cyrilzakka/clinical-trials huggingface dataset:
Bariederm Cream in Chronic Contact Dermatitis

We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in protecting hands of individuals with hand dermatitis, either due to allergy or irritation. We believe that the use of the cream would benefit with the skin.

The aim of the study is the evaluation of the effectiveness, tolerance and cosmetic acceptability of Bariéderm cream among patients presenting with chronic allergic or irritant contact dermatitis of the hands. We shall enrol adults presenting with CONTACT DERMATITIS EXCLUDING FLARE-UPS of the hands: whether allergic or irritant, able to understand the protocol and agrees to sign the information and informed consent form. Bariéderm cream will be applied minimum twice daily over 21 days. Response will be evaluated by self and physician filled questionnaires. effectiveness, tolerance and cosmetic acceptability will be evaluated by a scale of 1-10, 1 meaning "not at all" and 10 meaning "very much". Statistics will be performed by SPSS software with suitable statistical tests. In case of an adverse event caused by the product, patch-test with ingredients of Bariéderm cream will be performed.

Eligibility Criteria:
Inclusion Criteria:

* patients with dermatitis of the hands

Exclusion Criteria:

* pregnant ladies,
* known allergy to ingredients -
Clinical Evaluation of ExoDx Prostate(IntelliScore) in Men Presenting for Initial Prostate Biopsy

The study described here is being conducted to prospectively confirm the performance of the ExoDx Prostate gene expression assay in patients presenting for an initial prostate biopsy and support of CE-marking the test for a European Union Launch.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion for prostate cancer
* Elevated Prostate-specific Antigen between 2.0-10 ng/ mL
* Scheduled for a initial prostate biopsy

Exclusion Criteria:

* Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment.
* History of prostate cancer.
* History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary track symptoms within 6 months of study enrollment.
* Known hepatitis status (all types) and/or HIV documented in patient's medical record.
* Patients with history of concurrent renal/bladder tumors.
* Prior MRI used in the decision to biopsy
The Effects of Playing Live Music in Music Therapy/Occupational Therapy Co-treatment on Unilateral Spatial Neglect

Investigators hypothesize, based on anecdotal evidence to date, that active music making interventions conducted on a patient's neglected side will result in improved attention to that side and that this will be measurable within session.

An open, single group of ten patients selected will receive a 30 minute music therapy/occupational therapy co-treatment intervention. Music interventions will be performed by a licensed, Board-Certified Music Therapist while a licensed Occupational Therapist will provide support, assistance, and measurements of behavioral attention/inattention. At the outset of the first session patients will be briefly, informally interviewed to ascertain their musical preferences, which will then be integrated into the music therapist's interventions whenever possible to maximize engagement and therapeutic rapport. Live music will be provided on the patient's neglected side and patients will be encouraged to play music interactively with a focus towards that side whenever possible. An outcome measurement tool (Star Cancellation Test) will be focused on measuring hemispheric neglect and administered at the beginning and end of each session to measure within session changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients experiencing unilateral left spatial neglect post brain injury (stroke, TBI, N-TBI).
* Patients able to follow two step commands and maintain attention to task for five minutes in a quiet environment.
* The KF-NAP, which is administered to all patients with suspected neglect on admission, will be used as a screening tool for the neglect syndrome. Inclusion criteria will be participants with score of ≤ 5.
* Patients must be able to hold a pencil to complete the SCT
* Patients must be able to discriminate between distractor items (words versus big and small stars) and see items in picture cards
* Patients communicate willingness to participate in music therapy interventions.
* Admission to acute inpatient rehabilitation unit at NYU/HJD.
* Patient will have the ability to provide informed consent.

Exclusion Criteria:

* Visual impairment.
* Right side or dominant hand impairment.
* Any social or medical problem that precludes completion of the protocol.
* Patients who have sensory neglect or motor neglect , as the SCT cannot be used with this population
* Severe language comprehension impairment
Chinese Medicine Therapy on Menopausal Symptoms

The objective of this study is to evaluate whether a Chinese medicine formula (Erxian Decoction，EXD) is effective in alleviating menopausal symptoms, improving sex hormone profile and bone turn-over.

This is a double-blind randomized placebo-controlled clinical trial to evaluate whether a Chinese medicine formula (Erxian Decoction) is effective in alleviating menopausal symptoms. This study will be conducted in Queen Mary Hospital and Chinese Medicine Clinic cum Training and Research Centers of the University of Hong Kong (Sassoon Road and Central). Women will be recruited from the general population by advertisements and promotion through media coverage.108 Chinese women with menopausal symptoms will be recruited and randomized into two groups.One is treatment group with 12 weeks of Erxian Decoction (well-controlled granules), the other is controlled group with 12 weeks of placebo. The treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of daily frequency of vasomotor symptoms (hot flushes plus night sweats),the Menopause-Specific Quality of Life (MENQOL) Questionnaire and the Menopause Rating Scale(MRS). 2)biochemical indices:serum follicle-stimulating hormone(FSH),luteinizing hormone(LH),estradiol, progesterone levels. 3)safety indices: blood count,liver and renal function tests. All measures are conducted at baseline and endpoint except the self-recoding of vasomotor symptoms and MENQOL Questionnaire, MRS. We expect this research will provide an effective and low-cost therapy for menopausal symptoms.

Eligibility Criteria:
Inclusion Criteria:

1. Chinese women aged 45 to 55 years old
2. having irregular menstrual cycles (≥3 months) indicating perimenopausal status or with cessation of menstrual period for at least three months within the previous 12 months
3. Total scores of Menopause Rating Scale≥28 indicating the menopausal symptoms are moderate or severe
4. Not having used HRT or Chinese Medicine for at least 3 months prior to entry into the study
5. Willing to give informed ,written consent to participate in the clinical study

Exclusion Criteria:

1. Taking hormones or medications, which could affect the vasomotoric symptoms
2. Having chronic illness, such as gastrointestinal, renal or liver disease, diabetes mellitus requiring treatment, uncontrolled hypertension
3. Having serious diseases, such as cancer, autoimmune system diseases, thrombosis and thrombophlebitis
4. Consuming alcohol, or taking psychiatric or psychotherapeutic drugs
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome

The investigators hypothesize that there may exist different quantitative sensory profiles between radicular pain patients who respond and those who do not respond to the standard therapy of epidural steroid injections (ESI).

The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain tolerance, wind-up, and conditioned pain modulation (CPM) as measured by Quantitative Sensory Testing (QST) between subjects with a radicular pain condition. The investigators are comparing those who respond and those who do not respond to standard therapy (ESI) before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of lower extremity radicular pain regardless of specific or suspected etiologies
* scheduling an epidural steroid injection (ESI)

Exclusion Criteria:

* a major psychiatric disorder requiring a recent (within one month) hospitalization, such as major depression, bipolar disorder, schizophrenia, anxiety disorder, and psychosis
* subject is taking illicit or recreational drug detected through a urine toxicology screen
* subject has had an interventional pain management procedures within the last eight weeks that may alter QST responses including neuraxial or local anesthetic block
* subject had a change in dosage of neuromodulatory pain medication (including gabapentin, pregabalin, cymbalta, amitriptyline, nortriptyline, trileptal, etc) in the past two weeks
* subject is pregnant
* subject has pending litigation involving the current pain condition being treated and studied.
Vitamin K2 Intervention in Patients With Vitamin K Antagonists

The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.In addition, the study evaluates if regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.

Randomisation of the study subjects will be done by two randomisation lists depending on whether the dose of VKA is high or low. Randomisation will be balanced and stratified depending on the average dose of VKA before the inclusion in order that each arm would have the same number of patients receiving a dose lower than the used anticoagulant treatments.

The level of vitamin K intake will be determined during the study visits using dietary questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* treated with anticoagulants
* INR range between 2-3
* TTR (time in therapeutic range)equal or higher 56% during the 4 months before the inclusion

Exclusion Criteria:

* consumption of significant amounts of products conatining vitamin K
* regular consumption of dietary supplements susceptible to contain vitamin K
* milk intolerant or refusing a daily consumption of dairy product
* previous insufficient earlier therapeutic VKA follow-up
* cardiac, renal or severe respiratory insufficiency, diseases interfering fat absorption, significant abnormalities in safety parameters, clinically significant thrombotic or hemorrhagic event
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy

To investigate the effectiveness of carbetocin on reducing intraoperative blood loss during abdominal myomectomy


Eligibility Criteria:
Inclusion Criteria:

* • Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging

  * Age ≥ 25 years and ≤ 50 years
  * Pre-operative hemoglobin \>10 g/dl
  * Ability to understand and the willingness to sign a written informed consent.
  * Admissible medical/surgical history
  * Five or less symptomatic uterine myomas
  * symptomatic stage 3 to 6 fibroids, according to FIGO staging

Exclusion Criteria:

* • Post-menopausal women

  * Patients with known bleeding/clotting disorders
  * Patients with a history of gynecologic malignancy
  * Hypertension.
  * Cardiac and Pulmonary diseases.
  * History of allergic reactions attributed to carbetocin
Study to Compare U0267 Against Vehicle in Subjects With Plaque-type Psoriasis One of Two Phase 3 Studies

The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects at least 12 years old and in good general health.
* Mild to moderate plaque-type psoriasis

Exclusion Criteria:

* Known allergy or other adverse reaction to calcipotriene or other vitamin D analogs; or to any component of the investigational formulations
* History of hypercalcemia or of vitamin D toxicity.
* Diagnosis of generalized pustular or erythrodermic exfoliative psoriasis.
* Other serious skin disorder or any chronic medical condition that is not well controlled.
* Use of non-biologic systemic anti-psoriatic therapy or biologic therapy within four weeks of enrollment.
* Use of topical therapies that have a known beneficial effect on psoriasis, within 2 weeks of enrollment.
* Systemic medications for other medical conditions that are known to affect psoriasis within the past four weeks of enrollment.
* Use of any investigational therapy within 4 weeks of enrollment.
* Pregnant women, women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control.
IgG-4 Levels in Systemic Sclerosis

This is an observational - non interventional study. The investigators will compare IgG4 levels of 80 healthy donors (from Israel blood bank - MDA) and 80 Systemic Sclerosis patients from Meir Medical Center.

IgG4 levels will be obtained from medical records of 80 SSc patients between the years 2000-2019. These will be compared to IgG4 levels from sera of 80 healthy donors (from Israel blood-bank - MDA). Correlations between IgG4 levels and the following will be made: age, sex, disease type (limited or diffused SSc), disease duration, medications.

Eligibility Criteria:
Inclusion Criteria:

* SSc patients

Exclusion Criteria:

* other chronic co-morbidities
Mouthwashes During Orthodontic Treatment

The number of orthodontic treatment provided to Brazilian population has been increased. Unfortunately, some negative effects such as gum bleeding and bad breath are commonly observed. It partially happens because tooth brushing and flossing become more difficult in the presence of braces. Therefore, there is a need for clinical protocols able to maintain the mouth healthy during orthodontic treatment.

Considering that proper use of mouthwashes by in individuals without braces is accompanied by decrease in plaque and gum inflammation levels, it was hypothesized that, during orthodontic treatment their anti-gingivitis and anti-plaque properties would positively affect oral health. Objectives: The present study will compare the effects of two commercially available mouthwashes with a placebo mouthwash in orthodontic patients wearing fixed appliances.

Whole-mouth clinical examinations will be performed in periodontally healthy patients 15 days before, at the day of bonding and also 3 and 6 months after braces bonding. Hard and soft tissues status, presence of gingivitis and amount of dental plaque will be monitored to determine mouthwashes efficacy. At these same time-points plaque samples will be collected from dental sites and braces surfaces aiming at determining total levels of bacteria and levels of specific bacteria related to gum disease. After a full-mouth ultrasonic debridement to remove dental plaque, stains and tartar, patients will be randomly assigned to an Essential oils, Cetylpyridinium chloride or a placebo mouthwash for 6 months (40 ml/day). Further, samples of orthodontic wires will be analyzed under microscopy to check whether regular use of mouthwashes increases the risk of corrosion or not.


Eligibility Criteria:
Inclusion Criteria:

* good general health;
* class I or class II malocclusions with a nonsurgical orthodontic treatment plan for alignment and leveling including no-extraction, extraction of two upper premolars or extraction of four premolars; no previous orthodontic treatment; overbite and overjet that allowed brackets to be placed on the lower teeth without occlusal interferences;
* periodontal health (with no clinical signals of inflammation, GI \<1 e no clinical attachment loss);
* at least 26 natural teeth;

Exclusion Criteria:

* severe skeletal malocclusion in anteroposterior, vertical or transverse dimensions; surgical orthodontic plan;
* mouth breathing;
* gingivitis; periodontitis; gingival overgrowth;
* prosthetic fixed devices, removable partial dentures or overhanging restorations;
* systemic diseases or conditions that could influence the periodontal status;
* smokers and former-smokers;
* pregnancy or breast-feeding;
* history of sensitivity or suspected allergies following the use of oral hygiene products; any antibiotic prophylaxis;
* antibiotics and/or anti-inflammatory drug use in the six months prior to the beginning of the study;
* regular use of chemotherapeutic antiplaque/antigingivitis products;
* periodontal treatment performed within six months prior to study initiation;
* unwillingness to return for follow-up.
Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis

The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Plaque psoriasis for at least 6 months
* Moderate to severe disease
* Candidate for phototherapy or systemic therapy

Exclusion Criteria:

* Other forms of psoriasis
* History of recent infection
* Prior exposure to BMS-986165 or active comparator

Other protocol defined inclusion/exclusion criteria apply
Phase 2 Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before PCI (Percutaneous Coronary Intervention) in Patients with STEMI (ST-segment Elevation Myocardial Infarction)


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 75
* Within 12 hours after the onset of chest pain
* ST-segment elevation of more than 0.1 mV in two contiguous leads or new LBBB(left bundle-branch block) patients
* Signed for written informed consent

Exclusion Criteria:

* Left Main disease
* Multi-vessel disease
Melphalan 200 mg/m2 Versus Melphalan 100 mg/m2 in Newly Diagnosed Myeloma Patients

In this study will be randomised before induction treatment either to receive two courses of melphalan 200 mg/m2 (MEL200) or two courses of melphalan 100 mg/m2 (MEL100). Informed consent will be obtained upon enrolment. Inclusion criteria included: diagnosis of untreated Durie e Salmon stage IIA-IIIB measurable multiple myeloma; age \< 65 years. Exclusion criteria included: prior treatment for myeloma; abnormal cardiac function, defined as systolic ejection fraction \<50%; abnormal pulmonary spirometry test; serum bilirubins \> 2.5 times normal and ALAT and/or ASAT \> 2 times normal; seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.

Induction therapy, PBSC mobilization, and autografting Initial treatment plan included induction chemotherapy with 2 courses of vincristine, 1 mg/m2 on day 1, adriamycin, 50 mg/m2 on day 1, and dexamethasone, 40mg/day days 1-4, administered 28 days apart, followed by peripheral blood stem cell (PBSC) mobilisation and harvest after 1 or 2 cycles of cyclophosphamide, 4 g/m2, and G-CSF, 10 ug/kg given i.v. or subcutaneously. After at least one month from PBSC collection, autografting consisted of melphalan, 200 mg/m2 or melphalan, 100 mg/m2, on day -2, and cryopreserved PBSC infusion on day 0. Patients received G-CSF, 5 ug/kg, from days +3 until neutrophil count \> 1000/ul were achieved.

Supportive care and toxicity grading Following autografting, all patients received standard prophylaxis against bacterial and fungal infections; herpes simplex and varicella-zoster virus reactivation; and Pneumocystis carinii. Cytomegalovirus CMV reactivation was monitored through levels of CMV antigenemia and/or serum CMV DNA levels and treated with ganciclovir or foscarnet as clinically indicated. Standard criteria (Common Toxicity Criteria version 3.0) were used for grading hematological and non-hematological toxicity.


Eligibility Criteria:
Inclusion criteria included:

* diagnosis of untreated Durie \& Salmon stage IIA-IIIB measurable multiple myeloma;
* age \< 65 years.

Exclusion criteria included:

* prior treatment for myeloma;
* abnormal cardiac function, defined as systolic ejection fraction \<50%;
* abnormal pulmonary spirometry test;
* serum bilirubins \> 2.5 times normal and ALAT and/or ASAT \> 2 times normal;
* seropositivity for HIV, HCV or HBV, active non-hematologic malignancies.
Motor Imagery and Action Observation on Motor Learning

This study evaluates the influence of motor imagery and action observation on motor learning


Eligibility Criteria:
Inclusion Criteria:

* asymptomatic subjects
* men and women between 18 and 65 years of age
* participants with no systemic, neurological, cognitive or psychological disease.

Exclusion Criteria:

* underage participants
* presence of systemic pathology, pain and/or weakness that prevents the protocol
* participants who have undergone an operation in the spine
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis

Primary objective:

To demonstrate the long-term efficacy (response to treatment during initial therapy, time to relapse without treatment, durability and lesional recurrence during maintenance therapy) of V0034 CR 01B cream on uraemic xerosis in the real-life setting.

Secondary objectives:

1. To assess the local tolerance of V0034 CR 01B after long-term use
2. To assess the patient benefit and acceptability of V0034 CR 01B


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes, of at least 18 years of age
2. Women of childbearing potential having a reliable contraceptive method
3. Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or peritoneal dialysis, due to chronic renal failure
4. Patients whose xerosis is related to their renal insufficiency status (uraemic xerosis)
5. Patients suffering from xerosis with a severity score of at least two, on at least one of the five tests areas (right lower leg, left lower leg, forearm with no arterio-venous shunt, chest, dorsum of the neck)

Exclusion Criteria:

1. Patients under 18 years of age
2. Women with childbearing potential having a positive pregnancy test at baseline
3. Patients undergoing renal dialysis for another reason than chronic renal insufficiency
4. Patients whose xerosis is due to another reason than their MRD status
5. Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test areas)
6. Patients with a known history of allergy to one of the ingredients contained in the test product
7. Patients with an intercurrent condition which may interfere with a good conduct or the study parameters of the study
8. Patients treated with any other emollient/moisturising topical preparation within the seven days prior to study entry
9. Patients who participated in a study within the three months prior to study entry
10. Patients who are not affiliated to health insurance
11. Patients who are not able or willing to follow the study instructions -