cyrilzakka/clinical-trials huggingface dataset:
RNF213 Variants and Collateral Vessels in Moyamoya Disease

The purpose of this study is to detect the association between RNF213 variants and collateral vessels in patients with moyamoya disease.

Moyamoya disease (MMD) is a chronic cerebrovascular disorder characterized by the presence of occlusion which occurs at the internal carotid arteries and their main branches during the development of a basal collateral network. The ring finger 213 (RNF213) was identified as a strong susceptibility gene in patients with MMD in East Asia. The role of RNF213 variants in pathogenesis of MMD is still unclear. Specific "moyamoya vessels" correlate with the onset of stroke. The purpose of this study is to investigate the relationship between RNF213 variants and collateral vessels in patients with moyamoya disease, and provide potential pathogenesis of moyamoya disease.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained
* Patients with age between 4-60 years
* Cerebral digital subtraction contrast angiography (DSA) reveal severe stenosis or occlusion of the distal internal carotid or proximal middle and anterior cerebral arteries with prominent lenticulostriate 'moyamoya collaterals'

Exclusion Criteria:

* There are other vascular diseases, including systemic vasculitis, neurofibroma, meningitis, sickle cell disease, down's syndrome, and previous basilar radiotherapy
* Patients with cardiogenic embolism, including a history of atrial fibrillation, valvular disease or cardiac valve replacement
* Physical or subjective failure to cooperate with the examination or serious comorbid diseases
The Efficacy of Reiki in the Treatment of Fibromyalgia

The purpose of this study is to investigate the effectiveness of Reiki in the treatment of fibromyalgia (FM), a condition characterized by widespread muscle pain and stiffness, often accompanied by sleep disturbance, headaches, irritable bowel syndrome, and psychological distress. Reiki is a form of energy medicine in which practitioners reportedly access universal life energy to heal patients, either by direct contact at specific hand positions or from a distance.

Fibromyalgia is one of the most common rheumatologic diagnoses. Treatment is generally unsatisfactory and most randomized, controlled treatment trials have been unable to demonstrate a sustained effective intervention. A vast body of anecdotal literature as well as two randomized controlled trials suggest that Reiki may be an effective treatment for FM, appearing to relieve pain and improve psychological well being. Reiki appears to have no adverse effects and can eventually be self-administered, making it a low-risk, low-cost, potentially patient-empowering intervention. This study will investigate the efficacy of Reiki in the treatment of FM.

One hundred Reiki-naive FM patients will be recruited from a chronic fatigue referral clinic and will participate in an 8-week trial. Patients will be randomized into one of two Reiki groups (direct-contact and distant Reiki) or one of two control groups (sham and placebo). Patients will receive either Reiki or placebo 16 times during the course of the study. Patients will be assessed at study entry, at Weeks 4 and 8, and 12 weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria

* Fibromyalgia without concurrent medical conditions associated with chronic pain, such as diabetic neuropathy, systemic lupus erythematosus, or severe degenerative joint disease
* Willing to undergo randomization and attend treatments regularly
* Willing to stay on a stable medical regimen during the entire 8-week trial and use only acetaminophen for breakthrough pain
* Live within a one-hour drive of the study site

Exclusion Criteria

* Received Reiki or any other energy medicine (Therapeutic Touch, Qi Gong, SHEN Therapy, etc.)
* Pregnant
* Pending litigation or disability claim related to FM
Wireless Capsule Endoscopy in Small-Bowel Crohn's Disease

The purpose of this study is to determine the best role for capsule endoscopy in diagnosing Crohn's disease.

Wireless capsule endoscopy (CE) is a Food and Drug Administration (FDA) approved technology that allows viewing of the entire small-bowel. Capsule endoscopy involves swallowing a pill-sized camera that sends images to a data recorder worn on a vest. Because Crohn's disease (CD) often involves the small bowel, we would like to find out if capsule endoscopy is useful in diagnosing small-bowel Crohn's disease. Current methods for diagnosing small-bowel Crohn's disease include colonoscopy, esophagogastroduodenoscopy (EGD), enteroscopy (ENT), single contrast barium small-bowel follow through (SBFT), and double contrast small-bowel enteroclysis (SBE), but these tests are unable to identify the presence or extent of small-bowel disease in many patients.

Eligibility Criteria:
Inclusion Criteria:

* English speaking adult patients (\>18 years old) with known Crohn's disease

Exclusion Criteria:

* Severe medical or psychiatric co-morbidities
* Active swallowing problems
* Bowel obstruction
* History of stricture or fistula
* Pregnancy
* Taking aspirin/non-steroidal anti-inflammatory drug (NSAID) or potassium chloride (KCl) within 4 weeks prior to the colonoscopy and anytime after colonoscopy
* Inability to consent
* Exclusion of patients whose colonoscopy was done for reasons other than signs/symptoms suggestive of Crohn's disease
Evaluation of Anti-PD-1 Therapy by Monitoring T Cell Responses in Melanoma, Lung and Other Cancer Types

This study explores the role of T cells in monitoring disease status and response during anti-PD-1/PD-L1 treatment in patients with melanoma, lung and other cancer types. Measuring levels of specific targets such as Bim and soluble PD-L1 during therapy may help track treatment resistance and clinical outcomes. This information may also help researchers determine why some people with melanoma, lung and other cancer types respond to PD-1/PD-L1 treatment and others do not.

PRIMARY OBJECTIVES:

I. Establish the role of Bim for monitoring disease status during anti-PD-1 therapy.

II. Identify the mechanisms of resistance to anti-PD-1 blockade. III. Quantify and modulate levels of NKG7 messenger ribonucleic acid (mRNA) in CD8+ T cells.

OUTLINE: This is an observational study.

Patients undergo blood sample collection throughout the study. Patients also undergo optional stool sample collection and have their medical records reviewed on study. In addition, patients provide previously-collected tissue sample, if available.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years of age or older
* Have histologic evidence of locally or regionally advanced or stage IV malignancy
* Are considered appropriate for starting therapy with anti-PD-1/anti-PD-L1 monoclonal antibody by their treating physician (prior therapy with immune checkpoint inhibitor (ICI) is allowed)
* Have an understanding of the protocol and its requirements, risks, and discomforts
* Are willing to undergo peripheral blood collection at the time points mentioned in the protocol
* Are able and willing to sign an informed consent

Exclusion Criteria:

* Inability on the part of the patient to understand the informed consent or be compliant with the protocol
* Patients receiving any concurrent anti-cancer therapy or investigational agents (with the exception of an anti-PD-1/anti-PD-L1 agent as mentioned above)
* Patients who are pregnant, nursing, or are of childbearing potential and are unwilling to employ adequate contraception
"Impacts of the Letter of Condolence to the Bereaved Families Experience After a Death in ICU " - Study Famirea 22

After the death of a patient in the hyper-technical context of intensive care, his relatives are particularly vulnerable and often exhibit symptoms of anxiety, depression, post traumatic stress and complicated grief. The first results of a qualitative study Famiréa current (CAESAR) support the idea that the bereaved relatives suffer from persistent misunderstandings and a feeling of abandonment of the resuscitation team. Many families suggest the need for contact with the team after the patient's death. The letter of condolence received by some families allowed them to feel recognized in their pain resuscitation teams. This has led us to ask the question of post-death monitoring and interest to send to bereaved relatives a letter of condolence, as recommended by the American consensus conference in 2004 on good palliative care. This strategy would allow the recognition of both close to the pain but also the strong bond that united the resuscitation team. The hypothesis of the study is that the post-death followed in the form of a letter of condolence sent by the intensive care physician who was in charge of the patient, could reduce the risk of having symptoms of anxiety / depression and post-traumatic stress and reduce the rate of complicated grief.

Famirea 22 is randomized clinical trial aimin to compare two bereaved groups: one group who did not receive a letter of condolence and a group that received a letter of condolence 15 days after the death.


Eligibility Criteria:
Inclusion Criteria:

* death of a relative patient in intensive care whose relatives were interviewed at least once by resuscitation team
* death of an adult relative patient
* ICU stay of the relative patient more than 2 days

Exclusion Criteria:

* death of a pregnant woman
* opposition to the use of its data by the patient
* relative does not speak French
* refusal of the relative
Effect of a Test Meal on Satiation Hormones in Obese and Normal Weight Adolescents

The objective of this study is to examine ghrelin, amylin, glucagon and glucagon-like peptide (GLP)-1 responses to a test meal in lean and obese individuals.

The primary hypothesis is that obese adolescents have a disturbed balance of hormones associated with appetite regulation with less suppression of ghrelin and attenuated stimulation of GLP-1 secretion in response to meal intake compared to lean normal weight controls. A second aim of the study was to test which gastrointestinal peptides are most associated with insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* caucasian youth
* pubertal Tanner stage x, y, or z

Exclusion Criteria:

* fasting plasma glucose \> 7.0 mmol/L
* significant illness
* taking medications
Pre-Surgical Study: Effect of Metformin on Breast Cancer Proliferation

The purpose of this pilot study is to use a pre surgical intervention model to evaluate the biologic effects of metformin in women with newly diagnosed early invasive breast cancer. Metformin is a drug commonly used to treat patients with diabetes. This model will be used to evaluate the effects of metformin.

Breast cancer is the most common cancer and the second leading cause of cancer death among women in the United States. Several epidemiologic studies have found an increased risk of breast cancer in women with type 2 diabetes. This association appears to be mediated by a state of hyperinsulinemia and insulin resistance. Population based studies have also found a decreased risk of cancer in diabetic patients taking metformin, an oral biguanide derivative. Proposed mechanisms include its effect on lowering serum insulin levels as well as modulation of cellular signaling pathways which inhibit tumor cellular proliferation.

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed operable invasive breast cancer or ductal carcinoma in situ (DCIS) who undergo core needle biopsy followed by surgical excision at least 2 weeks after enrollment
* Body mass index \> 25
* Age ≥ 21 years
* No prior chemotherapy, radiation therapy, or surgery within 6 months of study entry
* Signed informed consent

Exclusion Criteria:

* History of diabetes mellitus requiring medical therapy
* Treatment with other investigational drugs within 6 months of study entry
* Significant renal impairment with a creatinine \> 1.4 mg/dl
* Other serious intercurrent medical illness
Safety and Efficacy of Gabapentin for Neuropathic Pain in Fabry Disease

The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain in patients with Fabry disease, and reducing their use of opioid analgesics. The investigators are conducting a randomized, double-blind, placebo controlled, single center, cross-over study. The primary endpoint is percent reduction in patients' use of hydrocodone-acetaminophen.

Fabry disease is an X-linked lysosomal storage disorder which results from reduced activity of the enzyme α-galactosidase A. This reduced enzyme activity results in accumulation of globotriaosylceramide (GL-3), which causes disturbances in multiple organ systems. Patients often complain of acroparesthesia, caused by small-fiber neuropathy. Limited information is available regarding effective treatments for small-fiber neuropathic pain in Fabry disease, and no standard-of-care has yet been established. Opioid analgesics are often used because of their pharmacokinetic properties. While effective, the use of opioids has complications such as constipation, physical dependence and addiction. The purpose of this study is to determine efficacy of gabapentin vs. placebo at controlling peripheral neuropathic pain and reducing the use of opioid analgesics. The investigators are conducting a randomized, double-blind, placebo controlled, single center, cross-over study. The primary endpoint is percent reduction in hydrocodone-acetaminophen use.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Fabry Disease
* age ≥ 18 years of age at study enrollment
* current neuropathic pain at any severity level

Exclusion Criteria:

* known sensitivity or allergy to study drug
* history of illicit drug use
* pregnancy
* suicidal thoughts at study enrollment as assess by the C-SSRS
AMS INSIGHT 1 Study - Bioabsorbable Metal Stent Investigation in Chronic Limb Ischemia Treatment

Prospective, multicenter, randomized clinical trial, Follow-up at 1-, 6- and 12 months

This clinical investigation is first of all designed to demonstrate the safety and effectiveness of the MAGIC EXPLORER stent system. The primary objectives of the study are to evaluate the safety and 6-month patency of the bioabsorbable MAGIC EXPLORER stent in patients with stenotic or occlusive atherosclerotic disease of the infrapopliteal arteries. Secondary endpoints are the procedural success, patency at all follow-ups, late lumen loss and limb-salvage rate. Peri-procedural complications (within 24 hours) will be evaluated. Furthermore, data of the balloon catheter PLEON EXPLORER will be collected to demonstrate its effectiveness and safety.


Eligibility Criteria:
Inclusion Criteria:

* Stenotic (\> 50%) or occlusive atherosclerotic disease of the infrapopliteal arteries
* Length of lesion \< 20mm (less than one stent length)
* Reference vessel diameter should be 3.0-3.5 mm
* A maximum of two lesions in one infrapopliteal vessel treated within the study, or in two vessels of two different legs. (PTA treatment of other infrapopliteal lesions in non-study vessels is allowed outside the study).
* Symptomatic critical limb ischemia (Rutherford 4, 5)
* The patient must be ≥ 50 years.
* Life-expectancy of more than 6 months
* The subject or legal guardian has been informed of the nature of the study; agrees to its provisions and has signed informed consent
* The patient must be available for the appropriate follow-up times for the duration of the study
* The patient is capable to follow all study requirements.

Exclusion Criteria:

* Patient refusing treatment
* The reference segment diameter is not suitable for available stent design
* Length of lesion requires more than one stent implantation
* Previously implanted stent(s) or PTA at the same lesion site
* Lesion lies within or adjacent to an aneurysm
* Inflow-limiting arterial lesions left untreated
* The patient has a known allergy to heparin, Aspirin or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
* The patient takes Phenprocoumon (Marcumar).
* The patient has a history of prior life-threatening contrast media reaction.
* The patient is currently enrolled in another investigational device or drug trial.
* The patient is currently breast-feeding, pregnant or intends to become pregnant.
* The patient is mentally ill or retarded.
* The patient is liable for military or civilian service.
Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

OBJECTIVES:

* Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
* Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.

OUTLINE: This is a multicenter study.

Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:

  * Prior diagnosis of acquired immune deficiency syndrome (AIDS)
  * CD4 count \< 100,000/mm3
  * ECOG performance status \> 2

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* See Disease Characteristics

Life expectancy:

* Not specified

Hematopoietic:

* See Disease Characteristics

Hepatic:

* Not specified

Renal:

* Not specified

PRIOR CONCURRENT THERAPY:

Biologic:

* Not specified

Chemotherapy:

* Not specified

Endocrine:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Hybrid Interactive Avatars for Post-COVID Sufferers

The goal of this observational study is to evaluate an app to improve communication and information flows for persons suffering from Post-COVID-19 syndrome (PCS). The main questions it aims to answer are:

* How can custom virtual characters (avatars) help to collect more data for the diagnosis of PCS?
* Can conversations with virtual (mobile) characters (avatars) and the presentation of health data help to improve the diagnosis and understanding of PCS?
* How should these virtual characters (avatars) be designed for people with PCS and healthcare professionals to be useful in the long term? This concerns appearance, dialog, personality and functions.

Participants will be asked to use and test the app and take part in two interviews at the beginning and end of the study.

The overarching goal of the HINT project is to develop an app that people affected by PCS can use on their own devices in a language of their choice (e.g. their native language) to increase their health and data literacy about PCS and to provide socially equitable access to PCS care. Multilingual avatars are used for independent data collection, as the embodiment of interaction systems offers advantages for health queries. The data collected during the survey and - if desired - data from wearables are combined with historical data from the participants, processed and visualized. This allows patients to communicate with their avatar as well as with medical staff about their illness and its progression without language barriers affecting treatment. The avatar can also inform patients about new research findings on PCS. To this end, the system's level of knowledge is constantly compared with the current state of science; new findings are prepared for the target group and added to the knowledge base. The project is aimed at all those affected by PCS, although the multilingualism and low-threshold health education are intended to appeal in particular to people who have previously had difficulty accessing adequate care. The project is aimed at all those affected by PCS, although the multilingualism and low-threshold health education are intended to appeal in particular to people who have previously had difficulty accessing adequate care. The participatory and iterative development of the system, which also involves medical staff, contributes to overarching issues relating to co-creation approaches in the healthcare sector.

Eligibility Criteria:
Inclusion Criteria:

* Existence of a declaration of consent
* Stable clinical condition
* Diagnosis of Post-COVID syndrome according to the World Health Organization (WHO):

  * Symptoms persist for more than 12 weeks
  * Duration: at least 2 months
  * Etiology: no alternative diagnosis
  * Progression: persistent, recurrent, fluctuating

Exclusion Criteria:

* Known psychiatric or somatic illness that can explain the symptoms
Topical Application of Chlorhexidine to the Umbilical Cord for Prevention of Omphalitis and Neonatal Mortality in Rural District of Pakistan

The investigators hypothesize that application of 4% Chlorhexidine to the cord stump and meticulous hand washing by primary health care providers of newborn infants will reduce the incidence of Omphalitis and thereby Neonatal Mortality as compared to standardized dry cord care.

The prime objective of this study is to estimate the independent effect of 4% Chlorhexidine solution application to cord stump and hand washing with soap by mothers of newborns for 2 weeks after birth in reducing Omphalitis in neonates compared to routine cord care by TBAs (Traditional Birth Attendant) in rural district of Sindh, Pakistan.

This study will be conducted in existing health infrastructure in a community setting with the help of two principal health care providers, TBAs and CHWs Community Health Workers) involved in maternal and newborn care. The TBAs conducting delivery wil be trained to wash hands with soap and water after completion of delivery and apply chlorhexidine to the Umbilical Cord Stump. The procedure will be repeated by the mother on the subsequent days up til 14 days from birth. The CHWs will also be trained to recognized signs of Omphalitis and record Cord Care in a systemic manner in a structured proforma.

The study will continue longitudinally for a period of one year to follow newborn for the signs of Omphalitis.

Eligibility Criteria:
Inclusion Criteria:

* All healthy newborns, born in the study setting will be systematically enrolled in the trial

Exclusion Criteria:

* Infants with congenital/birth defects
* Infants with any localized infection on the peri-umbilical region at the time of birth or application of any other material such as dung, etc before enrollment on the Cord.