cyrilzakka/clinical-trials huggingface dataset:
Safety/Effectiveness Study of a Single Session of Laying-on-of-hands in Various Settings in Japan

The purpose of this study is to determine the symptomatic changes after a single session of laying-on-of-hands in various settings, and to evaluate optimal conditions for the outcomes.

Laying-on-of-hands is applied in many different situations; however, most reports published previously described its efficacy in a clinical setting, with its administration conducted by a few expert practitioners. This study aimed to determine the symptomatic changes after a single session of the Okada Purifying Therapy, a form of laying-on-of-hands, in various settings, and to analyze factors influencing the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* able to receive laying-on-of-hands for 30 minutes or longer from the investigators
* able to self-evaluate the change of their symptoms
* competent to answer the Japanese questionnaires
* aged 16 years or older

Exclusion Criteria:

* those who did not match the inclusion criteria
Study of the ConforMIS iDuo(R) G2

To evaluate the ConforMIS iDuo G2 implant

This is a prospective, multicenter study. The investigators will be evaluating the ConforMIS iDuo G2 implant.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use for the iDuo® G2
2. Bicompartmental osteoarthritis defined as Medial and patellofemoral osteoarthritis, or Lateral and patellofemoral arthritis as confirmed by the investigator's assessment of disease status at screening visit. Disease status is assessed by Clinical and Radiographic assessment. In addition, CT arthrogram assessment may be utilized for diagnosis.
3. Willingness to participate in the clinical study, to give informed consent and to attend all follow-up visits
4. \> 18 years of age

Exclusion Criteria:

1. BMI \> 40
2. Active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years
3. Poorly controlled diabetes
4. Neuromuscular conditions which prevent patient from participating in study activities
5. Active local or systemic infection
6. Immunocompromised
7. Fibromyalgia or other general body pain related condition
8. Rheumatoid arthritis or other forms of inflammatory joint disease
9. Loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated to an extent that the procedure is unjustified
10. Diagnosed or receiving treatment for Osteoporosis
11. Other physical disability affecting the hips, spine, or contralateral knee
12. Severe instability due to advanced loss of osteochondral structure
13. Prior arthroplasty of the affected knee
14. Compromised ACL, PCL or collateral ligament
15. Severe fixed valgus or varus deformity of \>15º
16. Extensor lag \> 15 º
17. Fixed flexion contracture ≥ 10 º
18. Prior history of failed implant surgery of the joint to be treated, including high tibial osteotomy (HTO)
19. Unwilling or unable to comply with study requirements
20. Participation in another clinical study which would confound results
21. If during intra-op, it is noted that the patient has tri-compartmental disease, then the patient is considered a screen fail
Study of Ixabepilone (BMS-247550) in Patients With Solid Tumors

The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* 20 years or older
* Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors

Exclusion Criteria:

* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
Individualized Duration of Antibiotic Treatment in Early Onset Infection in Newborns.

A nationwide multicenter open label randomized controlled non-inferiority trial, including 18 departments. The study aims to compare an individualized antibiotic treatment duration with standard seven days of antibiotic treatment for culture negative early-onset infection in term newborns.

There is a documented antibiotic overuse in newborns, and a lack of evidence for the optimal duration of antibiotic therapy in culture-negative infection. The study aims to evaluate the effect of individualized treatment duration in early-onset infection.

The study aims to compare an individualized treatment duration with seven days of treatment for culture negative early-onset infection. The investigators hypothesize that the individualized treatment duration, based on structured clinical assessment of symptoms and level of CRP is non-inferior to the standard care being seven days of treatment. In the experimental treatment arm, antibiotics will be stopped when the participant had 24 hours without symptoms and at same time point have decreasing level of CRP, with an absolute threshold of CRP ≤ 30 mg/l. The investigators hypothesize that individualized treatment will shorten the duration of antibiotic therapy in newborns with early onset infection with very little risk of relapse. Newborns who fulfill criteria to stop antibiotics within 48 hours will not be eligible for inclusion.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 35 weeks
* Birth weight ≥ 2000
* Probable or possible infection according to the structured infection risk assessment
* Sufficient size blood culture, preferably 0.5-1 ml, but at least 0.2 ml, drawn after onset of symptoms but before start of antibiotic treatment
* Negative blood culture after 48 hours

Exclusion Criteria:

* Infants with positive blood culture
* Blood culture volume prior to antibiotics of \< 0.2 ml
* Site-specific infection as for example, meningitis or osteomyelitis
* Infant fulfill current recommendation to stop antibiotic treatment at 36-48 hours; Low suspicion of sepsis initially including few and vague symptoms, CRP maximum 35-50 mg/l, negative blood culture and no symptoms after 48 hours of treatment
Acetaminophen-Protein Adduct Resolution

The purpose of this study is to better understand the pharmacokinetics of acetaminophen and further clinical interpretations of laboratory results that confirm the presence of acetaminophen-cys adducts. This study will determine how long adducts persist in serum after a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265). Subjects will be asked to complete three study visits, each three days apart, following termination of COMIRB 06-1265. Each study visit will include collection of blood samples for batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions are planned.


