cyrilzakka/clinical-trials huggingface dataset:
Influence of Circadian Clock on Hormonal, Metabolic, Neurocognitive Markers in Adolescents With and Without Diabetes

Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c \< 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal ("biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night/day circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.


Eligibility Criteria:
Inclusion Criteria:

* Families living in areas with high access to medical care.
* Age: 12-18 years old
* T1D diagnosis for longer than 1 year
* speaking fluent Hebrew

Exclusion Criteria:

* significant renal or liver function abnormalities
* head injuries,
* epileptic episodes
* psychiatric medications
* lack of Hebrew abilities
* disagreement to comply with all the study requests
* history of more than one episode of a severe hypoglycemic event in the past, including loss of consciousness or more than one episode of diabetic ketoacidosis.
Autologous Stem Cell Transplantation for Myeloma Patients Over 65 Years

Autologous stem cell transplantation remains the gold standard of treatment for newly diagnosed patients under the age of 65. Even though it is also regularly performed above the age of 65, there are very few data in this patient population. The investigators will capture safety and efficacy data in that setting.

Newly diagnosed myeloma patients above the age of 65 years will be treated the following way: Bortezomib (Velcade®) based induction treatment (either Velcade Dexamethasone, Velcade Thalidomide Dexamethasone (VTD) or Velcade Cyclophosphamide Dexamethasone (VCD)). After the induction phase, for patients at least in partial remission, a collection of peripheral blood stem cells (PBSC) is done according to each center practice. High dose melphalan (140 mg/m2) followed by PBSC autologous transplantation is then performed. Three months post transplant, 2-3 cycles (similar to the initial induction phase) of consolidation are allowed.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed MM,
* age over 65,
* measurable disease

Exclusion Criteria:

* Patients less than 65 and/or not proceeding to autologous PBSC transplantation
Effects of C-section Delivery on Infant Brain Development

The study will help investigators learn more about whether different delivery modes influence infant's brain development

For this study, the investigators are enrolling women who are pregnant with their second child who are planning to have a planned C-section or a spontaneous vaginal birth after C-section. The investigators will see the pregnant mom at 36 weeks pregnant and then have the mom and the baby return for a visit at 2 weeks postnatal.

Eligibility Criteria:
Inclusion Criteria:

* Conceived without fertility treatments
* Singleton pregnancy recruited at or before 36 weeks of gestation
* Second parity with planned repeated C-section delivery or with planned spontaneous vaginal delivery after C-section.

Exclusion Criteria:

* Preexisting medical conditions
* Sexually transmitted diseases
* Medical complications developed during pregnancy
* Medical complications developed during labor and delivery
* Emergency c-section delivery
* Infants born preterm or post-term
* Infants needing mechanical ventilation, have congenital abnormalities, birth defects, intrauterine growth restriction, low Apgar score (\<7), or other medical issues developed at birth or before 2 weeks of age affecting the outcome of interest as determined by the PI.
The Clinical Effect of Fuke Qianjin Capsule on Chronic Pelvic Pain Caused by Pelvic Inflammation

A prospective random control clinical trials to research Fuke Qianjin capsule's effects on ameliorating the pain caused by chronic pelvic disease.

Fuke Qianjin capsule has been widely used in clinical medicine to ameliorate the pain caused by chronic pelvic disease.But random control trials on its effects are few.Our study was designed as a prospective random control clinical trials to research its effects.

Eligibility Criteria:
Inclusion Criteria:

* Subject is a female between the age of 18 and 50.
* Subject with a history of pelvic inflammatory disease suffered from one of the symptoms below and one of the signs below: symptoms:1.lower abdominal distension or pain;2.lumbosacral soreness. signs:1. enlarged,cable strip-like fallopian tube with mild tenderness palpated on one side or both sides of the uterine;2.restricted movement or adhesion fixed of the uterine;3.the sacral ligaments thicken and harden with mild tenderness.
* Subject VAS score of pelvic pain ≥4
* Subject without fertility requirements in 2 months
* Subject provides written informed consent.

Exclusion Criteria:

* Subject underwent recurrent urinary system infection or interstitial cystitis
* Subject underwent irritable bowel syndrome
* Subject has other complications in addition to chronic pelvis inflammation diseases leading to chronic pelvic pain,such as gynecological malignant disease,irregular vaginal bleeding, endometriosis,adenomyosis,ovarian neoplasm with a diameter \>5cm by ultrasound
* Subject is pregnant or lactating.
* Subject has a severe systemic disease, such as cardiovascular system
* Subject has a history of malignancy or radiotherapy.
* Subject has undergone any chronic pelvic pain treatment including antibiotics,paregoric,physiotherapy or any other related treatment within 1month prior to randomization.
* Subject has mental disorder incapable of elementary cooperations.
* Subject has an allergic history to the experimental drug.
* Subject has participated in other clinical researches of medicine within 1month prior to randomization.
Observational Clinical Investigation of Arthrosamid in Knee Osteoarthritis

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee osteoarthritis who is eligible for treatment with Arthrosamid® according to the Instruction for Use.

