cyrilzakka/clinical-trials huggingface dataset:
Study on Therapeutic Mechanism of Natural Psychotherapy for Neurosis

explore objective indicators of the efficacy of natural psychotherapy in the treatment of disorders such as obsessive-compulsive disorder

1. To evaluate the cognitive function, Cognitive control, emotion and other aspects of neurosis patients, and to understand and master the cognitive behavior indicators of this population.
2. Investigate the pathological mechanism of neurotic patients from the aspects of electroencephalic graph/functional magnetic resonance imaging (EEG/fMRI) and biology.
3. To investigate the therapeutic effect of natural psychotherapy on cognitive impairment and related mood, sleep and symptom intervention in neurotic patients. In order to achieve the symptoms of neurosis patients, cognitive impairment and related mood and sleep intervention and promotion, while providing a scientific basis for neurosis rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of obsessive-compulsive disorder or compulsive behavior
* Duration of symptoms for not less than 12 months
* Age 15-60 years old.
* You can participate in the whole experiment and offline assessment in Beijing

Exclusion Criteria:

* Documented disease of physical diseases including, but not limited to stroke, tumor, Parkinson's disease, Huntington's disease, seizure, epilepsy, history of brain trauma
* Subjects who suffered from alcohol or illegal drug abuse/dependence
Strengthening Evidence on Optimal Multidrug-resistant Tuberculosis Treatment Regimens

This is a multisite prospective cohort study of patients with multidrug- or rifampin-resistant tuberculosis who are treated with an all-oral shortened regimen under routine program conditions in one of three countries (Peru, Lesotho, Kazakhstan).


Eligibility Criteria:
Inclusion Criteria:

* All patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions, per local country guidance, will be included.

Exclusion Criteria:

* Exclusions are based on local guidance in each country. Currently, individuals with fluoroquinolone resistant tuberculosis are excluded from all-oral shortened treatment.
Enhancing Skin Cancer Early Detection and Treatment in Primary Care

Skin cancer screening may help find melanoma sooner, when it may be easier to treat. If found early melanoma and other types of skin cancer may be curable. Multi-component education may be an effective method to help primary care physicians (PCPs) learn about skin cancer screening. This clinical trial examines whether a clinician-focused educational intervention can improve PCP's knowledge and clinical performance to identify and triage skin cancer. This intervention may increase the PCP's ability to diagnose, treat and/or triage early-stage melanoma.

PRIMARY OBJECTIVE:

I. Evaluate whether a multi-component education strategy improves the ability of PCPs to identify and triage skin cancer.

OUTLINE:

Participants are assigned to 1 of 2 groups.

PCP participants complete group training. All training participants will also be offered series of short booster teaching points delivered virtually. Participants who complete the training also take part in pre-post knowledge assessments. PCP participants may also participate in a qualitative interview.

PCPs at the two clinics who do not receive the group training will serve as study comparators.

Eligibility Criteria:
Inclusion Criteria:

* Clinicians at two Oregon Health \& Science University (OHSU) primary care clinics will be invited to receive exposure to the melanoma early detection intervention
* Clinicians at the two clinics who do not receive the intervention will serve as study comparators
* These individuals are all aged 18 years or older
* All practice members speak English

Exclusion Criteria:

* No one will be intentionally excluded
Treatment of Coronary Artery Disease (CAD) With Bare Metal Stent (BMS) Followed by Paclitaxel-Coated Balloon Catheter Versus Paclitaxel-Eluting Stent

The purpose of this study is to compare the one-time application of Paclitaxel from SeQuent Please (Paclitaxel-coated Balloon Catheter) after using the Coroflex Blue (Cobalt Chromium Stent) with the slow releasing of small dose of Paclitaxel from the Coroflex Please (Paclitaxel-Eluting Stent) stent system in a non-inferiority trial.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease including patients with chronic stable angina, unstable angina and silent ischemia
* Presence of one or more coronary artery stenosis \>50% in a native coronary artery from 2.25 to 3.5 mm in diameter that can be covered with one stent
* One lesion treated with the study device

Exclusion Criteria:

