cyrilzakka/clinical-trials huggingface dataset:
Tamibarotene and Arsenic Trioxide for Relapsed Acute Promyelocytic Leukemia

Subjects have acute promyelocytic leukemia (APL) that has come back (relapsed) after initial treatment or has not gone away with initial therapy. This research study involves testing an investigational drug called Tamibarotene in combination with standard treatment for relapsed APL called arsenic trioxide. Tamibarotene has been approved in Japan to treat patients with relapsed APL since April 2005. Tamibarotene is in the same family of drugs as all-trans retinoic acid (ATRA), a medication that subjects received previously in their treatment. ATRA and tamibarotene both cause the APL cells to differentiate (or become) normal non-leukemia cells. Laboratory studies of tamibarotene have shown to be effective in APL. The purpose of this study is to determine if tamibarotene in combination with arsenic trioxide is safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* Must have diagnosis of relapsed APL
* Must have completed any prior cancer treatment at least 6 months prior to study
* Must have had prior treatment that included ATRA
Adiposity, Cardiometabolic and Neurocognitive Health Among Ethnic Groups: a Feasibility and Pilot Study

The goal of this pilot and feasibility study is to is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at Kings College Hospital NHS Foundation Trust (KCH).

The main aim is to assess and compare anthropometric measurements of adiposity (weight, Body Mass Index (BMI), Waist Circumference (WC), Waist-to-Hip ratio (WHR), Neck circumference (NC)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background.

Participants will come at KCH for one visit and will have their anthropometric measurements and cardio-metabolic profile assessed. They will also perform questionnaires on lifestyle, socio-economic status and neuro-cognitive health during their visit.

The first objective of this study is to test the feasibility of conducting a cross-sectional study on adiposity and cardiometabolic and neurocognitive risk factors at Kings College Hospital NHS Foundation Trust.

The second objective is to assess and compare anthropometric measurements of adiposity (weight, Body Mass Index (BMI), Waist Circumference (WC), Waist-to-Hip ratio (WHR), Neck circumference (NC)), liver fat (hepatic steatosis and fibrosis), cardiometabolic risk factors (dyslipidemia, insulin resistance, hypertension) and neurocognitive risk factors among participants, according to their ethnic background.

The third objective is to test the feasibility of assessing cognitive function, in relation to adiposity, by using standardised tests measuring cognitive function (MMSE, MoCA or an adapted version) among ethnic groups of various education levels and literacy, lifestyle and from different cultures. Our objective is also to test the feasibility of using lifestyle questionnaires \[Food Frequencies Questionnaires (FFQ) and International Physical Activity Questionnaires -(IPAQ-S)\] in various ethnic groups with regard to geographic variation (urban, rural).

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥18 years old
* Body mass index (BMI) ≥ 30 kg/m2

Exclusion Criteria:

* Severe obesity (BMI \> 50 kg/m2)
* Pregnancy (positive urine hCG) or a recent pregnancy (in the past 6 months)
* Known active chronic hepatic diseases
* Known diagnosis of human immunodeficiency virus
* Pre-established diagnosis of advanced renal failure (estimated Glomerular Filtration Rate (eGFR) \<30 ml/min)
* Diagnosis of decompensated heart failure
* History of bariatric surgery
* Uncontrolled thyroid disease
* Current use of the following medication: steroids (oral or injections only), weight-loss medication including over-the-counter products, glucagon-like peptide 1 (GLP-1) agonists , Sodium-Glucose Transport Protein 2 (SGLT2) Inhibitors
Effects of Dehydroepiandrosterone (DHEA) in Humans

The purpose of this study is to determine whether bringing back the DHEA levels of older persons to the young range produces beneficial effects.

DHEA and DHEA sulfate (DHEAS) plasma concentrations peak at about 20 years of age and decline rapidly and markedly after age 25 yr. DHEA is a PPAR-alpha activator. PPAR-alpha plays major roles in regulating lipid metabolism and controlling inflammation. DHEA also appears to have anabolic effects on muscle and bone. The study is designed to determine the effects of 12 months of DHEA replacement in 65-75 year old women and men on (a) truncal and visceral fat, (b) insulin resistance and serum triglycerides, (c) muscle mass and strength, (d) bone mineral density, (e) chronic inflammation, (f) arterial-endothelium-dependent vasodilation, and (g) sense of well being.

