cyrilzakka/clinical-trials huggingface dataset:
Long-term Open-label Treatment of Moderate to Severe Glabellar Lines With CORETOX®

This study evaluates the long-term safety and efficacy of CORETOX in the treatment of moderate to severe glabellar lines.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 20 and 65
* Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
* Patients who can comply with the study procedures and visit schedule
* Patients who voluntarily sign the informed consent

Exclusion Criteria:

* Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
* Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
* Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
* Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
* Patients who were injected with botulinum toxin within the past 3 months
* Patients with allergy or hypersensitivity to the investigational drugs or their components
* Patients who have bleeding tendency or taking anti-coagulant
* Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
* Patients with skin disorders or infection at the injection site
* Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
* Patients who are unable to communicate or follow the instructions
* Patients who are not eligible for this study based on the judgment of an investigator
Health Through Activity: A Pilot Study of a Rehabilitation Intervention for People Living With Multiple Myeloma

The purpose of this study is to explore whether a structured program can help reduce the challenges of decreased physical functioning and quality of life for participants with multiple myeloma by providing a customized exercise program and fostering engagement in meaningful activities.

The name of the study intervention involved in this study is:

Health Through Activity (HTA) (six-session, rehabilitation exercise regimen)

The goal of this single arm, pilot study of the Health Through Activity (HTA) rehabilitation intervention for people living with multiple myeloma is to determine if investigators can feasibly deliver the program out of the IMPACT Practice Center at the MGH Institute for Health Professions.

- The six-session 'Health Through Activity' program provides a customized exercise plan and encourages engagement in activities to reduce disability and improve quality of life.

* Study procedures including screening for eligibility, in-clinic visits, questionnaires, and surveys.
* Participation in this research study is expected to last up to 4 months.

It is expected that up to 20 people will take part in this research study.

An internal grant from the Massachusetts General Hospital Institute of Health Professions is providing equipment and staffing for this study.

Eligibility Criteria:
Inclusion Criteria:

-≥18 years of age

* Diagnosed with multiple myeloma currently receiving maintenance therapy,
* Experiencing disability as indicated by an answer of "yes" to the question "Do health problems interfere with your ability to carry out your social or day to day activities?"

Exclusion Criteria:

* Bone pain that is either a) new onset or increased in the past month or b) uncontrolled i.e., in the patient's estimation the bone pain "greatly interferes with daily activities"
* History of fracture in the past 12 months without fixation, or
* Any injury or medical condition that would prohibit being able to safely perform exercise as indicated by the Physical Activity Readiness Questionnaire\[29\] (i.e., atrial fibrillation, chest pain or angina, uncontrolled high blood pressure or hypertension, loss of balance due to dizziness in the past 12 months, or loss of consciousness in the past 12 months).
* We will also exclude individuals with moderate or worse cognitive impairment as indicated by a score of 3 or less on the Callahan six item cognitive screening tool.
The Impact of PM+For Moms Intervention on Improving Mother's Mental Health in Zambia (PM+FM)

CMHD are particularly prevalent among women, posing a major threat to their own and their children's wellbeing.

Despite the high prevalence of CMHD and the existence of effective treatments, interventions supporting women living in low-resourced settings remain limited.

This study builds on a parent study (Zamcharts NCT03991182), which identified a high prevalence of women with anxiety and/or depression. We propose to design, test, and validate a community-based intervention nested within the public primary health system in Zambia, to identify and treat women with mild-to-severe CMHDs.


Eligibility Criteria:
Inclusion Criteria:

* Women participating in ZamCharts parent study
* SRQ-20 \>7 (clinically significant symptoms of depression or/anxiety),
* not planning to move within the next 6 months,
* with capacity to consent
* not receiving current mental health care.

Exclusion Criteria:

* Women with active suicidal ideation (determined by Paykel=4 OR 5),
* severe substance use (ACOK-SUD \>4),
* mania or psychotic symptoms
Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance

Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks have been tested and they may reduce insulin resistance. No study so far has aimed to examine the possible benefits of whey protein drink in the composition of preoperative drinks.

The patients will be randomized into two groups: the carbohydrate-protein group (CHO-P) and the control group (CO). The patients will reeive a specific drink to their group on the evening prior to surgery and three hours before the operation. The CHO-P group will receive 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil) and the CO group will receive the same volume of water.

Outcome measures On the day of the surgery and on the first postoperative day blood samples will be collected for glucose, insulin, triglycerides, albumin, pre-albumin, CRP, and α-1-acid glycoprotein (α-1-GA) assays. HOMA-IR will be calculated

Eligibility Criteria:
Inclusion Criteria:

* Adults (18-65 years-old)
* Both sexes
* Candidates to elective moderate operations such as open cholecystectomy, laparoscopic cholecystectomy and unilateral repair of inguinal hernia).

Exclusion Criteria:

* Acute cholecystitis
* Diabetes mellitus
* Chronic kidney failure
* Chronic liver disease ot serum bilirubin greater than 2 mg/dL, body mass index (BMI) above 35Kg/m2
* American Anesthesiologists Association (ASA) score above 2
* Gastro-esophageal reflux
* Gastroparesis or intestinal obstruction
* Patients with any non-compliance with the study protocol, or who had associated operations, or presented significant intraoperative occurrences, or experienced prolonged operations (lasting more than 3 hours) were also excluded.
A Comparison of Antiarrhythmic Drug Therapy and Radio Frequency Catheter Ablation in Patients With Paroxysmal Atrial Fibrillation

The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Paroxysmal atrial fibrillation for at least 6 months with at least 2 symptomatic episodes (patient history) during the previous month
* Atrial fibrillation (patient history or echocardiogram documented) resistant to at least one antiarrhythmic drug of Class I or III
* Documentation of at least one episode of atrial fibrillation on 12-lead echocardiogram or Holter Monitor

Exclusion Criteria:

* Contraindications to more than 2 antiarrhythmic drugs of different classes, or to oral anticoagulants
* History of any previous ablation for atrial fibrillation
* Intracardiac thrombus
* Atrial fibrillation due to reversible cause
* Pregnancy
* Contraindication to stopping oral anticoagulation (for example as a result of a mechanical cardiac valve)
Strength Training and Stroke

People with stroke experience weakness and incoordination. Studies have shown that with functional task practice, people can increase motor control and strength to a certain extent. This study will investigate whether adding progressive resistance strength training to functional task practice modeled after Constraint-Induced Movement Therapy results in greater motor function gains than functional task practice alone

To date most investigations of UE rehabilitation have examined single interventions. However, combining 2 efficacious interventions may enhance effectiveness. Both functional task training and strength training are beneficial for promoting improved upper extremity function, but they have seldom been studied as a coupled therapy. The research proposed in this project will examine the effect on UE function of adding UE resistive exercises to functional task training. Secondary aims are to examine the effect of stroke severity on the response to therapy, the interrelationship between therapy-induced neural changes and movement composition and functional changes with therapy, and test for retention of UE function gains over 6 months. Individuals with chronic hemiparesis from stroke will complete baseline testing and then be randomly assigned to either the functional task + strength training group or the functional task training alone group. Each group will train 4 hours/day, 3 days/week for 4 weeks. Each will perform 3 hours of functional task training per session. The strengthening group will then complete 1 hour of UE progressive resistance exercises while the functional task training alone group will complete gravity eliminated range of motion exercises for 1 hour. All subjects will be post-tested and then complete follow-up testing 6 months later.

Eligibility Criteria:
Inclusion Criteria:

1. age 40-85;
2. a single unilateral middle cerebral artery ischemic stroke;
3. no history of drug/alcohol abuse;
4. ability to follow 3-step commands and provide informed consent;
5. no history of other neural disorder/dysfunction (including epilepsy), no serious medical illness or refractory depression;
6. at least 300 active upper extremity elevation in scapular plane (combination of flexion and abduction);
7. ability to extend the wrist 20 degrees, and two fingers and thumb 10 degrees three times in a minute;
8. permission of physician (BRRC medical director or BRRC neurologist) to participate in strength training.

