cyrilzakka/clinical-trials huggingface dataset:
MT10109L in the Treatment of Lateral Canthal Lines

To evaluate the safety and efficacy of MT10109L in the treatment of lateral canthal lines (LCL) in participants with moderate to severe LCL.


Eligibility Criteria:
Inclusion Criteria

• Female participants must not be pregnant or planning to get pregnant and willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period.

Exclusion Criteria

* Known immunization or hypersensitivity to any botulinum toxin serotype.
* Any medical condition that may put the participant at increased risk with exposure to MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function.
* History of facial nerve palsy.
* Any uncontrolled systemic disease.
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study intervention).
* Anticipated need for surgery or overnight hospitalization during the study.
* Prior exposure to botulinum toxin of any serotype for any reason.
* Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow lift, or related procedures (eg, eyelid \[blepharoplasty\] and/or eyebrow surgery).
* Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg, Gore-Tex®), and/or autologous fat transplantation.
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.
* Females who are pregnant, nursing, or planning a pregnancy during the study.
* Participants who plan for an extended absence away from the immediate area of the study site that would preclude them from returning for all protocol-specified study visits.
Puerto Rico COVID-19 Vaccine Uptake Study

The purpose of this study is to recruit a total of 386 participants to evaluate the effectiveness of an educational program to increase the proportion of men and women aged 21 years and older who have received the COVID-19 booster vaccine

This study will address vaccine hesitancy, evaluating the intervention's efficacy in a group of vulnerable and economically disadvantaged population in PR. Randomized Clinical Trial (study design) to evaluate the effectiveness of an educational intervention to increase vaccine uptake among socioeconomically disadvantaged adults. A total sample of 386 participants will be recruited. The duration of the study will consist of 1.5 hours for intervention group and 1 hour for control group.

Eligibility criteria for the study include the following: (1) age 21 years and older, (2) resident of Puerto Rico, (3) to be fully vaccinated (received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine), have not received booster doses against COVID-19, (4) no history of allergic reactions to any vaccine, (5) no history of mental health conditions that impede participation in the study, and (6) able to read, write, and understand Spanish.

Eligibility Criteria:
Inclusion Criteria:

1. age 21 years and older
2. resident of Puerto Rico
3. to be fully vaccinated (received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- received both doses of the two-dose Pfizer or Moderna vaccine)
4. have not received booster doses against COVID-19
5. no history of allergic reactions to any vaccine,
6. no history of mental health conditions that impede participation in the study
7. able to read, write, and understand Spanish.

Exclusion Criteria:

1. age 20 years and younger
2. not a resident of Puerto Rico
3. not to be fully vaccinated (have not received the one-dose Jansen/Johnson \& Johnson vaccine, -OR- have not received both doses of the two-dose Pfizer or Moderna vaccine)
4. have received booster doses against COVID-19
5. history of allergic reactions to any vaccine,
6. history of mental health conditions that impede participation in the study
7. not be able to read, write, and understand Spanish.
Use of Cryoenergy to Faciltate Myectomy in Hypertrophic Obstructive Cardiomyopathy: Comparison With the Classical Approach

In some patients, septal hypertrophy extends more distally, from the subaortic portion of the septum to the midventricular portion. In these patients, classic transaortic surgical myectomy may not be effective in removing the midventricular obstruction, resulting in a suboptimal surgical outcome. These patients may present recurrence of symptoms and not have an improvement in the prognosis related to the treatment of hypertrophic cardiomyopathy, in some cases determining the need for reoperation. Since 2015, our Institute has used a surgical technique that allows us to improve transaortic exposure of the interventricular septum, using a probe with application of cryoenergy the hypertrophic portion of the septum is hooked and in this way the myectomy can be extended more distally, performing a more complete removal of the myocardium.

The aim of this study is to compare the results obtained with classical myectomy compared to myectomy performed with the aid of cryoenergy.

The primary endpoint is the comparison in terms of mortality between patients undergoing classical myectomy versus those undergoing cryoenergy-assisted myectomy.

Secondary endpoints are: extent of myectomy, persistence of residual left ventricular outflow tract obstruction, persistence of mitral regurgitation related to systolic anterior motion of the mitral leaflets, occurrence of ventricular defect, and need for PM implantation.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (≥ 18 years)
* meeting the clinical and echocardiographic criteria that made them candidates for isolated myectomy or in combination with other surgical procedures:
* LV outflow tract instantaneous peak gradient \>50mmHg at rest or during stimulation
* interventricular septum \>16mm,
* NYHA functional class III-IV, despite maximal medical therapy
* operated in San Raffaele Hospital with classic or cryo myectomy between 2015 and 2018.