The specific aims of this study are to test the hypotheses that 12 months of DHEA replacement will (a) Result in significant decreases in truncal and visceral fat by shifting metabolism to fat oxidation and increasing energy wastage; (b) Decrease insulin resistance and decrease serum triglycerides; (c) Increase muscle mass and strength, by decreasing catabolic stimuli and increasing anabolic stimuli; (d) Increase bone mineral density by increasing anabolic stimuli and decreasing catabolic stimuli; (e) Reduce chronic inflammation and decrease pro-inflammatory cytokine production by peripheral blood mononuclear cells; (f) Improve arterial endothelium dependent vasodilation; and (g) Improve general sense of well being.

Eligibility Criteria:
Inclusion Criteria:

* 65 to 75 years old
* Physically healthy
* Non-smoker
* On stable medications for at least 6 months
* Stable body weight for the past year

Exclusion Criteria:

* Serious active medical problems
* Hormone therapy
* Abnormal PSA (prostate specific antigen) in men
Dose-ranging, PK, Safety, Efficacy Study of Osanetant in Patients With Moderate/Severe VMS Associated With Menopause

In this clinical research study, subjects will be given the study drug, ACER-801 (osanetant) or placebo (looks like the study drug but contains no active ingredients). The study drug works on a receptor in the brain and the intended purpose is for the study treatment of moderate to severe Vasomotor Symptoms (VMS) also referred to as hot flashes or flushes associated with menopause. Hot flashes are a change in your temperature that occurs due to changes in your hormones.

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study in post menopausal women in which the pharmacokinetics, safety and efficacy of ACER-801 (osanetant 50 mg twice daily \[BID\], 100 mg BID, and 200 mg BID) will be compared to placebo.

Subjects will enter a Screening Period to determine eligibility. Subjects will be required to complete hot flash diaries for 2 weeks prior to randomization. Eligible subjects will be admitted to a Clinical Research Unit and remain in the clinic for 14 days after completion of treatment and all study assessments. The study includes a 14 day safety follow-up assessment. Subjects will be randomized in a 1:1:1:1 ratio.

Eligibility Criteria:
Key Inclusion Criteria:

1. Post-menopausal female subjects 40-65 years of age, inclusive.

   Menopause will be defined as:
   1. At least 12 months of spontaneous, continuous amenorrhea, or
   2. At least 6 months of spontaneous, continuous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/mL at screening, or
   3. At least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
2. At baseline women:

   1. With an average number of moderate to severe hot flashes/day for 2 weeks prior to randomization (per continuous hot flash diary).
   2. That have a change of \< 50% in average 24-hour hot flash frequency 2 weeks prior to randomization.

      * Moderate: defined as sensation of heat with sweating, able to continue activity.
      * Severe: defined as sensation of heat with sweating, causing cessation of activity.

Key Exclusion Criteria:

1. Any active comorbid disease deemed by the investigator to be clinically significant, which could impact safety during study conduct including renal or hepatic impairment.
2. Use of any prohibited medications.
3. Body mass index (BMI) \>35 kg/m2.
4. Any active ongoing condition that could cause difficulty in interpreting vasomotor symptoms.
5. Inability to complete questionnaires and continuous hot flash diary for any reason.
6. Subjects who, in the opinion of the investigator, should not participate in the study for any other reason.
Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma

This is a first in human, phase 1, multicenter, open-label study to determine the safety and tolerability of IGM-2644 as a single agent in participants with relapsed and/or refractory MM, for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate. Dose escalation and dose expansion cohorts will be enrolled to evaluate safety, preliminary efficacy, and further define a RP2D. The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 60 months.

Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage. The escalation stage will investigate single agent IGM-2644 safety and tolerability in patients with relapsed and/or refractory multiple myeloma. The dose expansion cohort(s) will further evaluate safety, PK/PD, and preliminary efficacy of the recommended phase 2 dose (RP2D).

IGM-2644 will be administered intravenously (IV).

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years at time of consent
* ECOG performance status of 0 or 1
* Relapsed and/or refractory multiple myeloma after ≥ 3 prior lines; Must have failed treatment with an IMiD, PI, and anti-CD38 therapy
* Measurable disease per the IMWG response criteria
* Adequate marrow and organ function without transfusion or growth factor support within 7 days prior to screening
* Willing and able to undergo bone marrow aspirate and biopsy per protocol

Exclusion Criteria:

* Inability to comply with study and follow-up procedures
* History of clinically significant primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia or myelodysplastic syndrome
* Received chemotherapy, biologics, or small molecule therapy within 21 days or 5 half-lives, whichever is shorter
* Use of any non-approved or investigational agent ≤ 4 weeks prior to the first dose of study drug.
* Received last prior anti-CD38 monoclonal antibody treatment within 28 days before first planned dose of the study drug
* Current Grade \> 1 toxicity, with the exception of Grade 2 peripheral neuropathy, alopecia, or toxicities from prior anti-tumor therapy that are considered irreversible
* Large-field radiotherapy within 28 days prior to Day 1 (radiation to a single site as concurrent therapy is allowed)
* Prior autologous stem cell transplant within 180 days prior to Day 1
* Prior allogeneic stem cell transplant
Dysregulation of the C/EBPa Pathway in Human Lung Cancer and Search for New Biomarkers and/or Therapeutic Targets

The overall goal of this research is to enhance the investigators understanding of the pathways involved in lung cancer, and to identify new biomarkers and/or therapeutic targets. By comparing gene expression between normal lung tissue and tumors growing in lung-specific C/EBPa KO mice, the investigators have identified the Bmi-1 proto-oncogene as being abnormally upregulated in C/EBPa-deleted tumors. Subsequently, the investigators have validated this observation in human lung cancer, implicating the investigators KO mice are an effective discovery tool for lung cancer research. Through similar approaches, the investigators have already identified (Sonic Hedgehog, SHH), and plan to identify other pathways which are abnormally regulated in C/EBPa-/- tumors. In parallel, the investigators will proceed to define the clinical relevance of the SHH pathway and the other newly-discovered molecular aberrations, by analyzing their expression and correlate it to C/EBPa expression on the samples of patients with NSCLC at NUHS. If the investigators preliminary data on Bmi-1 will be confirmed, this proto-oncogene may generate useful correlates that could be used in diagnosis and treatment of lung cancer, as well as identify new prognostic/predictive markers in lung cancer. Similarly, SHH pathway-components may behave as potential biomarkers and therapeutic tools for C/EBPa-related lung cancers.

This proposal seeks to test the hypothesis that pathways which are dysregulated in lung tumors growing in a lung-specific C/EBPa KO model can be utilized as discovery tools to identify genes involved in human lung cancer pathogenesis.


Eligibility Criteria:
Inclusion Criteria:

Patients with lung cancer
THE EFFECT OF MOTHER'S VOICE AND LULLABY ON PRETERM INFANTS' PHYSIOLOGICAL PARAMETERS, STRESS AND SLEEPING- WAKING STATE

The study was planned in a randomized controlled manner in order to evaluate the effect of mother's voice and lullaby on stress and sleep-wake situations of premature babies.

Objective:This randomized controlled study was carried out to evaluate the effect of mother's voice and lullaby on preterm infants' stress and sleeping-waking states.