Exclusion Criteria:

1. spasticity in elbow or hand (Modified Ashworth Scale \> 2);
2. Motor Activity Log32 scores \>3 (which would indicate relatively good use of the upper extremity);
3. ability to complete 135 degrees shoulder elevation easily with elbow straight (e.g., doesn't hold breath, movement is fluid, little to no effort tremor observed);
4. ataxia, major sensory deficits, or hemi-inattention/neglect;
Biomarkers of Early Chronic Obstructive Pulmonary Disease (COPD) in Smokers - Longitudinal Study

This is a longitudinal observational study to identify and validate protein biomarkers for COPD (chronic obstructive pulmonary diseases) and cardiovascular disease in smokers and ex-smokers attending primary care. Special emphasize is to correlate biomarkers to different phases of COPD, to progression of the disease, and to treatment of the disease. Furthermore, linkage between COPD, cardiovascular disease, and lung cancer will be investigated by identifying protein biomarkers.


Eligibility Criteria:
Inclusion Criteria:

Diagnosed with COPD Gold stage 0-IV

Exclusion Criteria:

Patients with inflammatory diseases Patients with cancer Patients using immune system regulating drugs
Treatment Regimen in Menstrual Cycle Regularization and Persistence in Routine Clinical Practice in Russia, Ukraine, Kazakhstan and Uzbekistan

Dydrogesterone is approved in more than 100 countries including Russia, Ukraine, Kazakhstan and Uzbekistan and widely used for the treatment of progesterone deficiencies such as for management of dysmenorrhea, endometriosis, secondary amenorrhea, irregular cycles, dysfunctional uterine bleeding, pre-menstrual syndrome, threatened and habitual miscarriage, infertility due to luteal insufficiency, as well as part of hormone replacement therapy. There are limited data regarding dydrogesterone's role in achieving cycle regularization from post-marketing settings. There is need to assess the persistence of dydrogesterone therapy in a post-marketing setting after cessation of treatment and whether the persistence, if any, is related to the duration of dydrogesterone therapy. Hence, in this observational program, the goal is to observe the possible implications of such treatment in terms of treatment length and response pattern.

The program is designed as a prospective, multicentre, observational, non-interventional, non-randomized, non-controlled, single arm, post-marketing program. Being an observational program, the assignment of patients to dydrogesterone therapy will not be decided with an intention to include patients in the program, but will be guided as per standard clinical practice of the treating physician. Hence the prescribing of dydrogesterone will be clearly separate from the decision to include patients in this program. All dydrogesterone prescriptions will be made in accordance with locally approved package insert for dydrogesterone.

Eligibility Criteria:
Inclusion Criteria

* Women aged 18-40 years
* Irregular menstrual cycle due to progesterone deficiency for at least 3 months
* Dydrogesterone prescribed in accordance with locally approved package insert
* Signed written authorization to provide data for the program

Exclusion Criteria

* Known hypersensitivity to the active ingredient or excipients
* Known or suspected progesterone-dependent neoplasms
* Vaginal bleeding of unknown etiology
* Administration of oral contraceptives
* Any other condition that precludes use of dydrogesterone in a particular patient, in accordance with the contraindication, precautions and special warnings listed in the locally approve package insert (for example, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption)
Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder

The purpose of this study is to determine the efficacy of a 8-week program of Compassion Focused Therapy in Group comparing to Supportive Cognitive Behavioral Therapy in Group for patients with Posttraumatic Stress Disorder.

This study will be a randomized clinical trial with two parallel groups, with two models of treatment: Group 1 - Control Group - will receive CBT Supportive Group (CBT-SG) and Group 2 - Experimental Group - will receive Compassion Focused Therapy (CFT-G). Will be attended in total, the maximum of 80 patients, with 40 patients in each arm (CBT-SG versus CFT-G). Both groups will be formed by at least eight patients and a maximum of twelve patients who receive eight weekly sessions with an hour and a half each session, and the total duration of treatment will be eight weeks. The groups will be closed, that is, after the start will not be permitted to input any more participants. The experimental group (CFT-G) will be structured and the control group (CBT-SG) will be unstructured, and free format.

All patients will be assessed through self-report scales, within three distinct phases: Assessment I - Initial (before therapy); Assessment II - Final (after therapy); Assessment III - Follow-up (after 3 months of therapy ending).

