cyrilzakka/clinical-trials huggingface dataset:
The Alteration of Gut Microbiota and Analysis of Related Factors in Newly Diagnosed Type 2 Diabetes Patients

This Study aims to compare the characteristics of gut microbiota between the newly diagnosed T2DM and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota.

Previous studies have shown that gut microbiota imbalance is closely related to a variety of diseases, such as inflammatory bowel diseases (IBD), colorectal cancer (CRC), Alzheimer's disease (AD) and cardiovascular diseases. In recent years, more and more studies have found that gut microbiota plays an important role in chronic metabolic diseases such as obesity, fatty liver and diabetes. gut microbiota disorder may lead to insulin resistance，pancreatic islets injury and disorder of glycolipid metabolism through multiple metabolic pathways such as endotoxin, short chain fatty acids, bile acids, amino acids, promote the occurrence and development of T2DM. At present, there are relatively few population-based studies to assess the relationship between gut microbiota and diabetes, and the results are inconsistent or even contradictory, which may be due to the influence of the research population, disease status, diet, drugs and even detection technology. Therefore, the purpose of this study is to explore the difference of intestinal microbial characteristics between the initially diagnosed T2DM and the control group by using 16S rRNA gene sequencing analysis technology, so as to increase the understanding of the possible relationship between T2DM and intestinal microbiota, and provide theoretical support and direction guidance for the future biological treatment of diabetes.

Eligibility Criteria:
Inclusion Criteria:

1）18-65 years old 2）have no history of diabetes 3）fasting blood glucose \<5.6 mmol/L 4) HbA1c\<6.0%.

Exclusion Criteria:

1）BMI≥28kg/m2 2) People with type 1 diabetes, special type diabetes and pregnancy diabetes 3) Use antispasmodics, expanders, probiotics, prebiotics, antibacterial drugs or other drugs that affect intestinal microorganisms in the past month 4) Having inflammation, tumor, ulcer and other intestinal organic diseases, tumor, etc 5) History of abdominal surgery or gastrointestinal surgery 6) Suffer from mental illness or alcoholism, drug abuse or drug abuse. 7) Combined with other serious systemic diseases, such as cardiovascular disease, digestive disease, endocrine disease, skin disease, autoimmune disease, tumor, etc.
Changes in the Consumption of Psychoactive Substances During Containment Linked to COVID-19

The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020.

On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention.

Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence.

However,prisoners have a higher prevalence of substance use disorders than the general population.

What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.

* Anonymous questionnaire from the start
* Collection of socio-demographic data
* Collection of consumption data before and during containment
* Collection of monitoring data


Eligibility Criteria:
Inclusion criteria:

* Men incarcerated at Villeneuve Les Maguelone prison
* On a given date (May 12)
* Major
* French speaking
* non illiterate

Exclusion criteria:

* minors
* patients refusing
* non-French speaking
* illiterate
Effect of Chemotherapy Given Either by Mouth or by Infusion on the Quality of Life of Patients With Recurrent Ovarian Epithelial Cancer

RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of the treatment on these patients.

PURPOSE: This clinical trial studies the effects of chemotherapy given by mouth versus chemotherapy given by infusion on quality of life in patients with recurrent ovarian epithelial cancer.

OBJECTIVES: I. Determine the impact of oral versus parenteral chemotherapy on quality of life (QOL) in patients with recurrent ovarian epithelial cancer. II. Evaluate the QOL over time in this patient population. III. Determine the impact of disease symptoms, treatment side effects, performance status, and CA-125 levels on QOL assessment in this patient population.

OUTLINE: Patients receive a baseline quality of life (QOL) assessment, an attitudes/preference survey, and a performance status assessment at the time of diagnosis of recurrent disease. Patients are nonrandomly assigned to treatment with either IV or oral chemotherapy using drugs based on National Comprehensive Cancer Network guidelines, prior treatment history, and patient preference. QOL and performance status assessments are obtained again at 3 and 6 months during treatment. Attitudes/preferences are assessed at 6 months. Patients are withdrawn from study if treatment regimen is changed from oral to IV, or from IV to oral during this 6 months.

PROJECTED ACCRUAL: A total of 74 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed recurrent ovarian epithelial cancer or recurrent primary peritoneal cancer as evidenced by new clinical or radiologic detected mass or rising serum CA-125 level No progressive disease with ongoing treatment

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Fluent in English Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
Effects of Telemonitoring in Quality of Life Amongst Cancer Patients

This interventional study aims to explore the potential of a smartphone app, Contigo, in enhancing the quality of life for patients with various cancers compared to standard care. The investigators will asses effects on quality of life, depressive symptoms, and appointment adherence.

The primary objective of this study is to determine if utilizing a smartphone app for disease monitoring improves the self-reported quality of life using validated questionnaires in patients with diverse solid cancers compared to standard care. Secondary objectives focused on evaluating its impact on depressive symptoms and assessing adherence to in-person appointments. This study involves a randomized trial among patients recently diagnosed with specific forms of cancer and undergoing curative treatment at the UC Christus Cancer Center. The eligible participants, 80 adults with recent histologically confirmed cancer diagnoses, will be randomized to receive either the smartphone application (Contigo) or standard educational care. Randomization will be performed independently using an allocation sequence that will be kept concealed from clinical investigators. Contigo offers two primary functions: monitoring cancer patients and delivering educational content to aid patients in dealing with common clinical situations related to their disease. The study will assess outcomes such as quality of life changes, depressive symptom development, and adherence to in-person appointments. All analyses will be undertaken under the intention to treat principle by a statistician unaware of treatment allocation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\>18 years old).
* Recent histologically confirmed diagnosis (within the last 3 months) of bronchogenic, breast, gallbladder, gastric, colorectal, or prostate cancer in any of its forms.
* Awaiting initiation of curative intent treatment for the disease using any modality (radiation therapy, chemotherapy, immunotherapy, etc.) at the UC-Christus Cancer Center.
* Possession of a smartphone, regardless of its native operating system (iOS® or Android®).
* Willingness to sign an informed consent form to participate in the study.

Exclusion Criteria:

* Any form of sensory impairment preventing app usage.
* Cognitive impairment.
* Psychiatric pathology hindering app usage.
* Unwillingness to participate in the study.
* Concurrent participation in another clinical trial addressing healthcare technologies.
Health Related Quality of Life After Video Assisted Thoracoscopic Lobectomy for Lung Cancer

To test the effect of post operative complications on the health related quality of life (HRQOL) after Video Assisted Thoracoscopic Surgery (VATS) for Non-Small Cell Lung Cancer (NSCLC).

The HRQOL of patients with early stage NSCLC will be assessed at baseline (before surgery) using 3 different reliable and valid HRQOL questionnaire (SF-36, EQ-5D and QLQ30/13), then at regular intervals in the early post-operative period (2,4,8 and 12 weeks) the HRQOL will be assessed using the same questionnaires to determine the difference between patients with low/no post operative complications to those with high grade post-operative complications.

Post operative complications will be assess while the patients in the hospital on a daily basis using the Clavien classification system for surgical complications.


Eligibility Criteria:
Inclusion Criteria:

* Adults (more than 18 years)
* early stage NSCLC
* speak English
* No hearing/Speaking difficulties
* Able to walk without assistance
* Surgery via the VATS approach

Exclusion Criteria:

* Less than 18 years old
* Metastatic disease to the lung
* Benign Lung disease
* Advanced NSCLC
* Small Cell Lung Cancer
* Non English speakers
* Walking/Hearing/Speaking difficulties
Voyager I: Patient Discharge Using the AB5000 Portable Driver System

The AB Portable Driver System will allow patients supported with the Circulatory Support System to be discharged home when their medical condition improves to an ambulating status and will continue to receive the assistance of the AB 5000 ventricle for their heart recovery.


Eligibility Criteria:
Inclusion Criteria:

* The subject is an AB5000 Circulatory Support System patient (in accordance FDA-approved indications for use) who is suffering acute cardiac dysfunction and is potentially recoverable;
* The subject is male or female, age 18 years or older;
* The subject is able to ambulate unassisted;
* The subject is on stable oral anticoagulation over 7 days (INR 2-4) with no active bleeding;
* The subject is willing and able to read, understand and sign the study specific informed consent form;
* The subject agrees to comply with study protocol requirements, including all follow-up visits and completion of Qol and NIH stroke scale assessments.

Exclusion Criteria:

* The subject, pre-device implant, is qualified as a transplant candidate.
* There is an absence of a trained companion.
* There is an absence of a psycho-social support.
* The subject has an inadequate home environment, such as poor access which may hinder movements.
* The subject has experienced hypotension in last 24 hours based on two consecutive readings spaced by 8 hours with systolic blood pressures \< 90 mmHg.
* The subject requires respiratory assistance.
* The subject has an active infection (positive blood culture and/or body T ≥ 38 degrees C, and/or WBC ≥ 12K/µL).
* The subject requires tube feeding.
* The subject has any other medical condition requiring hospitalization.
The Study About the Efficacy of Oral Limaprost After Surgery for Cervical Myelopathy

The limaprost alfadex can improve the surgical outcomes in patients with cervical myelopathy.


Eligibility Criteria:
Inclusion Criteria:

* Older than 20 years old
* Compressive cervical myelopathy, confirmed by MRI, including C1-C2 instability, ossification of posterior longitudinal ligament
* Plan to undergo cervical surgery for myelopathy
* JOA score less than 15 points
* Signed informed consent of patient or legal guardian

Exclusion Criteria:

* Infection or malignancy
* Taking Limaprost before surgery
* Pregnancy or expected to be pregnant or breast feeding
* severe cardiovascular, pulmonary, renal disease or distress, brain pathology
* any related coagulopathy
* any drug to cause bleeding tendency
* severe pain from other disease
* any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study
* patient cannot follow study protocol, for any reason
Weight Gain in Surgically Treated Adult-onset Craniopharyngioma

The aim of the study was to describe postoperative weight change in adults undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Morbid obesity, intractable weight gain due to hypothalamic damage, is a common and troubling complication in patients undergoing surgery for craniopharyngioma combined or not with radiotherapy, with an incidence of 23\~62% in pediatric patients. It has a major negative impact on metabolic and cardiovascular health and quality of life in long-term survivors. Identifying patients at higher risks for developing postoperative weight gain is of great importance in preventing obesity and taking early actions in this population. Though a lot of previous studies have been made in pediatric patients and several factors, such as hypothalamic involvement, higher body mass index (BMI) standard deviation score (SDS) at diagnosis, age at diagnosis and hydrocephalus requiring a shunt, have been identified as risk factors for postoperative weight gain, data on this important morbidity in adult-onset patients are sparse, especially in Chinese population. Therefore, the investigators are going to undertake a retrospective evaluation of postoperative weight change in adult-onset patients undergoing surgery for craniopharyngioma and identify preoperative factors associated with it.

Eligibility Criteria:
Inclusion Criteria:

adult-onset, aged 18 years or more; pathologically confirmed craniopharyngioma; primary surgery performed at our hospital; at least 3 months of follow-up including body weight measurement; ambulatory (since lack of ambulation may predispose to weight gain); not receiving supraphysiologic doses of glucocorticoid (e.g. hydrocortisone, prednisone, or dexamethasone to exceed 12mg/m2•d hydrocortisone equivalent) for more than 2 months after tumor therapy.

Exclusion Criteria:

Childhood-onset, \<18 years old; Inconsistent pathology; Without follow-up records in the investigators' institution.
Evaluation of SP Resistance and Effectiveness of IPTp in Nigeria

The study has two components: component A is a cohort study to determine the in vivo efficacy of SP to clear and prevent malaria parasitaemia in asymptomatic pregnant women and component B is a cross sectional study of women delivering at the study hospitals to assess the effectiveness of SP-IPTp to reduce adverse maternal and birth outcomes in the current context of increasing SP resistance. Results of component A and B studies will be used to model the relationship between the prevalence of molecular markers of SP resistance, in vivo efficacy to clear parasite and the effectiveness of SP-IPTp and to develop guidelines for routine monitoring effectiveness of SP-IPTp as part of ANC surveillance.

Study sites will include different levels of transmission and social factors affecting ANC attendance Damboa hospital in Borno state has a catchment area with pop of 231,573 with a semi arid climate and where malaria is mesoendemic. The expected number of patients is 15-25 per week for new bookings Park Lane hospital serves a semiurban population. Malaria transmission is holoendemic and stable. 1400 women attend ANC services per month Women will receive SP-IPTp according to National guidelines and will be followed for 42 days to assess the therapeutic efficacy in parasitaemic women and to assess the ability to remain parasite free. PCR will be used to determine reinfection from recrudescence

Eligibility Criteria:
Inclusion Criteria:

* gestational age 16-30 weeks
* Axillary temperature ,37.5 Degrees
* informed consent

Exclusion Criteria:

* gravida \> 2
* previous inclusion in this study
* history of hypersensitivity to SP or components of SP
* Use of IPTp with SP during this pregnancy
* history of taking other antimalarials in the past month
* Known HIV infection
ABM for ACO Beneficiaries

The primary objective of the study is to evaluate how engaging ACO beneficiaries in the appointment based model for one year impacts medication adherence and healthcare costs compared to usual care.

The American Pharmacists Association (APhA) Foundation has partnered with a federally qualified health center (FQHC), a supermarket community pharmacy, and an accountable care organization (ACO) to participate in this ABM for ACO Beneficiaries initiative. The FQHC, El Rio Community Health Center pharmacy, and supermarket pharmacy, Fry's Pharmacy, will serve as implementing pharmacy study sites and will implement the ABM for beneficiaries of the ACO who utilize their pharmacies for medication refill services. The ABM involves synchronizing all medications to come due on the same day of the month and the individual receives a pre-appointment phone call from the pharmacy staff to review medications and identify any changes. The ACO will provide medical and claims data on enrolled subjects as well as a control group for the intervention population. The APhA Foundation will aggregate intervention, prescription fill, and economic data from the 3 partners in an effort to evaluate the impact of the ABM on healthcare costs and medication adherence. The APhA Foundation has an a priori intent to publish the project results.

Eligibility Criteria:
Inclusion Criteria: Individuals eligible to be enrolled in the study include those who:

* Are beneficiaries of the partnering ACO;
* Are receiving medical care at El Rio and have been since before May 1, 2013;
* Are taking 2 or more medications that are refilled on 30, 60, or 90 day schedules;
* Speak English or Spanish;
* Are at least 18 years of age; and
* Are not institutionalized (i.e., residents of nursing homes, psychiatric institutions, or prisons).

Exclusion Criteria:

* Use of a legal authorized representative
Effects of Melatonin and Oxygen Consumption and Choroidal Blood Flow

Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (VS)?

The main questions are:

Do women with VS exhibit...

* a different basal metabolic rate
* a reduced choroidal blood flow
* a reduced increase of oxygen consumption after intake of ice-water
* a different oxygen consumption after melatonin intake
* a different choroidal blood flow after melatonin intake
* a different oxygen consumption after melatonin intake and after intake of ice-water....?

Study description:

Melatonin, a natural hormone of the pineal gland exclusively released during the dark phase, exhibits vasodilatatory effects in distal skin regions and reduces core body temperature. This study investigates whether exogenous melatonin (5mg p.o. at 2p.m.) in the afternoon, when no endogenous melatonin is secreted, increases not only distal skin blood flow, but also choroidal blood flow and changes oxygen consumption. Two subject groups were studied, women with vasospastic syndrome (VS) and controls. The main hypothesis is: melatonin normalizes distal vasoconstriction in VS.

Further questions will also be answered:

Does melatonin affect basal metabolic rate, increase choroidal blood flow and reduce the vasospastic syndrome (VS)?

Do women with VS exhibit:

* a different basal metabolic rate
* a reduced choroidal blood flow
* a reduced increase of oxygen consumption after intake of ice-water
* a different oxygen consumption after melatonin intake
* a different choroidal blood flow after melatonin intake
* a different oxygen consumption after melatonin intake and after intake of ice-water....?

Eligibility Criteria:
Inclusion Criteria:

* vasospastic syndrome
* healthy

Exclusion Criteria:

* sick
* BMI \>25 or \<18
* migraine
* drug intake
Effectiveness of Haptic Technology in Teaching Urinary Catheterization Skill

Background: Haptic systems represent the highest level of computer based education technologies and enable students to learn at the highest level. These applications increase the student's focus as well as making the education non-monotonous and insuring teaching permanent by ensuring the active participation of the student.

Objective: The study was conducted to determine the effectiveness of using haptic technology in teaching urinary catheter application skill on the level of success and satisfaction about this skill.

Method: This randomized-controlled experimental study was conducted with nursing students registered at a public university between December 2018 and March 2019. The sample of the study included 78 second grade students who gave consent after being informed about the aim of the study and who met the inclusion criteria. Control (n=39) and experimental (n=39) groups were determined through randomization using simple numbers table. Urinary catheterization application skill was taught with the standard curriculum (demonstration on the model) to the control group while it was taught with haptic-controlled computer based simulation technology to the experimental group. Data were collected using "Structured Student Introduction Form," "Skill Checklist for Teaching Urinary Catheterization Skill" and "Questionnaire for Satisfaction with Training Methods."

Eligibility Criteria:
Inclusion Criteria:

* being 18 years and over,
* enrolling for the first time in Fundamentals of Nursing course,
* participating in the study completely
* volunteering to participate

Exclusion Criteria:

* being a graduate of Health Vocational High School