cyrilzakka/clinical-trials huggingface dataset:
Intervention Study in Elderly With Sleep Problems

The main objective of the study is to improve subjective sleep quality using a multimodal intervention with an intervention and a control group. The multimodal intervention aims to improve circadian Zeitgeber strength. This will be achieved by optimizing daily light exposure, sleep, physical activity, and mealtimes.

The study lasts for 14 months and contains 6 visits. After the screening visit at the Centre for Chronobiology, Basel, Switzerland, participants are assigned to either the intervention or the control group which is followed by a 7-day baseline week at home and a co-design meeting to provide instructions to the intervention and the control group. At the occasion of 2 visits (spread over 6 months) at the participants' homes, different measurements will be performed such as saliva collection, questionnaires, cognitive performance tests, light and rest-activity measures. After the last visit at home, participants come for the second blood sample at the study centre. A follow-up visit 6 months after completion of the last data collection will provide qualitative feedback by the participants.

Eligibility Criteria:
Inclusion Criteria:

at least 65 years old women and men

* Pittsburgh Sleep Quality Index (PSQI) \> 5 (indicative of sleep problems)
* Living at home (including self-serviced retirement apartment)

Exclusion Criteria:

* Total blindness or VA \< 0.5
* Progressive NCDs (e.g., cancer)
* Acute infections (e.g., Covid-19)
* Neurodegenerative disease
* Psychiatric disease
* Sleep disorder (sleep apnea, narcolepsy)
* Not German speaking
Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury

Intervention - Subjects will be randomized to 2 groups

Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)

Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing

Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour

Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h

Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h

* Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals.
* Stopping rule-Development of sepsis, worsening of Liver functions.


Eligibility Criteria:
Inclusion Criteria:

* All patients with severe DILI (Drug Induced Liver Injury)
* Age more than or equal to 18 years

Exclusion Criteria:

* Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive
* Patients with sepsis
* AMA positive
* Low Ceruloplasmin
* Transferrin saturation \>45%
* Patients with Cirrhosis
* Patients with h/o jaundice prior to the intake of drug
Tripeptide/Hexapeptide Topical and Hybrid Laser Treatment for Acne Scarring

To evaluate the efficacy of a tripeptide/hexapeptide topical (Alastin Regenerating Skin Nectar with TriHex Technology®) in wound healing and scar reduction following Erbium:YAG hybrid resurfacing laser for acne scarring compared to the standard of post-procedure care consisting of a bland moisturizer.


Eligibility Criteria:
Inclusion Criteria:

* male or females
* age 18 and older
* with evidence of grade II-III acne scars on the face (mild to moderate) as determined by the Goodman \& Baron qualitative global acne scar grading system

Exclusion Criteria:

* treatment to face with any energy device within 6 months
* tanning within 7 days
* dermabrasion or chemical peel within 3 months
* current use of systemic retinoids
* keloidal scaring in the treatment area
* use of systemic steroids within 6 months
* use of topical products with retinoid, alpha-hydroxyacid, salicylic acid, vitamin C or E within 14 days
Phase 1 Safety Study of ALRN-5281 in Healthy Subjects

The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
2. Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
3. Ability to provide written informed consent and complying with all study requirements and restrictions.
4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening

Exclusion Criteria:

1. History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
2. Previous treatment with any GH Releasing Hormone (GHRH) analog.
3. Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
4. History of cancer within the past five years (excluding non-melanoma skin cancer).
5. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
6. Subjects with a body weight \> 120 kg.
Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients With Sensitive Small Cell Lung Cancer (SCLC)

This is a Phase II, open-label, multicenter, single-arm, exploratory "proof of concept" study. Diflomotecan (7 mg fixed dose) will be administered as a 20-minute IV infusion once every 3 weeks in patients with sensitive small cell lung cancer (SCLC) with progressive disease after first-line treatment with a platinum-based regimen.


Eligibility Criteria:
Main Inclusion Criteria:

* Documented small cell lung cancer (SCLC)
* Measurable disease
* One line of previous chemotherapy, including any platinum analogue, and excluding any camptothecin analogues, with objective response and relapsed no less than 3 months

Main Exclusion Criteria:

* Uncontrollable brain metastasis
* Treated with an investigational drug within 30 days
Sitagliptin (MK-0431) vs. Placebo in Patients With Inadequate Glycemic Control on Metformin With Pioglitazone (MK-0431-128)

This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.


Eligibility Criteria:
Inclusion Criteria:

* has type 2 diabetes and is at least 18 years of age and no older than 78 years of age
* is male or is a female who is unlikely to conceive children
* is on stable doses of a peroxisome proliferator-activated receptor gamma agonist and metformin OR metformin and a sulfonylurea agent

Exclusion Criteria:

* has type 1 diabetes
* has taken a dipeptidyl peptidase (DPP-4) inhibitor or a glucagon-like peptide-1 (GLP-1) analogue
* is on a weight loss program that is not in the maintenance phase or has started a weight loss medication within 8 weeks of screening
* has had surgery within 30 days of screening or has major surgery planned during the study
* is on or is likely to require treatment with corticosteroids for more than 2 weeks
* has a history of active liver disease, including hepatitis B or C, cirrhosis, or gallbladder disease
* is human immunodeficiency virus (HIV) positive
* has congestive heart failure, or has had new or worsening symptoms of coronary heart disease within 3 months prior to screening
* has had acute coronary syndrome, coronary artery intervention, or stroke within 3 months of screening
* has severe active peripheral vascular disease
* has a history of cancer or blood disorder
* is pregnant or breast feeding
Community Based Youth Injury Prevention Program

America's greatest resource is its youth, but that resource is increasingly threatened by violence. Recommendations for violence prevention have highlighted the need to focus on youth and to explore targeted interventions Nowhere is the need greater than in our nation's capital where the intentional injury fatality rate for youth age 14-19 is higher than any of the 50 states. This study builds on the CDC-supported project Adolescent Violence: A Community-Based Strategy which instituted citywide surveillance on injuries, conducted by researchers at the Children's National Medical Center. In this study, the same researchers will extend that work by testing an individualized intervention to reduce violent behavior among a sample of assault-injured youth, age 9-15, who present at the Emergency department (ED). 196 youths and their families will be included in this randomized trial, with 98 families assigned to the individualized intervention condition and 98 families assigned to the control condition. Families will be followed for 18 months. To address issues of attrition over the 18 months that the study follows, approximately twice as many families, or 400 families, will be recruited to participate in the study.

America's greatest resource is its youth, but that resource is increasingly threatened by violence. Recommendations for violence prevention have highlighted the need to focus on youth and to explore targeted interventions. Nowhere is the need greater than in our nation's capital where the intentional injury fatality rate for youth age 14-19 is higher than any of the 50 states. This study builds on the CDC-supported project Adolescent Violence: A Community-Based Strategy which instituted citywide surveillance on injuries, conducted by researchers at the Children's National Medical Center. In this study, the same researchers will extend that work by testing an individualized intervention to reduce violent behavior among a sample of assault-injured youth, age 9-15, who present at the Emergency Department (ED). 196 youths and their families will be included in this randomized trial, with 98 families assigned to the individualized intervention condition and 98 families assigned to the control condition. Families will be followed for 18 months. To address issues of attrition over the 18 months that the study follows, approximately twice as many families, or 400 families, will be recruited to participate in the study.

Eligibility Criteria:
* INCLUSION CRITERIA:

A consecutive sample of youth presenting to the ED or hospitalized for interpersonal assault injuries meeting the following criteria will be recruited: Interpersonal injuries; Youth age 9-15 and their parents or guardians.

Youth and their families will be excluded from participation for the following reasons: Injuries due to child abuse and sexual abuse; those with severe psychopathology (i.e., severe depression or psychosis s measured by extreme responses on selected CBCL questions); Youth or their parents with an inability to comprehend questions for reasons of cognitive ability or language will be excluded.
Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots

The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign informed consent.
* Able to complete study and comply with study procedures.
* Caucasian female ages 25-55.
* Presence of photodamage and lentigines of II-III on the Glogau Photoaging
* Must be willing to avoid laser and light treatments, treatments with filler, chemical peels, microdermabrasion, Botox or any other cosmetic treatment to the face during the duration of the study.
* Must be willing to avoid changing topical moisturizers and cosmetics during the study.
* Able to stop any alpha or beta hydroxy acids, topical retinol or retinoid derivatives, topical antioxidants, or any topical product that may interfere with the study 2 weeks prior to the study.

Exclusion Criteria:

* Cosmetic treatment of face, such as laser or light treatment, filler, Botox, microdermabrasion, or chemical peels 6 months prior to study or during study.
* Current smoker.
* Pregnant, nursing, or planning to become pregnant during study.
* Currently taking drugs including oral retinoids or any other medication with a known clinically significant drug interaction with topical tretinoin.
* Known hypersensitivity to retinoids. History of severe retinoid dermatitis.
* History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
* Concurrent participation in another clinical study or participation 30 days prior to enrollment that includes exposure to an investigational drug that would interfere with this study.
* Any disease or condition which would interfere with study participation or unduly increase risk.
* Presence of an electrically sensitive support system such as a pacemaker.
* Known history of epilepsy.
* Presence of metal implants or metal braces on teeth.
Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)

This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who undergo liver transplantation and azathioprine tablet was administered

Exclusion Criteria:

As this is PMS study, there are no exclusion criteria but contraindications are as follows.

* Subjects with hypersensitivity to the ingredients of azathioprine tablet
* Subjects who is pregnant or might be pregnant
* Subjects whose white count is lower than 3000/cubic millimeter
Treatment of Medial Epicondyle Fractures in Children and Adolescents

Cast immobilization in situ versus open reduction and internal fixation of displaced medial epicondyle fractures in children between 7 and 16 years old. A non-inferiority randomized controlled trial.

This is a multicenter, controlled, prospective, randomized non-inferiority study comparing operative treatment to non-operative treatment of over 3 mm dislocated pediatric medial epicondyle fractures without joint incarceration or ulnar nerve dysfunction. A total of 120 patients will be randomized in 1:1 ratio to either operative or non-operative treatment. The study will have a parallel non-randomized patient preference arm. Non-operative treatment will be upper limb immobilization with long arm cast for 4 weeks. Operative treatment will be open reduction and internal fixation (ORIF). Data is collected at baseline and at each follow-up up to 2 years. Quick-DASH is used as primary outcome measure. Secondary outcomes are patient reported pain, differences in range of motion, PedsQL Life inventory questionnaire as well as Mayo elbow preformance score.

Eligibility Criteria:
Inclusion Criteria:

- Over 2 mm displaced medial epicondyle fracture of humerus on primary AP or lateral X-ray

Exclusion Criteria:

* Ulnar nerve dysfunction
* Pathological fracture
* Open fracture
* Systemic bone disease
* Concomitant fracture or injury of the same upper limb requiring operative intervention
* Other disease preventing participation in full follow-up regime or range of motion exercises
The Effects of Different Ventilation Modes on Patients With Pulmonary Lobe Resection

The objective of this study was to discuss the effects of different ventilation modes on patients with plasma inflammatory factor and respiratory function in patients with pulmonary removal.

Patients who meet the inclusion criteria will be numbered in the order of admission, and a dedicated person will prepare codes and opaque envelopes for random allocation. This study was divided into 3 groups, one groups was ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side, the other groups was ventilation side volume control ventilation+continuous positive pressure ventilation on the non ventilation side; the other groups was ventilation side pressure regulated volume control ventilation+continuous positive pressure ventilation on the non ventilation side.

Eligibility Criteria:
Inclusion Criteria:

Comprehensive examination and analysis of imaging, laboratory examination and other comprehensive examinations, the diagnosis is clear, which is in line with lobe resection surgical indications

Age 18-75 years old, the gender is not limited;

ASA grading Ⅰ \~ III level;

It is expected that the single lung ventilation time is ≥1 hours, and ≤3 hours

Exclusion Criteria:

Emergency surgery;

There is a taboos on the existence of systemic anesthesia;

There is a history of acute chronic upper respiratory infections in the past January;

Previous bronchial asthma, chronic obstructive pulmonary disease, bronchial dilatation, phthisis ,aspergillosis , acute respiratory distress syndrome or history of respiratory failure;

Merge the function of important organs such as heart, liver, and kidney;

There was a history of chest surgery and the history of trauma;

Preoperative lung function test obvious abnormal abnormal abnormalities (1 second of exhalation (FEV1) \<60%);

Patients refuse to participate in the clinical trial
The Effects of Video Games in Stroke

Aims: To establish whether the effectiveness of conventional treatment is increased when it is complemented with video-based therapy, whether specific rehabilitation or commercial after subacute stroke.

