cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Efficacy of Internal Family Systems (IFS) Therapy

Study examining the effectiveness of 16 weeks of Internal Family Systems (IFS) therapy for adults with posttraumatic stress disorder (PTSD).

Evaluation study of IFS therapy among trauma-impacted adults in order to explore the applicability of IFS with this population, ensure fidelity of treatment administration, and examine initial efficacy. Evaluate the utility of IFS in reducing symptoms of PTSD, dissociation and depression and increasing self-regulatory capacity, self-awareness and self-compassion. 15 subjects between the ages of 18 and 56 who are receiving 16, 90-minute sessions of IFS therapy by certified IFS practitioners in the community will be recruited for this evaluation study. Blind evaluators will assess treatment effects at pre-treatment, mid-treatment, post-treatment and at one-month follow-up, measuring change in symptoms of PTSD, dissociation and depression, as well as self-regulation, self-compassion, and interoceptive awareness.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between 18 and 58 years old, any race.
* A minimum two traumatic events prior to the age of 18 years.
* Current PTSD diagnosis per CAPS assessment with total symptom scores indicative of a moderate degree of severity (i.e. CAPS total score between 55 and 80).
* Clinically significant depressive symptoms as indicated by a total score of 14 or above on the BDI.

Exclusion Criteria:

* GAF \< 40.
* Diagnosis of schizophrenia, DID, Bipolar Disorder or other psychotic disorder not stated above.
* Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria and judged by the PI.
* Current legal proceedings resulting from the traumatic events.
* Previous treatment in IFS.
Correlation Between Cognitive Functions and MRI in Multiple Sclerosis

The purpose of this study is to determine whether there is a correlation between cognitive functions and volume of specific brain area measured in MRI of multiple sclerosis patients.

Recent literature suggests that multiple sclerosis is accompanied by significant deficits in cognitive performance. The origin of these cognitive deficits is not known, since the severity of cognitive deficits was not found to be correlated with disease parameters such as duration, lesion load or disease intensity as measured on standard scales (e.g. EDSS). The research hypothesis we plan to test is that the individual intensity of cognitive deficits is correlated with degeneration of specific neuronal structures related to cognitive performance, such as the hippocampus and prefrontal cortex.

To test this hypothesis, we plan to perform volumetric measurements of such regions on MRI scans obtained from MS patients during the course of their clinical evaluation, and attempt to correlate those with the results of neuropsychological tests performed by the same subjects around the time of MRI scanning.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis
* Age 18-65

Exclusion Criteria:

* Another brain disease
* Stroke
* Brain trauma
* Neurosurgery
Safety and Efficacy of Vaniprevir (MK7009) Administered With Pegylated-Interferon and Ribavirin (MK-7009-007)

A study to evaluate how effective different levels of Vaniprevir (MK-7009), when administered with Pegylated-Interferon (Peg-IFN) and Ribavirin, are at achieving rapid viral response (RVR) i.e., undetectable hepatitis C virus \[HCV\] viral ribonucleic acid \[RNA\] at Week 4 in participants with chronic HCV infection. The primary hypothesis was that the proportion of participants in one or more of the Vaniprevir treatment groups achieving RVR would be greater than the proportion of placebo participants achieving RVR when Vaniprevir and placebo were co-administered with Peg-IFN/Ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Patient has chronic Genotype 1 Hepatitis C infection

Exclusion Criteria:

* Subject has been previously treated for HCV
* Has Human Immunodeficiency Virus (HIV)
* Has Hepatitis B
* Has a history of clinically significant medical condition that may interfere with the study (e.g., stroke or chronic seizures or major neurological disorder) or is contraindicated for treatment with peg-IFN and Ribavirin
Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

The primary objective of this study is to evaluate the clinical effect of TV-1106.


Eligibility Criteria:
Inclusion Criteria:

* Patient agrees to provide written informed consent and to comply with the study protocol after reading the informed consent and discussing the study with the investigator.
* Males and females between 23 and 65 years of age must have a confirmed diagnosis of adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary disease or due to genetic causes.
* Diagnosis of GH deficiency must be confirmed by documented (medical records) diagnostic testing.
* Patients should have been treated with a stable dose of daily rhGH for at least 3 months prior to screening.
* Other criteria apply.

