cyrilzakka/clinical-trials huggingface dataset:
Platelet Rich Plasma in Treatment of Melasma

Melasma is a common acquired disorder characterized by symmetric, hyperpigmented patches with an irregular outline, occurring most commonly on the face. The therapy for melasma has always been challenging and discouraging. Platelet rich plasma has been used over the last several years as an effective treatment in various surgical and medical ﬁelds. In recent years, Platelet rich plasma has also started to be used in the field of cosmetology. This study is designed to evaluate the therapeutic effect of platelet rich plasma in melasma.

Melasma is a pigmentary disorder that can be disfiguring and can cause to significant emotional stresses for sufferers, for which a universally effective treatment is still lacking. Platelet rich plasma is commonly used in dermatology and plastic surgery, especially for treating chronic wounds, ulcers, and burns. The most important contents of platelets are contained in the α-granules. Some of the bioactive substances present in the α-granules include platelet-derived growth factor, transforming growth factor -β1 and -β2epidermal growth factor, and mitogenic growth factors such as platelet-derived angiogenesis factor and fibrinogen.

transforming growth factor -β1 decreases melanogenesis via delayed extracellular signal-regulated kinase activation. The regression of melasma in a 27-years-old woman after injecting platelet rich plasma for skin rejuvenation was observed, but controlled clinical trials are still lacking to confirm this preliminary observation.

Eligibility Criteria:
Inclusion Criteria:

* patients with melasma 18 years old or more

Exclusion Criteria:

* Patients less than 18 years.
* Pregnant females and females on oral contraceptive pills.
* Patients with a history of hypertrophic scars or keloids.
* Patients with recurrent herpes infection or with present cutaneous infection and those with facial cancer.
* Patients with blood disorders and platelet abnormalities and chronic liver disease.
* Patients using systemic chemotherapy, anticoagulation therapy and antiplatelet agents.
The Effect of Therapeutic Touch on Sleep Patterns

The aim of this study is to determine the effect of the therapeutic touch applied to the sleep patterns of individuals aged 65-85 years with chronic diseases who are treated in the Neurology Intensive Care Unit of Ankara City Hospital, taking into account the circadian cycle.The type of the research is the experimental model with pre-test and post-test control group.Ankara City Hospital has included the research population in the last year.

It will consist of 1593 patients between the ages of 65-85 who are hospitalized in the Neurology Intensive Care Unit.Experimental and control groups will be created with simple randomization in randomization.The data were obtained from the socio-demographic characteristics form and the sleep pattern form developed by the researcher.

will be collected with

The aim of this study is to determine the effect of the therapeutic touch applied to the sleep patterns of individuals aged 65-85 years with chronic diseases who are treated in the Neurology Intensive Care Unit of Ankara City Hospital, taking into account the circadian cycle.Research Hospitalization in Ankara City Hospital Neurology Intensive Care It will be done with individuals who have chronic diseases in the 65-85 age range. Research It is planned to be held between November 2021 and December 2022.Therapeutic touch will be applied to the patients selected in the experimental and control groups among the patients who meet the research criteria in the intensive care units. After this application, the sleep pattern changes in the patients will be evaluated.Therapeutic touch will be applied to the patients selected in the experimental and control groups among the patients who meet the research criteria in the intensive care units. After this application, sleep pattern changes in patients will be evaluated. In the analysis of the research, dependent groups t test andindependent groups t test, Mann Whitney U and Kruskal Wallis tests will be used in non-parametric cases

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 1.65-85 years
* Having a Chronic Disease
* The patient's hospitalization in the Neurology Intensive Care Unit

Exclusion Criteria:

* Not in the age range of 65-85 years
* Not being able to communicate (being intubated, having hearing impairment, etc.)
PMR Versus MLD on RLS and Sleep Quality in Hemodialysis Patients

Progressive muscle relaxation versus manual lymphatic drainage on restless leg syndrome and sleep quality in hemodialysis patients

Restless legs syndrome (RLS) is a sensory motor disturbance with features of both neurologic and sleeps disorders. The patients complain of strong, irresistible urge to move the legs, often accompanied by uncomfortable sensations deeply in the legs. Poor sleep quality affects many hemodialysis patients and can potentially predict their morbidity, mortality, quality of life and pattern of medication use. Progressive muscle relaxation (PMR) is one way to improve physical work capacity and reduce functional limitations. Manual lymphatic drainage (MLD) is a traditional therapy in which the hands work on the tissues of the body, including tuina, acupressure, and the likes. It is beneficial to the well-being of patients both physically and mentally

