cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis

The objective of the study is to evaluate the safety and efficacy of a topical lotion.

The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, of any race, at least 18 years of age (inclusive).
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers

Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.


Eligibility Criteria:
Inclusion Criteria:

1. healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
2. Volunteers without apriority of chronic disease
3. Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
4. Volunteers who comply with the protocol, understand and sign an informed consent

Exclusion Criteria:

1. Sensitive response to acebrophylline and xanthine
2. Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
3. Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
4. Known history of gastrointestinal disease which affects the absorption of medicine.
5. Excluded by screening tests
6. Upper limit of AST, ALT\>1.25 times Upper limit of total bilirubin\>1.5 times
7. Estimated GFR\<80mL/min/1.73m2)
8. systolic blood pressure \< 90 or \> 150, diastolic blood pressure \<50 or \>100
9. Known history of drug abuse
10. caffeine\>5cups/day, alcohol\>210g/week, 10 more cigarettes/day
11. Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
12. Participation in any clinical investigation within 60 days prior to study start
13. Donation of blood within 60 days, donation of component blood within 30days
14. Judged by the investigators to be undesirable as subjects
Evaluation of the TAC Program

This is a mixed-methods evaluative study examining the effectiveness of the Transition to Adult Care Program at the Hospital for Sick Children (TAC) Program on high-risk youth with medical and psychosocial complexity transitioning to adult and/or primary care services.

The overarching aim is to study the effectiveness of a new interdisciplinary and holistic Transition to Adult Care Program (TAC) on health-related outcomes for high-risk youth with multimorbidity or rare diseases and their caregivers by:

1. Assess the effect of the TAC program on the youth's transition readiness, self-efficacy, self-management, health-related quality of life, and satisfaction.
2. Assess the effect of the TAC program on the caregiver's satisfaction.
3. Explore the experiences, perceptions, needs, and priorities of youth and caregivers participating in the TAC program using qualitative research methods.
4. Describe the feasibility of the TAC program (defined as success in patient recruitment, attendance, participation, retention and transfer).


Eligibility Criteria:
Inclusion Criteria:

Aged 16-18 years old and have a complex medical history, as defined by:

1. Clinical Characteristics: Multi-morbidity (≥ 3 long-term chronic physical and/or mental health conditions (with primary condition being a physical health condition AND/OR Rare disease/ genetic condition.
2. High Risk: No clearly identified adult provider/services following transfer AND/OR experiencing significant barriers related to Social and Structural Determinants of Health.

Exclusion Criteria:

1. Moderate to severe developmental/intellectual disabilities
2. Followed by services at SickKids which has an established transition program/provider
3. Does not provide consent
Transradial Versus Transulnar Artery Approach for Coronary Interventions

The transradial route is increasingly used as an access site in percutaneous coronary interventions, as it is considered equivalent to transfemoral approach in terms of efficacy but with a decreased vascular complication risk. Information concerning the efficacy and safety of transulnar approach is sparse. This is a prospective, randomized, investigator-initiated study to compare transradial versus transulnar approach as a default strategy for coronary angiography, ad-hoc or elective percutaneous coronary intervention (PCI). Consecutive eligible patients with an indication for coronary angiography, will be randomized after written informed consent in a 1:1 ratio to either transradial or transulnar access. Assessment of angiographic and procedural characteristics(including amount of contrast medium, arterial access, fluoroscopy and procedural time), as well as any vascular or other peri-procedural complications of the cases enrolled, will be performed. After hospital discharge, all patients will return at Day 60 ±5 days for Doppler ultrasound assessment of the forearm vessels and documentation of major adverse cardiovascular events (defined as death, myocardial infarction, target vessel revascularization and stroke. Coronary angiography patients will be additionally randomized in a 1:1 ratio to either 2500 or 5000 IU of unfractioned heparin.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Plan for Coro- and ad hoc PCI, if necessary
* Written informed consent

Exclusion Criteria:

* Cardiogenic shock, haemodynamic instability, Killip class III
* Chronic hemodialysis
* Coronary artery bypass grafting (CABG) with either bilateral internal mammary artery (IMA) or bilateral radial artery use
Combined Use of a Novel Cardioplegic Formula With MPS® Versus Cardioplexol ® in Urgent Isolated CABG Using MiECC in Patients With Recent Acute Myocardial Infarction

The goal of this study is to compare the two cardioplegia solutions (blood cardioplegia by means of MPS ® vs. Cardioplexol ®) regarding perioperative outcome and with special attention to cardiac markers in patients with a recent heart attack.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent a CABG using MPS® or Cardioplexol ®
* Heart attack less than 7 days before surgery

Exclusion Criteria:

* use of other cardioplegia solution than Cardioplexol ® or MPS®
* other inventions than CABG
* explicit will of the patient that his data may not be used
* denied general consent
Empathy in Action: Sunshine Calls for Life With Diabetes

Randomized controlled trial of the effectiveness in managing diabetes and improving mental health through a telephonic layperson-delivered empathy and relationship-focused program for patients at a Federally Qualified Health Center (FQHC) against usual care.