* Pregnancy
* Known intolerance to aspirin, clopidogrel, heparin, stainless steel, paclitaxel, cobalt, chromium or contrast material
* Inability to provide informed consent
* Currently participating in another trial before reaching the primary endpoint
* Elective surgery within 12 months of percutaneous coronary intervention (PCI) unless dual antiplatelet therapy is maintained throughout the peri-surgical period
* Acute or recent myocardial infarction
* left ventricular ejection fraction (LVEF) \< 30 %
* Stroke or transient ischemic attack within 6 months
* Stented segment longer than 23 mm
* Vessel diameter of less than 2,5 mm
* Significant calcification, chronic total occlusion (CTO) or thrombus in the target lesion
Thiamine Supplementation to Improve Cardiac Function in Patients With Congestive Heart Failure

Working Hypothesis: a treatment with thiamine improves functional status and heart function of patients with congestive heart failure when on a diuretic treatment.

In the treatment of congestive heart failure, diuretic drugs have become a firm cornerstone of therapy. Up to 50% of patients with congestive heart failure in industrialized nations will undergo long-term diuretic treatment. Diuretic therapy is associated with a loss of water soluble vitamins, including vitamin B1 (thiamine). Electrolyte dysbalance, a major side effect of diuretic therapy, has been extensively studied. In sharp contrast, only few data are available about the effects of vitamin loss and in particular of thiamine in this setting. Available data suggest that a diuretic treatment is associated with an increased risk for thiamine deficiency. Thiamine plays a crucial role for normal cardiac function, since severe thiamine deficiency leads to congestive heart failure (wet beriberi). Consequently, patients undergoing diuretic treatment might have compromised heart function. Supplementation of thiamine has been reported to improve cardiac function in patients with congestive heart failure on long-term treatment with diuretic drugs. However, no efforts have been made to confirm those preliminary observations by a placebo-controlled, double-blind study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable congestive heart failure on a prescription for diuretic drugs

Exclusion Criteria:

* Acute heart failure
* Foreseeable need for further changes in medication
* Current medication containing vitamins
* Patients with a creatinine above 250 μmol/l
Microplastic Exposure From Clear Aligner Wear (MPE)

An observational longitudinal study measuring microplastic exposure and physiologic uptake in orthodontic patients receiving clear aligner treatment.

This study is investigating whether orthodontic patients already scheduled to receive clear aligner treatment have changes in their microplastic exposure and physiologic uptake pre- and post-treatment. Consented and enrolled participants will provide unstimulated saliva and urine samples at three timepoints before regularly scheduled orthodontic appointments: Pre-treatment (Visit 1), 6-12 weeks post-treatment (Visit 2), and 16-24 weeks post-treatment (Visit 3). The saliva and urine samples will be filtered and then analyzed for microplastic content using mass spectroscopy, Raman spectroscopy and scanning electron microscopy approaches.

Eligibility Criteria:
Inclusion Criteria:

* Individuals (all sexes, genders, races, and ethnicities) aged at least 10 years (in adult dentition) and at most 90 years
* Receiving comprehensive, Phase II orthodontic treatment with clear aligner therapy
* Stable physical health (ASA I or II), as determined by study coordinator or PI
* Able to comprehend and follow requirements of study (including availability on scheduled visit dates)
* Patient and parental consent (and assent for minors) for participation in the study

Exclusion Criteria:

* Receiving orthodontic treatment with fixed appliances
* Receiving hybrid treatment with fixed appliances and aligners
* Receiving Phase I orthodontic treatment with fixed appliances
* Established history of severe xerostomia (dry mouth), severe periodontal disease with actively bleeding gums, significant oral abrasions/ulcers or growths, current alcohol abuse, and/or recreational drug abuse
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase risk associated with participation
* Drinking, eating, or brushing teeth within 1 hour of study visit
* Removing aligners within 1 hour of study visit
* Developmental or cognitive disability such that the patient cannot self-consent, comprehend, and follow the requirements of the study based on research site personnel's assessment
A Treatment Access Program To Provide Maraviroc To Eligible Adult Patients Completing A4001050 Study Until Commercial Availability Of Maraviroc (Celsentri) In India

The new protocol will allow the patients enrolled on A4001050 to have continuous access of Maraviroc and the treatment will not be interrupted until the drug is commercially available in India.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who complete the A4001050 study and are continuing to derive benefit from Maraviroc.
* Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures.

