cyrilzakka/clinical-trials huggingface dataset:
Culturally Based Family Therapy for Improving Treatment Outcome for People With Schizophrenia

This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

Schizophrenia is a disabling mental disorder that affects approximately 1% of the population worldwide. People with schizophrenia frequently experience hallucinations, delusions, disordered thinking, movement disorders, emotional numbness, social withdrawal, and cognitive deficits. These symptoms can hinder a person's ability to perform everyday functions, such as hold a job and maintain normal social relationships. When combined with medication, family-oriented therapy interventions have been beneficial for people with schizophrenia. There are few programs, however, that are tailored to the needs of minorities. With the rising number of minority populations in the U.S., it is important to develop psychotherapy interventions that are designed specifically for these groups. This study will evaluate the effectiveness of a culturally based family therapy intervention in improving treatment outcome in people with schizophrenia.

Participants in this 12-month, open label study will first attend a 2-hour screening visit, at which information will be gathered regarding coping styles, spirituality, and expressed emotion. Participants will then be randomly assigned to receive either culturally based therapy or treatment as usual. Although the culturally based therapy will be tailored to the needs and values of Hispanics, people who are not Hispanic will not be excluded. The culturally based therapy will entail 15 weekly therapy sessions, which will focus on family unity, psychoeducation, spirituality, communication skills, and problem-solving. The group receiving treatment as usual will attend 3 weekly psychoeducation sessions that will focus on informing participants about schizophrenia. Outcomes for both groups will be assessed upon completion of treatment and at follow-up visits at Months 6 and 12.

Eligibility Criteria:
Inclusion Criteria:

For participants with schizophrenia or schizoaffective disorder:

* Diagnosis of schizophrenia or schizoaffective disorder
* Currently taking medication
* 18 or older

For all participants:

* Two or more family members, including patient, are available for participation (therapy can be conducted if patient is not available, as long as two other family members are interested in participating)
* Family members must be at least 13 years old

Exclusion Criteria:

* N/A
Moxifloxacin in Situ Gel to Treat Periodontal Pocket.

In this Randomized clinical trial locally delivered moxifloxacin in situ gel was evaluated as an adjunct to scaling and root planing for efficacy in the treatment of chronic periodontitis and for short-term effects on the periodontal microflora.

Moxifloxacin exerts excellent antibacterial activity against a wide range of putative periodontal pathogens, including Porphyromonas gingivalis, Tannerella forsythia, Prevotella species, Fusobacterium nucleatum, Actinomyces species, Peptostreptococcus species, Campylobacter rectus, and Actinobacillus actinomycetemcomitans. Moxifloxacin penetrates well into soft tissues and is effective against intracellular periodontal pathogens when used in the treatment of periodontitis as an adjunct to scaling and root planning (SRP). Systemic administration of moxifloxacin has provided superior outcomes compared with SRP in conjunction with systemic administration of doxycycline, or SRP alone. We hypothesized similar benefits with local drug delivery of Moxifloxacin in the treatment of chronic periodontitis. To the best of our knowledge, there is no published literature on in situ gel using moxifloxacin employing gellan gum as the vehicle, for direct placement in the periodontal pocket for the treatment of chronic periodontitis.

Among various drug delivery systems for treating periodontitis, gel formulations have some advantages. Despite a relatively faster release of the drug, gels can be more easily prepared and administered. Moreover, they possess a higher bio compatibility and bio adhesivity, by allowing adhesion to the mucosa in the dental pocket and by decreasing the risk of dilution of the material by saliva.

Keeping the above facts in mind, the goals of this study were to (1) evaluate in situ gel as a vehicle in a local drug delivery system, (2) evaluate the efficacy of moxifloxacin for local drug delivery, (3) evaluate the efficacy of gellan gum for in situ gelation of moxifloxacin, and (4) evaluate and compare the clinical and microbiological parameters of moxifloxacin with those of the gold standard, chlorhexidine di gluconate.

Eligibility Criteria:
Inclusion Criteria:

* patients with good systemic health
* Patients with Chronic periodontitis with sites with probing pocket depth (PPD) of ≥ 5 mm
* a minimum of 12 natural teeth with radiographic evidence of bone loss
* willingness to comply with the study protocol.

Exclusion Criteria:

* Patients with a history of drug allergy to quinolones or those who were taking medication that might interact with moxifloxacin
* Patients with history of antibiotic coverage in the 6 months preceding the study
* Pregnant or lactating patients.
Evaluation of Standard of Care Practices, Procedural Outcomes and In-hospital Complications of Peripheral Endovascular Procedures

Significant advances in dedicated materials and techniques along with increased operator experience led to a significant increment in procedural success rate of peripheral endovascular interventions, exceeding 90% in expert hands with reported low procedural complication rates. However, there are still lack of data on procedural outcomes, in-hospital complications, and resource utilization on treatment of (complex) lesions in the femoral, popliteal and infrapopliteal artery in the real-world condition in Europe.

The study will enroll consecutive eligible subjects who have peripheral artery disease (PAD) requiring endovascular treatment of de-novo and restenotic atherosclerotic lesions in femoral, popliteal and infrapopliteal arteries.

The purpose of this prospective, multicenter, observational European Study is to evaluate the standard of care practices, procedural outcomes, and in-hospital complications of endovascular peripheral interventions for treatment of lesions in the femoral, popliteal and infrapopliteal arteries.

Eligibility Criteria:
Inclusion Criteria:

1. Subject ≥18 years old
2. Subject has provided written informed consent
3. Subject has Rutherford classification 2 to 6
4. Reference vessel diameter ≥2 and ≤7 mm
5. Target lesion(s) has stenosis \>70% by visual assessment
6. Multiple consecutive single lesions with a healthy segment(s) of ≤ 3cm in-between the lesions will be considered one lesion.

   For Above the knee (ATK) group
7. Target lesions located in the superficial femoral artery or popliteal arteries (above the tibial plateau)
8. At least 1 below-knee artery patent to the ankle
9. Successful treatment of inflow iliac stenosis to the target lesion. Inflow lesion stenosis can be treated during the same procedure as per local standard of care.

   For Below the knee (BTK) group:
10. Target lesions involve arteries below the tibial plateau
11. Successful treatment of inflow vessel (from ipsilateral iliac to the target lesion) resulting in ≤30% residual stenosis with no evidence of embolization or significant complications.

Exclusion Criteria:

1. Subject has a single target lesion that involves both ATK and BTK segment.
2. Subject not suitable for receiving endovascular procedures of lower limb arteries
3. Prior planned major amputation in the target limb (above the ankle)
4. Subject with previous bypass surgery of target vessel.
5. History of any open surgical procedure within the past 30 days.
6. Planned vascular surgery procedure within the next 30 days after the ATK and/or BTK procedure on the target limb. Note: The inflow vessels can be treated on the day of the procedure
7. Subject under dialysis
8. Subject currently enrolled in another investigational device, biologic, or drug trial in which the primary endpoint has not yet been reached
9. Subject lacking capacity to provide informed consent
10. Subject under judicial protection, tutorship, or curatorship (for France only)
A Study to Examine the Long Term Effect of Pramlintide on Body Weight and Its Safety and Tolerability in Obese Subjects

This is a long term extension to study 137OB-201 which is designed to examine the effect of pramlintide on body weight and its safety and tolerability in obese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed Protocol 137OB-201.
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace

The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing atrioventricular (AV) node ablation and permanent pacing therapy.

This study is a multi-center, prospective, randomized, blinded trial. The study will consist of approximately 265 patients who require treatment of persistent or permanent, symptomatic atrial fibrillation by atrioventricular (AV) node ablation and permanent pacing therapy i.e. "Ablate and Pace" therapy. All patients enrolled into the clinical study will be randomly assigned to one of three groups using a randomization ratio of 2:2:1. Patients will be assigned to receive either biventricular (biV) pacing with CLS-based rate adaptive pacing using the legally marketed Protos DR/CLS (Group 1), or biventricular pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 2), or right ventricular (RV) pacing with accelerometer-based rate adaptive pacing using the Stratos LV (Group 3). Patients in all three groups will be implanted with legally marketed right and left ventricular pacing leads. The patients, the core lab used to interpret the echocardiographic data and the Clinical Events Committee adjudicating crossover, patient death and congestive heart failure (CHF) hospitalizations will be blinded to the randomization assignment.

Eligibility Criteria:
Inclusion Criteria:

* Meet the indications for therapy
* Persistent, symptomatic AF with poorly controlled rapid ventricular rates or permanent, symptomatic AF with poorly controlled rapid ventricular rates.
* Eligible for AV nodal ablation and permanent pacemaker implantation
* NYHA Class II or III heart failure
* Age ≥ 18 years
* Understand the nature of the procedure
* Ability to tolerate the surgical procedure required for implantation
* Give informed consent
* Able to complete all testing required by the clinical protocol
* Available for follow-up visits on a regular basis at the investigational site

Exclusion Criteria:

* Meet one or more of the contraindications
* Have a life expectancy of less than six months
* Expected to receive heart transplantation within six months
* Enrolled in another cardiovascular or pharmacological clinical investigation
* Patients with an ICD, or being considered for an ICD
* Patients with previously implanted biventricular pacing systems
* Patients with previously implanted single or dual chamber pacing system with \> 50% documented ventricular pacing
* Patients with previous AV node ablation
* Six-minute walk test distance greater than 450 meters
* Any condition preventing the patient from being able to perform required testing
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Conditions that prohibit placement of any of the lead systems
Fexofenadine Versus Gabapentin for Uremic Pruritus in Patients on Regular Hemodialysis

Several studies investigated the effectiveness of Gabapentin in Uremic Pruritus (UP). No previous studies investigated the use of fexofenadine in UP. The aim of this trial is to assess the safety and possible efficacy of fexofenadine in patients with UP.

A randomized controlled single center parallel study, that will recruit 60 participants with end stage renal disease (ESRD) on regular hemodialysis (RHD) with uremic pruritus (UP). Patients will be randomized to either Fexofenadine (60 mg orally once daily), or Gabapentin (100 mg orally after each dialysis session, "thrice weekly", with titration according to response to 100 mg orally once daily). Participants will continue treatment for 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* ESRD on regular hemodialysis.
* Moderate and severe Uremic Pruritus as assessed by Visual Analogue Scale.
* Able to provide an informed consent.

Exclusion Criteria:

* Age \&lt; 18 years old.
* Patients not on regular hemodialysis.
* Pruritus due to other cause.
* Cancer patients.
* Pregnancy or breastfeeding.
* Patients with history of substance abuse.
* Patients with myasthenia gravis.
* Patients who refuse or are unable to provide an informed consent.
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Therapy for Patients With Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD), an X-linked recessive genetic disease always progressed slowly，tends to leading proximal skeletal muscle atrophy and weakness of limbs, as well as impaired respiratory muscle and cardiac muscle. To a large extent, patients always lose motor function gradually and die for heart failure or severe infection at the end stage of DMD. At present, the treatment strategy relies on heteropathy accompanied with rehabilitation training. However, the therapeutic effect remains extremely limited.

Human umbilical cord mesenchymal stem cells (hUC-MSCs) have been evidenced to improve motor function, increase muscle strength and reduce abnormal levels of related enzymes, such as creatine kinase (CK), lactate dehydrogenase (LDH), alanine aminotransferase (ALT) and aspartate aminotransferase (AST). This study is aimed to explore the safety and efficacy of hUC-MSCs transplantation for DMD.

This study is designed to investigate the safety and efficacy of human umbilical cord mesenchymal stem cells transplantation in patients with progressive muscular dystrophy.

Eligibility Criteria:
Inclusion Criteria:

* Aged 5-12 years
* Clinical manifestation, enzymology, electromyogram, gene type confirmed the diagnose of Duchenne muscular dystrophy
* Sign the consent form and follow the clinic trail procedure

Exclusion Criteria:

* Not Duchenne muscular dystrophy
* Any history of hypersensitivity to serum products,or other know drug and food allergy
* Combined Pneumonia or other Severe systemic bacteria infection
* HIV+, TPPA +， patients diagnosed as HBV or HCV
* Tumor Markers +
* Severe psychotic patients, cognitive dysfunction
* Coagulation disorders
* Uncontrolled hypertension after treatment，blood pressure≥180mmHg/110 mmHg
* Other severe systemic or organic disease
* Enrollment in other trials in the last 3 months
* Received any stem cell therapy in past 6 months
* Other criteria that investigator consider improper for inclusion
A Study of Poziotinib in Previously Treated Participants With Locally Advanced or Metastatic NSCLC Harboring HER2 Exon 20 Mutations

The primary purpose of this study is to compare the progression-free survival (PFS) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring human epidermal growth factor receptor 2 (HER2) exon 20 mutations when treated with poziotinib versus docetaxel.

This is a Phase 3, active-controlled, multicenter study to compare the efficacy and safety/tolerability of poziotinib versus docetaxel in previously treated participants with locally advanced or metastatic NSCLC harboring HER2 exon 20 mutations.

Participants will be randomized in a 2:1 ratio to:

* Arm A: Poziotinib 8 milligrams (mg), twice daily (BID) or
* Arm B: Docetaxel 75 milligrams per meter square (mg/m\^2)

The Screening Period lasts up to 21 days prior to Cycle 1, Day 1 (C1D1). Participants will be treated in 21-day cycles or until disease progression, death, intolerable adverse events (AEs), initiation of non-protocol anti-cancer treatment, or other protocol-specified reasons.

Eligibility Criteria:
Inclusion Criteria:

Participant must:

1. Be willing and capable of providing signed and dated Informed Consent, adhering to dosing and visit schedules, and meeting the study requirements
2. Have histologically or cytologically confirmed NSCLC
3. Have at least one measurable NSCLC target lesion per RECIST v.1.1 by local assessment
4. Participant has had at least one prior systemic treatment for locally advanced or metastatic NSCLC, including platinum and a checkpoint inhibitor (CPI) therapy, unless the investigator affirms that a CPI was not medically indicated.
5. Have documentation of HER2 exon 20 mutation
6. Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
7. Have adequate hematologic, hepatic, and renal function at Baseline as per protocol

Exclusion Criteria:

Participant:

1. Has had previous treatment with poziotinib for treatment of NSCLC
2. Has EGFR or anaplastic lymphoma kinase (ALK) genome tumor alterations
3. Has had previous treatment with docetaxel for locally advanced or metastatic NSCLC. If docetaxel was received in the neo-adjuvant or adjuvant setting, progressive disease must have occurred ≥6 months after the last dose to be eligible
4. Has spinal cord compression or leptomeningeal disease
5. Has a high risk of cardiac disease, as determined by the Investigator
6. Has a history of, or signs of Grade ≥2 pneumonitis on current imaging studies
7. Is unable to take drugs orally
8. Is pregnant or breast-feeding
Postoperative Environment on Pain Following Pelvic Reconstructive Surgery

This study is to determine if patients following prolapse repair including vaginal vault suspension have decreased pain measured via a visual analog scale (VAS) on postoperative day one and just prior to discharge when exposed to the diad of music and positive images compared to patients receiving standard care.

Over the past decade, interest has grown in improving the patient experience. As part of this movement, studies have sought to evaluate the mechanisms by which the postoperative environment affects a patient's outcome and perception of healing.

Literature review reveals efforts by both medical and design teams towards improving the experience of the patient and developing an environment that promotes healing. Changes to the physical environment have been shown to have an impact on satisfaction. These parameters have included music and art. Considering the effort that is now going into improving the patient experience and developing this theory of healing spaces, there has yet to be a randomized controlled trial evaluating these alternative therapies in the urogynecologic patient population. Although each of these modalities appears beneficial, we believe that a combination of these would be even more useful. Indeed, these treatments are also relatively easy to implement without undue cost or burden to the hospital. This study seeks to determine the influence of applying music and art to the post operative environment for patients recovering from major urogynecologic surgery on pain.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-85 years of age
* English speaking
* Undergoing surgery for pelvic organ prolapse to include an apical vaginal vault suspension by a physician at Cincinnati Urogynecology Associates, TriHealth
* Concomitant procedures such as hysterectomy, suburethral sling, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy will be included
* Ability to complete the questionnaires and provide consent
* Willingness to listen to music at the minimum recommended time intervals

Exclusion Criteria:

* Unwillingness to participate in the study
* Physical or mental impairment that would affect the subject's ability to utilize the modified environment such as deafness, blindness or dementia
* Patients who take daily narcotics or NSAIDS
* Patients with history of Drug or Alcohol Abuse
* Patients with chronic pain syndromes
* Non English speaking
* Patients that do not undergo a vaginal apical suspension procedure
High Fructose Corn Syrup

The purpose of this research study is to learn more about how high fructose corn syrup, a sugar used to sweeten drinks and foods, affects metabolism in obese persons with and without nonalcoholic fatty liver disease. Eligible participants will be studied before and after eating a diet high in high fructose corn syrup or a standard diet (low in high fructose corn syrup) for four weeks.


Eligibility Criteria:
Inclusion Criteria:

* IHTG \>6.5% or \<5%
* BMI 30.0-45.0 kg/m²
* Sedentary
* Consume \<10% calories from high fructose corn syrup
* Weight stable for previous 3 months

Exclusion Criteria:

* IHTG 5.1-7.9%
* Children
* Adults over 65 years
* Pregnant
* Lactating
* Exercise \>1.5 hours/week
* Hepatitis B or C
* Diabetes
* History of liver disease
* History of alcohol abuse
* Severe hypertriglyceridemia (\>300 mg/dl)
* Smokers
* Anemia (Hemoglobin \<10mg/dl)
* Not weight stable
RNA Sequencing of Solid and Cystic Lesions of the Pancreas

The nature of cysts and solid masses in the pancreas can be difficult to diagnose. They may be benign, precancerous, or cancer. Current tests such as cytology (looking under a microscope) and tumor markers do not always give us the answer. The investigators are looking for genetic markers on biopsy specimens from the pancreas that will give us a better test for diagnosis. This study is only for diagnosing these lesions. The investigators are not treating any patients.


Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years old,
* not pregnant,
* referred for endoscopic ultrasound,
* have a cyst or mass of the pancreas needing diagnosis.

Exclusion Criteria:

* pregnant,
* less than age 18,
* no mass or cyst found.