cyrilzakka/clinical-trials huggingface dataset:
Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate

The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.

Previous anatomical studies have shown that the capitate had a widened distal base. The distal articulation was mainly with the base of the third metacarpal and partially with the base of the second metacarpal. The articulation was slightly flattened with a convex and concave dorsal articular surface. The contour stimulates our imagination and creativity to use a portion of the articular surface for PIP arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

1. an articular defect at the proximal aspect of the PIP joint;
2. the defect larger than 5 mm × 5 mm in size based on intraoperative findings.

Exclusion Criteria:

1. large defects involved double joint surfaces;
2. the size of the defect less than 5 mm × 5 mm;
3. mult-digital articular defects that all required osteoarticular grafting;
4. associate with infection or other diseases that restrict to use the technique.
KET-RO Plus RO DBT for Treatment Resistant Depression

This pilot study will assess the safety and feasibility of intravenous (IV) ketamine combined with RO DBT in young adults with Treatment-Resistant Depression (TRD). In addition, this study will develop and utilize innovative methodological approaches to demonstrate the feasibility of precision medicine with this type of therapy.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18-65
* Moderate to severe persistent depression \[treatment resistant depression - TRD\] (exhibiting 2+ unipolar major depression episodes (non-delusional) with prior treatment non-response to antidepressant or psychosocial treatment
* Treatment-resistant depression: defined as unipolar major depressive disorder, non-delusional (diagnosed by SCID-5, Structured Clinical Interview for the DSM ) that persists despite ≥ 2 adequate antidepressant trials of different classes in the current episode; including at least one evidence-based second-line treatment in the current episode (including serotonin norepinephrine reuptake inhibitors, bupropion, tricyclics, monoamine oxidase inhibitors, or augmentation with an atypical antipsychotic, stimulant, bupropion, lithium, or Triiodothyroinine) higher proportion of OC (over controlled) words endorsed compared to UC (Under controlled) words on the Word Pairs Checklist
* no current or past psychosis
* English speaking
* Able to attend in-person behavioral sessions and ketamine/therapy visits
* Willingness to have RO DBT-A as only psychosocial treatment engaged in (medication treatment may continue-but see below for exclusion)

Exclusion Criteria:

* Outside age range
* Significant neurological condition (i.e., seizure, stroke, severe head injury) or mental retardation (IQ\<70)
* Current or recent substance use disorder, actively suicidal or homicidal (e.g., requires hospitalization)
* Use of naltrexone, memantine or medication considered contraindicated with ketamine
* Baseline systolic BP \> 150 systolic or 90 diastolic at evaluation. Participants who initially present with elevated blood pressure may be re-assessed; and if needed, referred to their healthcare provider for hypertension management
* Taking more than 2 adequately-dosed oral antidepressants
* Inability to understand, speak and read English sufficiently
* Not be pregnant or at risk of becoming pregnant
* Medical conditions or medication usage that in the judgement of the investigators puts the patient at unreasonable safety risk
* First degree relative with a psychotic diagnosis involving hallucinations, delusions, or disorganized thinking and speech (e.g. schizophrenia, schizoaffective disorder, etc)
Effects of rTMS and tDCS Treatment on Brain Function, Craving and Relapse Prevention

Addiction is known as a chronic relapsing brain disorder that has a high cost to patients, family and society. Its ranking in cause of death is 8th globally, and substance abuse contributes 5.4% of the total global burden of disease. Brain stimulation procedures such as repetitive trans-cranial magnetic stimulation (rTMS) and trans-cranial direct current stimulation (tDCS) are considered minimal risk interventions and are used for the treatment of depression, pain, and other neurological and psychiatric disorders. There is some evidence that rTMS applied to the left prefrontal cortex results in significantly lowered craving. To date, no studies have investigated the effects of a course of either rTMS or tDCS treatment on opioid craving, brain function, and relapse prevention in opioid addicts. Individuals with prescription opioid dependence experience high rates of desire and intense cravings to use opioids. The present study aims to examine the effects of a course of daily prefrontal rTMS and tDCS on brain function, desire and craving and help to relapse prevention in abstinence phase.

The investigators plan to compare and contrast TMS and tDCS alone or in combination to treat opioid abuse. We will use a 4 cell randomised parallel controlled trial, consisting of active or sham TMS, and active or sham tDCS \[a-tDCS, a-TMS; s-tDCS, a-TMS; a-tDCS, s-TMS; s-tDCS, s-TMS). The investigators hypothesise that each of the active interventions alone will be superior to pure sham in reducing craving and use. Moreover, The investigators hypothesise that COMBINING the two active treatments will be synergistic and will produce the largest reductions in craving and use.

Eligibility Criteria:
Inclusion Criteria:

* 40 treatment-seeking opioid-dependent subjects (between the ages of 21 and 65) with at least 30 days of abstinence under maintenance treatment will be included in this single blind study.

Exclusion criteria includes:

* history of seizures,
* receiving any medications known to lower seizure threshold,
* pregnancy,
* metal implants above the waist,
* brain lesions or tumors,
* a history of negative reactions to TMS, and
* a positive opioid urine screen (except methadone and suboxone
Effectiveness of Cervico-isthmic Cerclage

This study compares the rate of live births before and after cervico-isthmic cerclage in 3 hospitals in the last 10 years. The hypothesis is that cerclage significantly increases the rate of live births in women with cervical insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* History of premature delivery or late miscarriage unrelated to maternal pathology, chorioamnionitis, fetal or placental pathology
* Patient aged over 18 at the time of the phone call
* Cerclage performed according to the Benson technique verified on the operative report
* Cerclage performed in one of the 3 obstetric gynecology departments of the CHU de Lyon (Lyon Sud, Croix Rousse and HFME) between January 1, 2010 and April 1, 2019

Exclusion Criteria:

* History of trachelectomy
* Surgical technique not specified or not deductible from the operating report
* Refusal to participate in the study
* Patient under legal protection
Short Term Outcomes in Hospitalized Patients With Liver Cirrhosis

This study will be conducted to assess the baseline characteristics and evaluate the 90-day mortality of patients admitted with liver cirrhosis. Also, the study will be done to identify the risk factors of 90-day mortality.

Liver cirrhosis is the end spectrum of all chronic liver diseases characterized by advanced fibrosis, scarring, and formation of regenerative nodules leading to hepatic architectural distortion.

Liver cirrhosis is a major cause of health burden worldwide. According to the Global Burden of Disease study, liver cirrhosis caused 1.2% of global disability-adjusted life years and 2% of all deaths worldwide in 2010, the 14th leading cause of mortality.

The progress rate of compensated cirrhosis to decompensated cirrhosis is approximately 58% and once it progresses to decompensated cirrhosis, its mortality rate within 5 years becomes 85% without liver transplantation. Since the progression of cirrhosis is accelerated each time a complication recurs, the management and treatment of the complication are critical in enhancing the quality of life and the life expectancy of patients .

Post-discharge outcomes are an integral component of healthcare, as they may aid in determining the success and longevity of treatment and how clinicians approach future cases .

This study will focus on the short-term outcomes of patients hospitalized with liver cirrhosis to provide insight into methods for future healthcare interventions.

Eligibility Criteria:
Inclusion Criteria:

- diagnosis of liver cirrhosis, adult (age ≥ 18 years old) and patients willing to give consent during the selected period.

Exclusion Criteria:

- Patients with ages \< 18 years or patients that will be lost on follow-up will be excluded from the study.
Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)

Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have been described in severe obstructive sleep apnea (OSA), and are reverted by continuous positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these biomarkers in mild-moderate OSA.

The investigators aimed to compare NOx and U-NE levels and blood pressure (BP) between male patients with mild-moderate and severe OSA and determine the impact of 1 month of CPAP therapy on these parameters.