Eligibility Criteria:
Inclusion Criteria:

* Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets completion criteria

Exclusion Criteria:

* Subjects who enter the extended dosing period in protocol 06-1265.
* Subjects who were randomized to placebo.
Safety, Tolerability and Pharmacokinetics of MK-0873 Following Patch Application in Healthy Participants and Psoriasis Participants (MK-0873-020)

This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. The primary hypotheses of the study are: 1) that MK-0873 is safe and well tolerated in healthy participants and participants with psoriasis and 2) that the maximum plasma concentration of MK-0873 is \<20 nM in healthy participants and participants with psoriasis.


Eligibility Criteria:
Inclusion Criteria:

Part I, II and III:

* Female participants of reproductive potential must test negative for pregnancy and agree to use two acceptable methods of birth control;
* In good general health;
* Nonsmoker;

Part III only:

* Has diagnosis of plaque-type psoriasis, and has lesions covering at least 3% of total body surface area;

Exclusion Criteria:

Part I, II and III:

* Has a history of stroke, chronic seizures or major neurological disease;
* Has a history of cancer;
* Is a nursing mother;

Part III only:

* Has nonplaque forms of psoriasis;
* Has current drug-induced psoriasis;
* Has received phototherapy, systemic medications/treatments, or used topical medication that could affect psoriasis;
* Has used any systemic immunosuppressants or biologics within the past 4 weeks.
Human Ovarian Follicular Dynamics and Emergency Contraception

The researchers hypothesize that emergency contraception (EC) will initiate the changes associated with atresia or ovulatory failure at all stages of follicular development and that the image attributes associated with atresia will be similar regardless of the diameter of the dominant follicle when ovarian suppression is initiated. Second, changes associated with atresia may be observed, but ovulation of the dominant follicle is unimpeded.

This study is a single-center, randomized, open-label, double-controlled protocol to study the pattern of ovarian follicular growth and regression in two groups of women. The first group will use Plan B, which is a progesterone only OC containing 0.75 levonorgestrel. The second group of women will use the Yuzpe regimen, which uses 50 mg ethinyl estradiol/0.5 mg levonorgestrel pills at different stages of the menstrual follicular cycle.

Eligibility Criteria:
Inclusion Criteria:

1. Female volunteers of childbearing potential;
2. Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
3. Age between 18 and 40 years old;
4. Normal body mass index (18-38);
5. Has signed informed consent form; and
6. Is in good health as confirmed by medical history, physical examination.

Exclusion Criteria:

1. A positive pregnancy test will automatically exclude the volunteer from participation in this study.
2. Any contraindication for oral contraception use;
3. Irregular menstrual cycles;
4. Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
5. Pregnancy (suspected or diagnosed) or lactation;
6. History or suspicion of drug or alcohol abuse;
7. Participation in an investigational drug trial within the 30 days prior to selection;
8. Exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:

   * history of, or actual, thrombophlebitis or thromboembolic disorders.
   * history of, or actual, cerebrovascular disorders.
   * history of, or actual, myocardial infarction or coronary artery disease.
   * acute liver disease.
   * history of, or actual, benign or malignant liver tumors.
   * history of, or suspected, carcinoma of the breast.
   * known, or suspected, estrogen-dependent neoplasia.
   * undiagnosed abnormal vaginal bleeding.
   * any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.
Topical Garlic Concentrate for Alopecia Areata in Children

Management of pediatric alopecia is particularly challenging given the chronicity of the condition, limited therapeutic response and devastating psychological effects. There is a paucity of safe and effective therapies in this population.

The investigators propose to conduct and open label, prospective cohort pilot study using topical garlic concentrate ( GarlicRich) for treatment of children with alopecia areata. Study medication will be applied topically on affected area of the skin daily for 6 months. Follow up visits will occur monthly to access the efficacy and safety of the proposed treatment .

The investigators are planning to enroll in the study 20 participants at Sickkids.

It is an open label, prospective cohort pilot study. Patients enrolled in the study will be followed at the Hospital for Sick Children for 6 months. Participants will come for the study visits every month (7 study visits). During each study visit two investigators will independently access patient's hair density and calculate the SALT score (Severity of Alopecia Tool Score), using the participant's digital photographs.