Exclusion Criteria:

* Subjects who discontinued in A4001050 study.
* Unable to provide consent.
Precision Dosing of Alemtuzumab

The purpose of this study is to conduct a pilot trial of a Precision Dosing approach to alemtuzumab dosing for allogeneic hematopoietic cell transplantation of patients with non-malignant diseases. The investigators will measure the ability to use a population PK model of alemtuzumab to target patient Day 0 alemtuzumab levels to 0.15-0.6ug/mL in a pilot study of 20 patients.

The hypothesis is that the model-informed dosing regimen will prospectively allow the precision dosing of alemtuzumab to target Day 0 levels to fall between 0.15-0.6ug/mL in greater than 80% of patients. The investigators have chosen a conservative pilot study approach, and the aim is to achieve Day 0 alemtuzumab levels between 0.15-0.6ug/mL in greater than 60% of 20 patients enrolled in this pilot study based on a Simon two-stage design as detailed below.

A Simon two-stage design (Simon, 1989) is being used. The null hypothesis that 30% of patients will achieve a Day 0 alemtuzumab level between 0.15-0.6ug/mL will be tested against a one-sided alternative that the alemtuzumab dose modification will result in 60% of patients achieving a Day 0 alemtuzumab level between 0.15-0.6ug/mL. In the first stage, 7 patients will be accrued. If there are 2 or fewer patients that achieve Day 0 alemtuzumab levels within the range of 0.15-0.6ug/mL, the study will be stopped. Otherwise, 13 additional patients will be accrued for a total of 20. The null hypothesis will be rejected if 11 or more patients achieve a Day 0 level of 0.15-0.6ug/mL within the total 20 patients. This design yields a type I error rate of 0.04 and power of 0.82 when the true response rate is 0.60. The investigators will enroll up to 30 patients in order allow for subject withdrawal, but will stop enrollment once 20 patients reach Day 0.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are undergoing RIC HCT with alemtuzumab, fludarabine, and melphalan at CCHMC for treatment of a non-malignant disease.
2. Age ≥ 6 weeks to ≤ 30 years (at time of enrollment).
3. For the first 7 patients, patients must have a 10/10 HLA matched related or unrelated stem cell donor, or be receiving a CD34+ selected stem cell product. After the first 7 patients, any donor match may be allowed after data review by the PI and medical monitor.

Exclusion Criteria:

1. Patients with a history of anaphylaxis to alemtuzumab.
2. Patients who have previously received alemtuzumab and have not cleared alemtuzumab prior to the start of the preparative regimen.
3. Life expectancy less than 2 weeks.
4. Patients receiving dialysis.
5. Failure to sign informed consent and/or assent, or inability to undergo informed consent process.
6. It is not medically advisable to obtain the specimens necessary for this study.
7. Not able to tolerate subcutaneous dosing (patients with severe skin conditions such as epidermolysis bullosa).
Caria: Digital Intervention for Menopause Symptom

Menopause is the time of life when menstrual cycles cease. Women typically spend 30-40% of their lives in menopause. Individual experiences of menopause vary and although some women do not experience any significant symptoms, common symptoms include vasomotor dysfunction, vaginal dryness, mood changes, sleep disturbances, urinary incontinence, cognitive changes, somatic complaints and sexual dysfunction. Reduced quality of life can occur as a result of these symptoms. A mobile app has been developed to reduce the impact of these symptoms using a variety of behavioral change techniques including education, goal setting, motivational enhancement, social support and cognitive behavioral approaches. Participants will complete self report assessments of women's symptoms and QOL at baseline, 3 weeks and 6 weeks of app use.


Eligibility Criteria:
Inclusion Criteria:

- Women with variable menstrual cycles (menopausal transition) or those who were more than 1 year from their last menstrual period (postmenopause)

Hot flash/night sweats should be experienced as problematic (as indicated by an average score of 2 or higher on three items of the Hot Flush Rating Scale

Elevated score on at least one measure - either depression (PHQ8=10 or greater, sleep (PSQI of 5 or greater) or anxiety (GAD7=10 or greater)

Own an apple device able to run the Caria app

English speaking

Exclusion Criteria:

* None
Clinical and Genetic Factors Associated With Psychotic Symptoms Among Cocaine Abusers

The aim of this study is to determine the clinical, genetic and environmental factors associated with the phenotype "severe psychotic symptoms" caused by cocaine.