This is a prospective, long-term, observational, all-comers, open-label, multi-centre clinical investigation enrolling subjects with knee OA who is eligible for treatment with Arthrosamid® according to the Instruction for Use (IFU).

All subjects will be followed over an observational period of five years with yearly follow-up check points. The first follow-up visit should be six months after the treatment. All follow up visits can be performed as telephone visits.

Eligibility Criteria:
Inclusion Criteria:

* Stated willingness to comply with all study procedures and availability for the duration of the study
* Male or female, aged ≥ 18 years
* Clinical diagnosis of knee OA

Exclusion Criteria:

* If an active skin disease or infection is present at or near the injection site
* If the joint is infected or severely inflamed
* If a degradable intra-articular injectable such as hyaluronic acid is present, it must be expected to be absorbed according to manufacturer's information for the specific product, before injection with Arthrosamid®
* If the patient has previously received treatment with a different non-absorbable injectable/implant
* If the patient has received a knee alloplasty or has any foreign material in the knee
* If the patient has undergone knee arthroscopy within the last 6 months
* If the patient has haemophilia or is in uncontrolled anticoagulant treatment
Usefulness of Contrast Enhanced Harmonic Endoscopic Ultrasound for Pancreatic Cysts

The study evaluates the role of contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) for the differentiation of the pancreatic cysts and their malignant potential.

Due to the increase use of cross-sectional imaging techniques for varied medical conditions more and more pancreatic cysts are incidentally found. Magnetic resonance imaging revealed a prevalence of incidental pancreatic cystic neoplasm (PCN) in adults between 2,4-49,1% and autopsy studies showed that half of the individuals had pancreatic cysts.

There is a great variety of pancreatic cysts, they are mainly divided in neoplastic or non-neoplastic (i.e pseudocyst). Pseudocysts appear after acute or chronic pancreatitis and represent only 20% of all pancreatic cysts.. PCN include a diverse group of pancreatic cysts including mucin-producing (Intraductal papillary mucinous neoplasm (IPMN), mucinous cystic neoplasm (MCN)) and nonmucin-producing lesions (Serous cystadenoma (SCN), Solid pseudopapillary neoplasm(SPN) cystic neuroendocrine tumor(cNET)) with different morphology and progression to malignancy. SPN's,cNET are considered premalignant or malignant conditions and require surveillance or surgical resection. SCN instead are benign and surveillance is not necessary. Resection is considered only if symptoms are present.

The discrimination between the different cyst types is crucial for the therapeutic approach. Their morphology can be similar and sometimes it's a challenge to diagnose them.There are many tools but none is good enough to be used alone.

Contrast-enhanced harmonic endoscopic ultrasound using low mechanical index (0.12-0.4) is an additional test to assess the vascularization of the cystic wall and the septa and solid component for the differential diagnosis of PCN.

Our aim was to identify specific imaging characteristics using CH-EUS in order to increase the diagnostic accuracy for potential malignant pancreatic cysts.

Eligibility Criteria:
Inclusion Criteria:

* presence of an undetermined pancreatic cyst \>10mm (Computer tomography, Magnetic resonance imaging);
* written informed consent.

Exclusion Criteria:

* platelet count under 50.000 platelets per microliter (mcL)
* patients with cardiorespiratory instability
* refuse of the patient to participate.
Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease

The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease (PD).


Eligibility Criteria:
Inclusion:

1. Confirmed Parkinson's Disease according to movement disorder neurologist with documented exclusion of other disorders such as fronto-temporal dementia (FTD)/ frontal gait disorder/normal pressure hydrocephalus (NPH)/progressive supranuclear palsy (PSP)
2. PD stage3 ON medication, with severe gait dysfunction and predominant axial symptoms: Movement Disorder Society-Unified Parkinson's Disease Rating Scale Tremor Dominant (MDS-UPDRS TD), Postural Instability Gait Difficulty (PIGD) ratio ≤ 0.90 and Freezing Of Gait Questionnaire (FOGQ) score \> 12.
3. Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in UPDRS score)
4. FOG refractory to LEVODOPA\>600 mg
5. 6. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS.
6. a) Poor candidate for STN or GPi DBS due to good control of tremor, bradykinesia, and rigidity symptoms with Levodopa b) or Post-operative STN/GPi DBS PD patients with significant residual non-levodopa responsive postural and gait instability
7. Must agree to full 6-month participation in study.

Exclusion:

1. Individuals with major executive dysfunction
2. Individuals with dementia, as defined by the Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
3. Individuals with other neurocognitive impairments
4. Individuals who have depression, as defined for example by the Beck Depression Inventory II (BDI-II) \> 25
5. Presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy
6. Individuals who require diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
7. Individuals with a history of prior intracranial surgery
8. Individuals with a metallic implant in their head that is not MRI compatible (e.g., aneurysm clip, cochlear implant)
9. Individuals with active implantable devices anywhere in the body (e.g. cardiac pacemaker, defibrillator, spinal cord stimulator, implanted medication pump)
10. Individuals who are pregnancy or desire to become pregnant during the study
11. Individuals who are breastfeeding12.
12. Individuals who are on investigational drugs and any other intervention (not part of the guidelines for management of Parkinson's Disease) known to have a potential impact on outcome
13. Subjects utilizing recreational drugs at the time of screening will be excluded from the study with the exception of medicinal marijuana
The Biodistribution of 1-[2 Deoxy-2, -18 Fluroarabinfuranosyl]Cytosine [18FAC] in Healthy Subjects and Patients With Cancer, Autoimmune/Inflammatory Diseases

The purpose of the study is to determine whether positron emission tomography using the new imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.


Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* women of childbearing potential will undergo a pregnancy test free of charge
* patients with cancer or autoimmune diseases or healthy subjects
The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae

The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.

Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.

Eligibility Criteria:
Inclusion Criteria:

* Striae alba on abdomen for more than 3 months
* Fitzpatrick skin type III-V

Exclusion Criteria:

* Pregnancy and breastfeeding
* Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study
* History of using Isotretinoin
* Photosensitive dermatoses, Infection, eczema
* Past history or family history of malignancy
* History of herpes infection
* History of hypertrophic scar or keloid, connective tissue disease
* History of collagen or elastin disease
* History of smoking
* Significant fluctuations in weight in the past 6 months
Antibiotic Combination for H. Pylori Eradication in Penicillin-allergic Patients

This randomized controlled clinical trial will compare the eradication efficacy of bismuth quadruple therapy containing clarithromycin+metronidazole, clarithromycin+levofloxacin, or metronidazole+levofloxacin for Helicobacter pylori first-line treatment in penicillin-allergic patients. The completion of this trial will expand new therapy for the treatment of Helicobacter pylori, which can not only ensure clinical efficacy, but also reduce the use of antibiotics.


Eligibility Criteria:
Inclusion Criteria:

* Participate in the trial voluntarily, fully understand the trial, and sign the informed consent form (ICF).
* 18-75 years old on the day of signing the ICF.
* Helicobacter pylori infection confirmed by 13C-urea breath test or rapid urease test.
* Have not received Helicobacter pylori eradication treatment before.
* allergic to penicillin.

Exclusion Criteria:

* Have received Hp eradication treatment.
* Patients with severe heart, lung, kidney, liver, blood, nerve, endocrine, and psychiatric diseases.
* Subjects or guardians refused to participate in the trial.
* Alcohol and/or drugs Abuse (addiction or dependence) or poor compliance with doctor's judgment.
* Have taken antibiotics, bismuth, proton pump inhibitors or Chinese traditional medicine 4 weeks before treatment.
* Pregnant or lactating women.
* Active peptic ulcer.
* allergic to drugs used in the trial.
* any other circumstances that are not suitable for recruitment.
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial

This randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities.


Eligibility Criteria:
Inclusion Criteria:

* The trial will include patients who are rostered to the family practice as of March 31, 2015, are eligible and overdue for cervical, breast and/or colorectal cancer screening and are verified by their primary care physician as needing recall.

Exclusion Criteria:

* Patients will be excluded if their primary care physician noted they should not be recalled for screening or if the patient does not have both an address and a phone number on file.
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era

This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.

Patients who received previous adjuvant or salvage radiotherapy to the prostate bed \>

Isolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible \>

Baseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning \>

Two fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) \>

Follow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)

Eligibility Criteria:
Inclusion Criteria:

1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions
2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan
3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl
4. With or without ADT PSA doubling time from nadir greater than 6 months
5. ECOG 0-2
6. Age greater than 18 years

Exclusion Criteria:

1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases
2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT
3. Any contraindications to MR and/or brachytherapy
Micra Accelerometer Sensor Study 2

The purpose of the MASS2 is to characterize accelerometer signals of Micra implantable device during different postures and activities and to understand the source of the sensed motion, in order to test feasibility for future enhancements in device functionalities.


Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years old
* Subject is implanted with a Micra device
* Subject or witness (if applicable as per local regulation) is able and willing to provide Informed Consent

Exclusion Criteria:

* Subject is in atrial fibrillation
* Subject is not able to perform study requirements
Pivotal Study to Evaluate the Safety and Efficacy of GelrinC for Treatment of Cartilage Defects

Multicenter, open-label, controlled, non-randomized, double arm trial with a prospective treatment arm (GelrinC). This study compares the efficacy and safety of GelrinC to a historical control arm (microfracture) in the treatment of cartilage defects in the knee.


Eligibility Criteria:
Main Inclusion Criteria:

* Age between 18 and 50.
* Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.
* Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
* BMI ≤35
* Contralateral knee is asymptomatic, stable, fully functional and not medically treated.

Main Exclusion Criteria:

* Presence of an additional grade III or IV symptomatic lesion.
* Recent Osteochondritis Dissecans within 1 year of baseline visit.
* Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.
* Patient is excluded if presenting untreated current meniscal tear or if previous menisci resection was within the last 6 months.
* Previous tendon repair or ligament reconstruction within the last 6 months.
* Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.
* Microfracture performed less than 1 year before baseline visit.