Exclusion Criteria:

* extent of myectomy not reported in the operative report;
* left ventricular outflow tract gradient not reported in pre- or postoperative echocardiography.
Vocal Warm-up and Respiratory Muscle Training

The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.

Randomized Clinical Trial where participants were allocated into groups: Vocal Warm-up (to perform exercises of resistance and flexibility for 13 minutes before teaching, during six weeks) and Respiratory Muscle Training (to perform exercises to strengthen the respiratory muscles through the use of incentive respiratory equipment. Five repetitions of exhales with an interval of thirty seconds between each one were performed. It was requested rest for two minutes, repeating the procedure four times with the total of five series. These exercises were performed for 13 minutes before teaching, during six weeks).

Outcomes analyzed: demographics and teaching activity characteristics; symptoms, habits and factors associated with voice disorders; self-reported voice handicap (Voice Handicap Index-VHI-10); vocal severity rating (Vocal Severity Scale); and acoustic parameters through the computerized acoustic voice analysis program VoxMetria (CTS Informatics).

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-60.
* No occurence of speech therapy simultaneously to the intervention

Exclusion Criteria:

* Professional voice use in another activity;
* Frequent use of alcohol and tobacco;
* Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.
A 24-Week Safety and Pharmacodynamic Study of AT1001 (Migalastat Hydrochloride) in Participants With Fabry Disease

Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

This was a Phase 2, open-label study in male participants with Fabry disease. The study consisted of a 4-week screening period, during which participants' galactosidase (GLA) genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 24-week treatment period, followed by an optional 24-week extension period. Participants received migalastat once every other day (QOD) for 24 weeks during the treatment period and the optional 24-week extension for a total treatment duration of up to 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Males between 18 and 65 years of age (inclusive)
* Hemizygous for Fabry disease
* Had a confirmed diagnosis of Fabry disease with a documented missense gene mutation (individual or familial)
* Had enhanceable enzyme activity based on in vitro tests
* Had documented evidence of cardiac and/or renal dysfunction (for example, abnormal electrocardiogram (ECG), left ventricular hypertrophy, renal insufficiency)
* Were previously untreated by enzyme replacement therapy (ERT) or substrate depletion for Fabry disease, or if ERT or other specific treatment for Fabry disease was administered, were able to stop ERT for at least 30 weeks.
* Were willing to undergo 2 kidney and 3 skin biopsies
* Agreed to be sexually abstinent or use a condom with spermicide when engaging in sexual activity during the course of the study and for a period of 30 days following completion of the study
* Were willing and able to sign an informed consent form

Exclusion Criteria:

* History of significant disease other than Fabry disease (for example, end-stage renal disease; Class III or IV heart disease \[per the New York Heart Association classification\]; current diagnosis of cancer, except for basal cell carcinoma of the skin; diabetes \[unless hemoglobin A1c ≤8\]; or neurological disease that would have impaired the participant's ability to participate in the study)
* History of organ transplant
* Serum creatinine \>176 millimole per deciliter on Day -2
* Screening 12-lead ECG demonstrating corrected QT interval \>450 milliseconds prior to dosing
* Taking a medication prohibited by the protocol: Fabrazyme® (agalsidase beta), Replagal™ (agalsidase alfa), Glyset® (miglitol), Zavesca® (miglustat), or any experimental therapy for any indication
* Participated in a previous clinical trial in the last 30 days
* Any other condition, which, in the opinion of the investigator, would jeopardize the safety of the participant or impact the validity of the study results
Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis

This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.


Eligibility Criteria:
Inclusion Criteria:

1. 16 to 65 years old, having signed the informed consent;
2. fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
3. have inflammatory back pain defined by Calin criteria;
4. disease duration range from 6 months to 2 years;
5. BASDAI score more than 4;
6. MRI score of sacroiliac joint more than 4;
7. lab examination: hemoglobin more than 90 gram/liter. Aspartate aminotransferase and Alanine aminotransferase less than 2 fold of upper level of normal range. Creatine less than upper level of normal range.

Exclusion Criteria:

1. History of psoriasis or inflammatory bowel disease.
2. Intra-articular injection of cortisone within 3 months.
3. Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
4. Active iritis.
5. History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
6. Female of pregnancy or breast feeding.
7. History of mental disease and poor compliance.
8. History of drug abuse or alcoholism.
A Pilot Study of Psychodynamic Psychotherapy for Bipolar Disorder

The purpose of this study was to compare a group psychotherapy intervention, the Integrative Outpatient Model, to a convenience control, in adults with bipolar disorder.

The psychotherapy literature suggests that psychological treatments can have a significant impact on the clinical course and outcome for bipolar disorder (Swartz \& Frank, 2001). Very few outcome studies have been conducted in group psychotherapy for bipolar disorder, and there are no preliminary studies conducted using the Integrative Outpatient Model, developed specifically for bipolar disorder. Given the lack of preliminary data, a pilot study with a matched-control design is indicated to obtain preliminary data regarding this treatment modality and approach. The IOM is a weekly, long term psychotherapy.

Comparison: Individuals who participate in group psychotherapy will be compared to a control group on mood and symptom ratings, up to 1 year post intervention.

Eligibility Criteria:
Inclusion Criteria:bipolar disorder; functioning level appropriate for outpatient group psychotherapy; willingness to engage in a psychotherapeutic intervention -

Exclusion Criteria: cognitive impairment; prominent psychosis; under 18 years old

-
Comparing Minilaparotomy and Laparoscopic Cholecystectomy as a Day Surgery Procedure

Minlaparotomy (MC) and laparoscopic cholecystoctomy (LC) are commonly applied surgical techniques for the management of symptomatic gallstone disease and both techiques have shown to be feasible for day surgery. However, to our knowledge the long-term outcome between these approaches has not been compared in randomised trials as day surgery procedures.


Eligibility Criteria:
Inclusion Criteria:

* Cholelithiasis confirmed by preoperative ulrasound
* No significant co-morbidities
* The ASA physical status classification 1 or 2
* Age 18 to 65 yrs.
* BMI less than 35
* Less than a one hour journey from hospital to home
* Patient´s own motivation to daysurgery

Exclusion Criteria:

* Elevated liver laboratory tests
* Earlier jaundice
* A suspicion or verified stones in the common bile duct
* Acute cholecystitis
* A history of pancreatitis
* Hepatic cirrhosis
* Suspicion of cancer
* Previous open upper abdominal surgery
* Asthma
* Peptic ulcer
* Bleeding disorders
Re-Inventing Yourself After Spinal Cord Injury

The purpose of this study is to evaluate the efficacy of a replicable, psychologically-based group education intervention, Re-Inventing Yourself after Spinal Cord Injury (SCI), which aims to enhance personal self-efficacy. A structured six-week, manualized, group therapy intervention that delivers positive psychology concepts within a cognitive-behavioral therapy-based model has been created for the purpose of developing a resilient and optimistic sense of efficacy for people with SCI. Concepts covered within this intervention include: reframing and restructuring a person's method of looking at events, building confidence by focusing on personal strengths, developing methods of recognizing and appreciating the good in one's life and expressing gratitude for positive attributes. The goals of this intervention are to increase personal self-efficacy, enhance emotional well-being and improve participation in society for people with SCI living in the community. The investigators hypothesize that persons receiving the intervention will demonstrate improved SCI-specific and overall self-efficacy as compared to waitlist controls.


Eligibility Criteria:
Inclusion Criteria:

1. History of traumatic SCI at any level;
2. at least 4 weeks post-discharge from initial inpatient rehabilitation;
3. 18 years of age or older at the time of study enrollment;
4. English speaking in order to complete study measures and participate in group interactions; and
5. able to provide informed consent to participate

Exclusion Criteria:

1. History of moderate or severe traumatic brain injury;
2. current participation in another RCT;
3. live beyond a reasonable commuting distance from Craig Hospital;
4. unable to verbally communicate;
5. unable to attend group sessions;
6. active participation in another formal clinical group or psychological therapy;
7. are currently experiencing moderately severe or greater levels of depression which would require more intense treatment than is provided in this intervention, as evidenced by a score of 15 or higher on the Personal Health Questionnaire-9;37
8. are currently of high self efficacy, as determined by a score of 90 or higher on the MSES,32 which has a range of 16 to 112, with higher scores representing higher SCI-specific self-efficacy; or
9. have any condition that, in the judgment of the investigators, precludes successful participation in the study.
Clinical and Histopathologic Characteristics of BAP1 Mutations

The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.