The second purpose is to include gene x environment interaction and to analyse the factors associated with the presence or the absence of severe psychotic symptoms induced by cocaine.

Eligibility Criteria:
Inclusion criteria:

* Adults, cocaine users, who have signed an informed consent

Exclusion criteria:

* Poor venous condition (for blood samples), specially protected people, non French speaking, people who refuse to sign the consent.
Functional Magnetic Resonance Imaging (MRI) of Hypnosis and Mindfulness Meditation

Hypnotic trance and mindfulness meditation have both been shown to have benefits for physical health. The current study seeks to determine if there are distinct patterns of brain activity that correlate with hypnotic trance, mindfulness meditation or both, and to relate these patterns to measurable markers of physical well-being. Precise neuroimaging of heightened attentional states will guide future researchers and practitioners toward more effective techniques of mind/body control.

Our goal is to determine the functional brain networks that define and distinguish two induced states of sustained attention -- hypnosis and mindfulness -- that may be of substantial relevance to medicine.

Defining the neural underpinnings of these states would have broad implications for understanding how cognitive states emerge from functional networks, how they affect peripheral autonomic nervous system activity, and how their therapeutic efficacy can be optimized.

We propose a functional MRI study using resting state methodology to study 20-40 subjects from each of the four following groups:

1. Highly hypnotizable subjects
2. Minimally hypnotizable subjects
3. Experienced mindfulness meditators
4. Novice mindfulness meditators. The ability to be hypnotized is a stable and measurable trait that can be pre-screened and quantified. Dr. Spiegel will select subjects according to their ability to be hypnotized prior to the MRI visit (see ?recruiting? below). We will seek greatest contrast between groups by enrolling those with the highest (8-10) and lowest (0-2) scores on the Hypnotic Induction Profile. The presence of a poorly hypnotizable group allows for a control condition of those who have undergone an identical induction routine without achieving hypnotic trance. Similarly, novice meditators will serve as a control for the group experienced in mindfulness meditation.

Prior studies have shown differences in both brain activation and grey matter volume associated with longer practice of meditation (\> 4 years) compared with novice meditators. As such, experienced meditators will be defined as those with a regular meditation practice of four years or longer. Novice meditators will be new practitioners who are interested in mindfulness meditation practice, and who completed a one-hour meditation training during the week before their study participation.

Eligibility Criteria:
Inclusion Criteria:

* Participants must not have contraindications to the MRI exam, such as metal in the body.

Exclusion Criteria:

* Contraindications to the MRI exam, such as metal in the body.
* Use of psychotropic medications.
Spatially Fractionated Radiation Treatment for Gynaecological Cancers

This is a prospective study to evaluate in-field disease control, survival and late toxicity in patients with cervical cancer or pelvic recurrence treated with spatially fractionated RT.

The study will include patients with primary cervical cancer or pelvic recurrence not suitable for brachytherapy in view of anticipated or actual suboptimal target coverage due to aberrant anatomy or large residual disease at the time of brachytherapy.

Patients will be treated with spatially fractionated radiation therapy (SFRT) after EBRT completion to a dose of 25-30 Gy in 5-6 fractions in the primary setting. For patients receiving re-irradiation, 20-25 Gy in 4-5 fractions will be delivered with SFRT, which however may be individualised to match with clinical practice in the re-RT setting. Total EQD2 Gy for organs at risk will be matched to brachytherapy.

