cyrilzakka/clinical-trials huggingface dataset:
Lung MRI and Allergic Broncho-pulmonary Aspergillosis in Cystic Fibrosis

In this diagnostic study, the aim is at evaluating the diagnostic accuracy of MRI (Magnetic Resonance Imaging) to detect allergic broncho-pulmonary aspergillosis in patients with cystic fibrosis.

Allergic broncho-pulmonary aspergillosis (ABPA) is not rare in the context of cystic fibrosis (CF), with a prevalence reported between 2% to 16%. This complication is a diagnostic challenge for clinicians, since it is related with poorer outcome and higher worsening of the disease. Therefore, the treatment relies on corticosteroid and antifungal therapy and thus, it is important to detect with good sensitivity because CF patients are usually treated with antibiotics. However, the treatment is often difficult to be initiated because of potential secondary side effects related to diabetes mellitus, growth impairment, bone mineralisation or immunodepression. Therefore, there is a need for specific diagnostic tool to discriminate ABPA amongst other polymicrobial infection.

Lung MRI is a radiation-free imaging modality which offers the potential to combine several contrasts, in order to enable in vivo tissue characterization non-invasively. Investigators hypothesize that characterization of mucoid impaction using lung MR T1-weighted and T2-weighted contrasts may be a specific tool to diagnose ABPA in CF non invasively. Additional information on functional information related to ventilation and/or perfusion will be assessed using functional MR sequences, to assess the severity of small airway impairment. Moreover, the diagnostic value of structural alterations such as bronchiectasis, mucoid impaction and consolidation/atelectasis using either MRI with ultrashort echo times or CT using reduction of doses down to chest radiograph levels will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Cystic fibrosis proven by sweat chloride and genetic tests
* Age superior or equal to 6 year-old
* Diagnosis of ABPA available on the basis of the criteria by Cystic Fibrosis Foundation Consensus Conference
* No contraindication to perform MRI

Non-Inclusion Criteria:

. Age inferior to 6-year-old

* Cystic fibrosis not proven
* ABPA status not documented
* MRI contraindications: Pregancy, Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants...), metal inside the eye or the brain (aneurysm clip, ocular foreign body not compatible with MRI), cardiac valvular prothesis not compatible with MRI, subject with claustrophobia.

Exclusion Criteria: None
tVNS Effects on Motivation in Depression

Attaining goals or rewards commonly entails response costs. In light of cost and benefits, how do participants decide what effort should be put in to give it a shot? Figuratively, you may "go with your gut", but the literal contribution of the gut-brain axis in allocating effort is poorly understood to date. Here, the investigators propose to investigate non-invasive transcutaneous vagal nerve stimulation (tVNS) as a potential modulator of energy metabolism and response vigor. Since the neural mechanisms causing the diverse cognitive and behavioral effects of the stimulation remain largely elusive, the investigators will use computational modeling of instrumental behavior and determine the primary metabolic effects of the stimulation. The investigators hypothesize that tVNS will lead to activation of afferent targets in the brain. In turn, the elicited brain activation is expected to mediate the cognitive effects of the stimulation. This may affect both sides of the utility equation because anti-depressive effects may correspond to boosting the benefit of effort whereas anti-nociceptive effects may reduce perceived costs of effort. Collectively, dissecting the cognitive effects of non-invasive tVNS in healthy individuals may facilitate the more widespread use as a treatment in mental disorders that are characterized by metabolic alterations such as depression.


Eligibility Criteria:
Inclusion Criteria:

* 30 kg/m\^2 \> BMI \> 18.5 kg/m\^2

Exclusion Criteria:

lifetime

* brain injury
* coronary heart disease and occurred apoplexy
* schizophrenia
* bipolar disorder
* implants (e.g., cochlea implant)
* asthma

  12 month
* severe substance use disorders (DSM-V), except tobacco
* obessive compulsive disorder
* somatic symptom disorder
* eating disorder
The Effect of Ganglion Sphenopalatine Block (GSP-block) Versus Placebo on Postdural Puncture Headache

The purpose of this study is to evaluate the effect of the ganglion sphenopalatine block (GSP block) on postdural puncture headache.

Adult patients with postdural puncture headache will be enrolled in the study. The patients will be randomised to receive a ganglion sphenopalatine block (GSP-block) with either local anesthetic (lidocaine + ropivacaine) or placebo (isotone NaCl).

Primary outcome is hyperactivity in the sphenopalatine ganglion assessed by pain intensity (0-100mm on a visual analogue scale, VAS) of the postdural headache in standing position 30 minutes after block.

