cyrilzakka/clinical-trials huggingface dataset:
Health After Covid-19 in Tyrol

The aim of the regional online questionnaire is to better understand the pattern of acute infection and the time of recovery of various symptoms.

The ongoing COVID-19 pandemic considerably increases the demand for healthcare and raises concerns on longterm disease outcome. Accordingly, to increase the knowledge on recovery from symptoms of acute infection and longterm health effects, a regional COVID-19 online survey on the health-status after infection will be performed.

This cross-sectional anonymous online survey is initiated and conducted by an interdisciplinary study team of the Medical University of Innsbruck, Austria.

For each participant, demographic characteristics (e.g. age, gender, district affiliation, profession), medical history (presence of comorbidities, medication), diagnosis of COVID-19, symptoms and their duration, treatments and special conditions will be collected.

The aim of the survey is to better understand the pattern of acute infection and the time of recovery of various symptoms.

The anonymous online survey is open to individuals after COVID-19 infection (proven by SARS-Cov-2 positive PCR or antibody test) over the age of 16 and living in Tyrol (Western-Austria).

The survey takes around 30 minutes to complete.

Eligibility Criteria:
Inclusion Criteria:

* status post COVID-19 infection, defined by a positive SARS-Cov-2 PCR or antibody test
* age ≥ 16years
* resident in Tyrol (Austria)

Exclusion Criteria:
Standardising Care for Hepatitis Delta in the Netherlands

Rationale: Hepatitis delta virus (HDV) is a defective RNA virus that requires presence of hepatitis B virus (HBV) to complete virion assembly and secretion. HBV-HDV coinfection ("hepatitis delta") has been associated with severe liver injury that may result in rapid progression to cirrhosis and hepatic decompensation, as well as a higher risk of liver cancer when compared to patients with HBV mono-infection. Given the low incidence of hepatitis D, experience in caring for individuals with hepatitis delta is limited and management practices vary.

Objective: Generate prospective follow-up data to increase our understanding of this rare disease.

Study design: Prospective observational cohort study spanning 5 years, during which we will collect standard clinical data as well as blood samples and quality of life questionnaires.

Study population: hepatitis delta patients aged ≥18 years Intervention (if applicable): not applicable Main study parameters/endpoints: Incidence of liver related events (liver cancer, (decompensation of) cirrhosis, liver transplantation) during follow-up and changes in markers of viral replication, inflammatory activity and liver stiffness over time.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The risks associated with participation can be considered negligible and the burden can be considered minimal. The only additional action that the participants must perform are the filling out of two annual quality of life questionnaires, which are considered non-invasive, and collection of 10 ml blood during regular blood sample collections


Eligibility Criteria:
Inclusion Criteria:

* Active hepatitis delta based on a positive anti-HDV and a positive HDV-RNA test
* Patients must be ≥18 years
* Written informed consent

Exclusion Criteria:

* None
Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids.

Patients diagnosed with bullous pemphigoid were confirmed based on the investigators national diagnostic criteria. Patients who meet all inclusion criteria and conflict the exclusion criteria will receive NPB-01(intravenous immunoglobulin) 400mg/kg/day for five consecutive days or Placebo(physiological saline). Subsequently, efficacy of NPB-01 for therapy of bullous pemphigoid will evaluate using pemphigoid activity score involving skin lesion area and Number of new blisters.

As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 57 days after the start of the study treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with corticosteroids over 20mg/day(Prednisolone) at informed consent.
2. Patients with continued treatment for bullous pemphigoid without add or change the treatment after informed consent.
3. Patients who pemphigoid activity score is score1 and more before study medication received.
4. Patients who symptom is not improve before study medication received.
5. Patients with twenty years old at informed consent.
6. Patients with hospitalization during five consecutive days of study medication.

Exclusion Criteria:

1. Patients treated with plasmapheresis at 28 days before informed consent.
2. Patients treated with corticosteroids pulse therapy(methylprednisolone over 0.5g/day) at 14 days before informed consent.
3. Patients treated with intravenous immunoglobulin at 56 days before informed consent.
4. Patients who receive or adjust in increments immunosuppressants at 14 days before informed consent.
5. Patients with malignancy or a history of this disease.
6. Patients with history of shock for NPB-01.
7. Patients with history of hypersensitivity for NPB-01.
8. Patients with IgA deficiency.
9. Patients with impaired liver function.
10. Patients with impaired renal function.
11. Patients with cerebro- or cardiovascular disorders.
12. Patients with high risk of thromboembolism.
13. Patients with hemolytic/hemorrhagic anemia.
14. Patients with decreased cardiac function.
15. Patients with decreased platelet.
Effects of Bariatric Surgery on Inspiratory Metaboreflex in Obese Subjects

The hypothesis of this study is that reductions in body weight could improve inspiratory muscle function attenuating the inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome.

Introduction: Peripheral metaboreflex activation appears to be exacerbated in obese individuals with metabolic syndrome. Interestingly, bariatric surgery attenuates the peripheral metaboreflex. Obese individuals have impaired inspiratory muscle function, which can be reversed by the reduction in body weight. Therefore, bariatric surgery could attenuate inspiratory metaboreflex in metabolically healthy obese individuals and obese individuals with metabolic syndrome. Objectives: To investigate the effects of bariatric surgery on inspiratory metaboreflex in metabolically healthy obese individuals and in obese patients with metabolic syndrome. Patients and Methods: A sample comprising of 15 obese subjects with metabolic syndrome, 15 obese subjects without metabolic syndrome and 15 healthy nonobese individuals. These subjects will be submitted to pulmonary function, respiratory muscle strength, inspiratory muscle resistance, exercise tolerance, quality of life, autonomic cardiovascular control and the inspiratory metaboreflex evaluation. The evaluations performed in obese patients with and without metabolic syndrome pre-surgery will be repeated 6 months after bariatric surgery.

Eligibility Criteria:
Obese with Metabolic Syndrome

Inclusion Criteria:

* Body mass index (BMI)\> 35 kg / m²
* Diagnosis of metabolic syndrome

Exclusion Criteria:

* Acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions)
* Diseases of the nervous system or conditions that affect the understanding or participation in the study
* Pregnancy
* Type I diabetes mellitus
* Arterial hypertension
* Dyslipidemias
* Coronary artery disease
* Left ventricular dysfunction
* Any condition interfering with locomotion
* Bronchial asthma
* Chronic obstructive pulmonary disease
* Chronic neuropathies
* Use of drugs such as corticosteroids or bronchodilators
* Smokers.

Obese without Metabolic Syndrome

Inclusion Criteria:

* Body mass index (BMI)\> 35 kg / m²

Exclusion Criteria:

* Metabolic Syndrome
* Acute health problems in the last month (viral or bacterial infections, accidents, allergic reactions)
* Diseases of the nervous system or conditions that affect the understanding or participation in the study
* Pregnancy
* Type I diabetes mellitus
* Arterial hypertension
* Dyslipidemias
* Coronary artery disease
* Left ventricular dysfunction
* Any condition interfering with locomotion
* Bronchial asthma
* Chronic obstructive pulmonary disease
* Chronic neuropathies
* Use of drugs such as corticosteroids or bronchodilators
* Smokers.

Healthy nonobese subjects

Inclusion Criteria:

* BMI \<25 kg / m²

Exclusion Criteria:

* Non-smokers
* Any diagnosed disease.
Effects of Neurocognitive and Social Cognitive Remediation in Patients at Ultra-High Risk of Psychosis

Cognitive deficits are known to be a core feature of schizophrenia and seem to become manifest in the prodromal or Ultra-High Risk (UHR) state of psychosis. The cognitive deficits are known to pose a critical barrier to functional recovery. Hence it is of vital importance to find intervention strategies that can alleviate these cognitive deficits and consequently improve daily functioning, and quality of life, as well as the prognosis for UHR-patients. The investigators will examine whether:

* Cognitive remediation therapy will be superior to standard treatment in improving cognitive functioning in UHR- patients (null hypothesis: No difference between the two groups).
* Cognitive remediation therapy will be superior to standard treatment in improving psychosocial functioning and clinical symptoms in UHR-patients (null hypothesis: No difference between the two groups).


Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 yrs.
* Fulfill criteria for being at Ultra-High Risk of psychosis (defined by one or more of the following):

  * Vulnerability (Trait and State Risk Factor) Group: Individuals with a combination of a trait risk factor (schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in functioning, or sustained low functioning during the past year.
  * Attenuated Psychotic Symptoms (APS) Group: Individuals with sub-threshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year.
  * Brief Limited Intermittent Psychotic Symptoms Group (BLIPS): Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year.
* Provided informed consent.

Exclusion Criteria:

* Past history of a treated or untreated psychotic episode of one week's duration or longer
* Psychiatric symptoms that are explained by a physical illness with psychotropic effect or acute intoxication (e.g., cannabis use).
* Diagnosis of a serious developmental disorder, e.g,. Asperger's syndrome
* Currently receiving treatment with metylphenidate.
* Rejects providing informed consent.
A Study Evaluating the Efficacy and Safety of Sildenafil in Men With Traumatic Spinal Cord Injury and Erectile Dysfunction

To demonstrate the efficacy, safety and tolerability of sildenafil administered orally, as required, approximately 1 hour prior to sexual activity to men with erectile dysfunction (ED) associated with spinal cord injury (SCI), as well as its effects on the quality of life (QoL) of these patients.


Eligibility Criteria:
Inclusion Criteria:

-Patients were men with spinal cord injury and erectile dysfunction

Exclusion Criteria:

-N/A
Intermittent Low Energy Diet in CKD: MIX UP Feasibility Study

This study proposes to investigate the acceptability and efficacy of intermittent VLED (5:2 diet) plus exercise, compared with the investigator's established Weight Management Programme (WMP), in obese patients with CKD, using feasibility study methodology.

Patients will be invited to participate in the parallel arm, single blinded, randomised controlled feasibility study, and randomly allocated to 1 of 2 treatments for 6 months. The experimental arm involves an intermittent modified fasting regimen consisting of VLED (600 kcal/day) on 2 consecutive days, and 5 days each week on a modified diet to maintain an overall energy deficit of 600 kcal/day across the week (5:2 diet). The control arm will be the standard renal WMP with a continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day.

The feasibility outcomes are: recruitment rate \>50%; intervention retention rate at 6 months \>60%; dietary intervention compliance; and weight loss. Secondary outcomes include safety, body composition, proteinuria, lipids, blood pressure, and eating desire. Measurements will be made at baseline, midpoint, and twice at endpoint.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-75 years
* KDIGO defined CKD (all categories)
* BMI ≥30kg/m2
* able to provide written informed consent in English

Exclusion Criteria:

* pregnant or breastfeeding women
* conservatively managed CKD stage 5
* palliative or active treatment for cancer
* unstable chronic liver disease
* type 1 diabetes and type 2 diabetes controlled with anti-hyperglycaemic medication
* previous bariatric surgery
* unable to provide written informed consent
* significant psychiatric disorder or uncontrolled depression
* participated in a weight management drug trial in the previous 3 months
* uncontrolled epilepsy
* alcohol or substance abuse
Phone-Based Based Walk with Ease Program for Adults with Arthritis

The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.

Participants will be randomized to either start the 6-week program immediately or after one year. Our Walk with Ease by Telephone (WWE-T) program is adapted from the original 6-week community-based group walking program developed by the Arthritis Foundation for adults with arthritis. The phone-based program will include 2 phone calls each week with a trained Walk With Ease Leader for 6 weeks. Assessments will be completed before at the start of the study, 6 weeks, 6 months and at 12 months.

Eligibility Criteria:
Inclusion Criteria:

* told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia
* able to read and write in English
* plan to live in the Columbia, SC region for next year
* willing to be randomized to either group
* complete all baseline measure

Exclusion Criteria:

* contraindications to exercise (besides arthritis)
* are pregnant, breastfeeding, or planning to become pregnant in the next year
* have a serious cognitive impairment
Device to Assist With Abdominal Access During Laparoscopic Surgery

The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18
* Scheduled for laparoscopic surgery
* Able to understand and willing to sign a written informed consent form

Exclusion Criteria:

* Age \< 18
* Any situation where blind, peri-umbilical passage of a Veress needle is contraindicated.
* Any situation where patients have suspected or confirmed intra-abdominal adhesions involving the peri-umbilical abdominal wall.
* Any situation where patients have a suspected or confirmed umbilical hernia or peri-umbilical ventral hernia.
* Any situation where there is not intact, uncompromised skin of the peri-umbilical region where the device is to be placed.
Initial Versus Delayed PDT Combination With Conbercept in PCV

To compare the initial versus delayed verteporfin photodynamic therapy (PDT) in combination with conbercept in patients with symptomatic polypoidal choroidal vasculopathy (PCV).

Polypoidal choroidal vasculopathy (PCV) is characterized by polypoidal choroidal vascular dilatation with or without abnormally branching vascular networks(BVN) on indocyanine green angiography (ICGA). It has been considered to be a subtype of wet age-related macular degeneration(wAMD). PCV is more prevalent in Asian patients than in white patients; nearly half of Chinese patients who was diagnosed with wAMD actually was PCV.

However, recently, the first choice treatment for wAMD has shifted to anti-vascular endothelial growth factor (VEGF) drugs, such as bevacizumab(Avastin,Genentech Inc), ranibizumab (Lucentis, Genentech Inc)and aflibercept (Eylea, Regeneron,Berlin,Germany) from PDT, and the vision improving effect has been confirmed regardless of race or disease subtype. Therefore, eyes with PCV can be treated initially with anti-VEGF drugs, however, they are limited in their ability to resolve polypoidal lesions, for which PDT works effectively.

Combination therapy of PDT and anti-VEGF drugs provides the complementary effects of both treatments, but it remains unknown whether PDT should have been administered at the beginning of treatment or during follow-up of anti-VEGF therapy. The purpose of this study was to compare the 12-months treatment results of initial and delayed PDT combined with conbercept (Lumitin, Chengdu Kang Hong Biotech Co., Ltd., Sichuan, China) for PCV.

Eligibility Criteria:
Inclusion Criteria:

1. Either gender，age ≥ 40.
2. BCVA at study entry of 34 to 79 letters (Snellen Equivalent 20/200 to 20/25).
3. Naive symptomatic PCV patients.
4. Presence of PCV assessed based on ICG with active polyps with or without abnormal vascular network.
5. No refractive media opacity or small pupil narrow that influence the fundus examination.
6. Women must be using effective contraception, be post-menopausal for at least months prior to trial entry, or surgically sterile.
7. Ability to provide written informed consent and to return for all study visits.

Exclusion Criteria:

1. Active inflammation or infection in the study eye.
2. Uncontrolled intraocular pressure (\>25 mmHg) in the study eye.
3. Ocular condition in the study eye which may impact vision and confound study outcomes (e.g. vitreomacular traction, epiretinal membrane with BCVA impact, ocular inflammation, retinal vascular diseases like diabetic retinopathy or diabetic macular edema).
4. Presence of centro macular scarring or atrophy indicating irreversible BCVA loss.
5. Prior treatment of the study eye with anti-VEGF therapy or systemic use of anti-VEGF products within 3 months prior to the study entry.
6. Previous vitrectomy, macular laser treatment, PDT, or intraocular steroids in the study eye.
7. Allergy to fluorescein, ICG, iodine, shellfish.
8. Pregnant or breast-feeding women.
Altitude Sickness Prevention With Ibuprofen Relative to Acetazolamide and Treatment Efficacy

This double blind randomized trial will compare ibuprofen to acetazolamide for the prevention of acute mountain sickness. These drugs have never been directly compared for efficacy. The study population is hikers who are ascending at their own rate under their own power in a true hiking environment at the White Mountain Research Station, Owen Valley Lab (OVL) and Bancroft Station (BAR), Bancroft Peak, White Mountain, California.

