cyrilzakka/clinical-trials huggingface dataset:
LetSync: Pilot Test of Mobile Health (mHealth) Intervention

The Pilot Test (AKA Study B) will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. In the ensuing 2 months, the investigators will make refinements based on participants' data to produce LetSync v2.0. Then, participants in the waitlist-control arm will receive LetSync v2.0, use it for 6 months, and provide acceptability and feasibility data. The intervention arm will continue using LetSync v1.0, for a total of 14 months. Based on acceptability and feasibility data from waitlist control arm participants between T3 and T4, the investigators will develop LetSync v3.0, which will be used for efficacy testing in a full RCT trial in the future.


Eligibility Criteria:
Inclusion Criteria:

Individuals are eligible if they:

* Self-identify as racial/ethnic minority
* Self-identify as a cisgender man
* Are HIV-Positive themselves, or are the partner of someone who is living with HIV
* Are age 18 or older
* Have a primary relationship partner, defined as someone to whom the participant is committed above anyone else for three or more months
* Uses and owns a personal smartphone
* Willing and able to provide informed consent

Partners are eligible if they:

* Self-identify as a cisgender man
* Are age 18 or older
* Have a primary relationship partner that is the referring participant
* Uses and owns a personal smartphone
* Willing and able to provide informed consent

Exclusion Criteria:

Those who:

* Report fear of intimate partner violence (IPV) resulting from participation
* Are unwilling or unable to disclose HIV status to primary partner
* Present evidence of severe cognitive impairment that would prevent comprehension of study procedures assessed during informed consent
Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss

1. Establish a multi-platform detection system for neutrophil extracellular traps in blood and tissues, and evaluate the detection performance;
2. Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of patients with antiphospholipid antibody-induced pregnancy loss and normal control group;
3. Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of mice with antiphospholipid antibody-induced pregnancy loss and normal control group;
4. After treatment of antiphospholipid antibody-induced mouse abortion model with metformin,the effect of metformin on embryo loss rate and viable embryo body weight was observed.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Recurrent spontaneous abortion
* Clinical diagnosis of Antiphospholipid syndrome

Exclusion Criteria:

* Other autoimmune diseases
* Hematopoietic system diseases
* Cardiovascular system diseases
* Gastrointestinal system diseases
* Urinary system diseases
* Nervous system or mental diseases
* Have taken other drugs recently
Clinical Evaluation of the TITAN™ Total Shoulder System

A post market, non-randomized, multi-center, open-label,clinical study using survivorship to study the safety and efficacy of the Integra® TITAN™ Total Shoulder System 1.0 (TAS) when used for total shoulder arthroplasty.

Observational, multi-center, post-market study to provide data on the performance and safety of the TITAN™ Total Shoulder System. The study will enroll patients that underwent total shoulder arthroplasty with the TITAN™ Total Shoulder System per standard of care less than 5 years ago. Available retrospective data up to the 2-year time point will be collected, per the study protocol, from medical record reviews. Prospective observational data will be collected from the time of patient enrollment during the following postoperative clinical visits: 1 year, 2 years, 5 years and 10 years post-surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has undergone shoulder arthroplasty with the first generation TITAN Total Shoulder System.
2. The first generation TITAN Total Shoulder System is still intact and the subject has not received any revision surgeries involving the TITAN Total Shoulder System.
3. Subject is willing and able to participate in required follow-up visits at the investigational site and to complete study procedures.

Exclusion Criteria:

1. Subject, in the opinion of the PI, has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study such as mental illness, or drug or alcohol abuse.
2. Subject is known to be at risk for lost to follow-up, or failure to return for scheduled visits.
Correlation Between Intestinal Microecology Imbalance and Stroke in Young Adults

The relationship between the intestinal microecology and stroke has become a research hotspot in neurology field today. Maintaining the balance of the intestinal microbiota are expected to bring new breakthroughs for prevention and treatment of stroke. In recent years, stroke in young adults has an increasing incidence and a considerable socioeconomic impact because of high disability rate and health-care costs. So there is an urgent need to explore the role and mechanism of intestinal microecology imbalance in stroke, especially in the development and prognosis of stroke in young people. This study aims to use multi-omics technologies, including microbial diversity, metagenomics and metabonomics, to reveal the characteristics of intestinal flora in young stroke patients, identify biomarkers for predicting outcome after stroke and early detection of young people at high risk of stroke, and to further explore the role of gut-brain axis in the pathogenesis of stroke.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic or hemorrhagic stroke
* Admission within 12 hours
* Aged 18-45 years

Exclusion Criteria:

* History of neurological diseases, myocardial infarction, renal and hepatic abnormalities and metabolic diseases
* Combined with tumors, inflammatory bowel disease and other digestive system diseases
* Combined with serious life-threatening diseases or condition
* Any antibiotics, probiotics or prebiotic treatment within 3 months
* Deteriorate and die before collecting faecal samples
the Clinical Effect of TCM Sniffing Therapy Combined With Electroacupuncture in PSCI

The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. After the end of the treatment, the clinical efficacy was evaluated.

The patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. All patients were treated with conventional drugs and general supportive treatment, and on the basis of this, the electroacupuncture group was given electroacupuncture treatment at bilateral Fengchi and Gongxue, the smell suction therapy group was given the intervention of volatile oil nasal suction of Acorus calamus, and the electroacupuncture group combined with smell and suction therapy group was given electroacupuncture treatment at the same time as the electroacupuncture treatment of bilateral Fengchi and Gongxue. In the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. After the 1 month innervation,the main efficacy indicators: Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Barthel Index (MBI) score, and the secondary efficacy indicators: Transcranial Doppler (TCD), near-infrared functional brain imaging , magnetic resonance examination， the heart rate,blood pressure and the State Trait Anxiety Inventory （STAI）are collected.

Eligibility Criteria:
Inclusion Criteria:

* (1) Stroke as per the TCM definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. PSCI diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental ADLs/ADLs.; (2) The scores on the MMSE scale must adhere to the following criteria: Less than 17 points for individuals with illiteracy, less than 20 points for those with primary school education, and less than 24 points for individuals with a middle school education or higher.; (3) Aged under 70 years; (4) No history of mental illness, clear consciousness, stable vital signs, and able to complete the scale assessment; (5) Within 6 months post-stroke, diagnosed as a patient in the recovery period of cerebral infarction (or cerebral hemorrhage) at admission; (6) Signed informed consent by the patient or their family.

Exclusion Criteria:

* (1) Transient ischemic attack; (2) Subarachnoid hemorrhage; (3) History of severe liver or kidney diseases, mental illness, epilepsy, asthma, or obstructive pulmonary diseases; (4) Occurrence of cognitive impairment prior to stroke; (5) Severe communication barriers; (6) Substance abuse or heavy alcohol consumption; (7) Implanted cardiac pacemakers or other electronic devices.
Impact of Implementing the Modified A-DIVA Scale on Successful Access to a Venous Line on the First Attempt

Peripheral venous access (PVA), although commonly used, can be a difficult procedure for patients with precarious venous capital. The difficulty of insertion can lead to multiple attempts, with the consequences of pain, anxiety, delayed management and worsening of the potentially already precarious venous capital. One study assessed the risk of failure according to a score based on venous status criteria. This study first established a link between venous status criteria and the risk of failure. The criteria defined as determinants were used to establish a venous status score. The data were then repeated by analyzing the success rate as a function of the scale score. A clear link between score and risk of failure was established. It seems worthwhile to evaluate the impact of implementing this scale prior to the placement of a peripheral venous line.

The hypothesis is that obtaining a score predictive of failure would modify the therapeutic attitude of the registered nurse. They would opt for techniques that would increase their chances of success. This in turn would lead to a reduction in unsuccessful attempts, which generate pain and anxiety for the patient. Preserving venous capital by increasing first-attempt success is both a health issue for the patient and a guarantee of quality of care.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient of legal age included in a care program requiring a VVP;
* Fluency in French
* Patient affiliated to a social security scheme;
* Written, signed and dated informed consent.

