cyrilzakka/clinical-trials huggingface dataset:
Behavioral Health Technician Delivered Written Exposure Therapy

This study has two main goals. First, it aims to test a treatment called written exposure therapy to see if it can help military service members who have posttraumatic stress disorder (PTSD). Second, it aims to test a new way of making this therapy more accessible in military clinics by utilizing task-sharing with Behavioral Health Technicians (BHTs). PTSD is a common and serious issue among service members. Written exposure therapy (WET) has been proven to be effective for improving PTSD that requires five therapy sessions delivered weekly. This study aims to determine:

1. How well does written exposure therapy help to reduce symptoms of posttraumatic stress for service members with PTSD?
2. Is sharing the therapy tasks with behavioral health technicians is a helpful approach for managing behavioral health clinic patient volume and improving patient outcomes?

We plan to recruit a total of 40-59 staff participants, as well as 150 active-duty patient participants with PTSD. We will randomize patient participants to one of two treatment conditions: 1) treatment-as-usual (TAU) or 2) TAU and 5 sessions of WET. Staff and participants will be recruited from two military treatment facilities: 1) Fort Sam Houston in San Antonio (Brooke Army Medical Center) and 2) Camp Pendleton (Naval Hospital at Camp Pendleton).

Consented patient participants will:

* Complete a PTSD interview via telehealth with a study team member to determine if you are eligible for the study
* Be randomly assigned to one of the following conditions: 1) TAU + WET or 2) TAU
* Complete up to 8 weeks of behavioral health treatment (either TAU + WET or TAU)
* Complete self-report measures before, during, and after treatment, and at a 3- and 6-month follow up assessment after the treatment period
* Complete a posttreatment PTSD interview via telehealth with a study team member
* A subset of participants will be asked to complete a brief treatment experience interview posttreatment

Consented staff participants will:

* Participate in an interview about your perceptions of and experiences supporting BHT-delivered WET with a study team member at the VAPAHCS
* A subset of participants will also be asked to participate in a brief staff feedback interview approximately 6 months after their first interview


Eligibility Criteria:
Inclusion Criteria:

Patient participants:

1. Adult active duty personnel ages ≥18
2. Clinically significant PTSD symptoms (CAPS-5 ≥ 25).

Clinic staff participants: Individuals working as BHTs, clinic providers, and clinic leaders working at the behavioral health clinics participating in the study

Exclusion Criteria:

Patient participants:

1. Current suicide or homicide risk meriting crisis intervention
2. Serious mental health symptoms, such as mania, psychosis, alcohol or substance use disorders warranting immediate attention
3. Inability to comprehend the baseline screening questionnaires
4. Definite plans to leave the military within 10 weeks

Clinic staff participants:

None
Endoscopic Retrograde Cholangiopancreatography (ERCP) With Cholangiopancreatoscopy Using a Thin Scope

The purpose of this study is to evaluate the use of a thin scope/anchoring Balloon endoscopy system for the medical care of pancreatic and/or biliary disorders.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 18 years or older
2. Subject has clinical indication for Endoscopic Retrograde Cholangiopancreatography (ERCP) with Cholangioscopy and/or pancreatoscopy
3. Subject must be able to give informed consent.

Exclusion Criteria:

1. Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
2. The subject is unable to give informed consent.
Smoking Cessation Treatment for Head and Neck Cancer Patients

This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch. The study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* smoking 10 or more cigarettes per day
* diagnosed with and completed an initial course of treatment for any type of head and neck cancer
* life expectancy of 12 months or more

Exclusion Criteria:

* history of allergic reactions to adhesives
* unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
* females of childbearing potential who are pregnant, nursing, or not practicing effective contraception
Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19

A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.


Eligibility Criteria:
Inclusion Criteria:

• Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Exclusion Criteria:

* Participants with uncontrolled clinical status who were hospitalized from the before.
* Contraindication / possible drug interaction.
* Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, pregnancy, Corpulmonale, etc.
Safety and Tolerability Study of Oral NS-018 in Patients With Primary Myelofibrosis (MF), Post-polycythemia Vera MF or Post-essential Thrombocythemia MF

The purpose of this study is to determine the safety and tolerability of orally administered NS-018 in patients with Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (post-PV MF), or Post-essential Thrombocythemia Myelofibrosis (post-ET MF)

This is a Phase 1/2 study that is currently enrolling Janus kinase 2 (JAK2) failures into the Phase 2 portion of the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary myelofibrosis, post-PV MF, or post-ET MF that requires therapy
* MF patients must have received prior JAK2 inhibitor therapy, and been found to be intolerant, or refractory/relapsed from prior JAK2 inhibitor therapy, based on investigator assessment
* ≥18 years old
* ECOG Performance Status of ≤ 3
* Estimated life expectancy of ≥12 weeks
* Male or non-pregnant, non-lactating female patients
* Serum creatinine of ≤1.5 × the upper limit of normal (ULN)OR estimated creatinine clearance (CrCl) ≥ 40 ml/min/1.73 m2
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × the upper limit of normal (ULN) and total bilirubin ≤1.5 × ULN. If the total bilirubin is elevated between 1.5 x and 3 x ULN, patients with a direct bilirubin ≤ 1.5 X ULN are eligible during the Phase II portion.
* Absolute neutrophil count (ANC) \>1000/μL and Platelet count \> 25,000/μL
* QTcB ≤ 480 msec
* No MF-directed treatment for at least 2 weeks prior to initiation of NS-018, including any use of corticosteroids for Myelofibrosis symptom or blood count management. Low dose corticosteroids ≤ 10 mg/day prednisone or equivalent is allowed for non-myelofibrosis purposes.

Exclusion Criteria:

* Active, uncontrolled systemic infection
* Patients with any unresolved toxicity greater than Grade 1 from previous anticancer therapy
* Potentially curative therapy is available
* Currently taking medication that is substantially metabolized by cytochrome P450 (CYP) 1A2 or CYP3A4 or taking medication known to be strong inhibitors or inducers of CYP3A4
* Patients with a serious cardiac condition within the past 6 months
* Pregnant or lactating
* Radiation therapy for splenomegaly within 6 months prior to study entry
* Splenectomy (Phase 2 portion of the study only)
* Known HIV positive status
* Known active hepatitis, a history of viral hepatitis B or hepatitis C
Biliary Cancer in Italy: a Study on Cholangiocarcinoma cAUSEs and Risk Factors

Multi-centric, observational, prospective study, designed for pts with diagnosis of all-stages cholangiocarcinoma, including rare and crossing-over histological types, and excluding gallbladder cancer and ampullary carcinoma.

Patients will undergo basal blood sample exams regarding blood cell count, renal and liver function, tumor markers, inflammatory and metabolic state, along with a screening (and, if needed, a more in-depth laboratory analysis) for viral hepatitis infections. Information will be collected about radiological, clinical and pathological features of the neoplasm at time of diagnosis, as well, at a later time, about its natural history. A two-step data analysis will be performed: Task-1 analysis will define the risk factors landscape, Task-2 analysis will examine the influence of etiology on clinical outcomes. Anonymized data will be stored in a central database, kept at the Leading Centre.

Eligibility Criteria:
Inclusion Criteria:

* voluntary, written, dated and signed informed consent;
* age ≥ 18 years;
* histologically documented diagnosis of cholangiocarcinoma (including histological variants and mixed forms). Neoplasms under investigation do not include gallbladder cancer and ampullary carcinoma.

Exclusion Criteria:

* Dementia or altered mental status leading to inability to understand or render the informed consent.
* Patients who already underwent a systemic treatment (chemotherapy and/or targeted therapy) may be enrolled but will not be subject to data collection about BI-CAUSE - Study Protocol Version 1.0 Oct 18th, 2015 10 blood laboratory tests (with the exception of viral screening) and natural history, and will not be factored in the data analysis of prognostic factors. Performance status, life expectancy, tumour staging, tumour site (distal or hilar extrahepatic, intrahepatic), previous surgical resection, previous biliary stenting, previous radiotherapy are not part of inclusion/exclusion criteria.
Laparoscopic Enucleation of Frantz's Tumor of the Pancreas

The present study describes a 32-year-old female patient, in whom a preoperative imaging diagnosis confirmed a mass in the junction of the body and tail of the pancreas. Based on the anamnesis, on the preoperative diagnosis, and on the general status of the patient, the decision was made to performed laparoscopic enucleation of the pancreatic tumor. The operation and postoperative recovery passed without complications. A minimally invasive surgical approach should be applied whenever the dimensions and the localization of the tumor permits it, bearing in mind all the benefits and advantages that this surgical technique has to offer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with benign tumor of the pancreas
* Patients with a size tumor of less than 3 cm on the pancreas

Exclusion Criteria:

* Patients with a size tumor greater than 3 cm on the pancreas
* Malignant tumors of the pancreas
Early Detection of Lung Cancer

This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

PRIMARY OBJECTIVES:

I. To provide screening for lung cancer in an underserved and high risk population for lung cancer.

II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.

III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.

IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.

V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.

VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).

OUTLINE:

Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years
* \>= 30 pack year of smoking history
* Participant is uninsured

Exclusion Criteria:

* History of diagnosis/treatment of lung cancer in the past 2 years
* History of head/neck or esophageal cancer in the last 1 year
* Inability to provide informed consent
The Effect of Mulligan's Mobilization with Movement Versus Dry Needling on Pain,Function,and Range of Motion Among Athletes with Hip Adductor Related Groin Pain and Dysfunction

This study aims to highlight and investigate the effectiveness of two common management practices in physiotherapy, dry needling intervention as a soft tissue technique and Mulligan mobilization with movements MWM as a joint technique, on pain, function, and range of motion among athletes with hip adductor-related groin pain and dysfunction.

Background:

Injuries are considered a common challenge in the sports field, 31% of the injuries are muscular, especially in the lower extremities. Injuries in the groin area are a major and serious problem because they are common, lead to prolonged symptoms, and had a high recurrence rate.

Study objective:

This study aims to highlight and investigate the effectiveness of two common management practices in physiotherapy, dry needling DN intervention as a soft tissue technique and Mulligan mobilization with movements MWM as a joint technique.

Methods:

A convenience sampling of thirty football players who were diagnosed with hip adductor-related groin pain and dysfunction were recruited from different cities in the west bank who participated in this randomized clinical trial, the participants were randomly divided into two groups, the dry needling group (15), and dry needling combined with Mulligan mobilization MWM (15).

Numiric Pain Rating Scale (NPRS), Five-Second Copenhagen Squeeze test, Hip Abduction Range of Motion, Adductor Squeeze Test, Flexion Abduction External Rotation Test (FABER), Y Balance Test, and The Copenhagen Hip and Groin Outcome Score (HAGOS) were used as outcome measures (NPRS and 5-second squeeze test performed each session for the two groups).

Eligibility Criteria:
Inclusion Criteria:

1. Athletes suffered from unilateral adductor-related groin pain, grades 1 and 2.
2. Acute, subacute, or chronic athletes with hip adductor-related groin pain and dysfunction.
3. Groin pain during or after activities.
4. Pain at palpation of the adductors and their origin.
5. Pain on resistance against adduction.
6. Aged 15- 35 years old.

Exclusion criteria:

Patients with other causes of groin pain such as:

1. Lymphadenitis.
2. Prostatitis, Urinary infections, Malignancy.
3. Spinal pathology.
4. Hip joint osteoarthritis.
5. Inguinal-related or Iliopsoas-related groin pain.
6. Femoral or Inguinal hernia.
7. Referral pain and adductor strain grade 3.
8. Current use of medication.
Measuring Blood Pressure in Pregnancy Using Mercury and Automated Device

The aim of the PRAM study was to determine whether women diagnosed with hypertension in pregnancy, using the traditional mercury device, have the same pregnancy outcomes when blood pressure is measured by either an automated device or a mercury device throughout the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* women with a diagnosis of hypertension in pregnancy

Exclusion Criteria:

* non-pregnant and normotensive pregnancy women
The Impact of Myofascial Therapy on Connective Tissue

The study involved patients who suffered from myofascial pain caused occupational or sports overloads or muscle strains caused by sports or improper preparation for physical activity. The patients had not been previously treated for this reason. The only form of therapy was self-administered over-the-counter painkillers and ointments. Due to lack of relief, patients received one of two types of treatments, myofascial therapy or deep tissue massage. Each group was divided into three subgroups, depending on the location of the symptoms: arm, forearm, calf. The patients received three treatments on alternate days. Ultrasound imaging examination was performed by a physiotherapist, qualified to assess soft tissues using an USG. Two measurements were taken, before and seven days after therapy. To standardise the assessment, ultrasound imaging protocol was used.

The thickness of the fascia was measured by ImageJ software. The aim of the study was an ultrasound imaging assessment of connective tissue of patients undergone myofascial therapy.


