cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo

The purpose of this study is to evaluate the efficacy and safety of INCB054707 over a 24-week placebo-controlled double-blind treatment period, followed by a 28-week double-blind extension period in participants with nonsegmental vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of nonsegmental vitiligo.
* History of prior vitiligo treatment with a total duration of at least 3 months.
* Agreement to discontinue all agents and procedures used to treat vitiligo from screening through the final safety follow-up visit.
* Willingness to avoid pregnancy or fathering children
* Further inclusion criteria apply.

Exclusion Criteria:

* Other forms of vitiligo (eg, segmental) or other skin depigmentation disorders.
* Uncontrolled thyroid function at screening as determined by the investigator.
* Women who are pregnant (or who are considering pregnancy) or lactating.
* Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
* Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
* Participants known to be infected with HIV, Hepatitis B, or Hepatitis C.
* Laboratory values outside of the protocol-defined ranges.
* Further exclusion criteria apply.
Neuramis® Deep Lidocaine Compared to YVOIRE® Volume Plus for Correction of Nasolabial Folds

This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Males or females between 18 and 75 years of age, who want to correct both NLFs with 3 or 4 points in the WSRS and who provided written informed consent are to be included in the investigation.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 75 years of age.
2. Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.

Exclusion Criteria:

1. Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
2. Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.
NO Donors and Inhibitors to Study Imbalance of Nitrogen Stress and Antioxidant Defense in COPD

The primary aim of this study is to investigate the effects of oral and inhaled administration of L-arginine and of inhaled aminoguanidine on bronchial and alveolar exhaled NO and NO metabolites in exhaled breath condensate, induced sputum, nasal lavage and mouth wash fluid in healthy non-smokers, current smokers and patients with COPD.

Nitric oxide (NO) is produced by resident and inflammatory cells in the respiratory tract by the enzyme NO synthase (NOS), which exists in three isoforms: neuronal NOS (nNOS), inducible NOS (iNOS), and endothelial NOS. NO production is increased in patients with COPD, and the production of NO under oxidative stress conditions generates reactive nitrogen species that may amplify the inflammatory response in COPD.

Eligibility Criteria:
Inclusion Criteria:

* Healthy non-smokers
* Normal spirometry (FEV1 \>90 % predicted; exhaled NO bigger than or equal to 10 ppb; flow 50 ml/s)
* At risk (current smokers)

  * Normal spirometry, with or without chronic symptoms (cough, sputum production)
  * FEV1 reversibility of \<15% after inhaled beta2-agonists\*
* Moderate COPD

  * FEV1 greater than or equal to 30% and \< 80%
  * FEV1/FVC \< 70% predicted
  * FEV1 reversibility of \<15% after inhaled beta2-agonists
  * With or without chronic symptoms (cough, sputum production, dyspnea)
* Able to comprehend and grant a written informed consent

Exclusion Criteria:

* Concomitant use or pre-treatment within the last 4 weeks with oral steroids
* Respiratory infection within 4 weeks prior to entry into the trial
* Females who are pregnant or lactating
* History of current or past drug or alcohol abuse
Upper Endoscopy in Ulcerative Colitis Patients in Assiut University

Aim of study:

Primary Outcomes:

Patients with ulcerative colitis-associated upper gas- trointestinal inflammation may require specific treat- ment for the gastroduodenal lesions. Hence, recogni- tion and detection of the upper gastrointestinal lesions are important. Here we describe 2 cases of ulcerative colitis and summarize the results of our investigation of the prevalence of upper gastrointestinal involvement detected by esophagogastroduodenoscopy. We also analyzed the macroscopic and microscopic features of the upper gastrointestinal lesions

Secondary Outcomes:

correct and timely treatment of upprt GIT lesions in UC .

Ulcerative colitis (UC) is an idiopathic, chronic, relapsing inflammatory bowel disease (IBD) occurring in the colon and rectum . The main typical symptoms of UC include frequent bowel movement, mucus pus, bloody diarrhea, abdominal pain and discomfort, urgency, weight loss, and tenesmus . Apart from these typical symptoms, emerging evidence supports that there are a variety of accompanying symptoms involving the upper gastrointestinal (UGI) tract in patients with UC upon macroscopic and microscopic analyses, such as eosinophilic esophagitis\[9\], gastroduodenitis, ulcers, or UGI inflammation In addition, the positive rate of UGI endoscopy in asymptomatic individuals was lower than that in symptomatic patients. The reported clinically significant UGI lesions include multiple erosions, granular changes, white spots, friable mucosa, ulcer, and purulent deposits during fibrogastroduodenoscopy (FGDS)\[ط UGI involvement may be unnoticed by the attending physician due to the lack of the knowledge of gastroduodenal lesions, which should raise concerns during UC treatment. Furthermore, there is no established standard or criteria available for patients with UC who should undergo FGDS , because the clinical backgrounds of these patients with UC-associated UGI lesions have not been fully and exactly demonstrated. Specific management may be required for patients with UC-associated UGI lesions. Henceforth, we conducted this study with the aim of describing various UGI tract presentations in UC and their differential diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Patients' age is 18 years or above.
* Patient who are diagnosed with UC..
* Patient who are fit to undergo upper endoscopy .

Exclusion Criteria:

* Pediatric patients.
* patient refuse to participate at this study
* patient with known upper GIT disorder .
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus

The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;
* Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);

Exclusion Criteria:

Subjects expected to discontinue tacrolimus therapy;

* Patients with thrombocytopenia (\<75,000/mm3), an absolute neutrophil count of \<1,500/mm3 and/or leukopenia (\<2,500/mm3), or anemia (hemoglobin \<6 g/dl) at baseline;
* Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \>2.5 mg/dL) or worsening renal function in the previous two months.
Comparison of the Detection Rates of 50 Gr-100 Gr OGTT and 75 Gr OGTT That Require Medical Treatment of GDM

Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women

Exclusion Criteria:

* Already diagnosed by diabetes mellitus
* Multiple pregnancy
Cortical Reorganisation in Patients With Primary Headache Disorders

Primary headache disorders are now accepted as physiological diseases, and advanced imaging-techniques have demonstrated a migraine generator in the brain stem and increased stimulus sensitivity in these patients. The underlying neuronal dysfunctions remain to to clarified and the existing neurophysiological methods have not yet been useful. More sensitive and reliable methods are therefore highly needed. The aims of the study are therefore to develop a sensitive and reliable method to demonstrate a cortical reorganisation and expansion of pain sensitive cortical areas in patients with migraine or tension-type headache.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis og migraine without aura or chronic tension-type headache

Exclusion Criteria:

* serious somatic or psychiatric diseases including depression
* overuse of analgesics
* regular intake of opiates or benzodiazepines
* intake of prophylactic headache medication
* pregnancy
International BPA Registry

The International Balloon Pulmonary Angioplasty (BPA) Registry is a prospective, multi-center, long-term observational project. Scheduled to start data collection in Q4 2017, the registry will run for approximately four years with a follow-up time for each patient of at least two years. Its primary objective is to investigate the efficacy and safety of BPA intervention in patients with chronic thromboembolic pulmonary hypertension (CTEPH) not amenable to pulmonary endarterectomy (PEA).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis with CTEPH according to the following criteria:

  * Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease
  * Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines
* Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH
* Naïve to BPA treatment
* Scheduled to undergo their first BPA session ≥ 1 day after enrollment. Enrollment is defined as date the consent is signed by the patient. Enrollment must occur before any BPA session
* Willing to provide informed consent

Exclusion Criteria:

* BPA treatment prior to enrollment
* Pulmonary hypertension cause other than World Health Organization (WHO) group IV (CTEPH)
* Targeted BPA treatment lesion other than from WHO group IV (CTEPH)
Dexmedetomidine Combined With Bupivacaine for Erector Spinae Plane Block

As the posterior lumbosacral spine fixation surgeries are common spine procedures done nowadays due to different causes and as this spine procedure is mostly accompanied with moderate to severe postoperative pain, so it is necessary to find an effective and efficient postoperative analgesia for patients with this surgery.


Eligibility Criteria:
Inclusion Criteria:

* elective posterior lumbosacral spine fixation and fusion surgery due to different causes that diagnosed clinically and radiologically including MRI and Plain X ray

Exclusion Criteria:

* hypersensitivity to the drugs used in the study \[local anesthetics, non-steroidal anti-inflammatory drugs, opioids and the drug under investigation (dexmedetomidine)\]
* patients with any contraindication to regional anesthesia as skin infections at the site of the block
* history of bleeding disorders or receiving anticoagulant medications
Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine

This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.

Eligibility Criteria:
Key inclusion criteria:

1. Documented history of migraine in the 12 months prior to screening
2. 4-14 days per month of migraine symptoms
3. \>=80% diary compliance during the Baseline period

Key exclusion criteria:

1. \>50 years old at migraine onset
2. Pregnant or nursing
3. History of cluster or hemiplegic headache
4. Evidence of seizure or major psychiatric disorder
5. Score of 19 or higher on the BDI
6. Active chronic pain syndrome
7. Cardiac or hepatic disease
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are currently not being treated.


Eligibility Criteria:
Key Inclusion Criteria:

* Adult males or females between the ages of 18-65
* Chronic hepatitis B virus (HBV) infection
* HBV deoxyribonucleic acid (DNA ) ≥ 2000 IU/mL at screening

Key Exclusion Criteria:

* Extensive bridging fibrosis or cirrhosis
* Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators or biologics within 3 months of screening
* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV) or hepatitis D virus (HDV)
* Chronic liver disease other than HBV
* Lactating or pregnant females or those that wish to become pregnant during the course of the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy & Safety Study of YH22162 vs Telmisartan/Amlodipine in Patients With Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment

To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Men and women ≥ 19 years of age
* Essential hypertensive patients

  1. If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP \< 200 mmHg
  2. If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP \< 200 mmHg

Exclusion Criteria:

* Patients with known or suspected secondary hypertension
* Other exclusions applied
Bedside Ultrasonic Assessment for Gastric Content in Patients With Upper GI Bleeding Undergoing Endoscopy

Emerging studies have evaluated POCUS (Point of Care Ultrasound) for assessing of gastric content prior to anesthesia to reduce the risk of aspiration and demonstrated that POCUS can accurately identify presence of gastric food or fluid. Despite accumulating studies evaluating POCUS as a diagnostic modality to evaluate for gastric food content prior to anesthesia, there is no study to date that has evaluated the role of POCUS prior to endoscopy among patients with upper GI bleeding. Therefore, this study is to evaluate the diagnostic accuracy of POCUS for retained gastric content prior to endoscopy among patient hospitalized/admitted with upper GI bleeding. This study would take place at Loma Linda University Medical Center. Subjects will be any one who has upper GI bleed required EGD and age of greater than 18 years old. The study will plan for 1 year or reach 50 patients (whichever one comes first). In addition, subjects will be recruited from ED, ICU, Medicine ward by the PI, SubPI, and Collaborators. Subject will received ultrasound up to 6 hours prior the start of endoscopy. The location of Ultrasound would either take place at GI lab prior to scope or at the ward prior to transportation to GI lab or at ICU prior to endoscopy. The ultrasound would focus upper abdomen area and look for antrum. the result will be immediately read before endoscopy and fill out on the sheet before the endoscopy. Patient then proceed with endoscopy. At the end of the scope, the researcher will ask the endoscopist questions regarding how well they could see each part of the stomach in order to complete the study. Both results are compared between US and Endoscopy. Endoscopist is blinded in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18
2. patient presents with hematemesis
3. and/or melena
4. and/or hematochezia accompanied by hemodynamic changes (pulse \>100/min and/or systolic blood pressure \<100/min)
5. Patient is scheduled for upper endoscopy due to the above.

Exclusion Criteria:

1. Decline consent for study
2. Patients with last solid meal \<6 hours and clear liquids \<2 hours prior to the endoscopy
3. Prior surgery in the stomach
4. Patient has duodenum, Ileus, or bowel obstruction
5. patient has history of gastric cancer
Oxygen Saturation and Perfusion Index ın Neonates at High Altitude

Congenital heart diseases are among the most common congenital anomalies and occur with an incidence of approximately 8ınd12 / 1,000 live births worldwide. This figure does not cover minor lesions such as bicuspid aortic valves and small atrial or ventricular septal defects. Most of these defects do not need treatment or treatment is needed after infancy. Other defects are severe and usually require early treatment in the neonatal period. Critical congenital heart disease is defined as structural heart defects that are associated with hypoxia in the neonatal period and have significant morbidity and mortality potential in early life. Critical congenital heart disease is estimated to be \~3 in 1000 live births. It is estimated that 50% of congenital heart diseases are detected by prenatal ultrasound. Even if a standard neonatal examination is performed, 13 to 55% of patients with critical congenital heart disease can be discharged from the hospital without being diagnosed.

Screening of infants with non-invasive oxygen saturation measurement has been proposed as an adjunct to early detection of critical congenital heart disease.

The American Academy of Pediatrics, the American Cardiology Foundation and the American Heart Association have targeted 7 specific lesions for the pulse oximetry screening protocol: truncus arteriosus, transposition of the great arteries, tricuspid atresia, tetralogy of Fallot, total pulmonary venous return anomaly, hypoplastic left heart syndrome and pulmonary atresia.

The reference values of peripheral perfusion (PPI) index has been established for normal newborns between 1 and 120 h of age.

Lower PPI values than 0.70 may indicate illness. Including cut-off values for PPI in pulse-oximetry screening for duct dependent congenital heart disease is a promising tool for improving the detection of critical congenital heart disease with duct-dependent systemic circulation.

We aimed to investigate screening critical congenital heart disease and also to establish normal values of oxygen saturation and perfusion index at high altitude.


Eligibility Criteria:
Inclusion Criteria:

* The newborns delivered in Ataturk University Hospital and ≥34 weeks of gestational age were eligible for the study.

Exclusion Criteria:

* Outborn and premature babies (\<34 weeks) were not included. Babies with a prenatal diagnosis of congenital heart disease were excluded.
Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP Study)

This study is to examine the superiority of the combined treatments of transdiagnostic cognitive-behavior therapy (Unified Protocol; UP) and Treatment-As-Usual in comparison with the waiting-list with Treatment-As-Usual in the reduction of depressive and anxiety symptoms among depressive and anxiety disorders.

Participants with depressive or anxiety disorders will be randomized to either Unified Protocol with Treatment-As-Usual or Wail-list with Treatment-As-Usual. Intervention period will be 20-week and the follow-up period will be 43 week from registration.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of Major Depressive Disorder, Dysthymia, Depressive Disorder Not Otherwise Specified, Panic Disorder With Agoraphobia, Panic Disorder Without Agoraphobia, Agoraphobia Without History of Panic Disorder, Social Phobia(Social Anxiety Disorder), Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified assessed by SCID.
* Depressive and anxiety symptoms is mild or more severe (GRID-HAMD \>= 8).
* Ages 20 years or older, and 65 years or younger at screening.
* Subjects who give full consent in the participation of the study.

Exclusion Criteria:

* No alcohol or substance use disorder in 6 months prior to the screening assessed by SCID
* No current manic episode or current schizophrenia and other psychotic disorders at baseline assessed by SCID
* No serious suicidal ideation at baseline (GRID-HAMD Item3 severity is 3 or higher.)
* No life-threatening, severe or unstable physical disorders or major cognitive deficits at baseline.
* Evidence of unable to participate half or more of the intervention phase.
* No structured psychotherapy during at baseline.
* Other relevant reason decided by the investigators.
Pain Modulation - Experimental Assessments Using Different Modalities

The goal of this study is to investigate how different painful stimuli are processed and modulated in the nervous system. In various pain conditions, including low back pain, often no specific source can be identified as the cause of the pain. Scientific findings point towards a possible involvement of sensitization processes in the central nervous system (spinal cord and brain) that can contribute to the development and persistence of chronic pain. There is a need for reliable and well established experimental methods to better investigate and understand these processes. Frequently used methods comprise the application of thermal, mechanical or electrical stimulations. These modalities are processed in different parts of the nervous system, each allowing its own conclusions. This can be an advantage, but it also poses a challenge regarding comparability and generalizability of obtained results.

This study aims to apply and compare various experimental methods in people without and people with low back pain and shed light on the methodological differences. In the future, this could enable better identification and characterization of sensitization processes in the nervous system and build the basis for individually adapted, mechanism-targeted treatments with better patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

* German or English proficiency
* Informed consent
* primary pain complaint localized between the 12th rib and the gluteal fold
* low back pain for more than one week
* low back pain clinically not attributable to "red flags" (including infection, trauma, fractures, inflammatory)

Exclusion Criteria:

* unable to give informed consent (e.g. due to language problems)
* any neurological condition
* any major medical or psychiatric condition (e.g. severe heart disease, diabetes, autoimmune disorders, major depressive disorder), any chronic pain condition other than low back pain
* pregnancy
* Radiating pain below knee level (radicular pain)