If the patients in the timeframe of 1 hour to 1 week after block does not achieve remission (VAS \<30mm while standing) they will be offered a "rescue GSP-block" defined as a new GSP-block with "open-label" local anesthetic and if continued lack of remission at least 1 hour thereafter then an epidural blood patch will be offered.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patients with postdural puncture headache defined as moderate to severe postural headache (VAS \>= 30mm) after lumbar puncture or accidental dural puncture during epidural insertion with an onset within 3 days following the puncture.
* Lack of headache remission within 1 day after dural puncture and after treatment with fluids, caffeine and paracetamol
* Patients who have given their written informed consent for participation in the study after fully understanding the protocol content and limitations.

Exclusion Criteria:

* Patients who cannot cooperate to the study
* Patients who does not understand or speak Danish
* Allergy to the drugs used in the study
* Has taken opioids within 12 hours prior to intervention
Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes

This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Type 2 diabetes
* HbA1c between 7-9%
* Insulin naive
* Inadequate control with oral antidiabetics therapy as judged by investigator

Exclusion Criteria:

* Patients with type 1 diabetes
* Hypersensitivity to Levemir® or to any of the excipients
* Pregnancy, or desire of pregnancy within next 6 months
* HbA1c greater than or equal to 9%
* Known or suspected allergy to the trial product or to any of the excipients
* Subjects who are unlikely to comply with protocol
Tai Chi Chuan as Rehabilitation Program for Mild Cognitive Impairment in Type 2 Diabetes Mellitus Patients

The patients with type 2 diabetes mellitus (T2DM) is expected to rise to 439 million in 2030, accounting for 7.7% the population in the world. There are nearly 10 million T2DM patients with mild cognitive impairment (MCI) among people over 65 years old , accounting for about 8% of the people over 65 years old in China. The medical cost for patients with T2DM/MCI is 2.5 to 4 times higher than those without T2DM. And T2DM will increase the risk of cognitive impairment, and lead to various complications which will bring serious social and medical economic burden.

It is critically important to identify effective treatments to enhance functional status of T2DM/MCI patients. Exercise has been shown to be beneficial for T2DM/MCI patients. As a Chinese traditional mind-body exercise that consists of both physical and mediation components, Tai Chi Chuan has been proved to be helpful in global cognition, memory, executive function and attention of MCI, and blood sugar of T2DM. However, the evidence of the effect of Tai Chi Chuan on T2DM/MCI patients is limited. The purpose of this study is to explore the effect of Tai Chi Chuan treating T2DM/MCI patients in cognitive function, balance, motor and sensation function, blood sugar, biochemistry profile and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. clinician diagnosis of T2DM;
2. presence of mild cognitive impairment, not demented;
3. age ≥ 60 years old;
4. did not engage in regular exercise in the last three months (at least 3 times a week, at least 20 minutes of regular exercise each time);
5. informed consent and voluntary participation.

Exclusion Criteria:

1. cognitive impairment caused by other reasons, taking drugs, poisoning, etc;
2. presence of medical conditions that unable or unsafe to exercise, such as depression symptoms, uncontrolled hypertension/ blood pressure/ blood glucose, nervous system diseases(stroke, Parkinson's disease, etc), musculoskeletal system diseases(arthritis, history of hip and/or knee joint replacement, etc), etc;
3. participating in other experiments that influence this study.
Focused Ultrasound Thalamotomy for Tremor Relief in Atypical Parkinsonism

The goal of this retrospective observational study is to describe the efficacy of focused ultrasound ventral-intermediate nucleus thalamotomy in patients with atypical parkinsonism.

* Is this treatment efficacious in patients with multiple system atrophy?
* Is this treatment efficacious in patients with diffuse Lewy Body Dementia? Data will be collected from patients charts.


Eligibility Criteria:
Inclusion Patients that underwent FUS ventral-intermediate nucleus thalamotomy Suffer from multiple system atrophy-Parkinsonian type (MSA-P) or dementia with Lewy bodies (DLBD).

-

Exclusion Criteria:

* Patients that did not underwent FUS ventral-intermediate nucleus thalamotomy
* Patients that underwent FUS ventral-intermediate nucleus thalamotomy and do not suffer from MSA or DLBD
Effect of Acupressure on Carpal Tunnel Syndrome in Pregnant Women

This study will be conducted to investigate the effect of acupressure on carpal tunnel syndrome in pregnant women.

The pregnant women are more prone to develop carpal tunnel syndrome because they retain more fluid during the later stages of their pregnancies. The more fluid retained , the more swelling occurs , squeezing the nerves that run through the hand and finger. Also most women who experience pain, numbness and tingling in the hand for the first time due to pregnancy have no idea that they have carpal tunnel syndrome.

Given the importance of treating CTS and preventing the limitations caused by this syndrome, and since it can turn into a debilitating disease if left untreated, acupressure can be recommended as a safe and noninvasive technique for reducing the severity of clinical symptoms.