The investigators undertook a prospective study of 67 consecutive OSA patients (36 mild-moderate, 31 severe). Measurements of plasma NOx at 11 pm, 4 am and 7 am, 24-h U-NE and ambulatory BP were obtained at baseline and after 1 month of CPAP.

Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of obstructive sleep apnea

Exclusion Criteria:

* current smoker
* respiratory disease
* cardiac disease (except for arterial hypertension)
* renal disorder
* hepatic disorder
* psychiatric disorder
* diabetes mellitus
* dyslipidemia
* rhinitis
* sinusitis
* acute illness
* daytime hypoxemia or hypercapnia
* therapy with oral nitrates
* therapy with angiotensin-converting enzyme inhibitors
* therapy with beta-blockers
* therapy with statins
* therapy with non-steroidal anti-inflammatory drugs
* presence of central respiratory events
* previous CPAP therapy
* previous uvulopalatopharyngoplasty
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults

The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.

This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 to 49 years, inclusive.
* Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
* The individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
* Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria:

* Females who are pregnant or breastfeeding.
* Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
* Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
* Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
* Any serious chronic or progressive disease (including hepatitis B or C).
* Previous exposure to an experimental norovirus vaccine.
* Subject or subject's first-degree relatives are involved in the trial conduct.
Pharmacokinetic Interaction and Safety/Tolerability Between NVP-1603-1 and NVP-1603-2

The purpose of this study is to compare the pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

pharmacokinetics and safety/tolerability between NVP-1603-1 and NVP-1603-2

Eligibility Criteria:
Inclusion Criteria:

* Men 19years of age or older at screening test.
* BMI of \>18.5kg/㎡ and \<27.0kg/㎡ subject, weight more than 50kg.
* Subject has signed and dated informed consent.

Exclusion Criteria:

* Treatment with an investigational product (Phase I study or Biological study) within 3month preceeding the first dose of study medication.
* History of (or presence) study medication absortion, distribution, metabolism(e.g., liver/ductal, kidney, cardio-vascular, endocrine, respiratory, GI, hematology, oncology, CNS, musculo-skeletal) or related past medical/surgery history
* Current alcohol abuse.
The Combination of Zanubrutinib and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Randomized, open-label, multicenter study to compare the efficacy and safety of zanubrutinib plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of patients with ITP in China. Patients were randomized to Zanubrutinib + high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed newly-diagnosed, treatment-naive ITP;
2. Platelet counts \<30×10\^9/L ;
3. Platelet counts \< 50×10\^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
4. Active infection;
5. Maligancy;
6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy;
8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
Health, Environment and Action in Louisville (HEAL) Green Heart Louisville Project

The purpose of this study is to examine how the environment and neighborhood characteristics affects the health of the area residents. The study will help determine how changing neighborhood characteristics, such as green space, affect heart health, risk factors for other diseases, sense of well- being or neighborhood cohesion.


Eligibility Criteria:
Inclusion Criteria:

* 30-70 years of age.
* Live within the targeted study location

Exclusion Criteria:

* Unwilling or unable to provide consent.
* HIV/AIDS, active treatment for cancer, active bleeding including wounds.
* Body weight less than 100 pounds or BMI\>40.
* Prisoners and other vulnerable populations.
* Anyone that PI thinks is unsafe to participate in study.
Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC)

Optical Coherence Tomography Angiography (OCT-A) is a noninvasive imaging technique that allows one to see blood vessels in the retina. The investigating team used this approach in patients with acute, recurrent and persistent subtypes of Central Serous Chorioretinopathy (CSC) to check for possible Choriocapillaris hypoperfusion. The presence or absence of these microvascular changes was explored in both eyes of the patients and compared to a control group of healthy volunteers. The possibility of a correlation between Choriocapillaris flow deficits, age and spontaneous resolution of serous retinal detachment was also evaluated. This study was conducted in an effort to improve one's understanding of this disease and other pachychoroid disorders.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute, recurrent or persistent forms of central serous chorioretinopathy

Exclusion Criteria:

* Patients with chronic central serous chorioretinopathy were not eligible for inclusion
The Role of Gut Microbiota in Heart Failure and Pre-Heart Failure With Preserved Ejection Fraction

Gut microbiota play an important role in normal cardiovascular function and pathophysiology of cardiovascular diseases. Patients with heart failure (HF) have substantial hemodynamic changes which lead to intestinal hypoperfusion and congestion and eventually change gut morphology, permeability, function and composition of gut microbiota and cause translocation of microbial and endotoxins into the blood stream. Additionally, metabolites derived from gut microbiota modulate the pathophysiology of HF. Patients with HF have intestinal overgrowth of pathogenic bacteria and increased gut permeability. Accumulating evidence demonstrates that antibiotic treatment benefits patients with acute coronary syndromes and reduces the incidence of ischemic cardiovascular events. Taking the strong association of gut microbiota with HF into account, it is reasonable to speculate that gut microbiota could contribute to the progression of pre-HF with preserved ejection fraction (pre-HFpEF) to HF with preserved ejection fraction (HFpEF). Pre-HFpEF remains poorly understood, yet has high prevalence and a significantly high risk for death in comparison to patient without pre-HFpEF. We hypothesize that altered gut microbiota is involved in the initiation and establishment of HF and pre-HFpEF.

The research study will initially enroll 50 subjects without HF as normal controls,120 subjects with history of HF and 50 subjects with pre-HFpEF to characterize gut microbiota. The subjects will provide blood samples and a stool sample.

Eligibility Criteria:
Inclusion Criteria:

* Competent and willing to provide consent
* Control subjects with normal heart function
* Subjects with history of HF
* Subjects with impaired ventricular relaxation and/or elevated left ventricular end diastolic pressure measured by echocardiography and/or catheterization, yet has not had HF clinical presentations

Exclusion Criteria:

* intestinal surgery,
* inflammatory bowel disease,
* celiac disease,
* lactose intolerance,
* chronic pancreatitis or
* other malabsorption disorder
Premedication on Sevoflurane Induction

The goal of this study was to investigate the effects of fentanyl-midazolam premedication during sevoflurane induction pertaining to time to loss of eyelash reflex (LER), time and conditions of insertion of proseal laryngeal mask airway (PLMA), as well as cardio-respiratory data. Participants' anxiety level was also evaluated.

Eighty adult patients undergoing minor surgery were randomized in a double-blind fashion. Each group received either a NaCL placebo (NaCl), or a premedication consisting of fentanyl 0,6 ug/kg and midazolam 9 ug/kg (FM), five minutes before tidal volume sevoflurane 8% induction with 6 L/min O2. Times to LER and LMA insertion were recorded. Adverse events were also noted. Systolic blood pressure (sBP), heart rate (HR), respiratory rate (RR) and tidal volume (Vt) were recorded at one-minute intervals. End-tidal sevoflurane (EtSevo) and end-tidal CO2 (EtCO2) were noted immediately following LMA insertion. Anxiety levels (0-10 verbal scale) were registered before and after premedication. Patients were contacted 24 hours postoperatively and were asked if they remembered the mask being applied to their face.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II
* Minor elective surgery
* General anesthesia

Exclusion Criteria:

* Gastroesophageal reflux
* Exhibited a body mass index \> 32 kg/m2
* Took sedative or opioid drugs.
Effects of WB-EMS and Dietetic Treatment on Cancer Patients

This study evaluates the effects of a 12-week whole-body electromyostimulation (WB-EMS) training combined with individualized nutritional support on body composition, muscle strength and function and quality of life of patients with malignant disease undergoing curative or palliative anti-cancer treatment


Eligibility Criteria:
Inclusion Criteria:

* malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
* ongoing or planned curative or palliative anti-cancer therapy

Exclusion Criteria:

* simultaneous participation in other nutritional or exercise intervention trials
* acute cardiovascular events
* use of anabolic medications
* epilepsy
* severe neurological diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis