cyrilzakka/clinical-trials huggingface dataset:
A Transdiagnostic, Self-guided Internet Intervention ("Velibra") for Waitlist Patients With Anxiety Disorders

The project's aim is to investigate the effect of a transdiagnostic, self-guided, internet-based cognitive behavioral therapy program in waitlist patients with anxiety disorders.

Patients who fulfill the inclusion criteria and are interested in psychotherapy are offered participation in the study to bridge the waiting time for face-to-face psychotherapy. After obtaining informed consent, a pre-treatment assessment is conducted. Then, participants are provided access to velibra, an internet-based cognitive behavioral therapy program which they can work through at their own pace. While velibra is a self-guided program, participants are supported by study personnel during four assessments at four time points: pre-treatment, mid-treatment (after the first three velibra modules), post-treatment and at the one-month follow-up. The investigators expect improvements on the primary as well as the secondary outcomes. Furthermore, the investigators are interested in studying the acceptability of velibra and whether positive changes already become observable after the first three modules, i.e., at the mid-treatment assessment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of panic disorder with or without agoraphobia, social anxiety disorder, or generalized anxiety disorder
* Knowledge of German that is sufficient for engaging with the treatment and responding to the questionnaires
* Written informed consent
* Internet access

Exclusion Criteria:

* Diagnoses of severe mental comorbidities (e.g., schizophrenia, severe major depression, borderline personality disorder)
* Acute suicidality
* Started or changed anxiolytic pharmacotherapy recently (currently or in the past four weeks)
Stroking Versus Ergon Technique in Pregnant Women

The study will focus on non-invasive management options for radiculopathy and functional activity in 3rd trimester women due to lateral cutaneous femoral nerve study. The findings of this study will help future clinicians to develop management plans for these patients that can include non-invasive and non-pharmacological treatment options like Ergon Technique and Stroking based on their effectiveness. The lateral femoral cutaneous nerve is formed by posterior divisions of the anterior rami of spinal nerves to enter the iliac fossa. It continues into the anterolateral thigh by passing either below or through the inguinal ligament, emerging anterior to the Sartorius muscle L2 and L3 In the thigh, it gives rise to two branches, The anterior branch supplies the skin of the anterolateral thigh to the knee and the posterior branch innervates the skin of the lateral aspect of the greater trochanter to the mid-thigh region. It can be compressed due to swelling, trauma or pressure in the surrounding areas. Common causes may include: Tight clothing, obesity or weight gain, and pregnancy. Symptoms may include anterior and lateral thigh burning, tingling, and numbness.

It will be a randomized clinical trial aimed to find the comparative effects of stroking and ergon technique on radiculopathy and functional activity in pregnant women. Women who meet the inclusion criteria that is they show positive femoral traction test, two point discrimination, light touch and pin prick maneuver will be recruited from Surya Azeem Hospital and Jinnah Hospital, Lahore. Two groups will be formed 13 patients will be allocated in each group. Before applying the techniques pre treatment reading will taken after that Hot Pack and TENS will be applied as a baseline treatment to both groups while Ergon technique will be applied to group A while stroking will be applied to the patients of group B. Two sessions per week will be given for 8 weeks. After that post treatment reading will be taken on 8th week. Data will be analyzed by using SPSS for windows version 25


Eligibility Criteria:
Inclusion Criteria:

* Pregnant ladies during 3rd trimester.
* Pregnant ladies of age between 30 to 40 years.
* Primigravida and Multigravida ladies.

Exclusion Criteria:

* Pregnant ladies with any previous hip fracture.
* Women with high risk pregnancy.
* Any previous history of disc herniation.
* Patients with lumbar radiculopathy.
Treatment of Hyperhidrosis With Oxybutynin

Evaluation of the effectiveness of oxybutynin in hyperhidrosis


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Patient affiliated to social security or beneficiary of such a regime
* Patient able to consent
* Patient with hyperhidrosis, generalized or localized (palmar, plantar, axillary) and whose score HDSS (Hyperidrosis Disease Severity Scale) is greater than two.

Exclusion Criteria:

* Age less than 18 years
* Patient who can't be followed
* Patient participating in another clinical trial
* Pregnant
* Woman breastfeeding
* Hypersensitivity to oxybutynin or any of the excipients
* Risk of urinary retention related disorders uretroprostatiques
* Intestinal obstruction
* Toxic megacolon
* Intestinal atony
* Severe Ulcerative Colitis
* Myasthenia
* Closure glaucoma the anterior chamber angle or slightly deep
Chromoendoscopy of the Colon After Oral Administration of Indigo Carmine

The purpose of this study is to examine whether oral administration of Indigo Carmine together with Polyethylene Glycol (PEG), the usual colon preparatory solution, can be used instead of staining during the examination itself.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Inflammatory Bowel Disease
* Patients under surveillance for Disease-Associated Lesions and Masses (DALM)

Exclusion Criteria:

* All others
DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO)

This is a prospective study to determine the incidence, morbidity, mortality and predisposing factors for the reactivation of hepatitis B virus replication during direct anti-HCV treatment of HCV/HBV co-infection patients.

Patients who receive direct-acting anti-HCV treatment will be prospectively studied during 2-year period. All patients have HCV/HBV co-infection.

The inclusion/exclusion criteria and the follow up plan will be listed in following part.

Eligibility Criteria:
Inclusion Criteria:

* HCV RNA positive,
* HBsAg positive with detectable or undetectable HBV DNA,
* Receiving pan oral direct-acting anti-HCV regimen

Exclusion Criteria:

* Pregnant or nursing female or male with pregnant female partner;
* HIV infection;
* Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.
Effects of Task Oriented Training in Patients With Stroke

The aim of the randomized controlled study is to investigate the effects of task-oriented training on motor and cognitive functions combined with Bobath training in patients with stroke.

Patients who meet the criteria will be informed about the study and volunteers will be included. When initial assessments will be completed, patients will be assigned to one of two possible sequences by simple randomization: study group (SG) or control group (CG).

All volunteers will recieve Bobath training program with the duration of 8 weeks. Additionally, task oriented training will be applied in SG, 5 days a week for 8 weeks.

All patients will be assessed in terms of motor functions and orientation, awareness, spatial perception, visuomotor construction, visual perception, praxis and thinking operations domains of cognitive funtions at the baseline and at the end of the study. Data will be collected from all the patients at baseline and at the end of the study (8 weeks) by the same physiotherapist who also will supervise the exercise sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteering to participate in the study
2. Be in the age range of 18-80 years
3. Clinical diagnosis of hemiplegia following stroke
4. Time since stroke between 2 and 8 weeks
5. Having stable vital signs
6. A score between 18-23 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

1. Having global aphasia and/or severe apraxia
2. Diagnosis of dementia or Alzheimer's prior to stroke
3. Participants who discontinued treatment
4. Receiving rehabilitation service before
DIC Markers and Thrombin Generation Parameters in Patients on ECMO Support: a Pilot Study

To study the correlation between novel DIC markers and thrombin generation parameters with thrombotic and hemorrhagic complications of patients on ECMO support.


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18; AND
* Admitted to the mixed medical-surgical intensive care units of Queen Mary Hospital or Tuen Mun Hospital in Hong Kong; AND
* Require either veno-arterial (VA) or veno-venous (VV) extracorporeal membrane oxygenation (ECMO) support.

Exclusion Criteria:

* Patients who are on central VA-ECMO support; OR
* Patients with missing clinical data; OR
* Patients with pre-existing thromboembolism requiring long term anticoagulation prior to ECMO cannulation; OR
* Post-operative admissions
Famotidine Outpatient COVID-19 Treatment Study

A retrospective case series of patients who self-medicated with Famotidine during coronavirus disease 2019 (COVID-19). The study will collect de-identified patient reported outcome measures of patients with confirmed COVID-19 who self-medicated with Famotidine at any dose during the period of illness. Data will be collected by questionnaire and telephone interview.

