cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate Efficacy and Safety of Glinib in Newly Diagnosed CML Patients

This study is to evaluate efficacy and safety of Imatinib in two groups of patients; all patients should be diagnosed less than 3 months as chronic myeloid leukemia in a chronic phase. The group A, the reference group, will have 10% or less than 10% of the BCR-ABL level after three month dosing and be maintained their dose of 400mg/day. On the other hand, the group B, will have more than 10% and the dose will be increased from 400mg/day to 600mg/day. The superiority of the group B will be proved by evaluating the MMR rate of these two groups after 12 months of administeration of Imatinib.


Eligibility Criteria:
Inclusion Criteria:

* at the age of 18 or more
* newly diagnosed within three months as a Chronic Myeloid Leukemia
* with positive Philadelphia chromosome and appearance of BCR-ABL transcript
* with 0 - 2 of ECOG Performance Status
* with normal renal function
* with normal hepatic function
* able to understand and decide to involve the study

Exclusion Criteria:

* history of radiation therapy for more than 25% of bone marrow due to other malignant diseases
* history of other clinically relevant malignant tumors
* with bleeding disorders which are not related to leukemia
* evidence of clinically relevant cardiac dysfunction
* with severe disease which cannot be regulated by other organs
* a previous administration of Imatinib more than a week prior to the first dose.
* participation in other drug study(eg. intervention trial) within 30 days prior to the screening visit
* HIV-infected
* females with pregnancy, childbearing or lactating potential
* other reasons determined by investigators
Detection of High-Risk HPV in Urine and Cervical Swab Specimen Using HPV Diagnostic Kit (Bio Farma)

This study is a cross-sectional study to evaluate accuracy of high-risk DNA-HPV testing using HPV Diagnostic Kit (Bio Farma) compared to Standard Kit (COBAS® 6800 HPV from Roche Molecular Systems) RT-PCR based in urine and cervical swab specimens.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active female aged 20-50 years
* Willing to participate in study and signed the informed consent form.

Exclusion Criteria:

* Pregnant women
* History of HIV infection
* On menstruation period
* History of complete HPV vaccination
Management of Tick-borne Encephalitis

In this retrospective cohort study of patients with tick-borne encephalitis (TBE), potential differences in the clinical presentation at admission and diagnostic and therapeutic management of patients with TBE initially referred to infectious diseases or neurology departments were assessed. Associations between severity of acute illness and clinical outcome were also explored.


Eligibility Criteria:
Inclusion Criteria:

* microbiologically confirmed tick-borne meningoencephalitis

Exclusion Criteria:

* Exchanged between ID and neurology within the first 48 hours due to organizational constraints
* Transferred from another hospital
* Lumbar puncture not performed
* Not fulfilling study criteria
Effectiveness of Fascial Manipulation for Chronic Low Back Pain

The purpose is to evaluate the effectiveness of a physiotherapy program for chronic low back pain. We'll randomize more about 35 patients in two groups. Both groups will receive an 8 physioterapy intervention in 4 weeks, in particular the first group (study) will receive 4 Fascial Manipulation treatment combined with 4 session of a standard approach (mobilization and stretching exercises); whereas the second (control) will receive only the standard approach.

All patients were assessed and randomised by a physician. The control group intervention concerned of: relaxation of lumbar and respiration muscles, stretching for posterior muscular chain and hip flexors, assisted/active mobilization of lumbar region in sagittal plane and rotation, exercises to improve proprioception of lumbar spine, active and progressive movement of lumbar spine in anterior flexion, extension, lateroflexion and rotation, active exercise for lumbar stabilizers muscles, occupational training for activity of daily living, indications and recommendations for correct postures. The study group intervention received 4 manual intervention on deep fascial tissues, according to fascial manipulation tecnique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.

Eligibility Criteria:
Inclusion Criteria:

* patients with a chronic low back pain (more than 7 weeks)
* age between 20 to 60 years old

Exclusion Criteria:

* presence of neurological red flags
* continuative assumption of drugs for low back pain
* no positive imaging for spine lesions (fractures, spondilolistesi,
* vascular desease (aneurism abdominal aorta)
* secondary lesions (oncological desease)
* rheumatic systemic desease
* any other neurological desease which could compromise the partecipation to the program exercise
Impact of Propionic Acid on Regulatory T Cell Function in Healthy Adults ( Pro-Health)

Pro-Health is a single-center, double-blind, randomized and placebo-controlled intervention study in healthy adults. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in healhty adults.