Till now, there is no previous studies explored the effect of acupressure on carpal tunnel syndrome in pregnant women. So, this study will be conducted to provide new information about the efficacy of acupressure in management of carpal tunnel syndrome in pregnant women, which will help such pregnant women to overcome this problem and will add new evidence to the field of physical therapy.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who are clinically diagnosed as having carpal tunnel syndrome .
* Their age will be ranged from 20 to 35years old.
* Their body mass index will not exceed 30kg/m2.
* All of them are in their 3rd trimester of pregnancy.(28-40weeks)
* All of them suffer from mild and moderate CTS.
* Degree of carpal tunnel pain will be 2 or more on Visual Analogue scale.

Exclusion Criteria:

* Dermatological abnormalities in the skin of acupionts.
* Internal fixation at the area of acupressure application.
* Smokers .
* Metabolic diseases such as Diabetes mellitus.
* Females who had history of fracture or trauma to the hand .
Post-COVID-19 Monitoring in Routine Health Insurance Data

The SARS-CoV-2 infection was in 2020 responsible for new disease related chronic conditions which have been referred to as Post-COVID. To date it is still unknown how common this condition is and which symptoms are related to it. The aim of the study is to monitor the onset of these conditions in a large observational study consisting of German health insurance data.

SARS-CoV-2 is a virus of the coronavirus family, which includes a large number of viruses that can cause a wide variety of diseases in humans. The SARS-CoV-2 virus causes acute symptoms associated with the infection and can cause chronic conditions known as Post-COVID. To understand the prevalence and variety of Post-COVID a large observational study of health insurance data from Germany was set up. The exposed patients were identified by a diagnosis indicating a confirmed laboratory test for COVID.

The basic question concerns the burden of the Post-COVID condition. The study investigate which symptoms are more common in humans after the exposure to the virus compared to a matched unexposed cohort. Further will this be investigated in the subgroup of children and adolescents and those who have been hospitalized due to the virus infection.

Eligibility Criteria:
Inclusion Criteria:

* At least one outpatient or inpatient diagnosis of COVID-19 with laboratory detection of the virus (ICD-10: U07.1!)
* Continuously insured with the respective health insurance between 2019-01-01/birth and 2020-12-31/death

Exclusion Criteria:

-
Source-monitoring & Psychosis

Source-monitoring is a cognitive process that refers to the ability to remember the source of an information. Some studies have showed source-monitoring deficits in patients with schizophrenia as well as in individuals at ultra-high risk for psychosis (UHR) and in first-episode psychosis patients (FEP). Source-monitoring deficits have thus been proposed as a potential early risk factor for psychosis. However, further studies are needed to better characterize this deficit.

The aim of this project is to investigate source-monitoring performances in UHR, FEP patients and healthy controls (HC) and to characterize these deficits in terms of brain anatomy, basic auditory processes and social functioning.

Ninety participants will be included in the study: 30 UHR, 30 FEP and 30 healthy controls. All the participants will complete a standardized source-monitoring task, an MRI acquisition (3D-T1 anatomical scan), a tone-matching task as well as a socio-demographic and clinical evaluation including an assessment of the social functioning.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women aged between 18 and 30
* Having given their written informed consent
* French speakers and readers
* Absence of hearing impairments (or tinnitus) that could prevent the successful completion of tasks involving listening to sounds or words
* Absence of visual impairments that could prevent the successful completion of tasks involving reading on the screen
* For the healthy control group, no history of previous diagnosed psychiatric disorders (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - DSM5), absence of relatives diagnosed with spectrum disorder schizophrenia and bipolar disorder (DSM5), absence of psychotic prodromes measured by a score of less than 6 in the "prodromal questionnaire" - PQ-16 (Ising et al., 2012), absence of drug treatments (except oral contraception).
* For the UHR group, meeting the UHR criteria according to the "Comprehensive Assessment of at-risk mental state" (CAARMS).
* For the FEP group, presenting with daily psychotic symptoms for at least a week.

Exclusion Criteria:

* Do not consent to be included in the study
* Contraindication to MRI scan
* History of neurological disease
* Pregnancy
* Being under tutorship or curatorship
* Having developed musical abilities (that is, regularly practicing a musical instrument)
The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients

SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.