Eligibility Criteria:
Inclusion Criteria:

* undergone myofascial therapy
* undergone deep tissue massage
* patients with pain of musculoskeletal origin
* without contraindications to myofascial therapy
* without neurological diseases
* voluntary consent to participate in the study

Exclusion Criteria:

* resignation from the study
* lack of patient consent
* cancers
* disturbed continuity of skin tissue at the examination site
* previous surgical procedures at the study site
* large vascular changes
* inflammatory changes in the examined areas of the body
* sensory disturbances in the examined body areas
* resignation from therapy
* changing the type of therapy
Safety and Efficacy Study of Betamarc to Treat Loss of Weight and Appetite in Non-Small Cell Lung Cancer

The purpose of this study is to determine whether Betamarc is effective in improving the appetite and reversing weight loss in patients with advanced Non-Small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Stage IIIB or IV non-resectable NSCLC. Recurrent disease after resection for earlier stage disease is acceptable as long as patients are at least 6 months from surgery.
* Treatment plan includes a platinum-based doublet chemotherapy.
* ECOG 0, 1 or 2.
* Self-reported loss of body weight or anorexia.
* Serum C-reactive protein ≥5 mg/L.
* Life expectancy of at least 6 months.
* Adequate bone marrow, liver and renal function.
* Normal serum potassium.
* Ability to comply with the study requirements and give written informed consent.

Exclusion Criteria:

* Known physical or functional obstruction of the gastrointestinal tract, malabsorption, intractable vomiting, uncontrollable diarrhea, concurrently receiving tube feeding or parenteral nutrition, or unable to swallow investigational drug product.
* Concomitant therapy with an appetite stimulant.
* History of poorly controlled hypertension or congestive heart failure.
* Any implanted devices that could interfere with DXA scanning.
* Prolongation of QT interval.
* History of additional risk factors for torsades de pointe.
* Concomitant therapy with beta-adrenergic receptor antagonists (beta-blockers) or ergot derivatives.
* Females who are breast feeding, pregnant or of child-bearing potential who are not using adequate birth control.
* Any second malignancy which might confound the interpretation of safety or efficacy assessments.
* Any condition which increases the patient's risk for participating in the study.
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.


Eligibility Criteria:
Outpatients of either sex, aged \>/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted \[ECCS criteria\] and FEV1/FVC \</= 70%)
Baduanjin Exercise on Meridian Energy, Lung Function and Heart Rate Variability in Patients Undergoing Lung Operative.

Lung cancer (LC) is the leading cause of cancer-related death and is the most frequent cancer in both sexes.Respectable lung tumor with abnormal lung function, usually because of tobacco use, have chronic obstructive pulmonary disease (COPD), coronary artery disease, and/or old age as underlying comorbidities. Until recent, most exercise prescribed using aerobic exercise programs. Baduanjin is a type of movement-based mind-body intervention. It is a form of traditional practice designed to promote physical and psychological health, manage symptoms, and relieve stress during illness. The impacts of a Baduanjin exercise-based cardiopulmonary rehabilitation program for patients recovering from respectable lung tumor on Meridian Energy Analysis Device (MEAD100, Med- Pex Enterprises, Taichung, Taiwan), lung function and heart rate variability has yet to be assessed. This trial evaluates whether the Baduanjin exercise would provide effective lung function, meridian energy and HRV in patients following lung operative.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary NSCLC based on preoperative pathologic examination
* Had no surgical contraindication to and were willing to undergo video-assisted thoracic surgery or traditional thoracotomy (open) lobectomy
* Agreed to receive exercise performed.

Exclusion Criteria:

* SpO2 \<90% during the 6-min walking test
* With an absence of NSCLC, as confirmed by postoperative pathologic examination or with sub-lobar resection or pneumonectomy
Lot-to-lot Consistency of Tritanrix™-HepB/Hib-MenAC & Its Non-inferiority vs Tritanrix™-HepB/Hiberix™ in Infants

The primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals' Hib-MenAC (Haemophilus influenzae type b and meningococcal serogroups A and C) vaccine when reconstituted with Tritanrix™-HepB (diphtheria, tetanus, pertussis, and hepatitis B) vaccine and administered as a single injection.

The study is double blind. However the active control vaccine Tritanrix™-HepB/Hiberix™ will be administered in a single-blind manner. Blood samples will be collected for immunogenicity analyses. GSK Biologicals' OPV vaccine will be administered concomitantly with the study vaccines at 2, 4 and 6 months of age according to local country regulation. The study will last approximately 5 months per subject

Eligibility Criteria:
Inclusion criteria:

* healthy male or female, between, and including, 56 and 83 days of age.
* Born after a gestation period between 36 and 42 weeks
* Birth dose of hepatitis B vaccine within the first 72 hours of life

Exclusion criteria:

* planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period.
* Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
* History of OR previous vaccination against OR known exposure since birth to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* A family history of congenital or hereditary immunodeficiency
* History of any neurologic disorders or seizures
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine