cyrilzakka/clinical-trials huggingface dataset:
Effects of Prednisolone and Infliximab on the Regulation of Urea Synthesis in Active Inflammatory Bowel Disease

Loss of total mass of muscles (catabolism) is a serious clinical problem in patients with active inflammatory bowel disease (IBD). The investigators have earlier shown that the liver plays an important role in this stress-catabolism by increasing the production of urea during the inflammatory process.

The purpose of this study is to examine the effect of the anti-inflammatory drugs prednisolone and infliximab on the regulation of the urea synthesis in patients with active ulcerative colitis and Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe active inflammatory bowel disease

Exclusion Criteria:

* Viral or bacterial infections
* Other chronical inflammatory diseases
* Cancer
* Other catabolic diseases
* Treatment with prednisolone or infliximab within the last 8 weeks
Exercising Together for Hispanic Prostate Cancer Survivor-Caregiver Dyads

The purpose of this study is to determine the feasibility and effects of an adapted Exercising Together, a partnered resistance training program, on the physical and mental health of prostate cancer survivors and their informal caregiver. The Exercising Together program is designed to promote teamwork during supervised group exercise classes delivered remotely through videoconferencing software. The intervention period will be 3-months with a 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria (Survivor only):

1. Self-identifies as Hispanic
2. Histologically confirmed prostate cancer diagnosis (self-report)
3. Completed primary treatment at least 6 weeks prior at time of enrollment
4. Has an identified caregiver in any relationship role (e.g., spouse, sibling, parent, friend) who can participate with them.

Inclusion Criteria (Caregivers):

1. Identifies as an individual (e.g., family member or friend) who provides unpaid care or support to a participating prostate cancer survivor.

Inclusion Criteria (Survivors and Caregivers):

1. ≥18 years of age
2. Understands (ability to read and speak) English or Spanish and able to provide informed consent
3. Meets the American College of Sports Medicine pre-participation screening criteria for exercise
4. Ability to ambulate (with or without assistive devices)
5. Willing to attend study group exercise classes online, complete remote assessments, and answer online surveys
6. Has access to a mobile device with camera and internet.
7. Able to participate in classes at same time as other participating member.

Exclusion Criteria:

1. Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent as determined by the professional opinion of the Principal Investigator
2. A medical condition, movement or neurological disorder, or medication use that contraindicates participation in moderate intensity exercise or poses a significant safety concern/risk for the well-being of the participant (e.g., declared pregnancy, poorly controlled diabetes, recent cardiac event, neuromuscular disease, untreated orthostatic hypertension, recent surgery, acute hernia, acute rheumatoid arthritis, severe memory disorders, severe balance disorder, severe hearing or vision impairment)
3. Knowingly unable to attend \>75% of the intervention classes due to conflict with the designated time of day, days of the week, and/or location for the exercise class which they initially enrolled
4. Incapable of providing informed consent, answering survey questions, participating in the intervention, and following directions during performance testing when English or Spanish language is used
5. Unable to be in the same location with participating member during remote exercise classes and performance testing and/or insufficient internet connectivity to support required videoconferencing software
A Study to Evaluate the Efficacy of Docetaxel and Carboplatin in Metastatic Malignant Melanoma Failed First-Line Dacabazine or Temozolomide Contained Therapy

This is the phase II, single-arm, single-center study assessing the efficacy of weekly docetaxel plus carboplatin in second-line treatment of malignant melanoma (unresectable or metastatic) who has failed dacarbazine or temozolomide contained therapy. The primary end point is overall response rate according to RECIST 1.1 criteria assessed using CT or MRI and secondary end point includes disease control rate, progression free survival, overall survival and safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically proven malignant melanoma (recurred or metastatic) that had progressed during or after receiving at least one cycle of a regimen containing dacarbazine or temozolomide in the advanced setting
* Measurable disease (RECIST)
* ECOG performance 0-2
* Adequate organ function
* Total bilirubin \<1.5N ; ASAT and ALAT \<2.5N
* Serum Creatinin \< 1.5N
* ANC ≥ 1,500/mm³ (G-CSF allowed)
* Platelets ≥ 100,000/mm³
* Hb ≥ 9.0 g/dL
* Life expectancy of at least 12 weeks
* Signed Written Informed Consent

Exclusion Criteria:

* Symptomatic brain metastasis
* Previous history of treatment with taxane or platinum agent containing chemotherapy
* Previous major surgery within 2 weeks before the start of the trial, or a failure to recover from the surgery
* Previous history of other malignancies within 5 years except for cured skin basal cell carcinoma or cured in-situ cervix cancer
* Other severe medical conditions (infection, uncontrolled hypertension, heart failure, MI history within 6 months)
* Sensitivity to platinum agents or docetaxel
* Uncontrolled seizure
* Women pregnant or nursing
* Alcohol or drug abuser
Non-inferiority Comparison of Efficacy and Safety of Penciclovir 10mg/g to Acyclovir 50mg/g in the Treatment of Recurrent Herpes Labialis

Herpes labialis is the most common recurrent manifestation of herpes simplex. The purpose of this study is to check the non-inferiority efficacy and safety of penciclovir 10mg/g as treatment for Herpes Labialis in comparison to acyclovir 50mg/g.

Study design:

• Double blinded non-inferiority prospective parallel-group, intend to treat trial.

Study design:

* Experiment duration: 10 days
* 3 visits (days 1,5 and 10)
* Erythema, papule, vesicle, ulcer, crust and healed skin evaluation
* Adverse events evaluation

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with clinical diagnosis of recurrent herpes labialis and are in the prodromal period (stinging, itching, burning and erythema) at the onset of signs / symptoms in the last 12-24 hours;
3. No history of reaction to topical products;

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study.)
4. Sunlight over exposure in the last 15 days.
5. Any pathology or past medical condition that can interfere with this protocol.
6. AINH use, hormonal anti-inflammatory, analgesic and immunosuppressive drugs (in the last 30 days and during the study);
7. Patients with immunodeficiency and/or immunosuppressive disease;
8. Sunlight exposure in the last 15 days;
9. Hypersensitivity to components of the formula;
10. Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
Tools Development for Geriatric Emergency Regulation

According to surveys, 13% to 20% of the Service Médical d'Urgence (SAMU) centre 15 (French 911) calls concern elderly patients above 75 years of age. For these patients, the clinical pathway should be decided on the basis of the symptomatology described during the call, but also with the gathering of specific data such as medical social and psychological evaluation. These items allow the regulating doctor to assess comorbidity, on-going treatment, psycho-cognitive status, previous hospitalisations, social situation, and patient expectations and needs.

However, data collected in order to assess the situation on the phone and take the orientation decision are mainly limited to the severity of clinical symptoms. Medical, psychological and social aspects are rarely gathered, for several reasons :

* Phone call shortness : emergency calls should be treated quickly
* Regulating doctors are not trained to take in account the specificities or geriatric patients in their decision making. Besides, they are not informed about alternatives to the hospital emergency department, such as "geriatric channel" system.

An observational study was performed in 2012 on 692 calls about elderly patients referred to the SAMU centre 15 during 7 days : 63% of these patients were transferred to an emergency department. Regardless of severe cases "hospital regulation", 55% of the least serious cases ("liberal regulation") were transferred to an emergency department.

Regulation is inadequate to elderly patients for whom 1) the situation assessment and the appropriate decision making require specific items that are not known by regulating doctors, 2) the medical care and the clinical pathway could be improved by the knowledge of on-field "geriatric channel", 3) the emergency department care is particularly long, 4) and could be pernicious to younger patients.

1920 patients will be recruited between January 2016 and August 2017, including a 6 months wash-out in order to train regulating doctors. This training will include geriatric patient's specificities, and geriatric channels. A 12% difference between the 2 groups (before and after the training) is expected, considering a 80% statistical power. The design is a time series experiment.


Eligibility Criteria:
Inclusion Criteria:

* Patient above 75 years olds
* Patient calling for a liberal regulation
* Patient calling between 8 a.m. and 6 p.m. from monday to friday

Exclusion Criteria:

* Patient calling for vital emergency (hospital regulation)
* Patient calling for inter-hospital transport
Intradialytic Physiotherapy in Patients With Chronic Kidney Disease

The objective is to evaluate in adult patients with chronic kidney disease the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength.

The hypothesis is that in people with chronic kidney disease on hemodialysis, the addition of neuromuscular electrical stimulation in the upper limbs associated with aerobic training of the lower limbs is superior to aerobic exercise alone in improving functional capacity, peripheral muscle strength, quality of life, safety intervention and patient adherence.

Objective: To evaluate, in adult patients with chronic kidney disease, the effect of neuromuscular electrical stimulation (NMES) in the upper limbs associated with a cycle ergometer in the lower limbs, during hemodialysis, on functional capacity and peripheral muscle strength.

Methods. This is a controlled, randomized, double-blind, intention-to-treat clinical trial carried out at the Cassiano Antônio Moraes University Hospital (HUCAM). Thirty individuals who will be randomly allocated to an intervention group (ie active NMES on upper limbs for 20 minutes and aerobic exercise on a cycle ergometer for 30 minutes) or a control group (ie NMES-Sham on upper limbs for 20 minutes and aerobic exercise on a cycle ergometer for 30 minutes). The treatment will be carried out for 8 weeks, with 3 weekly sessions totaling 24 sessions. Outcome measures will be collected by trained researchers before treatment (week 0) and at the end of treatment (week 9), always in the second hemodialysis session of the week. Functional capacity, peripheral muscle strength, activity level of daily living, quality of life, intervention safety, patient compliance, hemodialysis filtration rate (KT/V) and renal function (potassium, phosphate and magnesium clearance) will be evaluated.

Impact. This study could potentially provide important information and assist in clinical decision making regarding the combined use of NMES with a cycle ergometer to optimize the clinical benefits of therapeutic exercise in patients with chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Have chronic kidney disease;
* Undergo hemodialysis at HUCAM for at least 3 months;
* Present a hemoglobin level \> 9 g/dL;
* Present clinical stability for at least 3 months;
* Do not participate in another physical exercise program;
* Present the ability to perform the assessment tests;
* Age equal to or greater than 18 years, and can be of both sexes;
* Accept to participate in the research by signing the informed consent form.

Exclusion Criteria:

* Presents symptoms and/or health conditions (cardiovascular, respiratory, neurological, cognitive) that prevent the performance of evaluation tests and participation in the exercise program.
Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia

X-linked hypophosphatemia (XLH) is the most common form of heritable rickets. Current treatments include active vitamin D metabolites (e.g. calcitriol) and phosphate salts. There is no consistent weight-based dosing of calcitriol and phosphate now. The primary objective of this study is to establish the efficacy of different dose of calcitriol combined with neutral phosphate in children with XLH.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 1-12 years, inclusive
* Diagnosis of XLH by clinical features: serum phosphorus level \< 2.5 mg/dl; ALP?; RSS total score ≥2; bowed legs; short stature; family history with appropriate X-linked inheritance
* Meet at least one of the following: confirmed Phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX) mutation in the participant, or serum FGF23 level \>30 pg/ml (Kainos assay)
* Willing to participate the study, and provide an informed consent
* Able to complete all aspects of study and adhere to the visit schedule

Exclusion Criteria:

* Use of growth hormone within 12 months before first visit
* Height \>50 percentile for age and sex specific data
* Presence of nephrocalcinosis or nephrolithiasis
* Serum intact parathyroid hormone level\>170 pg/ml
* Plan to receive orthopaedic surgery in 12 months
* Poor compliance
* Use of gonadotropin-releasing hormone therapy right now
* Use of aluminium hydroxide, steroid, acetazolamide or thiazide drugs within 7 days before first visit
* Not be fit to participant in the study, by the judgement of investigators
Effect of a Combination of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate on Subjects With GastroEsophageal Reflux Disease

The aim of this study is to investigate whether a 3-week treatment with an oral melt in mouth medical device, made up with hyaluronic acid, chondroitin sulphate and magnesium trisilicate, can lead to a reduction of Gastroesophageal Reflux Disease symptoms and to an improvement of the integrity of esophageal mucosa in patients who are to experiencing esophagus symptoms. The study is a randomized, double-blind cross-over placebo controlled study. Every patient will get both the active study device during one study period and placebo during another another period.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, age 18 to 75 years
* GERD as defined by an acid exposure time \>4% on pH/impedance monitoring and/or esophagitis LA grade A or B on endoscopy
* Heartburn at least twice per week over the last 1 month
* ReQuest Symptoms sum score \>3,37 at screening
* GERD patients not treated with a PPI in the previous 2 months
* Subjects capable of understanding and be willing to provide signed and dated written voluntary informed consent

Exclusion Criteria:

* Patients suffering from gastrointestinal diseases other than GERD

  * Esophagitis LA grade C or D or Barrett's esophagus on endoscopy
  * Impaired kidney or liver function
  * Significant cardiac, pulmonary or psychiatric comorbidity as judged by the investigator
  * Medication use (including NSAIDS) that may interfere with GERD symptom assessment within 2 weeks before the start of the study or during the study
  * Pregnancy or breast-feeding
  * Females of childbearing potential in the absence of effective contraceptive methods
  * History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent
  * History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements
  * Treatment with any investigational drug within the previous 30 days
  * Active malignancy of any type, or history of cancer, including solid tumors and hematological malignancies (except patients with malignancies that have been surgically removed and/or with no evidence of recurrence for at least five years before study enrolment)
  * Inability to conform to protocol procedures
Phase II Study of FCN-159 in NF2 Nerve Sheath Tumors

The goal of this clinical trial is to evaluate the efficacy and safety of FCN-159 in patients with specific NF2-associated nerve sheath tumors.

1. A phase 2 single arm single center study, total 30 patients will be enrolled;
2. To evaluate the safety and efficacy of FCN-159, a Mek inhibitor, to treat NF2; associated nerve sheath tumors, age≥16, including benign and malignant tumors;
3. Primary endpoint: Objective response rate (ORR)；Secondary Outcome Measures： Clinical benefit rate (CBR)；24w WRS, OS et al..