Eligibility Criteria:
Inclusion Criteria:

All consents:

* \> or = to 18 years of age
* Ability to provide informed consent

Consent 1:

Mesothelioma

* Histologically proven diagnosis of Mesothelioma OR Choroidal nevus
* Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography OR Primary uveal melanoma
* Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography

Consent 2:

Mesothelioma

* Histologically proven diagnosis of Mesothelioma AND
* BAP1 mutation or loss of expression identified in tumor sample

OR one of the following:

* Age\<50 at diagnosis
* No history of asbestos exposure
* Personal history of choroidal nevus, uveal melanoma, melanoma, renal cell carcinoma, or cholangiocarcinoma
* Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
* History of malignancy in more than two first-degree relatives OR Choroidal nevus
* Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography AND one of the following:
* More than one clinical risk factor, which may include: orange pigment, thickness \> 1 \< 2.5mm
* Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
* Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma OR Primary uveal melanoma
* Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography

AND one of the following:

* Personal history of uveal melanoma, skin melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
* Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
* History of malignancy in more than two first-degree relatives OR Metastatic uveal melanoma
* Histologically proven diagnosis of metastatic uveal melanoma AND
* BAP1 mutation or loss of expression identified in tumor sample

OR one of the following:

* Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
* Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
* History of malignancy in more than two first-degree relatives

Consent 3:

* Relative of patient with germline BAP1 mutation identified through identified testing

Exclusion Criteria:

* none
Proton Pump Inhibitor Treatment Stop

The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease.

This is evaluated in a discontinuation trial.

Background:

Testing patients with a Helicobacter pylori (Hp) 13C-urea breath test and treatment with eradication of Hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. However, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (GORD). This group of patients contributed to 59% of the total use of acid-suppressive medication in the County of Funen in Denmark in 1997.

Aim/purpose:

It is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care.

Our secondary objective is to investigate the profile of symptoms, quality of life, Hp-status, consumption of drugs and use of health care services in the same context.

Methods:

To conduct a randomised, placebo-controlled, blinded, clinical discontinuation trial, 500 long-term users of acid-suppressive drugs are identified by general practitioners. Long-term use is defined as treatment for more than 2x28 days during a 6-month period. The patients are included with a 13C-urea Hp-breath test and randomised for treatment with PPI or placebo. Hp-positive patients are treated with an Hp-eradication treatment. The patients are followed for 1 year; the primary outcome is the need for open treatment with acid-suppressive medication due to failing symptom relief despite treatment with the randomised project medication. The patients are to fill in a symptom and medication diary every month for periods of 1 week. Questionnaires are to be given to the patients 3 times during the follow-up period. Medication diaries as well as questionnaires have proven useful in similar studies. The main outcome is analysed using Kaplan-Meier survival estimates analysis.

Eligibility Criteria:
Inclusion Criteria:

* Use of antisecretory medication for more than 2 months during the last 6 months

Exclusion Criteria:

* Malignity or severe, competing medical or psychiatric disease
* Esophagitis (proven by endoscopy)
* Prior complication to peptic ulcer disease
* Alarm symptoms
* Pregnancy or lactation
* Allergy towards esomeprazole
* Planned hospitalisation during study period
A Study Evaluating Potential Disease-Mediated Drug-Drug Interaction in Adult Participants With Active Eosinophilic Esophagitis Receiving Cendakimab

The purpose of this study to evaluate the potential for disease-mediated drug-drug interactions between cendakimab and selected substrates of metabolic enzymes in eosinophilic esophagitis participants.


Eligibility Criteria:
Inclusion Criteria:

* Active Eosinophilic esophagitis (EoE) with histologic evidence as a peak count of ≥ 15 eosinophils per higher-power field at any 2 levels of the esophagus
* Previously received an adequate trial of proton-pump inhibitor medication that did not provide complete response to EoE
* EoE symptoms documented in daily diary during the screening period

Exclusion Criteria:

* On a regimen of therapeutic anticoagulation
* Demonstrates evidence of immunosuppression or is receiving systemic immunosuppressive or immunomodulating drugs
* Currently receiving a high potency topical corticosteroid for dermatologic use

Other protocol-defined inclusion/exclusion criteria apply