The study will be conducted at Tata Memorial Hospital, Mumbai and Advanced Centre for Treatment, Research and Education In Cancer (ACTREC), Navi Mumbai.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with cervical cancer post EBRT, with expected suboptimal brachytherapy dose coverage due to-

   1. Aberrant uterine or pelvic anatomy leading to difficulty in localization of the cervical OS or negotiation of the uterine canal accurately by two independent clinicians in up to two procedures.
   2. Large residual disease at the time of brachytherapy with anticipated suboptimal target coverage either determined in clinic based on pre-brachytherapy imaging or at dose planning (e.g. figure 2).
   3. Very narrow vaginal canal not accommodating even the smallest intracavitary or vaginal cylinder applicators.
2. Patients with inoperable endometrial cancer not suitable for anaesthesia or have anticipated suboptimal coverage of target volume at brachytherapy as identified on pre-brachytherapy imaging obtained after EBRT.
3. Patients with large pelvic recurrences after surgery and/or (chemo) radiation, not amenable to surgical salvage or brachytherapy after salvage EBRT due to reasons specified in item 1.
4. Patients with contraindications to anaesthesia for brachytherapy with sufficient risk of on-table or post procedure adverse events.

Exclusion Criteria:

1. Any pre-existing fistula in bladder or rectum.
2. Pelvic prosthesis.
3. Refusal to provide consent.
L-Arginine and Sickle Cell Disease

One of the main problems in sickle cell disease is the decreased bioavailability of nitric oxide and arginine. This study was designed to assess if treating sickle cell disease patients with L-arginine would improve pulmonary arterial pressure and other aspects.

This is a phase III, randomized, double-blind, placebo-controlled clinical trial with sickle cell disease patients older than 1 year of age. The patients were randomly assigned to take 0.1 g/kg/day of either L-arginine or placebo orally. Adverse events were monitored by a safety committee. The variables were assessed while patients were in remission, as part of their routine care: weight, blood pressure, full blood cell count, creatinine and dosage of methemoglobin at baseline and at each follow-up visit. Peripheral oxygen saturation (SpO2), fetal hemoglobin, lactate dehydrogenase and tricuspid regurgitant jet velocity were measured through transthoracic Doppler echocardiogram before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sickle cell disease confirmed through hemoglobin electrophoresis
* Genotypes SS, SC and Sβ thalassemia
* Age \> 1 year

Exclusion Criteria:

* Liver dysfunction (alanine aminotransferase ALT \> 3 times the normal levels
* Renal dysfunction (creatinine \> twice the normal levels)
* Increase in methemoglobin levels (\> 5 times the normal levels)
* History of recent stroke (\< 1 month) and priapism
* Pregnancy
* Allergy to L-arginine
* Use of sildenafil, calcium channel blockers, nitroglycerin or other nitrates
Methotrexate Combined With Immunotherapy During Radiotherapy for Solid Tumors

Immune checkpoint inhibitors, such as programmed death 1 (PD-1) and programmed cell death-Ligand 1 (PD-L1), offer new approaches for systemic treatment of tumors, but clinical efficacy remains limited. Previous studies by our team have found that methotrexate can activate anti-tumor immunity. The discovery of a new effect of this drug will improve tumor response to immunotherapy and prognosis of patients.

Malignant tumor is a systemic and complex disease that seriously endangers human health, surgery is the preferred treatment for solid tumors. Due to the extensive invasion and metastasis of advanced tumors, radiotherapy and chemotherapy are the main treatment options. However, the tolerance of tumor to chemoradiotherapy often leads to treatment failure and poor prognosis. Immunotherapy provides a new approach for the systemic treatment of tumors, but the clinical efficacy is still limited. Therefore, it is important to find effective drugs to improve the tumor response to radiotherapy and immunotherapy. Previous studies by our team have found that methotrexate can activate anti-tumor immunity. The discovery of a new effect of this drug will improve tumor response to immunotherapy and prognosis of patients. The objective of this clinical trial is to explore the efficacy and safety of methotrexate combined with immunotherapy and radiotherapy in patients with unresectable/recurrence solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects have unresectable/ metastatic solid tumors;
2. ≥ 18 years old;
3. Life expectancy of at least 3 months;
4. Eastern Cooperative Oncology Group performance status 0-2;
5. Have at least one measurable lesion ≥ 1 cm as defined by response criteria;
6. Adequate organ function.

Exclusion Criteria:

1. Subjects with a history of autoimmune diseases or syndromes;
2. Serious uncontrolled medical disorders or active infections;
3. Women who are pregnant or breastfeeding;
4. Subjects have other factors that may cause them to terminate the study, such as other serious medical conditions (including mental illness) that require combined treatment.