Eligibility Criteria:
Inclusion Criteria:

1. ≥16 years of age, regardless of gender.
2. meet the revised 2022 diagnostic criteria for NF2-associated nerve sheath tumors or pathologically confirmed NF2-associated nerve sheath tumors.
3. should meet one of the following criteria: 1) Incomplete surgical resection, or postoperative recurrence. 2) Systemic therapy is required as determined by the Investigator.
4. the presence of a measurable lesion, as defined by REiNS or RECIST V1.1 criteria.
5. Karnofsky physical status score of ≥70.
6. the patient has adequate organ and bone marrow function.
7. International Normalized Ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
8. For patients of childbearing potential: During treatment and for at least 90 days after the last dose, patients should agree to use a highly effective method of contraception.
9. avoid excessive sun exposure and be willing to use an adequate amount of sunscreen in anticipation of sun exposure.
10. be able to understand and voluntarily sign a written informed consent form.

Exclusion Criteria:

* Previously received one of the following treatments:

  1. Pharmaceutical or biological therapy within 3 weeks or 5 half-lives prior to enrollment, whichever is longer.
  2. Use of growth factors that promote platelet, red blood cell, or white blood cell count or function within 7 days prior to enrollment.
  3. Patients who have received major surgery or anti-tumor immunotherapy within 4 weeks prior to enrollment.
  4. Radiation therapy for nerve sheath tumors within 4 weeks prior to enrollment.
  5. Dose adjustment for patients treated with dexamethasone or other corticosteroids within 1 week prior to enrollment.
  6. Patients who have participated in another interventional clinical trial within 4 weeks prior to enrollment.
  7. Prior treatment with Selumetinib or any other MEK 1/2 inhibitor. 2. history of or concurrent with other malignancies. 3. inability to undergo MRI and/or contraindications to MRI. 4. uncontrolled hypertension. 5. the presence of dysphagia, active gastrointestinal disease, malabsorption syndrome, or other condition that interferes with the absorption of the study medication.

     6. previous or current retinal vascular disease. 7. interstitial pneumonitis 8. cardiac function or co-morbidities 9. Immediate family history of sudden cardiac death before age 50. 10.History of any acute neurological condition 11. with active bacterial, fungal or viral infections 12. known hypersensitivity to the study drug, other MEK1/2 inhibitors, or their excipients.
Screening for AL Amyloidosis in Smoldering Multiple Myeloma

In this multicenter study, we will recruit 400 patients 40 years of age or older at 15 centers with a diagnosis of smoldering multiple myeloma (SMM), a group of patients for whom standard of care is observation not treatment. The main goal of this study is to screen for the diagnosis of light-chain amyloidosis (AL) before the onset of symptomatic disease and to develop a training set for a likelihood algorithm.

This study is based on results from two prior studies in which 4 of 36 patients with SMM and none of 14 patients with MGUS were found to have AL. The hypothesis that we test with this protocol is that patients with (1) a pre-existing diagnosis of SMM, (2) free light chain (FLC) abnormalities, (3) IGLV genes associated with AL,(4) t(11;14) or gain 1q, and (5) NT-proBNP \> 332pg/mL will have undiagnosed AL or risk of progression to AL. We will study the potential for SMM, the FLC screen, AL-related IGLV gene use, t(11;14) or gain 1q cytogenetic abnormalities, and NT-proBNP \> 332pg/mL to be the variables in a likelihood algorithm for AL.

Eligibility Criteria:
Inclusion Criteria:

* Patients 40 years of age and older
* diagnosed with Smoldering Multiple Myeloma
* dFLC greater than 23 mg/L
* abnormal FLC ratio
* If the patient has an eGFR less than 50 mL/min/1.73m2, the FLC ratio is inconsequential. The patient only needs to meet the age and dFLC criterion.

Exclusion Criteria:

* Patients younger than 40 years of age are not eligible
* Patients with a previous finding of amyloid in other biopsies will not be included
* Adults unable to consent are not eligible, including the cognitively impaired Pregnant women, pregnant minors, minors (i.e., individuals who are not yet adults), wards of the state, non-viable neonates, neonates of uncertain viability, and prisoners are not eligible
Bioequivalency Study of Perindopril Erbumine 8 mg Tablet Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Perindopril Erbumine 8 mg tablets under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to perindopril or any comparable or similar product.
V710 Clinical Study in Healthy Male Japanese Subjects (V710-006) (COMPLETED)

This study is to evaluate the safety and immunogenicity of V710 in Japanese male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Generally Good Physical Health

Exclusion Criteria:

* Received V710 Vaccine, Any Other Investigational S. Aureus Vaccine, Or Investigational S. Aureus Antibodies Before
* Temperature Of Equal/Greater Than 100.4 Degrees F(38 Degrees C) Within The Past 48 Hours