Exclusion Criteria:

* Patients with history or clinical evidence of active or chronic diseases that could confound results of the study or put the subject at undue risk as determined by the investigator.
* Patients with known active malignancy
* Patients with history of malignancy other than intracranial tumor causing GHD (excluding surgically cured basal cell or squamous cell cancer of the skin with documented 6 month remission)
* Patients with evidence of pituitary adenoma or other intracranial tumor within 12 months of enrollment, which is on day 0 (baseline, Visit 3)
* Patients without magnetic resonance imaging (MRI) or computerized tomography (CT) data to document tumor stability within the 12 months prior to enrollment, which is on day 0 (baseline, Visit 3)
* Presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past 1 year.
* Other criteria apply.
Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Forehead Lines (Frontalis)

This is a phase 2a, multicenter, open-label, dose-escalation study to evaluate treatment of moderate or severe dynamic forehead lines (FHL) (frontalis) in conjunction with treatment of the glabellar complex.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent consistent with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local laws, including authorization to release health information, signed prior to any study procedures being performed
* Be outpatient, male or female subjects, in good general health, 18-65 years of age
* Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Investigator Global Assessment Forehead Wrinkle Severity (IGA-FHWS)
* Have a score of moderate (2) or severe (3) FHL during maximum contraction (eyebrow elevation) as assessed by the Patient Forehead Wrinkle Severity (PFHWS)
* Have a score of moderate (2) or severe (3) GL during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
* Have a score of moderate (2) or severe (3) on GL during maximum frown as assessed by the Patient Frown Wrinkle Severity (PFWS)
* Be willing to refrain from receiving facial fillers, laser treatments, use of any product that affects skin remodeling, or a product that may cause an active dermal response in the treatment areas (e.g., above the inferior orbital rim) from screening through the end of the study
* Able to understand the requirements of the study and be willing and able to follow all study procedures, attend all scheduled visits, and successfully complete the study.

Exclusion Criteria:

* Active skin disease, infections, or inflammation at the injection sites
* Plans to receive botulinum toxin type A anywhere in the face (other than study treatment) from screening through the end of the study
* History of clinically significant bleeding disorders
* Non-ablative laser or light treatments, microdermabrasion, or chemical peels (medium depth or deeper, for example trichloroacetic acid (TCA) or phenol) in the treatment areas within 3 months before enrollment through the end of the study
* Clinically significant laboratory values at screening that may interfere with a subject's ability to complete the study as determined by the investigator
* History of upper or lower lid blepharoplasty or brow lift
* Prior periorbital or forehead surgery
Long Term Significance (Survival) of LCI in Patients With Cystic Fibrosis

The current dream in CF research is to discover safe drugs that correct the basic defect and prevent lung disease, allowing patients without significant lung damage to live nearly normal lives with a dramatic increase in life expectancy and without the burden of current treatment. The compound VX-770 (Ivacaftor Ò) is hoped to be the first milestone along this way. Progression of lung disease is now so gradual in many centres that sensitive indicators of early lung disease (small airways disease) are critically needed to assess the effects of such new treatments. In this context, assessment of ventilation inhomogeneity by the measurement called Lung clearance index (LCI) seems to be the most promising tool. However, to get approval by health authorities, new measures used in drug evaluation need to fulfill strict criteria. For LCI, the investigators still need to prove its long term significance: How well does the LCI measurement predict the long term lung disease course? Therefore, in this study the investigators want to measure LCI at baseline in a large patient cohort and establish how well it predicts the patients' disease course over the next 2 years.

Patients with CF ( 6 years and older and FEV1 above 40% predicted) will be invited to participate in this prospective non interventional study in 2 CF centers ( UCL and UZ Leuven). Jointly we take care of more than 40 % of the Belgian CF population. Median FEV1 of children (6 - \<18 y, n \>120) from these CTN centers is high ( around 100% pred), defining a study group of great interest in the current context.

To assess the predictive value of LCI over 2 years, the time to next pulmonary exacerbation will be evaluated in the entire cohort. To assess the predictive value of LCI over 2 years, the time to next pulmonary exacerbation will be evaluated in the entire cohort.

Repeat LCI measurements will be done at subsequent patient visits.

2 devices measuring the LCI will be tested and compared : Ecomedics and NDD.

LCI and spirometry will be measured in 120 healthy Belgian children and young adults. These subjects must be free of respiratory symptoms for at least two weeks and will not have any chronic or recurrent chest problem.

Eligibility Criteria:
Inclusion Criteria:

* FEV1(% predicted) \> 40%

Exclusion Criteria:

* FEV1(% predicted) \< 40%
* Exacerbation during baseline measurement
A Phase II Study of SHR2554 in Patients With Relapsed or Refractory Follicular Lymphoma

The study is being conducted to evaluate the efficacy and safety of SHR2554 in Patients with Relapsed or Refractory Follicular Lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. Males or females aged ≥18 years
2. Histologically confirmed follicular lymphoma
3. Eastern Cooperative Oncology Group performance status (ECOG PS) score ≤2
4. Life expectancy ≥ 12 weeks
5. Treated with CD20 antibody, refractory to or relapse from prior anti-cancer therapies
6. Have measurable lesions
7. The subject is willing and able to comply with the visit schedule, dosing schedule, laboratory tests, and other clinical study procedures

Exclusion Criteria:

1. Have been treated with a compound of the same machanism;
2. Accompanied by central nervous system infiltration;
3. Received autologous stem cell transplantation within 60 days before signing the agreement, and received allogeneic stem cell transplantation or CAR-T therapy within 90 days;
4. Underwent major surgery or experienced severe trauma within 4 weeks prior to the first dose of the investigational drug
5. Known active infection
6. History of clinically severe cardiovascular diseases
7. Have other malignancies within 5 years prior to screening Pregnant or lactating women
8. The subject is unable to swallow, or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticulosis, or a history of gastrectomy or gastric banding that affects drug absorption.
9. The subject is taking a known medium or strong CYP inducer.
10. Based on the investigator's judgment, there are objective conditions that may prevent the subject from completing the study as planned or the subject has other factors, concomitant diseases, concomitant treatments, or abnormal laboratory findings that may lead to early study termination
Visually Enhanced Education About Prostate Cancer

This randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.

PRIMARY OBJECTIVES:

I. Our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. Of note, the attending radiation oncologist will be responsible for reviewing the Powerpoint presentation with the patient, taking time to answer any questions that the patient has

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM A (STANDARD EDUCATION): Patients receive a standard prostate cancer radiation oncology consultation.

ARM B (VISUAL ENHANCED EDUCATION): Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have non-metastatic, biopsy proven prostate cancer
* Must be referred to radiation oncology clinic

Exclusion Criteria:

* Prior surgery or radiation therapy for prostate cancer
* Patients who are blind are excluded
Telomeres Evaluation in Endometriosis

The purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women.

Our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis.

The purpose of the study is to assess the telomere array of different endometriosis tissue and endometrium from women with endometriosis compared to healthy women. Our hypothesis is that telomere shortening and high telomerase activity will be found in tissues from women with endometriosis, compared to women without endometriosis.

A prospective study that compares telomeres and telomerase levels in different lesions of endometriosis and endometrial tissue of women with endometriosis and healthy women without endometriosis. The study group will consist of women with suspected endometriosis facing surgical treatment and the control group will consist of healthy women facing gynecologic surgery for different indication.

We will sample endometrial tissue in both groups. In the study group we additionally will sample endometriosis lesion.

The samples collected will test for histological diagnosis of endometriosis and verification tests will be done to characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy.

expect telomere shortening and high telomerase activity in endometrial tissue and in endometriosis tissue sample, that won't characterize samples from women without endometriosis.

Eligibility Criteria:
Inclusion Criteria:

* women with suspected endometriosis facing surgical treatment

Exclusion Criteria:

* no endometriosis on histology
* malignant finding on histology
Comparison of Efficacy of Oral Fluconazole Versus Oral Itraconazole in the Treatment of Pityriasis Versicolor

This study compares the efficacy of two drugs, namely flucanazole and itraconazole for the treatment of a common fungal infection of skin.

Pityriasis versicolor is a common fungal infection of the superficial skin layers. Avalible treatment options include topical and systemic drugs. fluconazole and itraconazole are commonly used systemic agents. The aim of this study is to compare the efficacy of the two systemic drugs.

Eligibility Criteria:
Inclusion Criteria:

* All cases of Pityriasis versicolor

Exclusion Criteria:

* Patients with history of chronic renal or liver disease, malignancy , or undergoing any kind of chemotherapy or radiotherapy or having cardiac conduction abnormalities.
* Patients who received any anti-fungal therapy in the last one month.
* Pregnant or lactating women.
Combination Chemotherapy, Radiation Therapy and Surgery for Esophageal Cancer

The purpose of this study is to find out what effects (good and bad) the combination of three chemotherapy drugs (cetuximab, cisplatin, and irinotecan) have on esophageal cancer when given with radiation therapy.

* Patients participating in this study must have a tumor biopsy taken to confirm the type of tumor.
* Outpatient therapy with cetuximab alone will be given intravenously on week 0.
* During week 1-8 outpatient radiation therapy will be started and continued once per day for 28 treatments or 5 1/2 weeks.
* Outpatient chemotherapy (cisplatin, irinotecan and cetuximab) is given once per week on weeks 1, 2, 4, and 5. Cetuximab alone will be given on weeks 3, 6, 7, and 8.
* A repeat CT scan and PET scan will be performed to restage the tumor on week 8. This is to confirm that the cancer has remained localized.
* Inpatient surgery is scheduled 4 to 8 weeks after completion of chemotherapy and radiation therapy.
* Cetuximab will be restarted within 4 weeks after surgery and continue weekly for 6 months.
* During chemotherapy and radiation therapy, physical exams and vital signs will be performed before each chemotherapy treatment. Routine blood tests will also be performed.
* Between chemotherapy-radiation therapy and surgery a CAT scan of chest, abdomen and pelvis along with a PET scan will be performed.
* After surgery a CAT scan of chest, abdomen and pelvis will be performed every 3 months for 2 years then every 6 months for 3 years. An EGD (upper endoscopy) with biopsy will be done every 6 months for 2 years and then yearly for 3 years. Physical exam, vital signs and routine blood tests will be done every 2 weeks for 6 months, then every 3 months for 1.5 years, and then every 6 months for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Negative pregnancy test
* Adenocarcinoma or squamous cell carcinoma of the esophagus, including the gastroesophageal junction, histologically confirmed, stage IIA, IIB and III.
* ECOG performance status of 0 or 1.
* Neutrophils greater or equal to 1,500/ul
* Platelets greater or equal to 100,000/ul
* Serum bilirubin less or equal to 1.5mg/ul
* Serum creatinine less or equal to 1.5mg/ul
* AST or SGOT less or equal to 2.5x upper normal limit
* Alkaline phosphatase less or equal to 5x upper normal limit

Exclusion Criteria:

* Prior surgery for esophageal or gastro-esophageal junction cancer.
* Prior chemotherapy or radiation therapy
* Biopsy proven tumor invasion of the tracheobronchial tree or tracheo-esophageal fistula.
* Metastatic disease to distant organs or non-regional lymph nodes.
* Co-morbid disease that in the opinion of the investigator makes combined chemo-radiotherapy inadvisable.
* Pregnant or lactating women
* Other active malignancy
* Patients with known Gilbert's Disease or interstitial pulmonary fibrosis.
* History of seizure disorder
* Uncontrolled diarrhea
* Peripheral neuropathy (Grade 2)
* Prior cetuximab or other therapy that specifically and directly targets the EGF pathway.
A NIS Registry of the Prospective Structured Care In Acute Coronary Syndrome

The purpose of the study is to analyse patient's acceptance and willingness to participate in a Structured Care Program (SCP) over 12 months following hospital discharge after Acute Coronary Syndrome (ACS) index event.

ProAcor: Prospective Structured Care In Acute Coronary Syndrome Registry

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized because of ACS (ST segment elevation myocardial infarction (STEMI)), non-ST elevation myocardial infarction (NSTEMI) Unstable Angina (UA)) and planned to be discharged alive soon.

Exclusion Criteria:

* Myocardial infarction (UA, STEMI and NSTEMI) precipitated by or as a complication of surgery, trauma, or Gastrointestinal Bleeding or post- percutaneous coronary intervention (PCI).
* Myocardial infarction (UA, STEMI and NSTEMI) occurring in patients already hospitalized for other reasons.
* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language, known diagnosed psychiatric illness
Short Duration Treatment of Non-severe Community Acquired Pneumonia

To investigate the non inferiority of a short lasting antibiotic treatment (3 days) when compared to a long lasting antibiotic treatment (8 days), at Day 15 after the beginning of treatment in terms of clinical efficacy, in adults admitted to emergency services for a non severe Community Acquired Pneumonia (PAC), who responded well to 3 days of beta-lactamin treatment (3GC or A/AC).


Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years old or over.
* admitted three days before for Community Acquired Pneumonia (CAP) defined by at least one clinical sign of pneumonia (dyspnea, cough, mucopurulent sputum, crackling sound on lungs) associated with a temperature \>38°C on admission, and a new infiltrate consistent with pneumonia on chest x-ray, who responded favorably to 3 days of treatment with β-lactams (third generation injectable cephalosporin or amoxicillin-clavulanate)
* able to take oral medication.
* has given its informed consent.

Exclusion Criteria:

* Creatinin \< 30ml/min
* History of jaundice / hepatic impairment associated with amoxicillin / clavulanic acid
* History of hypersensitivity to beta-lactam
* Presence of complications or severity of pneumonia (abscess , significant pleural effusion, severe chronic respiratory failure , septic shock, respiratory condition requiring the passage resuscitation).
* Known immunocompromised terrain ( asplenia , neutropenia, agammaglobulinemia , immunosuppressants, graft corticosteroids , myeloma , lymphoma, known HIV , sickle cell anemia , CHILD C cirrhosis).
* Antibiotic treatment exceeding 24 hours prior admission.
* Suspected atypical bacteria requiring combined antibiotics therapy .(Subjects who received a single dose of macrolides or fluoroquinolones emergency will not be excluded) .
* Legionella suspected on clinical, biological and radiological criteria .
* Subjects with clinical or epidemiological environment leading to suspect a healthcare-associated pneumonia with antibiotic resistant pathogen.
* Suspicion of pneumonia by aspiration.
* Intercurrent infection requiring antibiotic treatment.
* Pregnant women .
* Breastfeeding .
* Allergy to antibiotics in use.
* Life expectancy \<1 month .
* Subject without health insurance.
* Subjects without home adress