cyrilzakka/clinical-trials huggingface dataset:
Antiproteinuric Agents and Fabry Disease

Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Fabry disease is a rare disorder that often has kidney involvement with increased urine protein excretion. Proteinuria is recognized as an important risk factor for progression of chronic kidney disease. Our hypothesis is that using drugs that reduce urine protein excretion (ACE inhibitors and ARBs) will have a beneficial effect on patients with Fabry disease who already are receiving enzyme replacement therapy. A longitudinal, observational study is being undertaken to determine the utility of these agents in Fabry disease, realizing that these agents are primarily indicated for reducing systemic blood pressure, and most patients with Fabry disease have relatively low blood pressures at baseline.

Eligibility Criteria:
Inclusion Criteria:

* genetically confirmed Fabry disease
* institution of commercially available agalsidase-beta

Exclusion Criteria:

* s/p kidney transplant
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011

The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

All Subjects:

Male or female (sterile or postmenopausal) subjects between 18-75 (both inclusive) years of age and healthy as determined by absence of clinically significant deviation from normal in medical history, physical examination, vital signs, electrocardiograms, and clinical laboratory determinations.

Subjects must have a BMI between 18 kg/m2 and 36 kg/m2 and weight at least 50 kg and no more than 120 kg.

Other than hepatic impairment, subjects must be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, (except for additional inclusion criteria described below).

Subjects in Child-Pugh A, B and C cohorts: Additional inclusion criteria

Child-Pugh Clinical Assessment Score consistent with degree of hepatic impairment

No change in hepatic status at least one month prior to dosing (i.e. worsening of Child-Pugh score).

Exclusion Criteria:

All Subjects:

Subject has received a liver transplant at any time in the past and is on immunosuppressant therapy.

History or presence of impaired cardiac function

Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism or excretion of drugs

Administration of CYP3A4/5 inhibitors or inducers or CYP3A4 substrates with narrow therapeutic windows

Administration of medications that prolong the QT interval

History of immunodeficiency diseases, including HIV, as confirmed by (HIV-1, HIV-2) test.

Participation in another clinical trial within 4 weeks prior to the study drug administration.

Subjects with normal hepatic function:

Additional exclusion criteria A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Subjects in Child-Pugh A, B and C cohorts:

Additional exclusion criteria

Clinical evidence of severe ascites (e.g. requiring regular tapping).

Bilirubin \> 6 mg/dL
CRP-guided Transanal Drainage Removal After Rectal Surgery

Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma


Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 75 years old
* male and female
* primary rectal adenocarcinoma
* ASA I, II, or III
* laparoscopic LAR + DST
* with or without preoperative radio- or chemotherapy
* no distal metastasis
* no preoperative bowel obstruction
* no preventive ileostomy or colostomy
* patients and their families can understand and are willing to participate in this study and provide written informed consent

Exclusion Criteria:

* emergency operation
* preoperative abnormal liver function
* tatme or ISR procedure (healing process might differ from anterior resection)
* severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
* severe perioperative infection unrelated to anastomotic leak
* patients with serious mental illness
* pregnant or breastfeeding women
* patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial
The Effect of Wearing a Mask for Balance and Reaction Time

A mask is a protective equipment that covers the mouth and nose and is routinely used in workplaces, public transport and other communal settings preventing harmful particles, dust, droplets, bacteria, viruses, fog, gas, smoke and steam from entering the respiratory system. However, wearing a mask may impair the visual field, potentially affecting balance and reaction time. The investigators' aim is to determine whether the use of masks affects people's balance and reactions.


Eligibility Criteria:
Inclusion Criteria:

* To be healthy

Exclusion Criteria:

* present or previous balance disorder
Safety and Efficacy of High Intensity Focused Ultrasound in Solar Lentigo: A Self-controlled Study

This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab\* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab\* values and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively.


Eligibility Criteria:
Inclusion Criteria:

1. adults between 18 and 60 years old, regardless of gender;
2. comply the clinical diagnostic criteria for solar lentigo on both sides of the face;
3. patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form;

Exclusion Criteria:

1. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period;
2. those who are allergic to medical condensation gel;
3. those with photosensitive diseases, immune deficiencies, or those who are taking immunosuppressants;
4. those with diabetes, malignant tumors, epilepsy, severe liver, kidney, or heart conditions, or any other acute or chronic medical history that could potentially affect the effectiveness or safety outcomes of this trial;
5. those with scar physique;
6. those with inflammatory or infectious skin diseases;
7. those who have systemically used retinoic acid in the last six months or topically applied retinoic acid drugs in the last three months, or have a history of sun exposure in the four weeks prior to treatment;
8. those who have undergone high-intensity focused ultrasound treatment within the last six months;
9. Those with serious heart, brain, lung, liver and kidney function damage; Pregnant and lactating women;
10. Those who have a history of psychological and mental illness, recent history of alcoholism or drug abuse;
11. patients who are unwilling to sign the informed consent and who are unwilling to cooperate.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's Disease

This is a Phase I/II randomized, double-blind, placebo-controlled, multiple rising dose study in patients with stable idiopathic Parkinson's disease (PD) to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ITI-214.


Eligibility Criteria:
Major Inclusion Criteria:

* Clinical diagnosis of idiopathic Parkinson's disease (PD)
* Severity of PD assessed by Hoehn and Yahr Staging score of 1 to 3
* Maintenance on stable PD therapy

Major Exclusion Criteria:

* Clinical signs of dementia
* Suicidal ideation or behavior
* Considered medically inappropriate for study participation
Wine Consumption and Glycemic Control

Many studies have reported that alcoholic beverage consumption, especially in the form of wine, reduces the risk of developing type 2 diabetes by as much as 40%. This association suggests that wine consumption may somehow improve the body's ability to control its blood glucose concentration. Indeed, it has been reported that when wine is consumed immediately prior to ingestion of glucose, the release of insulin is enhanced and blood glucose concentration is lowered. The mechanism of wine's effects on blood glucose concentration is unknown, but is likely related to its ethanol or antioxidant content. In this study, the investigators plan to test whether wine or plain ethanol (vodka) ingestion alters the control of blood glucose in subjects who have diabetes or pre-diabetes.

Our central hypothesis is that improvement in glycemic control by acute consumption of wine is mediated by ethanol. Subjects will have type 2 diabetes, pre-diabetes, and be sedentary and obese (BMI \>30). Subjects' glycemic control will be assessed by an oral glucose tolerance test (OGTT) at three different time points. One OGTT will occur shortly after consumption of red wine, the second after consumption of vodka containing the identical amount of ethanol as the wine treatment, and the third OGTT will occur shortly after consumption of an equal volume of water. The three OGTTs will be administered in random order.

Eligibility Criteria:
Inclusion Criteria:

* insulin resistant: diagnosed with pre-diabetes or fasting blood glucose \>/= 97 mg/dL
* T2D: diagnosed by primary care physician
* at risk of type 2 diabetes (obesity and physically inactive)
* age: 21-65

Exclusion Criteria:

* smoking
* insulin use (other than once daily)
* physically active (\>30 mins aerobic exercise two days/week)
* recent (\>3 mo) changes in medication use or dose
* uncontrolled type two diabetes (HbA1C \>10%)
* advanced retinopathy or neuropathy
* pregnancy
Mental Health Telemetry for Self-Management in Major Depression

Mood journaling is a cornerstone of self-management in major depressive disorder (MDD). Research over the last decade has shown that electronic mood journals are superior to paper ones. One potential advantage of mental health telemetry (MHT), which use cell phones to collect mood journal data, is that electronic journal data can easily be converted into graphical records, allowing people living with MDD to readily spot trends, correlations, or patterns in ways that would be quite challenging using paper diaries. This information should make it easier to recognize and evaluate changes in mental health status -- the first two steps in the process of self-management. The investigators will develop and deploy a visualization module for patients with which to explore their own MHT data sets on the same cell phones which they record their journals, and test the investigators hypotheses that their enhanced MHT system will (i) improve patients' ability to self-manage MDD and (ii) enhance their quality-of-life.

The study is a non-randomized, un-blinded, A-B-A' (modified single-subject withdrawal design, with user choice of treatment or withdrawal in the A' stage) study, to explore the utility of MHT as a tool for enhancing self-management and QoL for persons living with MDD. The aims of this study are to explore the impact of MHT on subjects' self-management and QoL, and to gauge participants' perceptions of MHT's utility.


Eligibility Criteria:
We will recruit (n=113) patients with a Diagnostic and Statistical Manual, 4th Ed. (DSM-IV) diagnosis of MDD, confirmed using the MDD section of the M.I.N.I. International Neuropsychiatric Interview (MINI) version 5.0. All recruits will own or use a web-enabled cell phone.

Exclusion Criteria:

* self-disclosed illiteracy;
* blindness;
* inability to be successfully trained in the use of MHT
Evaluation of a Personcentered Internet-based CBT Program for Stress, Anxiety and Depressive Symptoms in Patients with Cardiovascular Disease

To evaluate a nine-week adaptable and person-centred I-CBT program that can be directed towards stress, anxiety and depressive symptoms in persons with CVD.

All patients diagnosed as CVD (i.e. diagnosis Ischemia (ICD-code I20., I25.), Heart Failure (ICD-code I50., I42.) or Arrhythmia (ICD-code I48, I49, DF016) and who received care in the last 12 months at hospitals in the south-east of Sweden will be contacted by letter with information about the study.

Participants who are interested are invited to visit our website for more information, registration and provision of informed consent. After registration, participants will respond to questions about demographics, medical history, stress, anxiety and depressive symptoms on the website. Inclusion or exclusion will be assessed by a group consisting of a psychologist, cardiology specialist nurse and a psychiatry specialist nurse.

Before final inclusion and randomization eligible participants will be contacted for a telephone interview held by the study nurses.

Included (n=400) participants will, on our website (www.xxxxxx), complete the baseline study questionnaires and then be randomized according to a 2 x2 factorial design.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years and above
* treatment for cardiovascular disease (CVD) according to European Society of Cardiology guidelines
* stable CVD (New York Heart Association class I-III) and not having been hospitalised for CVD in in the last four weeks.
* stress (Perceived Stress Scale (PSS)-10\>13 points) and/or
* anxiety (i.e. General Anxiety Disorder Scale (GAD) ≥5 points) and/or
* depressive symptoms (Patient Health Questionnaire-9 28 (PHQ-9) \> 5 points)

Exclusion Criteria:

* severe CVD (New York Heart Association classification IV) or another severe chronic life-threatening disease
* severe stress, anxiety or depression assessed as requiring acute treatment
* not being able to dedicate 3-4 hours per week to participate in the program
Etiological Classification-guided Individual Intervention in Primary Hypertension

Eligible participants will first undergo a 1-week home blood pressure diary and 24-hour ambulatory blood pressure assessment. After a confirmed diagnosis of hypertension, etiological subtyping will be performed. Based on the blood pressure evaluation results and etiological classification, the most appropriate antihypertensive medication will be selected. Simultaneously, a personalized lifestyle prescription will be provided according to the patient's individual circumstances. Following medication initiation, participants will continue to monitor their blood pressure through home diaries. Monthly evaluations will be conducted, and if blood pressure fails to reach the target value, medication adjustments will be made based on the blood pressure diary until target levels are achieved. This regimen will be maintained long-term.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* Diagnosed primary hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
* signed informed consent.

Exclusion Criteria:

* Secondary hypertension or arrhythmias affecting blood pressure accuracy (e.g., atrial fibrillation).
* Comorbidities such as diabetes, chronic kidney disease (eGFR \< 30 mL/min/1.73m²), coronary artery disease, heart failure, or serious valvular heart disease.
* History of stroke or myocardial infarction.
* Pregnancy, breastfeeding, or planning to become pregnant.
* Life expectancy \< 1 year.
* Participation in another clinical trial.
Reliability of All on 4 Using 2 Zygomatic and 2 Conventional Implants vs All on 4 Implants for Rehabilitation of Maxilla

Oral rehabilitation by dental implants in the severely atrophic maxilla often represents a challenge. To overcome this difficulty, bone augmentation procedures such as sinus augmentation, guided bone regeneration (GBR), or distraction osteogenesis have been used to obtain adequate bone height and width for proper three-dimensional implant placement. To avoid surgical morbidity and shorten treatment length, alternative methods such as short or tilted implants, as well as zygomatic implants (ZIs),have been proposed and have shown promising outcomes.

Placement of dental implants in the pterygo-maxillary region provides adequate posterior bone support for the prosthesis which permits better distribution of masticatory forces without the need of sinus floor augmentation, onlay and inlay grafts, split crest technique, or osteogenic distraction. This allows rehabilitating patients with satisfactory full arch fixed maxillary prosthesis, which is usually spanned from second molar to contralateral second molar tooth.

The purpose of the present study is to compare the Reliability of all on four by 2 zygomatic implants with 2 conventional implant in anterior region versus all on four approach by conventional implant for the rehabilitation of the atrophied maxilla in terms of survival rates and improving the quality of patient's life and involved complication with maxillary sinus.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with severely atrophic edentulous upper arch (Cawood class IV, V, VI) that could not be restored with other type of treatment.
2. Patients who had at least 8-12 mm vertical bone height in anterior maxilla to allow installation of at least 2 conventional implants.

Exclusion Criteria:

1. Patients with any systemic disease that might interfere with dental implants placement and/or osseointegration e.g. uncontrolled diabetes, hypertension and osteoporosis, etc.
2. Heavy smoker (\> 20 cigarettes daily) and patients with history para-functional habits (e.g. clenching or bruxism, etc.) were also excluded.
3. Intraoral pathological lesion, related to maxilla, maxillary sinus and zygoma.
Retrospective Encore Reverse Shoulder Prosthesis Study

The purpose of this study is to evaluate the survivorship and efficacy of the Encore Reverse Shoulder Prosthesis in a group of no more than 50 subjects for whom data collection has already begun.


Eligibility Criteria:
Inclusion Criteria:

* The RSP is indicated for use in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint.
* The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
* The glenoid baseplate is intended for Cementless application with the addition of screws for fixation. The humeral stem is intended for cemented use only.

Exclusion Criteria:

* Infection or sepsis
* Insufficient bone quality which may affect the stability of the implant, as determined by the physician
* Muscular, neurological, or vascular deficiencies, which compromise the affected extremity
* Alcoholism or other addictions
* Materials (metals, etc) sensitivity
* Loss of ligamentous structures
* High levels of physical activity
* Non-functional deltoid muscle
High Protein Diet Versus Normal Protein Diet in Treating Patients With Minimal Hepatic Encephalopathy

A total of 80 patients diagnosed with liver cirrhosis and minimal hepatic encephalopathy will be recruited. They will be randomized to receive high protein diet ( n = 40) and a normal protein diet ( n = 40 ) during one month. Randomization will be conducted by an external monitor and will keep the secret codes until the end of the study. All patients will be provided with structured menus and two snacks a day as an amaranth protein supplement. The supplement will content the same amount of fiber but the protein content will vary depending on the group to which the patient is assigned.

The protein in the diet is a major source of ammonia in blood, which is considered one of the factors involved in the pathogenesis of hepatic encephalopathy. However ; it is also known than the restriction on the consumption of protein predisposes to depletion of muscle mass, and increase the risk to develop overt hepatic encephalopathy, due to the muscle role in the detoxification of ammonia in presence of liver failure. Currently, the type and amount of protein in the diet to treat minimal hepatic encephalopathy (MHE) is unknown. In this study, the investigators will administrated two types of protein content in patients with MHE: a high protein diet (1.5 g/kg/day) vs a normal protein diet (0.8 g/kg/day) during 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cirrhosis of any etiology
* Men and women between 18 and 70 years.
* Right-holders of the Mexican Social Security Institute
* Patients who agree to participate in the study and signed the informed consent

Exclusion Criteria:

* Recent history of alcohol abuse and/or drugs (less than 6 weeks).
* Illiterate
* Alcoholic cirrhosis
* History and/or diagnosis of overt hepatic encephalopathy
* Consumption of psychotropic medications (benzodiazepines, antiepileptics)
* Patients under treatment with lactulose, lacitol, rifaximin, neomycin, metronidazole and/or fiber supplements.
* History of chronic renal disease or heart failure
* Patients with gastrointestinal bleeding
* History of neurological or psychiatric disorders that affect the ability to develop neuropsychological tests
* Diagnosis of bacterial overgrowth
* Diagnosis of liver cancer
* Patients with ophthalmologic disorders