Eligibility Criteria:
Inclusion Criteria:

* Male and female adults ranging from 35- 65 years old.
* Able to communicate verbally and agree to participate in the study.
* On maintenance arteriovenous fistula (AVF) hemodialysis 3 times weekly.
* None of the research participants had a lower extremity dialysis graft, and they were all taking medication to maintain their health.
* Prior to the study procedure, all patients underwent a nephrologist assessment
* All patients had good compliance with their dialysis treatment (not missing more than 2 dialysis sessions in the prior 3 months

Exclusion Criteria:

* Peripheral neuropathy or vascular diseases of the lower limbs.
* Skin diseases including acute psoriasis or eczema.
* Recent fractures or lower limbs surgeries.
* Feet injuries including severe muscle weakness, bruises, ulcers, Open wounds or recent burns
Web-Delivered Acceptance & Commitment Therapy for Smokers With Bipolar Disorder

This purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.

The study consist of two separate phases. Phase I consists of website usability testing. Investigators will collect feedback and incorporate the feedback into our website that is tailored for people with bipolar disorder. In Phase II investigators will be comparing quit rates of two groups both utilizing Nicotine Replacement Therapy and a website.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older
2. Daily smoker for the past year, averaging at least 5 cigarettes per day for the past 30 days, with expired-air carbon monoxide (CO) level ≥ 4 ppm
3. Motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening)
4. Meets lifetime criteria for bipolar I or II disorder, based on DSM-V criteria
5. Willing to be randomly assigned to either treatment group
6. Has at least weekly access to a high-speed Internet connection via a tablet, laptop or desktop computer
7. Willing and able to read in English
8. Is under care of a clinician for the treatment of bipolar disorder
9. Willing to authorize communication with the clinician regarding study participation and clinical deterioration
10. Willing to use the nicotine patch to help quit smoking

Exclusion Criteria:

1. Participating in other smoking cessation interventions
2. Currently using any pharmacotherapies for smoking cessation
3. Previous use of the Smokefree.gov website
4. Meets DSM-V criteria for current mania
5. Meets DSM-V criteria for a current major depressive episode and symptoms are currently severe (Patient Health Questionnaire-9 score \> 14)
6. Current psychotic symptoms
7. Psychiatric hospitalization within one month prior to enrollment
8. Current suicidal or homicidal ideation
9. Meets criteria for a DSM-V diagnosis of a moderate or severe substance use disorder in past month prior to enrollment
10. Unstable medical condition
11. Any medical or psychiatric condition that, in the opinion of the investigator, is severe enough to interfere with protocol adherence or ability to benefit from the intervention
12. Any medical conditions that would preclude use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
13. Employee or family member of the investigator or study center, or member of the same household as another research participant
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.


Eligibility Criteria:
Inclusion Criteria:

1. Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
2. Able and willing to give consent and able to attend all study visits.
3. Patient is pre or peri-menopausal (within 12 months of last menstrual period).
4. Able to communicate sensations during the ExAblate procedure.
5. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
6. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

1. Metallic implants that are incompatible with MRI
2. Sensitive to MRI contrast agents
3. Severe claustrophobia that would prevent completion of procedure in MR unit
4. Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
5. Pedunculated fibroids
6. Active pelvic inflammatory disease (PID)
7. Active local or systemic infection
8. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
9. Intrauterine device (IUD) anywhere in the treatment path
10. Dermoid cyst of the ovary anywhere in the treatment path
11. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
12. Undiagnosed vaginal bleeding
Transcatheter Aortic Valve Replacement Single Center Registry in Chinese Population

The purpose of this study is to evaluate the safety and effectiveness of transcatheter aortic valve replacement in Chinese population.

Subjects enrolled are those who undergo physical exams and screening tests and were classified as a patient with symptomatic aortic stenosis or severe aortic regurgitation. They are then performed transcatheter aortic valve replacement.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic aortic stenosis/regurgitation
* Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
* The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
* Patients are technical and anatomical eligible for interventions

Exclusion Criteria:

* A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: Aspirin Heparin (HIT/HITTS) and bivalirudin Nitinol (titanium or nickel) Ticlopidine and clopidogrel Contrast media
* Subject refuses a blood transfusion.
* Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent.
* Life expectancy is less than one year
Glucose Response in Persons with Type 2 Diabetes

This will be a randomized crossover design with oral nutrition supplement interventions.

