glucose lowering will be eligible if they have been on a stable dose for the 1 month prior to baseline

Exclusion Criteria:

* A member of the household is already enrolled (only one person per household will be eligible for inclusion in the study).
* Unstable medical conditions requiring active intervention (surgeries, medication/drug therapy for \< 3 months) as assessed during the telephone screening (e.g. cancer, kidney disease requiring dialysis, heart or gastrointestinal diseases requiring surgery).
* Received nutrition education for a medical condition within the past 6 months
* Currently following a weight loss diet
* Lost ≥ 10% body weight in the past 6 months
* Currently (within 6 months) smoke or use any tobacco or nicotine containing products
* Currently pregnant or given birth within the prior 6 months
* Currently participating in another clinical trial
* Principal investigator discretion (e.g., disrespectful or inappropriate interactions with study staff)
* Does not speak or understand English
Predicting Infant Extubation Using Diaphragm Surface Electromyography

This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

This study aims to assess whether the electrical signal of the diaphragm (diaphragm electromyogram) and the ratio of that to tidal volume (amount of air breathed in and out of the lungs) can predict which infants will be successfully extubated (have the breathing tube removed without needing it replaced.)

Eligibility Criteria:
Inclusion Criteria:

* intubated and mechanically ventilated on NICU

Exclusion Criteria:

* major congenital abnormalities
Wide Diameter Bone Anchored Implant Study

To assess implant stability, implant loss, adverse skin reactions, and Quality of Life Benefit following implantation of the Ponto 4.5mm Wide Diameter implant. Secondary: to determine the feasibility of fitting the sound processor 3 weeks after surgical implantation, and to investigate if the type of skin reactions following implantation could be related to the demographic data of subjects and the type of surgical technique used

Bone-anchored hearing systems have been an amplification choice for conductive, mixed, and profound, unilateral, sensorineural hearing loss for over three decades. So far, about 75,000 patients worldwide have received this surgical intervention (bone-anchored hearing system), since its first successful implantation in 1977. In 2009, Oticon Medical, LLC launched its bone-anchored hearing system called Ponto. In just over two years, the Ponto has been successfully implanted in over 3,000 patients by leading otolaryngologists and neurotologists in 18 countries worldwide.

The Ponto implant has previously been available with a 3.75mm diameter and comes in two lengths: 3mm and 4mm. Anew Ponto implant that is 4.5mm wide in diameter is now available in both 3mm and 4mm lengths. This Wide Diameter implant is designed to maximize bone-to-implant contact area and enhance implant stability which can potentially allow loading of the sound processor as early as 3 weeks after surgery. The abutment screw incorporates external threads at the screw head to make it possible to connect a SmartPeg (Osstell, Goteborg, Sweden) for stability measurements. All Ponto implants have the same universal implant-abutment interface. Therefore, they are fully compatible with existing instruments and abutments. Two new countersinks have been developed for the new Ponto Wide Diameter implant. The drill size of the countersink is 3.80mm. It is marked with a "W" to separate them from existing drills. All products are CE-marked and cleared for the US market by the FDA.

Objectives The present study will attempt to show that the Ponto 4.5mm Wide Diameter implant has similar or better outcomes in terms of Quality of Life (QoL) benefit; implant extrusion and revision surgery when compared to the 3.75mm diameter implant. Secondary objectives to be studied will include adverse skin reactions, the feasibility of fitting the sound processor three weeks after surgical implantation, and investigation to see if the type of skin reactions observed following implantation could be related to the demographic data of subjects or the type of surgical technique used.

Study Design This study is a prospective, multicenter study of subjects' demographic and implant data. Subjects will be enrolled at two US sites.

Subject Population Twenty adult subjects 18 years or older will be included in the study from each participating partner site.

Eligibility Criteria:
Inclusion Criteria:

* conductive, mixed or single sided deafness
* 18 years of age or older

Exclusion Criteria:

* younger than 18 years of age