Design: Randomized clinical trial with pre / post-test and follow-up evaluation, assessor blinded study.

Methodology: Three different groups: conventional treatment, conventional treatment and commercial videogame, or conventional treatment and specific rehabilitation videogame. The three groups completed 12 sessions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with stroke
* Hemiplegia on the non-dominant side
* More than 1 month since the stroke
* Score 3 in the shoulder and 2 in the elbow in the modified Medical Research Council scale
* No auditory alterations
* No visual disturbances
* Mini Mental Scale greater than or equal to 24

Exclusion Criteria:

* Patients with unstable blood pressure or angina.
* History of seizures.
* Do not use video games
Imiquimod in Children With Plaque Morphea

Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in children with plaque morphea.

Design: Prospective, open label, pilot study

Settings: The Hospital for Sick Children, Specialized Morphea Clinic

Study population:

* Children 6-18 years of age
* Plaque morphea measuring less than 10 cm2 in diameter ( for children with multiple lesions, only one will be treated)

Intervention: Topical imiquimod applied 3-5 times a week for 6 months

Outcome measures: Decrease in the thickness of the skin by clinical scores and ultrasonography

Duration of the study: 12 months ( 2 baseline visits, 1 intervention visit, 5 follow-up visits)

Eligibility Criteria:
Inclusion Criteria:

* Age at diagnosis 6 to 18 years of age
* Morphea plaques
* Female subjects of childbearing potential must have a negative urine pregnancy test
* Signed consent/assent form

Exclusion criteria:

* Children who received topical corticosteroids, tacrolimus, vitamin D derivatives (calcipotriol, calcipotriol-betamethasone dipropionate) to the affected area in the previous four weeks
* Children who were previously treated with Imiquimod on the affected areas
* Children with no demonstrable ultrasonographic changes at the baseline evaluation
* Children with evidence of skin breakdown on the proposed area to be treated at the time of enrollment due to potential increased absorption of the medication through impaired skin barrier
* Female subjects of childbearing potential who do not agree to practice effective birth control methods for the duration of the study
* Children who are/were (in the past 6 months) treated with systemic medications such as methotrexate and/or systemic corticosteroids
* Co-morbidities: systemic sclerosis, juvenile rheumatoid arthritis, other systemic diseases
Liquid Biopsy Evaluation and Repository Development at Princess Margaret

The objective of this protocol is to develop an institution-wide liquid biopsy protocol that will establish a common process for collecting blood and corresponding archived tumor specimens for future research studies at the University Health Network's Princess Margaret Cancer Centre. Circulating cell-free nucleic acids (cfNA), including cell-free DNA (cfDNA) and cell-free RNA (cfRNA), are non-invasive, real-time biomarkers that can provide diagnostic and prognostic information before cancer diagnosis, during cancer treatment, and at disease progression. Cancer research scientists and clinicians at the Princess Margaret are interested in incorporating the collection of peripheral blood samples ("liquid biopsies") into research protocols as a means of non-invasively assessing tumor progression and response to treatment at multiple time points during a patient's course of disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with either histological confirmation of a solid tumor or hematological malignancy, OR patients identified as high-risk for cancer (based on identified aberration in cancer predisposition gene or on hormonal and/or family history without known aberration).
2. Patient must be ≥ 18 years old.
3. All patients must have signed and dated an informed consent form for this LIBERATE study.
4. If patients are being co-consented for a separate primary research study listed in Appendix I, they must fulfill the eligibility criteria for that separate primary research study. If there is a discrepancy in the eligibility criteria between protocols, the separate primary research study's criteria take precedence.

Exclusion Criteria:

None