The specific aim of this study is to evaluate if acetazolamide will be similar to ibuprofen (i.e. Ibuprofen being non-inferior) in decreasing the incidence of Acute Mountain Sickness (AMS) in travelers to high altitude. It has been shown that ibuprofen taken 3 times a day 6 hours prior to ascent is effective for the prevention of AMS, with a number needed to treat of 4, decreasing the odds of getting AMS by a third. The efficacy appears to be similar to acetazolamide, with a NNT of 3 -8, although these two medications have not been directly compared in prevention of AMS. Acetazolamide is diuretic that is the only FDA approved AMS prophylactic medication and the most commonly used drug for AMS prevention. Although acetazolamide has been given a 1A indication, it has been shown to limit exercise capabilities at high altitude, and rapid ascent has been shown to attenuate its protective effects. Ibuprofen has been given a IIB recommendation by the Wilderness Medical Society Practice Guidelines, in part because it has not directly compared to acetazolamide. It is unknown if a non-steroidal anti-inflammatory can provide protection from AMS equivalent to acetazolamide.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 healthy non-pregnant volunteer
2. Sea-level dwelling (live at low elevation \< 4000 ft)
3. Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
4. Available for full study duration (Friday PM-Sunday AM)

Exclusion Criteria:

1. Age \<18 or \>65, Pregnant, Live at altitude \>4000 ft
2. Slept at altitude \> 4000ft within 1 week of study
3. Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
4. Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
5. Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.
Effects of Stress-reducing Aromatherapy

The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works.

The study purpose is to evaluate efficacy of stress-reducing aromatherapy and learn about how aromatherapy works by comparing participants' physiologic responses to laboratory challenge tasks with and without experiencing aromatherapy.

Eligibility Criteria:
Inclusion Criteria:

* in good physical and cognitive health
* reporting moderate level of stress
* able to perceive aromas
* able to understand and follow study instructions

Exclusion Criteria:

* taking medications affecting central nervous system (CNS) function or physiologic measures (e.g. steroids or neuroleptics)
* reporting smell sensitivities or allergies
* smoking presently or in the past less than one year prior to enrollment
Ultrasounds Evaluation of Asymptomatic Perimandibular Muscles Treated With Dry Needling

The articular disc of temporomandibular joint and three muscles of the cervico-facial region (temporal, masseter, sternocleidomastoid) are evaluated by means of sonographic images to observe and measure their dimensions' changes after a dry needling intervention. The participants are asymptomatic subjects and will be randomly divided in 2 groups: half of them are treated on the right side of the face, while the other half on the left side. Our hypothesis is that ultrasonography can reveal changes in the structures measured on the treated side.

The trial is designed as a before-and-after study conducted on asymptomatic subjects. The aim is to assess temporomandibular joint and three perimandibular muscles (temporal, masseter, sternocleidomastoid) by means of rehabilitative ultrasound imaging, carried out by a novice clinician. These evaluations are performed before and after a dry needling treatment directed to the tree studied muscles of one side of the face. The side to be treated is randomly assigned by using a computer-generated randomization process, the other side is used as control.

One month after the treatment sonographic images are taken by the novice clinician and by an expert one. The aim is to assess the reliability of ultrasonography comparing the results of their assessments.

Eligibility Criteria:
Inclusion Criteria:

* Age major then 18 years
* Must be asymptomatic in the face/head region at the time of the visit and in the previous 6 months.

Exclusion Criteria:

* Pregnancy
* medical history of systemic disease
* current pharmacological therapy
* history of recurrent headache and/or neck pain
* presence of orofacial pain or temporomandibular symptoms assessed with the DC/TMD (Diagnostic Criteria for TemporoMandibular Disorders)
* current use of a bite during sleep