Eligibility Criteria:
Inclusion Criteria:

* Subject should be capable of consent
* Age 18 and older
* Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010
* Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)
* Can be on steroid dose \<7.5mg
* Quantiferon negative
* Hepatitis B, C negative
* No recent history (\<5y) of malignancy

Exclusion Criteria:

* Overlap syndrome
* Previously treated with a biological medication
* Heart failure NYHA III/IV
* Active tuberculosis
* Active infections
* Previous history of DVT, PE, or Stroke
* Other significant comorbidities that will prevent them from taking any biologic medication as per EULAR guidelines on treating rheumatoid arthritis 2020.
* Pregnancy
PRO 140 for Human Immunodeficiency Virus

PRO 140 2102 is a multicenter, randomized, double-blind, placebo-controlled, clinical trial of observed systemic, long-acting, anti-HIV treatment with a monoclonal CCR5 antibody (PRO 140) as an adjunct to a new, optimized, oral antiretroviral regimen in HIV-infected injection drug users with viral rebound and documented poor adherence to the previous antiretroviral regimen. Eligible subjects (approximately 76) will be randomized 1:1 to receive an optimized background antiretroviral regimen (OBR) plus supervised weekly subcutaneous treatment with either PRO 140 or placebo. Blood samples for safety and efficacy variables will be obtained over the 24 week duration of the study. Safety will be monitored throughout the course of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Exclusive CCR5-tropic virus as determined by as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
2. Males and females, age ≥ 18 years
3. Screening plasma HIV-1 RNA \> 1,000 copies/mL confirmed by second test while on the current antiretroviral regimen
4. History of non-prescription injection and/or non-injection recreational drug use
5. CD4 lymphocyte cell counts \> 100 cells/mm3
6. Clinically normal resting 12-lead ECG at screening visit
7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit. Within hours prior to receiving the first dose of study drug, women of reproductive potential must have a negative urine pregnancy test. Male and female subjects must agree not to participate in a conception process and agree to use one barrier method of contraception plus one other highly reliable contraceptive method from the early screening visit through week 24.
8. Non-adherent, history of poor adherence to a previous antiretroviral regimen.

Exclusion Criteria:

1. CXCR4-tropic virus, dual/mixed tropic (R5X4) virus as determined by the Enhanced Sensitivity Trofile™ HIV Tropism Assay
2. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study
3. Diagnosis of acute viral hepatitis (defined as any active infection with hepatitis A or a new diagnosis of hepatitis B or C within 24 weeks of dosing)
4. Prior use of any entry, attachment, CCR5 coreceptor, or fusion inhibitor, including PRO 140, experimental or approved
5. Participation in an experimental drug trial(s) within 30 days of the early screening visit or during the study
Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings

Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.


Eligibility Criteria:
Inclusion Criteria:

* acute achilles tendon rupture diagnosed less than 48 hours from injury
* mid-substance rupture

Exclusion Criteria:

* previous achilles tendon rupture
* lower leg disability
* diabetes mellitus
* neurovascular disease
* immunosuppression
* non-Swedish speaker
Assessing the Ability of Warfarin Treated Patients to Predict Their INR

ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara, James Hoehns, Matthew Witry

The international normalized ratio (INR) is the accepted lab test used to measure the intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin are unable to correctly determine, in the absence of an INR result, whether or not they are therapeutic at any given time. Some warfarin treated patients express that they have insight into what their INR result will be. Various patient related factors may contribute to these opinions.

Our objective is to assess how accurately patients can guess their INR result before it is obtained and to describe factors which inform their opinion of what their INR will be.

ASSESSING THE ABILITY OF WARFARIN TREATED PATIENTS TO PREDICT THEIR INR Kathleen McNamara, James Hoehns, Matthew Witry

The international normalized ratio (INR) is the accepted lab test used to measure the intensity of warfarin effect. The conventional wisdom is that patients receiving warfarin are unable to correctly determine, in the absence of an INR result, whether or not they are therapeutic at any given time. Some warfarin treated patients express that they have insight into what their INR result will be. Various patient related factors may contribute to these opinions.

Our objective is to assess how accurately patients can guess their INR result before it is obtained and to describe factors which inform their opinion of what their INR will be. In this prospective study, the investigators will enroll warfarin treated patients from 7 anticoagulation clinics in Iowa. Inclusion criteria are: age ≥18 years, warfarin use ≥60 days, INR goal of 2.0-3.0 or 2.5-3.5, expected warfarin use \>6 months, and English speaking. Exclusion criteria include: use of self INR-testing, home INR draws, dementia, or residing in a long-term care facility. A data collection form will be completed prior to INR measurement for a 6 month period. Information will be collected for subject demographics, warfarin adherence, INR stability, INR prediction, and prediction rationale.

INR monitoring represents a significant burden with respect to cost and time. The results of this study may identify patient factors which could help individualize and decrease the frequency of INR monitoring in patients who receive maintenance warfarin therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Warfarin use ≥60 days
* INR goal of 2.0-3.0 or 2.5-3.5
* Expected warfarin use \>6 months
* English speaking

Exclusion Criteria:

* Self INR-testing
* Home INR draws
* Dementia
* Residence of a long-term care facility