This will be a randomized crossover design with two oral nutrition supplement interventions. The subjects will be randomized to one of two interventions on two separate study days, one week apart.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-75 years
* Type 2 diabetes controlled with diet or diet and metformin (Glucophage)
* Hemoglobin A1C less than 9.0%
* Fasting blood glucose less than 180 mg/dl
* Hematocrit levels within normal limits
* Having obtained his/her informed consent

Exclusion Criteria:

* Abnormal thyroid function
* Creatinine \>2.0 mg/dl
* Potassium \<3.5 mEq/l
* Gastrointestinal disease: ulcer, gastritis, diarrhea, gastroparesis, vomiting
* Currently unstable diabetes or under treatment for cancer, heart disease, renal disease
* Patients with anemia
* Current insulin therapy or insulin therapy within the past month
* Patient who are pregnant
* Allergies to milk, soy or any component of the test product
* Patient who in the investigators assessment cannot be expected to comply with treatment
* Patients with anemia
* Currently participating in another clinical trial
The MEADOW PROJECT (Mending the Effects of Alcohol and Depression on Women) and The Bridge Program (Connecting Recovery Treatment and Behavioral Health)

The aim of this study is to evaluate an interpersonally-focused intervention (Interpersonal Psychotherapy) for women with co-occurring alcohol dependence and depression. A sub-protocol has been added to pilot the current study with men with co-occurring alcohol dependence and depression.

Co-occurring alcohol dependence and major depression (AD-MD) is a serious and common public health problem, yet one that is largely unaddressed by conventional chemical dependency treatment. Among alcohol dependent patients, co-occurring depression is associated with poorer treatment outcomes, increased risk for relapse, worse long-term social and functional adjustment, and higher probability of dire outcomes such as suicide. Treatment research on AD-MD patients is needed to inform effective practice. This study provides an initial test of the applicability of Interpersonal Psychotherapy for alcohol dependent women with major depression (IPT-ADMD). The goal of the proposed research project is to refine and test a behavioral intervention that addresses women's co-occurring alcohol dependence and depression within a cohesive interpersonal frame. In Phase 1 of the project, IPT-ADMD will be piloted with 15 AD-MD women enrolled in a MICA (mentally-ill chemical abusers) group treatment program. Findings from Phase 1 will be used to refine the treatment, assessment, and therapist training procedures. In Phase 2, a randomized controlled trial with 60 AD-MD women will be conducted 1) to determine IPT-ADMD's feasibility and acceptability as an adjunct to standard MICA group treatment, and 2) to assess the comparative effects of IPT-ADMD to treatment-as-usual individual therapy (TAU-IT). Compared to TAU-IT, IPT-ADMD is hypothesized to lead to greater reductions in women's drinking frequency, drinking intensity, and depressive symptoms, and to improved interpersonal functioning.

In addition to the current intervention study comparing IPT-ADMD with TAU-IT, we are piloting IPT-ADMD with men in a sub-protocol of the main study. The target population of the Bridge Program will be men with alcohol dependence and co-occurring major depression. We hypothesize that IPT will be feasible and acceptable and will improve drinking frequency and intensity; depressive symptoms; and interpersonal functioning. The proposed sub-protocol will allow us to determine if future clinical trials of IPT should include both male and female patients with co-occurring alcohol dependence and depression.

Eligibility Criteria:
Inclusion Criteria:

* Current Alcohol Dependence and Major Depression

Exclusion Criteria:

* Bipolar Disorder
* Psychosis or schizophrenia
Assessment of an Electronic Voting System Within the Tutorial Setting. A Randomised Controlled Trial

A study of an electronic voting system as a learning aid during tutorials

A study of an electronic voting system as a learning aid during tutorials. This study was undertaken with clinical students over a one year period of observation

Eligibility Criteria:
Inclusion Criteria:

* All fourth year students
Implementation of a Clinical Decision Support Tool for Postpartum Depression

This study will evaluate the use of an automated process in the electronic health record (EHR) that will help providers to detect patients at risk of developing postpartum depression (PPD).

The goal of this randomized clinical trial is to assess the implementation of a clinical decision support (CDS) tool. The tool is designed to assist providers in managing patients at risk of developing of postpartum depression.

Investigators hypothesize that this tool will be acceptable and feasible for use and improve the use of mental health services for postpartum depression.

Patients in the control arm will receive usual care, while those in the intervention arm will receive CDS.

Clinicians will manage patients per usual care, including initiating PPD preventive such as conducting referrals to nutrition and behavioral health, suggest educational readings through patient portals, or no actions. Clinicians in the intervention arm will refer patients based on the CDS.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* being seen at one of participating clinics
* pregnancy at 20 week gestation or more

Exclusion Criteria:

* Does not speak inclusion
* does not have internet access

Clinician eligibility:

* If they manage patients in the three clinics as a board-certified OBGYN clinician.
* No exclusion criteria apply for clinician based on their knowledge and experience in treating PPD
Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma

The purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).

This is a Phase 1, multicenter, open-label, multiple-dose study designed in 2 parts: Part A, dose escalation, and Part B, dose expansion. The study is designed to establish the dosing schedule of XmAb819 administered IV and the dosing schedule of XmAb819 administered SC. The study is designed to evaluate safety and tolerability; to assess PK/PD and immunogenicity; and to preliminarily assess antitumor activity of XmAb819 in subjects with ccRCC. All eligible subjects will have relapsed or refractory disease after standard therapy.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the local site investigator. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
* Subjects who have relapsed and refractory ccRCC with evidence of disease progression on standard-of-care therapies
* ECOG performance status of 0 or 1.
* All subjects must have adequate tumor sample available (slides or archival FFPE blocks)

Exclusion Criteria:

* Prior treatment with an investigational anti-ENPP3/CD203c therapy
* History of serious allergic or anaphylactic/hypersensitivity reaction to monoclonal antibody therapy
* Systemic antineoplastic therapy within 5 half-lives on the first dose of study treatment.
* Failure to recover from any clinically significant toxicity related to previous anticancer treatment
* Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable,
* Active known autoimmune disease (except that subjects are permitted to enroll if they have vitiligo; type 1 diabetes mellitus; residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)
* Evidence of any serious infection requiring IV anti-infective treatment within 14 days prior to the first dose of study drug
* Have a known additional malignancy that is progressing or has required active treatment within the past 2 years
Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)

The goal of this \[ type of study:\]prospective randomized clinical trial. The main question is to compare the outcomes of mini-percutaneous nephrolithotomy (m-PCNL) and retrograde intrarenal surgery (RIRS) in treating upper urinary tract calculus in children ≤ 10 years.

With the increase in morbidity and incidence of pediatric kidney stone disease, childhood urolithiasis has become a significant health problem worldwide, especially in developing countries. Children with urinary calculi are at high risk for recurrent stone formation and may require multiple surgical interventions.

In recent decades, with the improvement of miniaturization of surgical equipment, the management of pediatric kidney stone disease has changed dramatically. As a result of these improvements, minimally invasive techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS) are alternative treatment options for children with upper urinary tract calculus.

Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of upper urinary tract calculus \< 2 cm. but, The significantly lower stone-free rates (SFR) of SWL as compared to the PCNL and RIRS, requirement for anesthesia, the possibility of parenchymal damage to the growing kidney and the need for additional sessions are the significant limitations of SWL

Mini-percutaneous nephrolithotomy (Mini-PCNL) is an adjustment of the standard PCNL procedure after the development of small-caliber instruments that has several advantages such as a smaller skin incision, smaller tract size, and less bleeding. However, mini-PCNL may cause severe complications because of fragile parenchyma, small caliber collecting system, and mobile kidney in pediatric patients.

with the persistent advancement of endoscopic instruments and flexible ureteroscope, the examination of the upper urinary tract has become more feasible, and retrograde intrarenal surgery (RIRS) can effectively compete with PCNL. However, the outcomes of the use of flexible ureteroscope in the pediatric population such as the risk of ureteral injury, stone-free rate especially in large stones (more than 2 cm), need for the ancillary procedure, the need to indwell double-J stent in advance and high cost of instrument and maintenance remain largely unknown, resulting in controversy about the clinical safety and efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus.

In the current study, the investigators aimed to compare RIRS and mini-PCNL by evaluating The operative and postoperative outcomes for children ≤10 years of age with upper urinary tract calculus (1-2.5 cm).

Eligibility Criteria:
Inclusion Criteria:

* This study will include all children (age \< 10 years) who undergo Mini-PCNL or RIRS with stone size (1_2.5 cm) for upper urinary tract stones

Exclusion Criteria:

* Children with urinary tract infections until treated
* Children with ureteral stricture
* Congenital urological anomalies
* Previous urological surgery