Chronic inflammation is a major risk factor of cardiovascular disease progression in CKD, irrespective of confounding comorbidities. Based on current knowledge, microbially-derived metabolites such as short chain fatty acids (SCFA) play an important role in the regulation of chronic inflammatory processes in CKD patients. Patients with CKD are known to have reduced serum levels of the SCFA propionic acid (PA), as a consequence of both gut microbial dysbiosis and reduced fiber intake. In animal and human studies the impact of PA on function and abundance of regulatory T cells (Treg) has been demonstrated. Consequently, the investigators aim to increase the PA serum levels by oral PA food supplementation in healthy adults in order to perspectively intervene with the same strategy in patients with CKD in the near future, with the target to increase abundance and function of antiinflammatory cells.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 40 years old
* Body weight: \> 30kg

Exclusion Criteria:

* Disease or dysfunctions, which disqualifies the patient
* Incapacity of contract or any other circumstances, which prohibit the patient from understanding setup, meaning and entity of the study
* Acute infections
* Immunosuppressive therapy within the last 12 weeks before the start of the study
* Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study
* Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study
* Malignant diseases
* Pregnancy
* chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease
* alcohol- or drug abuse
* parallel participation on other interventional trials
Overnight Closed Loop Study in U.S.

This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.

Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing.

The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American.

The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 2-75 years of age at time of screening
2. A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis

   Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures :
3. Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening
4. Adequate venous access as assessed by investigator or appropriate staff
5. Subject should have an established insulin carbohydrate and insulin sensitivity ratio.
6. Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL
7. Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)
HU007 Eye Drops in Patients With Dry Eye Syndrome

This study is a multicenter, randomized, double blind, Restasis-controlled non-inferiority, Phase III Study to evaluate the efficacy and safety of HU007 eye drops in patients With dry eye syndrome


Eligibility Criteria:
Inclusion Criteria:

* Male and Female who over 19 years old
* Those who meet below criteria at least one of two eyes

  1. Those who have over than score 2 in corneal staining test-Oxford grading
  2. Tear secretion test without anesthesia(Schirmer test) result would be under 10mm/5min (If the test result is 0mm/5min, it should be over than 3mm/5min on the nasal stimulation schirmer test in the same eye)
  3. TBUT(Tear film break-up time) test result should be under 10sec.
* Woman with no possibility of pregnancy or negative pregnancy test results at a screening visit, Women or men who have agreed to maintain at least one contraceptive method during study period
* Those who could understand this study and agree to informed consent voluntarily

Exclusion Criteria:

* Those who have clinically significant eye disease not related to dry eye symdrome
* Those who are in anti-inflammatory medication for dry eye syndrome
* Medication of systemic steroid or immunosuppressant
* Those who have worn contact lenses before 72hours or have to wear contact lenses or disagree not to wear contact lenses during study period
* Those who have medical history with intraocular surgery 90 days before screening visit
* Those who have any active ophthalmic diseases such as active allergy, anterior uveitis, stevens-johnson syndrom which could affect the surfece of eye
* Those who have any autoimmune diseases
* Those who need a surgery for surface elevation caused by meibomian gland dysfunction(MGD)
* Those who have any medical history of corneal transplantation or neurotrophic keratitis
* Those who have diagnosed with glaucoma or have an intraocular pressure over than 25mmHg at least in one of the eyes
* Those who have medicated cyclosporine or steroid eye-drops 30 days before screening visit
* Those who have underwent any eye correction surgery such as LASIK(Laser-assistant in situ keratomileusis) 12 months before screening visit
* Those who have underwent a silicone lacrimal punctal occlusion or cauterization of the punctum excluding collagen lacrimal punctal occlusion 90 days before screening visit
* Those who have a hypersensitivity reaction for cyclosporine, trehalose or protein-based medication related to investigational drug
* Those who have diagnosed a psychical disorder which could affect this study
* Women who is pregnant or breastfeeding or those who have a plan to be pregnant
* Those who have medical history on abusing medications or alchol
* Those who have received other investigational drugs/devices 30 days before screening visit
* Those who are inappropriate for participating in this study according to investigator's judgement
Results of 8 Strand Repair of Flexor Tendon Injuries

Functional results of 8 strand repair of flexor tendon injuries zone II with and without splinting of the wrist

Flexor tendon injuries of the hand, account for 30% of all hand injuries, but are difficult to treat and are associated with frequent poor outcomes . While major progress has been made with the treatment of these injuries, current surgical treatment relies mostly on conventional suturing techniques with variable results, concluding in re-operation rates of 12%, and complication rate of up to 20% Restoration of tendon gliding is the goal when repairing flexor tendon injuries. The tendon forces experienced during postoperative, active flexion exercises are significantly larger than the tendon forces experienced by patients engaging in only passive flexion. Multistrand sutures (typically four- or six-strand repairs) may withstand much greater tension than conventional two-strand sutures during early active mobilization.

However, multistrand (particularly eight-strand) repair requires complicated surgical skills; such repair is difficult. Here, we present a new eight-strand suture for flexor tendon repair that features easier passages through the tendons and fewer knots than existing approaches; it affords the necessary tensile strength to prevent both gap formation and ultimate failure.

The important aspects of flexor tendon repair are that the suture should have sufficient mechanical strength, and it should not result in a bulky configuration, which would affect tendon gliding .

Using the 8-strand repair technique and active mobilization performed by the patient is both practical and cost-saving. Intensive supervision of a hand therapist is generally not required. Notably improved outcomes have been achieved while preventing adhesions at the repair site.

Eligibility Criteria:
Inclusion Criteria

1. Adult patient
2. No fractures in the affected finger
3. Thumb is excluded
4. Duration of injury less than 2 weeks

Exclusion Criteria:

-
Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters

Catheter associated urinary tract infection is one of the most common types of catheter acquired infections and adds greatly to patient morbidity, mortality and medical cost. Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains in place, the greater the tendency of these organisms to develop biofilms and result in urinary tract infections, which are difficult to treathe UroShield System is intended to prevent bacterial biofilm formation by means of the Active NanoShield technology it has developed. A number of scientific concepts and principles shown in prior studies have shown some promising results in the treatment of biofilm based sequele using ultrasound energy. The NanoShield technological basis of the UroShield System has taken these concepts to a level where acoustical waves in the ultrasound range can be created by low cost disposable actuators which actually create a physical coating on all of the surfaces of the catheter thereby interfering with the attachment of bacteria which is the initial step in biofilm formation.

The UroShield™ System is comprised of 2 main components:· The Disposable UroShield Z-Patch - a disposable small lightweight patch that is attached to the PCN catheter, while its opposite side is attached directly to the patient's skin at the site of catheter entry. The patch has twofold function:

1. it receives energy and a signal from the UroShield Driver allowing it to generate the ultrasonic waves;
2. it acts as a fixation device for the PCN catheter.· The UroShield Driver - an external driver unit that is attached to the UroShield patch and contains batteries to power the system and electronics that control the patch unit

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring percoutaneous nephrostome
* First insertion

Exclusion Criteria:

* Blood coagulation disorders
* Trauma
A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD)

This multi-center, randomized, double-blind, parallel group, placebo-controlled, proof of concept study will investigate the efficacy and safety of RG7314 in adult participants with ASD. In Stage I of the study, participants will be randomized in 2:1 to receive daily oral doses of 1.5 milligrams (mg) RG7314 or placebo for 12 weeks. After an independent safety review, the study may proceed to Stage II. In Stage II of the study, additional participants will be randomized in 2:1 to receive daily oral doses of 4 mg RG7314 or placebo for 12 weeks. After an independent safety review, Stage III will be started wherein additional participants will be randomized in 2:1 to receive daily oral doses of 10 mg RG7314 or placebo for 12 weeks. During Stage III, safety will be reviewed by independent safety review twice and if no safety signal is observed, then additional participants will be randomized in 1:1:1 either to receive 1.5 milligrams per day (mg/day) or 10 mg/day RG7314 orally or placebo for 12 weeks in Stage IV.


Eligibility Criteria:
Inclusion Criteria:

* Participants meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ASD and Tenth Revision of the International Classification of Diseases and Related Health Problems (ICD-10) criteria for Autism diagnosis
* SRS-2 (T-score) greater than or equal to (\>/=) 66
* CGI-S \>/=4 (moderately ill)
* Participants have an Intelligence Quotient (IQ) \>/=70 (Wechsler Abbreviated State of Intelligence)
* A body mass index (BMI) between 18 to 40 kilograms per square meter (kg/m\^2) inclusive
* Language, hearing and vision compatible with the study measurements as judged by the investigator
* Lives with (or has substantial periods of contact with) a caregiver who is willing and able to attend visits when required, oversee the participant's compliance with protocol-specified procedures and study medication dosing, and report on the participant's status via completion of study assessments. Any period of absence must be covered by another caregiver. Non-cohabitating caregiver(s) must spend sufficient time with the participant so that, in the opinion of the investigator, the caregiver(s) can reliably assess participant's mental status, activities and behavior.

Exclusion Criteria:

* Alcohol and/or substance abuse/dependence during the last 12 months
* A significant risk for suicidal behavior, in the opinion of the investigator
* Systolic blood pressure greater than (\>) 140 or less than (\<) 90 millimeters of mercury (mm Hg), and diastolic blood pressure \>90 or less than (\<) 50 mm Hg
* Resting pulse rate \>90 or \<40 beats per minute
* Use of prohibited medications or herbal remedies within 2 weeks prior to randomization, or 5 half-lives (whichever is longer)
* Initiation of a new major change in psychological intervention within 4 weeks prior to randomization. Minor changes in ongoing treatment are not considered significant
* Participation in an investigational drug or device study within 60 days prior to randomization
The Effects of Traditional Herbal Dietary Supplements on General Fatigue and Negative Emotions of Graduate Students

The goal of this randomized controlled trial is to determine the effect of traditional herbal supplements on general fatigue and negative emotions in generally healthy graduate students. The main questions it aims to answer are:

• Whether the traditional herbal supplements can ameliorate fatigue and negative emotions of young adults

Participants will:

* Take oral herbal supplements or placebo as randomized for four weeks
* Be evaluated for the fatigue, anxiety, and depression levels at baseline and four weeks after the intervention
* Record sleep variables each day for five weeks

Researchers will compare the intervention group (receiving herbal supplements) with the placebo group (receiving placebo) to see if oral herbal supplements have effects on the outcomes and to examine the anti-fatigue effect two weeks after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Scoring at least 4 points on the dichotomous Chalder's Fatigue Scale at baseline
* Working on at least one ongoing research project and expecting to continue working for at least one month

Exclusion Criteria:

* Taking medications as:
* Antidepressants
* Anxiolytics
* CNS stimulants
* Immunosuppressants
* With underlying diseases as:
* Diabetes mellitus
* Hematologic diseases
* Other major diseases as defined my MOHW of Taiwan
Impact of GWG Tool on Patient Knowledge

Women with singleton pregnancies at one outpatient clinic to be recruited for controlled clinical trial. Over eight weeks, women 15 0/7--22 6/7 weeks' with at least one prior prenatal visit to be enrolled in the control group. Women 6 0/7--14 6/7 weeks' to be enrolled in the intervention group at their first prenatal visit and to receive a pregnancy-specific gestational weight gain card. Women to be encouraged to record their weight at each prenatal care visit. All women to complete a GWG knowledge--based questionnaire at 15 0/7-22 6/7 weeks'.


Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Primary prenatal care at MetroHealth Medical Center
* Planning to deliver at MetroHealth Medical Center

Exclusion Criteria:

* Any inclusion criteria not met
* Prior diagnosis of eating disorder
* Inadequate knowledge of English language
Long Term Follow up of Patients Under 5 Years of Age With High Grade Glioma Diagnosed in France Between 1990 and 2015

High grade glioma is a rare disorder affecting children at all ages with a high mortality rate. Overall survival is estimated at 40%, depending on the type of treatment administered. Major late sequelaes are experienced with the irradiation in this population under 5 years. Therefore, the current recommendations by The French Society for Childhood Cancers are based on a treatment including surgery followed by chemotherapy and avoiding radiotherapy as long as patients present no sign of treatment failure. The results published in 2006, underlying the fact that some patients treated exclusively with surgical resection and chemotherapy can achieve long term survival, are showing evidence of an acceptable long-term strategy. Few studies concerning evaluation of treatment toxicity and long term outcomes are available. Therefore, it is important to collect retrospective data concerning those small patients with high grade glioma in order to understand the reasons of treatment success or failure and treatment toxicities. This retrospective study will evaluate long term survivals comparatively to clinical, radiological and histological features at diagnosis and the treatment toxicities including neurological, endocrine and hearing impairment to go further and propose new potential guidelines and chemotherapy schedules


Eligibility Criteria:
Inclusion Criteria:

* Children under 5 years old
* High grade glioma (WHO status III or IV)
* No previous treatment with chemotherapy or radiotherapy
* No contraindication to chemotherapy
* Consent of legal representative for participation in the study

Exclusion Criteria:

* Low grade glioma
* Any other histological pattern
* Parent's denial to access data concerning their child in the frame of medical research