Exclusion Criteria:

* As the A-DIVA scale specifies a search for venous access to the upper limb, any patient without an upper limb or with a condition that contraindicates VVP placement in the upper limbs will be excluded;
* Patients treated as emergencies;
* Patients with a language barrier or known significant cognitive or psychiatric disorders;
* Patients under guardianship, curatorship, deprivation of liberty or legal protection;
* Pregnant or breast-feeding women.
Patient Presented With AKI Related to Pregnancy

The primary objective of this study is to identify characteristics of patient with PR AKI treated in Assiut university hospital

Secondary outcomes:

1. Assessment of pregnancy related AKI maternal outcome (complete recovery , partial recovery or progress to ESRD) within 3 months duration
2. To identify predictors of unfavorable outcome of patient with pregnancy related AKI

Acute kidney Injury (AKI) is a syndrome which is characterized by an rapid deterioration of the kidney function , manifested by increase in serum creatinine level with or without reduced urine output and linked to high rate of morbidity and mortality .AKI is considered a major public health problem despite much improvmnent in heakth care and especially, most of them (about 85 %) in developing countries with low resources.Pregnancy related AKI ( PR -AKI ) is a major obstetric complication which may cause termination of pregnancy (TOP ), Intensive care unit ( ICU ) admission , need for dialysiy , both maternal and perinatal morbidity and mortality with maternal mortality rang from 9% to 55 % .

PR-AKI has a major risk factors include preeclampsia which is the most common cause (15-20%) , hyperemesis gravidarum , acute fatty liver of pregnancy and placental abruption , puerperal sepsis and septic abortion .The maternal outcome of pregnancy related AKI include complete recovery with return of serum creatinine to normal (\&gt; 1.4 mg /dl ) about (40-75% ), partial recovery(4-9% require dialysis about 4 months after delivery) , progress to End stage renal disease (1.5 - 2.5 %) or maternal mortality . The maternal mortality rate (MMR) increases with increasing severity of pregnancy-related complications and can range from 13 to 24% in developing countries due to PR-AKI .

Timely identification of patients and management of underlying conditions is considered the cornerstone to improve maternal outcome.

Eligibility Criteria:
Inclusion Criteria:

* Women (\&gt;18 years) who developed AKI with or without need for dialysis treatment during pregnancy, childbirth , post abortion period and /or puerperium
* AKI as defined by KDIGO definition as follows:

  1. Increase in serum creatinine \&gt; 0.3 mg/dl within 48
  2. Increase in serum creatinine \&gt; 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days.
  3. urine volume of \&lt; .5 ml / kg / hours

Exclusion Criteria:

* Patients with preexisting kidney disease before pregnancy
* Patients with AKI not related to pregnancy.
* Patients with uncertain history for incident time of AKI.
* Patients refuse to participate in the study
Melatonin and the Metabolic Syndrome

This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.

The primary purpose of this Phase II crossover design trial is to examine the safety and efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to improve at least one of the five components associated with the metabolic syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Age 30-79 years.
2. Diagnosed with metabolic syndrome according to AdenosineTriphosphate-III criteria.
3. Availability for six months after enrolling in the study.

Exclusion Criteria:

1. Inability to understand informed consent and to cooperate with study procedures.
2. Supplemental intake of melatonin.
3. Current smoking.
4. Current use of calcium channel blockers.
5. Current, planned, or recent (12 months) participation in another clinical trial.
6. Women who are pregnant, breast-feeding, attempting conception, or planning to attempt conception over the next 6 months.
7. Presence of any of the following diagnosed health conditions:

   * Active malignancy other than nonmelanoma skin cancer (current therapy for this malignancy,diagnosis within five years of enrollment, recurrence within five years of enrollment, or metastasis)
   * Uncontrolled hypothyroidism or hyperthyroidism
   * Recent (\< 1 year ago) history of heart attack, bypass surgery, angioplasty, or stroke
   * Heart failure (New York Heart Association functional class 3 or 4)
   * On renal dialysis
   * Immunosuppressive therapy (systemic corticosteroids, azathioprine, methotrexate, cyclophosphamide,
   * etc.) or an immunodeficiency syndrome
   * Narcotic or alcohol dependence
   * Obstructive sleep apnea (OSA) , defined either by previous diagnosis (with or without use of nasal CPAP), or by a score of 0.80 or higher on the MAP (Multivariate Apnea Prediction), a validated screening algorithm with high positive and negative predictive value for identifying OSA.
8. Shift-workers.
The Effect of Liraglutide Adjunct to Insulin on Glucagon Response to Hypoglycaemia in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate if liraglutide adjunct to insulin treatment changes the glucagon response during hypoglycaemia in subjects with type 1 diabetes compared with conventional insulin treatment after 4 weeks' treatment with liraglutide or placebo.

Subjects will initially be randomised to one of the three dose groups, and subsequently randomly allocated to one of two treatment sequences (liraglutide/placebo or placebo/liraglutide).


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months prior to randomisation
* Body mass index (BMI) between 20.0 and 28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Use of liraglutide or exenatide within 3 months of randomisation
* Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months) or hypoglycaemic unawareness as judged by the trial physician or hospitalisation for diabetic ketoacidosis during the previous 6 months
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Stem Cell Treatment of Peyronie´s Disease.

Purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment.

Twentythree men \> 18 years with Peyronie´s Disease in the chronic phase will be recruited.

The operative same-day procedure will be performed in general anaesthesia by a plastic surgeon. Before the patient wake, local anaesthesia is put around the penis. Processed stem cells are injected into the plaque/fibrosis subcutaneously.

There will be a follow up at 1, 3, 6, 12 months. It is a pilot study with no randomisation. The group will be compared to a historical control group.


Eligibility Criteria:
Inclusion Criteria:

1. Acquired penile curvature \>30 and \<90 degrees associated with a palpable penile plaque on physical examination.
2. One or several plaques at ultrasound screening.
3. Willingness to attend follow-up at 1, 3, 6 and 12 months.
4. Understand and speak Danish.
5. Men \> 18 years of age

Exclusion Criteria:

Patients may not be:

1. Taking the medication Coumadin, Warfarin or NOAK (new oral anticoagulant).
2. Unable to achieve adequate erection with penile injection to access degree of curvature.
3. Undergoing definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, and cryotherapy.
4. With prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorders including but not limited to major depression, schizophrenia, bipolar disease.
5. With a history of cerebrovascular incidents, a history of deep venous thrombosis within the past 5 years or a history of untreated or severe sleep apnoea.
6. With a clinically significant abnormal, results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator. Blood tests will be analysed for HIV, Hepatitis B and C and syphilis and those applicable within guidelines of the department.
7. Involved with any other projects with an investigational drug within 30 days.
8. In treatment for alcohol or drug abuse within six months.
9. With congenital deviation of penis.
10. Within six months treated with Collagenase, ESWT and/or other therapeutic injection in the plaque treatment for PD.
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer

RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.

PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.

OBJECTIVES:

Primary

* Compare the incidence of capecitabine-induced palmar-plantar erythrodysesthesia (hand-foot syndrome \[HFS\]) ≥ grade 2 in patients with cancer treated with pyridoxine hydrochloride vs placebo.

Secondary

* Compare the time to onset of HFS ≥ grade 2 in patients treated with these regimens.
* Compare the quality of life changes in patients treated with these regimens.
* Identify factors predicting toxicity from capecitabine chemotherapy.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and treatment setting (adjuvant/neoadjuvant vs palliative setting). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Beginning concurrently with planned capecitabine treatment, patients receive oral pyridoxine hydrochloride once daily on days 1-21.
* Arm II: Beginning concurrently with planned capecitabine treatment, patients receive oral placebo once daily on days 1-21.

In both arms, treatment repeats every 21 days for up to 8 courses (until discontinuation of capecitabine treatment).

Quality of life is assessed at baseline, at the beginning of courses 2, 4, 6, and 8, and at the end of the study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer
* Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses)

PATIENT CHARACTERISTICS:

* Life expectancy \> 12 weeks
* No preexisting neuropathy
* No known allergy to pyridoxine hydrochloride and its incipients
* No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior capecitabine
* Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab \[Herceptin®\] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS)
* No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS
* No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy
* No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex)
* No concurrent over-the-counter products that contain urea or lactic acid
* No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)