Inclusion criteria:

Age\>18; Ability to give written informed consent for study participation; Confirmed diagnosis of COVID-19; Use of Famotidine at any dose during period of COVID-19 illness

Famotidine is a histamine-2 receptor antagonist, widely available over-the-counter, and is safely used for suppression of gastric acid production over a wide range of doses from 20mg once daily to 160mg four times daily. In computer-based simulations, Famotidine has been identified as a potential inhibitor of the 3-chymotrypsin-like protease (3CLpro). In a propensity score matched retrospective cohort study a significantly reduced risk for death or intubation (adjusted hazard ratio 0.43, 95% confidence interval 0.21-0.88) was identified for patients with COVID-19 who were taking Famotidine before or at the point of hospital admission. Some individuals have self-medicated with Famotidine while being outpatients with COVID-19. This study is aimed at collecting patient reported outcome measures from such individuals.

Eligibility Criteria:
Inclusion Criteria:

Age \>18 years; Ability to give written informed consent; Confirmed COVID-19 diagnosis; Famotidine use during COVID-19 illness

Exclusion Criteria:

none
Surgery for Traumatic Optic Neuropathy

The pathophysiology of Traumatic Optic Neuropathy (TON) include a primary and secondary mechanism of injury. At present, no studies validate a particular approach to the management of TON. There are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. Studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. The tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. In this study, investigators aim to make a randomized controlled trial to certify the efficiency of optic nerve canal decompression for TON patients.

surgical intervention's efficiency and outcome for TON patients will be clearly present after this randomized controlled trial study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with the history of Traumatic Brain Injury or Craniofacial Trauma
* Optic nerve compression（intraneural edema, nerve sheath hematoma or canal fracture with impingement)
* Amplitude and latency abnormal or Ratio of amplitude of abnormal to normal side.

Exclusion Criteria:

* Glasgow Coma Scale，Score\<8
* Patients with good Visual Acuity and Visual Evoked Potential amplitude ratio more than 50%
* Other Contraindications for surgery
A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282

The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients with Primary Hypercholesterolemia
* Other inclusions applied

Exclusion Criteria:

* Patients with Secondary Hypercholesterolemia
* Other exclusions applied
Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

This study aims to assess the efficacy and safety of linaclotide in patients with overlapping symptoms of both functional dyspepsia (FD) and constipation-predominant irritable bowel syndrome (IBS-C).

After being informed about the content and risks of the research, all eligible patients giving written informed consent will be randomly allocated in a 2:1 ratio to linaclotide (290μg, once daily) or lactulose (20mL, once daily). Treatment will last consecutively for 4 weeks, and patients' symptoms will be assessed before and after four-week treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Outpatients
2. Diagnosis of FD (including postprandial distress syndrome \[PDS\] with or without epigastric pain syndrome \[EPS\]) (Rome Ⅲ criteria)
3. Diagnosis of IBS-C (Rome Ⅲ criteria)

Exclusion Criteria:

1. Helicobacter Pylori infection
2. GI symptoms caused by taking non-steroidal anti-inflammatory drugs or other agents
3. Pregnancy
Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring

The Carevive registry collects patient characteristics, patient symptoms, and treatment experience data from patients receiving cancer treatment for breast, lung, GI or multiple myeloma. For this study, a core set of variables is collected on each patient in the Carevive platform. Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic Patient Reported Outcome surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.


Eligibility Criteria:
Inclusion Criteria:

* All participants must be 18 years of age or older.
* Subjects may be any stage and anywhere in the treatment continuum.
* Subject participants must have a diagnosis of breast, lung, GI or ovarian cancer or multiple myeloma.
* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
* Any patient on a treatment clinical trial.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.

Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

This randomized double blind clinical trial was performed in non-diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Dyspeptic patients with positive antibody to H.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.

Exclusion Criteria:

* Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), diabetes mellitus, heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of \> 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any medication during the past 3 months, previous history of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and pregnant or lactating women.
Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection

Numerous neurological disorders affecting the central and peripheral nervous system can be attributed to the immune system through multiple effector mechanisms. However, current treatments could be drastically improved by faster and more accurate diagnosis. The sample collection will benefit to patients with rare neuroimmune syndromes such as Autoimmune Encephalitis (AE) and Paraneoplastic Neurological Syndromes (PNS) leading to a better and early diagnosis, as well as treatment improvement.


Eligibility Criteria:
Inclusion Criteria:

* Patient with consent
* Patient with well-characterized antibodies in serum or cerebrospinal fluid or not
* Patient with neurological disorder compatible with PNS or auto-immune encephalitis

Exclusion Criteria:

* Refusal of consent
* Patient under guardianship
Estimation of Coagulation Factor XIII Activity Based on the Initial Plasma Fibrinogen Level in Trauma

Coagulation factor XIII (FXIII), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. It also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. It has been found that similar to plasma fibrinogen level, FXIII activity can be reduced in the early phase of severe trauma. Therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. However, unlike plasma fibrinogen level evaluation, measurement of the FXIII activity is not routinely available. Therefore, targeted substitution of FXIII is practically impossible. The plasma fibrinogen level is routinely measured in severe trauma patients. Based on pathophysiologic assumptions and a limited number of published data we hypothesize that the FXIII activity correlates with fibrinogen level. In such case, indirect FXIII activity prediction by fibrinogen level measurement would be a convenient approach to enable FXIII targeted substitution. Therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased FXIII activity.

Coagulation factor XIII (FXIII), a plasma transglutaminase, is known as the final enzyme of the coagulation cascade, responsible for a cross-linking of fibrin to strengthen blood clot. It also minimizes fibrin degradation by its cross-linking it with alfa2-antiplasmin molecules. It has been found that similar to plasma fibrinogen level, FXIII activity can be reduced in the early phase of severe trauma. Therefore, its immediate substitution is of potential therapeutic interest in trauma-induced coagulopathy. However, unlike plasma fibrinogen level evaluation, measurement of the FXIII activity is not routinely available. Therefore, targeted substitution of FXIII is practically impossible. The plasma fibrinogen level is routinely measured in severe trauma patients. Based on pathophysiologic assumptions and a limited number of published data we hypothesize that the FXIII activity correlates with fibrinogen level. In such case, indirect FXIII activity prediction by fibrinogen level measurement would be a convenient approach to enable FXIII targeted substitution. Therefore we decided to perform a prospective observational clinical trial to determine whether the low plasma fibrinogen level in severe trauma correlates with decreased FXIII activity.

Eligibility Criteria:
Inclusion Criteria:

* a patient with presumed severe trauma admitted to the participating centre

Exclusion Criteria:

* inflammatory disease
* malignant disease
* pregnancy
* receipt of any fibrinogen / coagulation factor XIII product before blood sampling
* patients on dabigatran
A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.


Eligibility Criteria:
Inclusion Criteria:

* 70 years of age or less with body mass index (BMI) between 30 and 45 kg/m2
* Informed Consent
* Females of child-bearing potential must be using adequate contraception

Exclusion Criteria:

* Stroke/myocardial infarction (MI)/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* Glaucoma or elevated intraocular pressure
* Pregnancy or breastfeeding
* Drug or Alcohol abuse
* Smoking cessation within previous 3 months or plans to quit smoking during study
* Eating disorders within past year
* Cholelithiasis within past 6 months
* Type 2 diabetes
* Previous bariatric surgery
* Bipolar disorder or psychosis
* Steroid hormone therapy not stable for 3 months
* Systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg