cyrilzakka/clinical-trials huggingface dataset:
Zentangle on Psychological Well-being

This study will examine the effects of Zentangle as an intervention for reducing stress and enhancing psychological wellbeing among Hong Kong adults. Zentangle is a mindful doodling process in which participants draw repetitive, structured patterns on small pieces of paper. The patterns consist of combinations of dots, lines, and curves. Zentangle is developed in 2003 by two Americans, and this concept is still new to many people. Some studies suggested that Zentangle can be effective in reducing stress and anxiety, but the number of research papers on Zentangle is limited. Although Zentangle has become a rather popular stress relief activity in Hong Kong recently due to its easiness to learn and minimal tool requirement, there is no related study on its effectiveness in promoting psychological wellbeing in Hong Kong.

This study will be a pilot randomized controlled trial on the effects of Zentangle as an intervention for reducing stress and enhancing psychological wellbeing among Hong Kong adults. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 30 eligible participants will be randomly assigned to either the Zentangle group or the waitlist control group in a ratio of 1:1.

Eligibility Criteria:
Inclusion Criteria:

1. Hong Kong residents
2. Aged from 18 to 65
3. Cantonese language fluency
4. Willingness to provide informed consent and comply with the trial protocol
5. Be able to join online webinar via a computer

Exclusion Criteria:

1. Have suicidal ideation
2. Are using medication or psychotherapy for any psychiatric disorder
3. Experiencing depression and anxiety
4. Have major psychiatric, medical or neurocognitive disorders that make participation infeasible based on the research team's judgment
5. Are currently participating in a mindfulness practice
Efficacy of Continuous Subcutaneous Insulin Infusion Versus Basal-bolus Multiple Daily Injections Regimen in Type 2 Diabetes

A lot of insulin-treated type 2 diabetic patients do not reach adequate glycemic control despite intensive basal-bolus insulin regimen. In such cases, continuous subcutaneous insulin infusion (CSII), using an external pump, could be a solution to improve diabetes control.

The aim of this study is to compare, over a one-year period, the efficacy of CSII (with aspart insulin) and basal-bolus multiple daily injections (MDI) treatment (with detemir x 2/d and aspart before meals) in type 2 diabetic patients, already treated by basal-bolus regimen for at least 6 months, who didn't reach adequate target for glycemic at baseline (HbA1c\>7 -10%).

Visit 1: patient information and eligibility criteria assessment Visit 2: Inform consent signature and randomisation (group CSII or MDI). Patients randomised in the CSII group are instructed to use pump between V2 and V3.

Visit 3: 5-day's hospitalisation. Start of CSII or MDI treatments. Stop of all oral diabetic medications except for metformin, which is followed up until the end of the study. Teaching program on diabetes management (diet, physical activity and self-adjustment of insulin doses). HbA1c, clinical and biological parameters. Questionnaires.

Follow-up visits 4-7 (1, 3, 6, 9 months): HbA1c. Treatment adjustment. Adverse events collection.

Final visit (12 months): HbA1c, clinical and biological parameters. Questionnaires. Adverse events collection.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Age \> 18 years
* Patients treated for at least 6 months by Multiple daily insulin injections associating long acting insulin (at least 1 long acting insulin analog injection -Glargine or Detemir- or at least 2 NPH insulin injections) plus mealtimes rapid acting insulin injections (Human or analogs) +/- oral hypoglycemic agents.
* 7,5% ≤ HbA1c ≤ 10%
* Patients able to perform self-monitoring blood glucose (SMBG) measurement and insulin injections.
* SMBG \> 3/day

Exclusion Criteria:

* Diabetic retinopathy contraindicating glycemic control intensification
* Situation or pathology not allowing therapeutic education program (blindness, deafness, low language fluency...)
* Situation or pathology not allowing insulin therapy self-management and / or portable insulin pump use (rheumatologic pathology, low visual acuity, ...)
* Recent (\<3 month) serious pathology
* Planned treatment or therapy able to induce long-term glycemic control worsening
* Long lasting (\> 2 month) planned treatment with glucocorticoids, octreotide, lanreotide or danazol
* Pregnancy wish or ongoing pregnancy
* Known Haemoglobinopathy.
* Creatinin clearance \<30ml/min (MDRD formula).
* Organ transplant.
Validity and Reliability of the Turkish Version of the Tegner Activity Score

The goal of this observational study is to learn about patients who will undergo anterior cruciate ligament reconstruction. The main questions it aims to answer are:

* Is the Turkish version of the Tegner Activity Score a valid scale?
* Is the Turkish version of the Tegner Activity Score a reliable scale?
* What is the minimal clinically important difference value of the Turkish version of the Tegner Activity Score?
* What is the substantial clinical benefit value of the Turkish version of the Tegner Activity Score?


Eligibility Criteria:
Inclusion Criteria:

* to be over 18 years old
* to undergo surgery for a ruptured anterior cruciate ligament

Exclusion Criteria:

* to have metabolic or autoimmune diseases
* to undergo revision anterior cruciate ligament surgery or anterior cruciate ligament repair
* to have cognitive issues that will hinder the completion of the study forms
* to lack sufficient proficiency in Turkish
Training With Virtual Reality in Upper Arm Reaching of Children With Cerebral Palsy

The objective of this study was to evaluate the effects of training with Virtual Reality in the movement range of children with Cerebral Palsy spastic hemiparetic.The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week no significant changes were observed for the angular variables and space-time between groups. The Virtual Reality used for intervention to improve upper arm function in children with Cerebral Palsy is still a relatively new method.

Introduction: The disability of upper limb function (MS) of children with Cerebral Palsy (CP) spastic hemiparetic restricts their participation in social activities. Virtual reality (VR) has shown promising results in functional recovery of this population, however, few studies have evaluated its effectiveness in the reaching of motion of these children. Objective: To assess the effects of training with VR in the movement range of children with CP spastic hemiparetic. Materials and Methods: We conducted a randomized crossover trial, where the sample consisted of 12 children diagnosed with CP hemiparetic, both genders, with a mean age of 9.63 ± 2.3 years. The sample description was performed by assessing muscle tone, range of motion, grip strength, functional performance and disability. Kinematic analysis of the upper limb was performed by Qualisys Motion Capture System®. The study protocol consisted of two days of training and 1 revaluation. The training A (Nintendo Wii®) and B (standard protocol) were randomized the children in AB and BA sequences, with one week interval. Immediately kinematics pre and post-training was held and after a week. Data were analyzed using SPSS 20.0 (Statistical Package for Social Science) assigning a 5% significance level. The kinematic variables were analyzed by two-way ANOVA for repeated measures.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of cerebral palsy spastic hemiparesis;
* Aged 6 to 12 years old;
* Preserved cognition to understand instructions;
* Present no significant auditory and visual deficits;
* The affected upper limb classified in levels II and III Rating System Manual (MACS, English Manual Abilities Classification System). The level II corresponds to children who are able to handle the majority of objects with low quality and / or speed of movement, while at level III are those that manipulate objects with difficulty and low speed, requiring assistance organization of activity. Spasticity ranked among the levels 0 and 3 of the Modified Scale Ashworth.It has not performed orthopedic surgeries, or have made use of botulinum toxin for less than six months, not presenting seizures, controlled medication.

Exclusion Criteria:

* Presence of pain or discomfort during the course of the training;
* Refusal to follow commands and instructions and discontinuity of interventions.
Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

This is an observational, retrospective, single-center study focused on the diagnosis of Central Precocious Puberty in female patients.

The study enrolls female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020 at the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola.

The study design provides 2 cohorts of female patients on the basis of the LH peak value in GnRH test: patients with LH peak value \< 5U/L, and patients with LH peak value \> 5U/L.

The primary aim is to assess the diagnostic power of basal LH comparing with the LH peak value after stimulus test with GnRH in female patients with suspected precocious puberty. The secondary aim is to assess the association of the following variables between the two cohorts: uterine volume, longitudinal uterine diameter, presence of endometrial rhyme, ratio of peak LH/FSH values and dose per kg of GnRH administered during stimulus test.

Eligibility Criteria:
Inclusion Criteria:

* Female patients with onset of signs of early pubertal development (onset of telarche) before the age of 8 years, who referred to the Pediatrics Unit of IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di Sant'Orsola between January 2017 and December 2020;
* Female patients undergoing GnRh testing for suspected diagnosis of Central Early Puberty between january 2017 and December 2020;
* Obtaining informed consent from parents/legal guardian of pediatric patients.

Exclusion Criteria:

• Patients with Peripheral precocious puberty.
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for the Care of Soft Contact Lenses in Symptomatic Patients

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses in patients who experience discomfort with their contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic for contact lens related discomfort at the end of the lens wearing day.
* Successful daily wear of FDA Group IV lenses on a two-week or longer replacement schedule for at least two weeks.
* Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
* Successful lens wear for at least 4 hours per day.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.
* No enrollment in another clinical study within 30 days prior to enrollment.
Embryonic Ploidy Status in the Oncofertility Population

looking at aneuploidy rates in embryos from patients who are going to or have undergone treatment for a malignancy with gonadotoxic treatment.

The study involves oncofertility patients--individuals who are undergoing or have undergone therapy for a malignancy--who are interested in pursuing or preserving fertility. In particular, it investigates chromosomal abnormalities or aneuploidy in the embryos of those individuals as compared to the general infertility population. Embryonic aneuploidy is largely due to reproductive senescence. As such the investigators will discuss oncofertility prevalence and treatment as well as reproductive senescence and assessment of embryonic aneuploidy. The study will seek to determine if there are changes in embryonic aneuploidy rates in oncofertility patients that differ from simple age related risks.

Eligibility Criteria:
Inclusion Criteria:

1.Present or past oncologic diagnosis requiring potentially gonadotoxic treatment

Exclusion Criteria:

1. Oocyte banking
2. Use of oocyte donation
3. Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
4. Single gene disorder requiring more detailed embryo genetic analysis
Blood Collection Sub-Study of Exact Sciences Protocol 2019-01: "Clinical Validation of an Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, For Colorectal Cancer Screening BLUE-C"

The primary objective of this sub-study, 2019-01B, is to collect blood specimens for research use in the development and validation of a blood-based test for colorectal cancer (CRC).

Subjects who consent to enroll in Exact Sciences Protocol 2019-01 BLUE-C, will be invited to participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2019-01 BLUE-C, who provide written informed consent to participate in this sub-study, will have a blood sample collected at enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is currently enrolled in Exact Sciences Protocol 2019-01 BLUE-C.
2. Subject is willing and able to provide a blood sample.
3. Subject is willing and able to sign informed consent.

Exclusion Criteria:

1. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
GU-01: Glycyrrhizin in Prostate Cancer

This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy)

This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer who are candidates for surgery (radical prostatectomy) will receive one cycle of therapy consisting of Glycyrrhizin (GLY) (Observation, Dose Level 1 75mg daily, or Dose Level 2, 150mg daily) for 6 weeks (+/- 2 weeks) prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years of age at time of consent
2. ECOG performance status of 0, 1, or 2
3. Histologic diagnosis of prostate cancer
4. Patient suitable for radical prostatectomy as determined by surgical team
5. Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
6. Willing to use barrier contraceptive method during study intervention

Exclusion Criteria:

1. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating urologic oncology team.
2. Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
3. Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
4. Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or History of Torsades de Pointes. This may include patients who have sub-optimally controlled hypertension, serum potassium levels \<4.0 mEq/L, serum magnesium ≤1.8 mg/dL, prolonged gastrointestinal transit time, or decreased 11-β-hydroxysteriod dehydrogenase-2 activity.
Immunotherapy with Autologous Tregs in T1DM

Type 1 diabetes (T1D) is an autoimmune disease characterized by a progressive immune distruction of pancreat beta cells and deterioration of endogenous insulin secretion. Regulatory T cells (Treg) are fuctionally deficient in T1D, leading to the loss of immune tolerance to the islets and the initiation of an autoimmune attack. Previouse studies have revealed the potential theraputic effects of autologous Treg transplantation in T1D. We have modified the preparation protocol for autologous Tregs. The purpose of this study is to assess the safety and effect of autologous Treg therapy in patients with T1D.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria of T1DM based on the 2021 version of the Chinese Guidelines for Diagnosis and Treatment of Type 1 Diabetes;
* Aged 8 to 65 years;
* At least one islet autoantibody positive and/or fasting C-peptide does not exceed 300pmol/L;
* Must be capable of providing written, signed, and dated informed consent and willing to comply with research requirements in the study.

Exclusion Criteria:

* The condition of diabetic ketoacidosis has not been controlled;
* Severe allergic constitution;
* Known or suspected tumor;
* Acute pancreatitis, and severe heart, liver, kidney, rheumatic immune, respiratory, nervous or infectious diseases.
* Suffering from gestational diabetes mellitus, single gene mutation diabetes mellitus, diabetes mellitus caused by pancreatic damage or other secondary diabetes mellitus (such as diabetes mellitus caused by Cushing's syndrome, thyroid dysfunction or acromegaly, etc.);
* Women who are pregnant or have a pregnancy plan before and after treatment, and women who are breastfeeding.
* Mental illness, alcohol or drug abuse, unable to cooperate with treatment;
* According to the judgment of the investigator, there are other clinical conditions that may endanger the safety of the subjects.
The Point of View of Hematological Cancer Patients and Their Loved Ones Regarding Spirituality

The management of patients with malignant hemopathy is based on comprehensive management. In this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central. Spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not. Although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia) and in treatment;
* Patients who speak and read French;
* Patients in general condition (physical and mental) judged emotionally and physically fit by the referring nurse to answer the questionnaires;
* Patients benefiting from a social security scheme,
* Patients who signed the non-objection form after being informed of the study,

family person:

* Have been designated by the patient as being the loved one they wish to include with them;
* Aged ≥ 18 years;
* Fluent in and reading French;
* Having signed the non-objection form after being informed of the study.

Exclusion Criteria:

* Patients in recurrence / progress or in remission of cancer;
* Patients in the terminal phase of the disease.

Family person:

person in the curative phase of cancer
A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma

Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma

This is a single arm, open-label, single-center study. This study is indicated for relapsed BCMA+ multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 50 patients will be enrolled for this trial. Primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of multiple myeloma (MM):

   1. Patients with BCMA positive relapsed/refractory MM;
   2. Relapsed after hematopoietic stem cell transplantation;
   3. Cases with recurrent positive minimal residual disease;
   4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
2. Anticipated survival time more than 12 weeks;
3. Male or female aged 30-75 years;
4. Those who voluntarily participated in this trial and provided informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Effects of Cilostazol on Plasma Adipocytokine and Arterial Stiffness

Cilostazol is an antiplatelet agent used to reduce the symptoms of intermittent claudication. Cilostazol inhibits phosphodiesterase III (PDE III), which causes it to be a vasodilator and inhibitor of platelet aggregation. Recently there were report of beneficial effect of cilostazol like vasodilation, lipid metabolism, and cytokine production. But there were few clinical studies that support these effects of cilostazol. The purpose of this study is to evaluate the vasodilatory and anti-inflammatory effect of cilostazol presented by PWV and plasma adipocytokines.


Eligibility Criteria:
* Eligible for study: 18 year and above, Gender eligible for study: both Inclusion Criteria:Type 2 diabetes patients with metabolic syndrome criteria of Asian-Pacific ATP III guideline
* Type 2 diabetes (at least 1 criteria below)

  1. fasting blood glucose ≥ 126 mg/dL
  2. postprandial 2hour glucose ≥ 200 mg/dL
  3. random blood glucose ≥ 200 mg/dL with typical diabetes symptoms
* Metabolic syndrome : Asian-Pacific ATP III guideline

  1. Fasting blood glucose ≥ 110 mg/dL, or previously diagnosed type 2 diabetes
  2. systolic and/or diastolic blood pressure ≥130/85 mmHg, or treatment of previously diagnosed hypertension
  3. Triglyceride ≥ 150 mg/dL, or Specific treatment for this lipid abnormality
  4. HDL-cholesterol \< 40 mg/dL for men and \< 50 mg/dL for women, or Specific treatment for this lipid abnormality
  5. Waist circumference ≥ 90 for men and ≥ 80 for women

Exclusion Criteria:

* Hypertensive patients with the use of ACE inhibitor or ARB
* Hyperlipidemic patients with the use of statin or fenofibrate
* Hepatic dysfunction
* Chronic alcohol or drug abuse
* Renal dysfunction
* Heart failure
* Patients who takes hormone replace therapy or steroid containing drugs
* Patients who take drugs like anticoagulant (warfarin), anti-platelet agent (aspirin, ticlopidin), thrombolytic agent (urikinase, alteplase), prostaglandine E1 , drugs inhibit CYP3A4 or CYP2C19, or drugs become substrate of CYP3A4
* Patients who haves disease influencing the results of the study such as neurologic, digestive and neoplastic disease