cyrilzakka/clinical-trials huggingface dataset:
Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC) disease in AIDS patients.

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.

Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Recommended in patients with CD4 count \<= 200 cells/mm3:

* Antiretroviral therapy.
* PCP prophylaxis.

Allowed in all patients:

* Isoniazid preventive therapy.

Patients must have:

* HIV infection.
* Evidence of disseminated MAC infection.

NOTE:

* Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Known hypersensitivity to the study drugs.
* Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.

Concurrent Medication:

Excluded:

* Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
* Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
Study in Letrozole Combined With Metronomic Oral Cyclophosphamide in Elderly Metastasis Breast Cancer Patients

This is a randomized clinical trial to investigate the efficacy of letrozole combined with metronomic oral cyclophosphamide in elderly metastasis breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancers patients with estrogen receptor positive and/or progesterone receptor positive;
* Elderly women (age ≥ 65years)
* Failure or relapse from standard chemotherapy or unfit for chemotherapy
* Measurable disease per Response Evaluation Criteria in Solid Tumors(RECIST);
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Adequate bone marrow, liver and renal function;
* Estimated life expectancy of at least 3 months.

Exclusion Criteria:

* Serious or uncontrolled concurrent medical illness
* Uncontrolled primary and metastatic brain tumor
* History of second primary malignancies
* Having been enrolled in other clinical trials within a month
Adrenal Venous Sampling in Patients With Overt or Subclinical Cushings Syndrome, and Bilateral Adrenal Tumors

Patients with tumors in both adrenal glands and slightly elevated cortisol (subclinical Cushings syndrome) are offered to go through an adrenal venous sampling to try to quantify if the overproduction of cortisol is from one adrenal, or from both sides. If it is one-sided, the investigators offer the patient operation.

Adrenal incidentalomas are quite common. About 4 % of the population have adrenal tumors that they are unknown of. Some percentage of this patients produce a little to much cortisol, but not enough to give overt Cushings syndrome. It is shown that slightly elevated cortisol production will give higher blood pressure, higher blood sugar and maybe higher BMI. For another hormone produced in the adrenal glands , aldosterone, we know that even if you have an adrenal tumor on one adrenal, you could have bilateral overproduction of the hormone.In that situations it is no need of an operation of the adrenal with the tumor. When the overproduction is unilateral it is of great value to the patient to operate the adrenal gland, and the symptoms from the hormone excess will disappear. For aldosterone Adrenal venous sampling (AVS) has been used for several years to try to determine if the hormone overproduction is one-sided or to sided. We are in this study using the same principle for cortisol overproduction.

Eligibility Criteria:
Inclusion Criteria:

* Benign tumors/adenomas in the adrenals and biochemically overproduction of cortisol

Exclusion Criteria:

* Use of steroids ( tablets, inhalations, lotions)
Moderate-vigorous Intermittent Physical Activity (M-VILPA) in Stroke

Stroke is the leading cause of disability in Spain. Additionally, it is the second leading cause of death in women and the third in both sexes. Regular physical activity (PA) helps prevent and manage stroke. It also helps with hypertension, maintains a healthy body weight, and improves mental health, quality of life, and well-being. PA plays a prominent role in inpatient care after stroke. However, stroke survivors become more sedentary when discharged from the hospital. They have muscle weakness, reduced balance, and fatigue. Consequently, PA levels of community-dwelling post-stroke individuals remain lower than their age-matched counterparts. Continued PA can help this population maintain and improve physical function, and reduce long-term functional limitations, and mortality risk.

Previous studies that performed a comparative analysis of physical activity between individuals with and without stroke have consistently reported that stroke survivors tend to spend less time in moderate to vigorous physical activity The 2021 AHA guideline recommends smaller sessions of PA, with suggestions such as 10 minutes of moderate activity, 4 times a week, or 20 minutes of vigorous activity twice a week. This contrasts the weekly physical activity recommendations in 2011 (30 minutes of moderate to vigorous, 1 to 3 times) and 2014 (40 minutes of moderate to vigorous, 3 to 4 times). We hypothesise that older stroke survivors are physically active more frequently but for smaller durations than younger stroke survivors who are physically active for longer durations but less regularly. Understanding these subtle changes will not only help to tailor physical activity interventions based on specific recommendations but also help design future recommendations.

Moderate-to-vigorous PA could be an adequate approach for stroke survivors as it requires less time to achieve the same benefits as light PA. More concretely, a new concept called moderate-to-vigorous intermittent lifestyle physical activity (MV-ILPA) has recently emerged for adults who do not habitually exercise in their leisure time. MV-ILPA refers to brief and sporadic bouts of moderate-vigorous intensity PA performed as part of the activities of daily living, such as bursts of very fast walking, sitting and standing up from a chair, or stair climbing. MV-ILPA is associated with a substantially lower risk of all-cause cardiovascular disease and cancer mortality. However, there is no evidence to directly support the potential benefits of MV-ILPA in the elderly post-stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* adults aged ≥57 in the late subacute phase post-stroke.
* who live in the community
* whose clinician confirmed a diagnosis of stroke (ischaemic/haemorrhagic)
* discharged from hospital inpatient regimen
* with independent mobility skills (Barthel Index ≥ 40 points).

Exclusion Criteria:

• other neurological diseases (e.g. Parkinson disease) or severe lower limb injuries.
Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets

The hypotheses tested in this study are: There is a statistical significant difference, in treatment duration and result of treatment in cases treated using traditional Damon Q brackets or using Insignia.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, both male and female
* No cleft lip or palate or other craniofacial anomalies
* Treatment with full fixed orthodontic appliances is indicated
* Complete permanent dentition except for upper second and all third molars
* Class I, Class II or Class III first molar relationship )1/2 pb or less off)
* No previous orthodontic treatment
* Age between 12 and 30 years of age
* Study models and lateral cephalograms taken not more than 1 month before selection
* Informed consent signed by patients and parents

Exclusion Criteria:

* Cleft lip and palate and craniofacial anomalies
* Syndromes affecting bone (formation) or teeth
* Agenesis of teeth
* Missing first molars
* No bridges or implants
* Orthognathic cases
* History of periodontal disease
* Intake of drugs affecting tooth movement and/or bone formation
* Pregnancy
Mindfulness and Self-compassion Focussed Walking

This research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy.

This randomized research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking (MSCW)) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy. The results of both groups are compared with each other and with those of a control group.

The MSCW program combines endurance based physical activity in the form of medically controlled walking, as well as standardized, evidence-based mindfulness exercise elements in a training program.

The participants of both active groups (Walking and MSCW) practice for 12 weeks, once a week for 60 minutes under the guidance of a trainer in a group and 2 additional times (60 minutes each) independently at home.

The purpose of this study is to prevent a sharp decline in quality of life due to fatigue symptoms by participating in the MSCW training program.

A total of 135 participants will be included in the study. All participants are followed for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with breast cancer who have started antineoplastic therapy (chemotherapy / radiotherapy).
* Age ≥18 years
* The patient must be able to perform the study intervention (physically and psychologically).
* oral and written consent to participate in the study.

Exclusion Criteria:

* distant metastases
* Severe mental and / or additional organic illnesses
* Clinically relevant cardiac arrhythmias or angina pectoris
* Severe pulmonary disease
* inadequate walking ability or gait disturbance (including neurological deficits, endoprosthesis supply that lead to gait insecurity)
* regular meditation practice (several times a week)
* Planned start of meditation, relaxation, MBSR, yoga, Qi Gong courses over the next 24 weeks.
* Participation in other intervention studies on walking or meditation
* Insufficient knowledge of the German language
Treatment of Obstructive Jaundice in Autoimmune Pancreatitis and/or Immunoglobulin G4-related Sclerosing Cholangitis by Corticosteroids

This study evaluates corticosteroids in the treatment of obstructive jaundice in autoimmune pancreatitis and/or immunoglobulin G4 (IgG4)-related sclerosing cholangitis in adults. Half of participants will receive corticosteroids alone, while the other half will receive corticosteroids with biliary stent at the beginning.


Eligibility Criteria:
Inclusion Criteria:

* adults greater than 18 years-old;
* autoimmune pancreatitis and/or IgG4-related sclerosing cholangitis;
* obstructive jaundice

Exclusion Criteria:

* malignancies; active infections;
* pregnancy or breast feeding;
* standard contraindications to ERCP;
* unwillingness or inability to consent for the study
The Effect of Soy Isoflavones on Non-alcoholic Fatty Liver Disease and the Level of FGF-21 and Fetuin A

In this research, the investigators tested the effect of 12-week supplementation with soy isoflavones on non alcoholic fatty liver disease (NAFLD) management and the level of fibroblast growth factor-21 (FGF-21) and fetuin A as markers of NAFLD progression.

Non-alcoholic fatty liver disease (NAFLD) accounts as a crucial health concern with a huge burden on health and economic systems. The aim of the present study was to investigate the effect of soy isoflavone intake on hepatic outcomes and the level of fibroblast growth factor-21 (FGF-21) and fetuin A in patients with NAFLD. Fifty patients with NAFLD were randomized to either receive two tablets of soy isoflavone (100 mg/d) or placebo. Dietary intakes, anthropometric parameters, the serum levels of liver function tests including alanine amino transferase (ALT), aspartate amino transferase (AST) and gamma glutamyl transferase (GGT), FGF-21, fetuin A and hepatic histological features by Fibroscan assessed at study initiation and after week 12.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* without any history of allergy to soy or excessive consumption of soy products
* without chronic diseases including renal, liver, heart, respiratory, cardiovascular, malignancies, auto immune disorders, cushing's syndrome, thyroid dysfunction, hepatitis, cirrhosis, biliary disorders, diabetes, gastrointestinal tract diseases affecting the gut absorption and psychiatric disorders considering as an obstacle for patients to prepare written informed consent;
* hepatic steatosis grade 2 and higher with fibroscan confirmation (CAP \> 260 dB/m);
* without history of excessive alcohol drink (≥10 g/day);
* without history of drug consumption with approved positive effects on NAFLD treatment (i.e. metformin, vitamin E, ursodeoxycholic acid, phenytoin, tamoxifen, lithium, corticosteroids and methotrexate) in last three months;
* without the history of bariatric surgery or following weight loss diets within 6 months;
* without history of smoking;
* not being a pregnant or lactating woman

Exclusion Criteria:

* consuming less than 90% of intended supplements.
* unwillingness for study collaboration
Clinical Application of Patented Lyophilized PLT in Acne Scar Repairment.

All kinds of skin problems will cause a person's life caused by varying degrees of trouble, especially issues at face. No matter diseases or aging would cause mental pressure and the inconvenience in different ages.

Scar caused by acne is the most common skin issue amount young people. While acne recovering, due to the destruction of collagen forming fibrous tissue, and scars be left. Clinical treatments are facial laser, argon laser and carbon dioxide laser. With the combination of rejuvenation to accelerate growth of collagen when needed. According to journal articles, facial laser combined with Platelet-rich plasma is more curative than facial laser treatment alone and can significantly reduce side effects (Dermatol Surg. 2014 Feb;40(2):152-61).

Platelet has been valued in regeneration medicine due to its various growth factors with repairment, induction and promotion functions. Moreover, low risk of allergy for it is an autologous material. Platelet had been officially applied in orthopedics and more clinical studies in many other fields. Nowadays, preparation of PRP is by single-use centrifuge tube, patients have to go through blood collection process every time before therapy due to short shelf life of PRP. Meanwhile, amount of platelet in PRP would be different due to difference of individual, health condition and separation methods. Thus, leaving unknown of active principle and uncertainty of treatments.

In this trial, a patented technique of lyophilized PLT preparation method is applied, collect 250 c.c. of blood specimen by using blood bag, separate platelet in germ-free clean room, then lyophilize platelet to extend shelf life to at least three years after quantifying platelet amount. Therefore, treatment could be done after simple dissolution process of PLT leads to the convenience of multiple therapy lessons.


Eligibility Criteria:
Inclusion Criteria:

- all subjects of acne scars are defined of grades 1, 2, and 3 \[Goodman and Baron Grading scale\] were enrolled in the study.

Exclusion Criteria:

* Exclusion criteria included treatment with any laser device treatment to the face within 1 month, use of systemic retinoids within 3 months, pregnancy or lactation, a history of hypertrophic scarring or keloids, cancer therapies, uncontrolled diabetes, chronic liver or kidney disease, cardiovascular disease or hematologic disorders. Subjects were requested to avoid using any topical products containing alpha-hydroxy acids and salicylic acid on the face during the study period.
A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India

This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid \[IRF\], sub-retinal fluid \[SRF\], and pigment epithelial detachment \[PED\]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events \[AEs\]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve nAMD patients or patients previously treated with a single or a combination of other intravitreal anti-VEGFs
* Patients (male or female) ≥50 years of age at the index date
* Patients with visual acuity (VA) and optical coherence tomography (OCT) assessments at baseline and at least 1 month after initiating treatment with brolucizumab
* Patients treated with IVI of brolucizumab (received the first dose of anti-VEGF injection during the index period \[01 October 2020 to 31 March 2021\])

Exclusion Criteria:

* Patients with dry AMD, geographic atrophy, and other retinal diseases in the study eye
* Patients who were part of any other nAMD trial/study during the study period
* Patients undergoing additional ocular treatment along with other anti-VEGF agents
Pain and Anxiety Evaluation in Children Using Different Techniques of Local Anesthesia for Dental Treatment

Fear and dental anxiety are often associated with the use of needles and syringes for local anesthesia, and painful perception during the administration of local anesthetics is often the main reason for anxiety behaviors and defensive reactions. Dental trauma originates in childhood, through experience misconduct. The objective of this study is to evaluate the pain and anxiety related to 4 different modalities of anesthesia in children. Will be selected volunteers aged between 5 and 12 years who need restorative dental treatment in posterior teeth in the upper 2 quadrants. All patients will receive 1 modality of anesthesia: conventional anesthesia (control group), computerized anesthesia, Dental Vibe anesthesia and computerized anesthesia + DentalVibe anesthesia. Evaluations will be made with physiological and behavioral criteria. For the physiological evaluation will be measured the blood pressure, respiratory rate, heart rate, oximetry and salivary cortisol before and during each anesthesia. As criteria for evaluation of anxiety will be applied the methods, Corah and modified VPT before anesthesia and modified VPT will be repeated after anesthesia. The pain will be assessed at the end of each anesthesia with Visual Analogue Scale (VAS) and Wong Baker Faces. The results will be submitted to parametric and non-parametric statistical analysis, according to the data obtained in the different evaluation criteria.


Eligibility Criteria:
Inclusion Criteria:

* Children of both sexes, aged between 5 and 12 years, requiring dental treatment under local anesthesia in the first permanent molars or deciduous maxilla.

Exclusion Criteria:

* The person responsible does not authorize the participation of the child as a research volunteer.
* Be using pain modulating drugs.
* Be using anxiety modulating drugs.
* Patients with a history of hypersensitivity to local anesthetics.
* Patients with a history of systemic diseases.
The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach

The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care.

The primary objective of this study is to examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.

The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care.

The primary objective of this study is:

To examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.

This study will address the following secondary objectives:

1. To examine bivariate relationships between SB, PsD, and SN.
2. To explore effects of patients' spirituality on the relationship between patients' SN and SWB.

This study is not powered to test hypotheses concerning the secondary objectives but will specifically examine through descriptive statistics and confidence intervals the following:

1. SN, PsD, and SB are positively correlated with each other.
2. SN negatively influences SWB.
3. SN positively influences spirituality.
4. Spirituality positively influences SWB.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients at MDACC who are 18 years or older;
* Are being/have been seen at the MD Anderson Neurosurgery clinic;
* Have a diagnosis of a primary or metastatic intracranial or skull-based brain, pituitary, or meningeal lesions;
* Are scheduled to undergo surgical intervention.

Exclusion Criteria:

* Have preferred language listed other than English on the chart;
* Present with cognitive functional impairment, evidence of expressive or receptive aphasia, or gross dysfunction limiting memory or ability to complete a self-report questionnaire, which will be determined by reviewing provider's notes;
* Refusal to participate in research.