Study design:The study was carried out in a newborn unit in a public hospital in Turkey. In this study, 90 preterm newborn were divided into three groups equally as mother's voice (n=30), lullaby (n=30) and control groups (n=30). Data were obtained by Mother and Newborn Identification Form, Newborn Stress Evaluation Form (NSEF) and Newborn Sleepıng-Wakıng State Evaluation Form (NSWEF). On the 1st, 3rd and 5th days of the study; Newborns' NSEF and NSWEF scores at pre-, post-study and on the fifth minutes were evaluated. Data were evaluated by using descriptive statistics, homogeneity tests, chi-square, intra-class correlation coefficent, two way of analysis on repeated measures, generalized linear model, pearson correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

* 32 0/6 -36 6 weeks of gestation
* Not connected to respiratory support device
* No surgical intervention
* Not receiving medical treatment other than appropriate vitamin supplements and antibiotic treatments
* Does not have a congenital or acquired malformation related to hearing,
* Can tolerate enterally given food (no NEC, digestive system and chromosomal abnormalities)
* The mother is at least a primary school graduate
* Diabetic mother without a baby • SGA and no IUGR

Exclusion Criteria:

Premature babies who do not meet the inclusion criteria.

-
The Long-term Benefit of Hydrogel Spacer in Reducing Rectal Radiation Dose in Cervical Cancer Radiation Therapy.

This study is an exploratory study based on the previous study " A prospective, multicenter, randomized, parallel arm-controlled, superiority clinical study to evaluate the role of hydrogel spacer in reducing rectal radiation dose in cervical cancer radiation therapy", in which additional follow up study on the subjects of the previous study were conducted. Subjects (6 subjects in Phase I; 100 subjects in Phase II, 50 in the test group and 50 in the control group) who completed the pre-study will be enrolled in this study if they are willing to participate in the long-term follow-up by signing the informed consent form.

The purpose of this study is to evaluate the long-term benefit of hydrogel spacer when hydrogel is injected between the rectum and cervix in women undergoing radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Karnofsky score ≥ 70. Subjects aged ≥ 18 years and ≤ 75 years. Subjects must be able to cooperate in completing the entire study. The subjects' pelvic and abdominal cavity and joints are free of metal implants and can tolerate MRI.

No contraindications to CT scanning. Subjects must be able to understand the purpose of the trial, voluntarily participate and sign an informed consent form

Exclusion Criteria:

* Subjects whose target tumors have been previously treated (chemotherapy, immunotherapy, surgical treatment, etc.) Subjects with other primary malignancies Subjects with contraindications to radiotherapy, as determined by the investigators Subjects with injection site infections. Subjects who are allergic to the ingredients of the device. Subjects whose tumors invade the injection site and affect the injection process and injection safety, as determined by the investigators Persons with severe mental illness, cognitive impairment and thinking disorders.

Participants in other drug clinical trials or medical device clinical trials 1 month prior to screening Pregnant or lactating women or those who plan to get pregnant within the last six months Subjects who cannot be followed up as prescribed by the doctor Other conditions that, in the judgment of the investigator, make the subject unsuitable for enrollmen
Diagnostic Approach for Cholangiocarcinoma Using Liquid Bile Biopsy

The main aim of the study is to develop a diagnostic proteomic profile of cholangiocarcinoma using bile samples. The primary endpoint will be the rate of concordant positive diagnoses obtained from bile samples based on proteomic profiling compared with histological reference diagnoses (concomitant cytological sampling and/or final histological sampling).

Cholangiocarcinoma has a poor 5-year prognosis (less than 5%) and is rarely resectable at diagnosis. Diagnosis is made by histological sampling (biopsy or endo-biliary brushing) during endoscopic retrograde catheterization of the papilla or radiologically during transparietohepatic drainage. Conventional histology techniques have a low sensitivity of around 14-60%, which leads to diagnostic delays, repeated invasive examinations and delays in therapeutic management, sometimes with progression from a resectable to an unresectable stage.

New techniques are emerging to optimize the diagnosis of cholangiocarcinoma, in particular molecular techniques. This is the case with proteomics and proteomic profiling, which consists of obtaining diagnostic information from all the proteins contained in biological samples.

Furthermore, during diagnostic procedures for cholangiocarcinoma, bile samples are taken, initially for bacteriological purposes. Proteomics has been shown to be a tool capable of identifying potential diagnostic biomarkers in bile samples. To date, proteomic profiling has never been tested on bile samples for diagnostic purposes, although its proof of concept has been established.

Obtaining a proteomic profile for the diagnosis of cholangiocarcinoma from bile samples would enable the development of an innovative tool that has not yet been described in this field. It would optimize the management of patients with cholangiocarcinoma, with the possibility of a quicker diagnosis enabling optimal management as soon as the first clinical symptoms appear, while reducing the number of examinations required to obtain a diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years and older
* Patients with bile duct stenosis who require endoscopy with retrograde papillary catheterization or a radiological procedure for diagnostic purposes (histological samples) as part of their management
* Oral consent

Exclusion Criteria:

* Pregnant woman
* Patient under legal protection
Flavor Test Results in General Population

Dietary choices are influenced by several factors, including physiological, social or genetic factors. Among these, flavor is the most important determinant modulating the preferences versus specific foods.

Flavor perception is the result from the sensory integration of taste and odor properties of food.

Aim of the present study was to assess flavor abilities in a large population using a validated perceptive test.

This protocol investigates flavor perception using the flavor test, a specific test to assess the retro-nasal olfactory function.

A decrease in taste and smell abilities can result in loss of appetite, inadequate dietary intake and malnutrition. Several diseases and conditions have been associated with taste disorders and a decline in gustatory function is very common in the elderly.

The flavor test was previously developed, validated and patented by our group. It consists of a series of 20 aromatic extracts, corresponding to routine dietary use flavors for Italian people.

Each tastant, originally stored in a 30 mL amber bottle, is diluted in distilled water and stored at 4 °C, then it is kept at room temperature for 20 min before administration.

An aliquot of approximately 0,5 mL of each tastant is administered in the oral cavity using a 3mL Transfer Pipet and left for approximately 5 seconds; the mouth is then rinsed twice with distilled water before the administration of the following tastant.

At each administration, participants are invited to identify the aromatic by making a choice from 5 proposed items. A total of 21 aromatics (including one blank) are administered sequentially. The flavor score (FS) is calculated as the sum of correctly identified aromatics and ranged from 0 to 21.

Eligibility Criteria:
Inclusion Criteria:

Age ≥ 18 years

Exclusion Criteria:

Allergies, drug usage
Safety Study of Prucalopride in Healthy Volunteers

In this study healthy volunteers received increasing doses of prucalopride to study the tolerability and cardiac safety of prucalopride. The study hypothesis was that prucalopride at doses up to 10 mg has no clinically relevant effect on the cardiovascular safety in healthy volunteers.

Single-centre, double-blind, placebo-controlled, cross-over study in 33 healthy volunteers with 2 sessions. Each session consisted of a run-in day for baseline assessments, 8 treatment days and 5 additional days for followup assessments. Subjects were randomised to start with either the prucalopride or placebo session. The prucalopride dose was consecutively escalated in 2 mg steps per day, starting from 2 mg up to 10 mg once daily If a subject did not tolerate the 10- or 8-mg dose, 1 step back in the dosage scheme was allowed, from 10 to 8 mg on Day 6, or from 8 to 6 mg on Day 5. Subjects with intolerance for doses of less than 6 mg, were withdrawn from the study. Repeated dosing (6, 8 or 10 mg) was continued once daily until Day 8, to achieve steady-state. During placebo, the number of placebo tablets was consecutively escalated in an identical way as described for prucalopride. Between the 2 sessions, there was a washout period of 14 to 21 days, to avoid any carry-over effect.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 45 years.
* Normal weight.
* Healthy on the basis of a pre-study physical examination, medical history, anamnesis,ECG, 24-hour Holter monitoring, echocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomisation.

Exclusion Criteria:

* History or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse.
* Smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection.
* History of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g. ischaemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis,Parkinsonism.
* Presence of prolonged QTc (Bazett) on ECG at screening (QTc \>450 ms in male subjects, QTc \>470 ms in female subjects).
* Use of concomitant medication, except for oral contraceptives and paracetamol.
* Participation in an investigational drug study in 30 days prior to the first visit.
* Donation of blood in the 60 days preceding the first visit.
* Pregnancy or breast-feeding female.
* Female subjects of childbearing potential without adequate contraceptive protection during the study.