In this study, we will assess the effectiveness of a 6-month program delivered by phone by lightly-trained lay people to individuals with diabetes, with the goal of empathetic relationship building and engagement to support day-to-day challenges of managing diabetes and working towards self-management goals. We will recruit from a collaborating Federally Qualified Health Center (FQHC) and use a randomized controlled trial, comparing program to usual care. Telephone callers will be lay people (no formal health training) who will be recruited for authentic interest and empathetic skills and lightly trained on conversational skills, cultural nuances, and how best to support people's individual lifestyle goals on nutrition, exercise, sleep and medication adherence. Callers will encourage participants to seek additional help from their clinic or specific social services as needs arise that benefit from early escalation.

Eligibility Criteria:
Inclusion Criteria:

* HbA1c ≥ 7.5% at baseline measurement and 8.0% at least one time 12 months prior to study enrollment.
* At least one visit with Lone Star Circle of Care within the past 12 months (in person or telehealth)
* Willing to answer the PHQ-9 form in its entirety at baseline data collection (due to stratified randomization design).

Exclusion Criteria:

* HbA1c \< 7.5% at baseline measurement.
* Refusal to answer the PHQ-9 form in its entirety at baseline data collection.
* Moderate to severe cognitive impairment
* Currently pregnant (if of female sex)
* Undergoing cancer treatment
* Having diagnosis of end-stage renal disease or serious mental illness
* Having moderate to severe cognitive impairment
* Receiving systemic treatment with prednisone or immunosuppressant therapy following an organ transplant
Novel Endpoints in Cough Challenge Testing

The sensitivity of a person's cough reflex can be measured by getting them to breathe in (inhale) irritant chemicals. There are different methods by which subjects are asked to inhale these chemicals, either by taking one deep breath in, or by asking them to just continue to take a number of breaths. The purpose of this clinical research study is to see if the coughing responses are different in healthy people and people with respiratory problems that make them cough when they are given these chemicals in these two methods.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects aged 18 and over.

Meet criteria for subject groups as outlined below:

Healthy volunteers:

* Must be non smokers.
* No history of respiratory disease.

Healthy smokers:

* Current smokers with at least 10 pack year history of smoking.
* Spirometry within normal limits i.e. FEV1 \> 80% predicted and FEV1/FVC ratio of \> 75% predicted.

Asthma:

* Physician diagnosis of asthma
* Stable asthma.
* Airway hyperresponsiveness to methacoline; PC20\< 16mg/ml.
* Non smokers or ex-smokers with smoking history of less than 10 pack years.

COPD:

* Physician diagnosis of COPD
* Ex smokers with smoking history of at least 20 pack years
* Spirometry demonstating evidence of airflow obstruction i.e. FEV1/FVC ratio of \< 70%

Chronic cough:

* History of dry cough for at least 8 weeks.
* Normal chest x ray.
* Non smokers or ex smokers of less than 10 pack years history of smoking.

Exclusion Criteria:

* Symptoms of upper respiratory tract infection within the last 4 weeks.
* Participation in another clinical trial of an investigational drug within 4 weeks.
* Use of medication likely to alter cough reflex sensitivity i.e. ACE inhibitors, codeine phosphate, morphine sulphate.
* Patients with severe respiratory disease i.e. FEV1 \< 1.0 litre.
* Use of steroid tablets in previous 2 months or taken more than 3 courses of steroid tablets in the preceding 12 months in subjects with asthma or COPD.
* Change in asthma treatment in the preceding 6 weeks in asthma group
* Significant medical co-morbidities likely to affect ability to participate in the trial or affect cough reflex sensitivity e.g. diabetes, stroke, Parkinson's disease, multiple sclerosis etc.
BRCA1/2 and Effect of Mifepristone on the Breast

Ovarian steroids, as well as their synthetic counterparts gestagens and estrogens have a role in breast cell proliferation and the development of breast cancer. Here, the effect of a progesterone receptor modulator, mifepristone, on cell proliferation in human breast tissue in vivo will be studied in women with BRCA-1 or -2 mutations. Our preliminary results implicate a possible protective effect of mifepristone in breast epithelium. The ability of mifepristone to block breast epithelial cell proliferation may prevent tumorigenesis and may also prove beneficial when used for contraceptive purposes and on other indications. The proposed project concerns a Randomized Controlled Trial on mifepristone versus placebo treatment of women with BRCA-1or -2 mutations with a high risk/incidence of breast cancer and ovarian cancer.

Objectives • Research objective To study the safety and effect of treatment with mifepristone, a progesterone receptor modulator, on epithelial cell proliferation in human breast tissue in women with BRCA-1 or -2 mutations prior to protective mastectomy.

Project description

• Hypothesis/ Theory Mifepristone treatment exerts an antiproliferative, protective effect on breast tissue in women with BRCA-1 or -2 mutations

Study Design Randomized, double blind, placebo controlled trial. Women will be recruited among patients with BRCA-1 or -2 mutations scheduled for prophylactic mastectomy. Included women will be randomized to a 3-month treatment with mifepristone, 50 mg (Mifegyne, Exelgyn, Paris, France) or placebo taken orally every second day. Breast biopsies will be obtained in the luteal phase prior to start of treatment and again during surgery.

Eligibility Criteria:
Inclusion criteria:

* Pre-menopausal women, \>/= 18 years of age
* with good general health and
* regular menstrual cycles (25-35 days) who are willing and
* able to participate after giving informed consent.
* women having BRCA1/2 mutation and have decided to undergo risk reducing mastectomy

Exclusion criteria includes:

* Any hormonal treatment used within 2 months prior to study start and
* Any contraindication to mifepristone
Development of a Standardized Reference Guide for Tuning Adherence to Dispense During a Initial Pharmaceutical Consulting (CP ) to the Patient With Multiple Myeloma Oral Chemotherapy Primocure

The hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment.

The aim of this study is therefore to develop a standardised reference guide of information to be provided during prostate cancer in order to optimise the compliance of patients treated for multiple myeloma as a first course of chemotherapy per os.


Eligibility Criteria:
Inclusion criteria

* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.

Criteria for non-inclusion

* The subject is participating in another study
* The subject is in an exclusion period determined by a previous study
* The subject is under the protection of justice, guardianship or curatorship
* It is impossible to give informed information about
* The patient is pregnant, parturient, or breastfeeding
* The patient receives a follow-up by a home nurse for the administration of oral medication
* The patient is treated only with oral chemotherapy in the city
* The patient has early dementia.

Translated with www.DeepL.com/Translator

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Autologous Mesenchymal Stem Cell Transplantation in Liver Cirrhosis

This study is aiming to investigate the efficacy of autologous mesenchymal stem cell (MSC) transplantation in 25 randomized patients with liver cirrhosis autologous mesenchymal stem cell will be derived from patients' bone marrows and will be infused via peripheral vein. Liver biopsies will be performed in every patient in the beginning and at 6th month.


Eligibility Criteria:
Inclusion Criteria:

* radiological, clinical and histopathological diagnosis of liver cirrhosis
* absence of hepatocellular carcinoma or any malignancies
* no psychiatric disorder
* no serous cardiovascular and pulmonary comorbidities
* serum total bilirubin levels less than 5 mg/dL
* platelet counts more than 30.000 mm3
* more than one year follow up period after initiation of antiviral drugs

Exclusion Criteria:

* alcohol intake in last one year
* initiation of antiviral medication in last one year
* systemic diseases
RCT Novasure Versus Novasure + Mirena IUS in the Treatment of Menorrhagia

Hypothesis. Combined treatment with novasure and mirena IUS confers benefit over Novasure alone in the treatment of menorrhagia

Endometrial ablation is a commonly used treatment option for women with heavy periods. It is recommended as an initial treatment. It aims at destroying the lining of the womb to reduce heavy menstrual loss.

A hormone releasing device in the womb (MIRENA®)is another commonly used treatment for women with heavy menstrual bleeding and has added benefit of reducing cyclical pain.

There is an increase in the number of women presenting to gynaecology clinic with persistence of pain or cyclical pain with absent or light bleeding after second generation endometrial ablation (Novasure). This may be due to the pockets of active lining of the womb that remains after ablation or possible adhesions created by the treatment. Most women require surgical removal of the womb (hysterectomy) because of pain or a further surgical procedure to divide these adhesions in an attempt to relieve pain and drain any collections in the womb.

We aim to determine if the combined use of MIRENA® and NOVASURE® (which is the second generation endometrial ablation technique used in our unit) will help in reducing the number of women presenting with cyclical pain and requiring further intervention or surgery. The aim of the current study is to compare between women receiving only NOVASURE treatment and women receiving combined NOVASURE and MIRENA treatment for heavy menstrual bleeding. The primary and secondary outcomes will be assessed at 6 and 12 months by a patient questionnaire. The primary outcome is improvement in quality of life The secondary outcomes include

* Lowering of surgical intervention
* Reduction in pain
* Reduction in amount of bleeding This will be a pilot study to determine if the theory is correct and then a larger powered study can be undertaken

Eligibility Criteria:
Inclusion Criteria:

* Anybody suitable for novasure ablation

Exclusion Criteria:

* Mirena IUS is indicated as treatment
Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease

Assessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease


Eligibility Criteria:
Inclusion Criteria:

* clinically stable, hypercapnic GOLD stage IV COPD, aged 18 years or older, baseline arterial carbon dioxide pressure (PaCO2) of 6.7 kPa (50 mmHg) or higher and a pH higher than 7·35, measured after at least 1 h rest in a sitting position.

Exclusion Criteria:

* thorax or the lung other than COPD
* No smoking or Cigarette≤10/day
* obesity with a bodymass index (BMI) ≥40 kg/m²
* malignant co-morbidities,severe heart failure (New York Heart Association stage IV),unstable angina, and severe arrhythmias.
Treatment Trial for Psychogenic Nonepileptic Seizures

The investigators propose that patients who receive targeted pharmacotherapy (sertraline) or focused psychotherapy (cognitive behavioral therapy-informed psychotherapy (CBT-ip) for NES) or combined treatment (CBT-ip + sertraline) will report fewer nonepileptic seizures (NES) compared to patients who receive community care / treatment as usual (TAU). The purpose of this study is to provide pilot testing and data to inform the future multicenter randomized controlled trial based on the hypothesis.

This is a pilot, prospective, multi-center, randomized controlled trial, that assesses the number of NES in patients treated with either flexible dose sertraline (Zoloft), cognitive behavioral therapy-informed psychotherapy (CBT-ip), combined therapy (sertraline + CBT-ip) or community care (treatment as usual TAU). This study will provide outcomes data and the effect size necessary for a future R01, multi-center randomized control trial. Secondary objective variables include reduction in depression, anxiety, impulsivity scores, and improvement in psychosocial functioning.

After being diagnosed with NES by video EEG monitoring (vEEG), up to 40 participants will be enrolled and monitored during a two week lead in period for their baseline NES and psychosocial symptoms and functioning. At week 2, they will be randomized to either: flexible dose sertraline (25 to 200mg), CBT, CBT+med, or to the control arm, TAU. Participants randomized to the sertraline arm will be titrated over 6 weeks up to 200mg or to dose limited by side effects. The subjects will stay on their maximum fixed dose for the next 4 weeks. At week 10, the subjects may elect to remain on the sertraline or they can taper off the medication over the final two weeks of the treatment trial. Those randomized to the CBT-ip arm will receive 12 weekly sessions of CBT-ip for NES. Those randomized to the CBT-ip + med arm will receive both treatments. Those randomized to the TAU arm will follow with their treatment providers.

After the treatment trial, the subjects will have follow up phone calls at month 4, 8, and 12 after enrollment to assess seizure status, medication usage, and global functioning.

Upon enrollment, subjects will be evaluated with a structured psychiatric and neurological exam, and with bi-weekly, 30 to 60 minute appointments where they will complete symptom and function scales. They will keep a seizure diary to evaluate their daily seizure activity.

Eligibility Criteria:
Inclusion Criteria:

* Video electroencephalogram (EEG) confirmed diagnosis of NES
* Have at least one nonepileptic seizure per month
* Able to complete self report symptom scales
* Not receiving optimized sertraline

Exclusion Criteria:

* Equivocal EEG findings
* using monoamine oxidase inhibitors (MAOIs), pimozide, or sumatriptan
* allergy/sensitivity to sertraline
* current alcohol/drug dependence
* serious medical illness requiring current hospitalization