Patients will be provided with the study medication for all duration of the study.

The results of the treatment will be compared with the baseline data ( pictures/ scores/ hair density) to evaluate the efficacy and safety of garlic concentrate in children with patchy alopecia areata.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 4 years and older up to 18 years of age
* Patches of alopecia areata that affect less than 50% of the scalp.
* Alopecia of at least 1 year duration without evidence of regrowth
* Informed written consent

Exclusion Criteria:

* Any children experiencing significant spontaneous regrowth of terminal hair at the baseline visit.
* Any children treated with a topical, (including shampoos with active ingredients like minoxidil or clobetasol), intralesional or systemic agent likely to cause regrowth in alopecia areata within the past month from the baseline visit and during study period.
* Children with history of hypersensitivity to garlic.
* Children with widespread alopecia areata as alopecia totalis, universalis, ophiasis or diffuse Alopecia Areata.
Effect of BI 207127 + Faldaprevir on Blood Levels of Oral Contraceptives Containing Ethinylestradiol and Levonorgestrel

Investigate the effect of multiple oral doses of BI 207127 + faldaprevir (FDV) on the multiple dose pharmacokinetics of ethinylestradiol and levonorgestrel (Microgynon®) in healthy premenopausal female volunteers.


Eligibility Criteria:
Inclusion criteria:

* Healthy female subjects
* Age 18 to 35 years (inclusive)
* Body Mass Index 20-29.9 kg/m2
* Use of hormonal contraception (i.e. oral contraceptives, hormonal contraceptive vaginal ring, but not hormone-containing intrauterine devices, depot injections or contraceptive implants)

Exclusion criteria:

* Any relevant deviation from healthy conditions
* Subject is assessed by the investigator as unsuitable for inclusion, for instance, because considered not able to understand and comply with study requirements, or has a condition that would not allow safe participation in the study
* Positive pregnancy test, pregnancy or planning to become pregnant within 1 month of study completion, or lactation
* Any relevant finding of the gynaecological examination
* Thrombotic predisposition according to thrombophilic testing
* Existing or history of arterial thrombotic or embolic processes, conditions which predispose to them e.g. disorders of the clotting processes, valvular heart disease and atrial fibrillation
* Existing or history of confirmed venous thromboembolism, family history of venous thromboembolism, and other known risk factors for venous thromboembolism.
* Relevant varicosis
* No use of an additional contraceptive method from screening examination until 1 month after last study drug administration (acceptable methods are considered to be barrier methods, sexual abstinence, non-hormone-containing intrauterine device, or vasectomisation for the male partner).

Use of hormone-containing intrauterine device, depot injection or contraceptive implants

* Any history of relevant liver diseases (e.g. disturbances of liver function, jaundice or persistent itching during a previous pregnancy, Dubin-Johnson syndrome, Rotor syndrome, or previous or existing liver tumours)
* AST (aspartate transaminase) and/or ALT (alanine transaminase) \> 1.5 ULN (upper limit of normal)
Radiotherapy in Primary Mediastinal Lymphoma

The use of Rituximab has been proposed to be useful and avoid the use of radiotherapy in diffuse large B-cell lymphoma with bulky disease.We assess efficacy of adjuvant radiotherapy in patients treated with R-CHOP


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of primary mediastinal lymphoma No previous treatment performance status \< 2 HIV, Hepatis B and C negative Normal :Renal, hepatic, pulmonary and cardiac function

Exclusion Criteria:

pregnancy

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Detection of Coronary Artery Disease With Micro Electro-Mechanical Sensors

This study aims to validate the sensor data of gyroscope and accelerometer in detection of hemodynamically significant CAD.

Heart diseases are the most common cause of morbidity and mortality in the western world. Coronary artery disease (CAD) alone is estimated to affect 110 million people globally and resulted in 8.9 million deaths in 2015.

A hallmark phenomenon in the development of CAD is the formation of arterial stenoses eventually limiting the arterial circulation. Myocardial ischemia caused by the stenoses may present symptoms considered typical, i.e, angina pectoris chest pain, but the symptoms may vary up to an asymptomatic state. Estimating the pre-test likelihood of angiographically significant CAD (≥50% diameter stenotic CAD) is a fundamental component in the initial evaluation of symptomatic patients presenting with suspected CAD. This determination directly influences subsequent decisions for noninvasive diagnostic testing and treatment. However, studies have shown a relatively low prevalence of either ischemia or obstructive CAD on noninvasive imaging and invasive angiography (IA) in this population. Therefore, additional methods are needed to improve patient selection for such testing.

Mechanocardiography (MCG) assesses the condition of the heart by measuring the mechanical activity (cardiac muscle motion) of the heart from the surface of thorax. MCG can be measured with accelerometer and gyroscope which react to recoil and vibration caused my cardiac contraction.

This study aims to validate how the gyroscope and accelerometer derived parameters can identify patients with hemodynamically significant CAD in combined contrast computed tomography (CT) coronary angiography and positron emission tomography (PET) perfusion imaging in combination of high-sensitive troponin testing. The performance of different MCG algorithms will be tested offline as a head-to-head comparison with medical history, cardiovascular events, high-sensitive troponin values, coronary computed tomography angiography (CCTA) and PET scan results.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients visiting hospital for suspected CAD and undergoing CCTA
* Signed informed consent as an acceptance to participate to the trial

Exclusion Criteria:

* informed consent not signed
Antibiotic Therapy in Erupted Tooth Extractions

Evaluation of the efficacy of amox+clav and of a probiotic after tooth extraction. the aim is to evaluate efficacy of antibiotic therapy after tooth extractions in preventing infections as compared to no therapy, and efficacy of probiotics in preventing gastro-intestinal adverse effects during the antibiotic treatment. The number of patients to be included is 150. The study products are: Amoxicillin + Clavulanic Acid and Bifidobacterium Longum and Lactoferrin.

The main objective of this trial is to evaluate the efficacy of the antibiotic after tooth extraction in preventing infections and to evaluate the effect of probiotic in reducing the possible antibiotic side effects. In order to analyze the effect of the antibiotic in terms of patient's general discomfort, a tailored form was prepared (Appendix A). The local signs and symptoms to evaluate are swelling, pain (assessed by the Visual Analogic Scale), presence of abscess, fever, post-extraction dental alveolitis (dry socket) and presence of trismus assessed as maximal mouth opening variation (mm). In addition adverse post-extraction events will be evaluated as follows: chewing impairments (assessed by the Visual Analogic Scale), speaking impairments (assessed by the Visual Analogic Scale), daily oral hygiene maneuvers impairments (assessed by the Visual Analogic Scale) and daily activities alterations (days-off from job/study). Moreover, the patients will be provided with a painkiller's prescription and they are required to take note of the painkillers needed during the first 7 days, i.e. until the first time point recall. The prescribed painkillers will be Ibuprofen 600 mg or naproxen sodium 500mg for those patients who reported allergy to ibuprofen. Finally, it will be a researcher duty to ask the patients if they needed to assume painkillers beyond the 7th day. Since the post-surgical sequelae depend also on the difficulty of extraction, the Appendix A provides a table in which the surgeon can take note of the type of extraction.

Eligibility Criteria:
Inclusion Criteria:

* Patients who needed tooth extractions
* Patients older than 18 years
* Patients able to understand and to sign a consent form

Exclusion Criteria:

* General contraindications to oral surgery
* Third molar or impacted tooth extractions
* Patients treated or under treatment with immunosuppressive agents or patients immunocompromised
* Patients treated or under therapy with amino-bisphosphonate and anti-angiogenetic intravenous medications
* Patients who received head and neck irradiation treatments
* Patients who were diagnosed with uncontrolled diabetes
* Patients suffering from renal failure
* Pregnancy and breastfeeding patients
* Patients diagnosed with drug and alcohol addiction
* Patients who suffer from psychiatric disorders
* Patients diagnosed with allergy to penicillin and probiotic
Cohort/Ethics Study of Patients With Severe Alcoholic Hepatitis Undergoing Early Liver Transplantation

The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.

The research study is designed to improve the investigators' understanding of early liver transplantation for patients with severe alcoholic hepatitis. The goal of this research is twofold:

1. Establish a knowledge base necessary for appropriate liver transplant candidate selection by quantifying post-ELT mortality for SAH and compare to outcomes to liver transplantation for other indications
2. Develop an ethical framework for implementation of these transplants for SAH based on the opinions of healthcare providers and the general public.

Eligibility Criteria:
Inclusion Criteria for Severe Alcoholic Hepatitis patients:

* Patients with Severe Alcoholic Hepatitis (SAH) listed for liver transplantation at Johns Hopkins Hospital (JHH), have not been sober for at least 6 months at time of waitlisting, and are at least 18 years old.

Exclusion Criteria for Severe Alcoholic Hepatitis patients:

* Non-SAH patients listed for liver transplantation at JHH and patients who have been sober for at least 6 months at the time of waitlisting.

Inclusion Criteria for non-SAH comparison group:

* Patients 18 years or older undergoing liver transplantation at JHH for alcoholic liver disease and were sober for at least 6 months prior to transplantation.

Exclusion Criteria for non-SAH comparison group:

* Patients who do not meet inclusion criteria.