All groups will be led by a principal therapist and co-therapist. All sessions will be recorded for later evaluation of the researcher responsible for the research.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Administered PTSD Scale 5 Monthly version Criteria A and \>30 points

Exclusion Criteria:

* Suicidal patients and/or severe automutilation behavior and/or psychotic symptoms and/or lack of event memory.
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention

The purpose of this pilot is to initiate an academic-community partnership and launch a multi-level intervention that includes an asthma exposure pathway (an online decision support and resource) and a health Promotora program that will provide culturally responsive asthma support alongside legal and medical services to improve access to asthma care and ultimately improve asthma-related outcomes in the New Haven region.

In this will be a prospective, non-randomized, observational, multi-level pilot intervention, general pediatricians and specialists in New Haven, Connecticut will utilize a newly developed clinical pathway that will be publicly available at the Yale Pediatrics Clinical Pathways website and accessible within the electronic health record (EHR) via integrated software to submit referrals for participants in a Promotora (Community Health Worker) asthma home-visiting intervention.

The Hispanic Federation Promotoras, who are partners in this study who have received Human Subjects research training, will enroll participants in the study. For each participating family, Promotora home visits will be scheduled 6-8 weeks apart, with in-person or virtual visits conducted per the family's preference. The Promotoras, who have received specialized asthma training, will address concerns raised by families, using the clinical pathway as a resource (the pathway will have resources for asthma-related concerns that are raised). A clinician from the study team will be on call at all times for the Promotoras in case urgent questions arise, and weekly case-conferences will be arranged to discuss any additional needs for support.

In this study, the primary outcomes will include measures of feasibility of both Promotora home visits and pathway utilization. The investigators will evaluate secondary outcomes using an interrupted time series analysis to evaluate asthma-related outcomes. In addition to survey data, asthma exacerbation metrics will be collected from the electronic health record.

Eligibility Criteria:
Inclusion Criteria:

Children with a diagnosis of asthma with at least one of the following:

* Oral steroid prescription in past 12m
* ED visit for asthma in past 12m
* Hospital admission for asthma in past 12m
* Asthma control test (ACT) score at visit ≤19
* Concern for asthmogenic exposure in the home (such as mold, pests, smoking, or pollution)
* At least one missed follow-up appointment for asthma
* At least one asthma exacerbation in the prior year
* Interested in asthma education (such as education in how to prevent asthma or how to administer medications)
* Concern for medication non-adherence

Exclusion Criteria:

* Living outside of New Haven Zip Code
Prevention of Atrial Tachycardia After a Right Atriotomy II

The investigators performed a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy and the atriotomy with the inferior caval vein to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction time between electrodes placed on both sides of the lesions is measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line are performed three month after the operation.

We perform a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy (surgical dissection plus cryoablation) and the atriotomy with the inferior caval vein (cryoablation alone) to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction times between electrodes placed on both sides of the lesions are measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line and to try to induce atrial flutter are performed three month after the operation.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical indication for corrective operation for congenital heart disease with the use of a right lateral atriotomy,
2. Age \>18 years,
3. Ability to give an informed consent.

Exclusion Criteria:

1. Acute operation
2. Chronic atrial fibrillation
3. Indication for MAZE procedure
Randomized Control Trial (RCT) of Early Palliative Care for HCC

The purpose of this research study is to evaluate the effect of early palliative care consultation on quality of life, use of hospital resources, end-of-life care and survival among Hepatocellular Carcinoma (HCC) patients with advanced End Stage Live Disease not eligible for potentially curative or local area therapy. Half of patients will receive early palliative care at diagnosis of HCC and other half will receive palliative care when all standard therapy treatments have been exhausted.

Intro:

Hypothesis Methods Analysis Anticipated Results

Palliative care will focus on providing relief from the symptoms and stress associated from cancer. This helps improve quality of life for cancer patients and their family. This care is usually offered to patients when all standard therapy treatments have been exhausted.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed HCC by biopsy or liver protocol CT scan or MRI characteristics
* Permanent street address with Harris County, Texas and consent to study participation
* English or Spanish speaking with ability to respond to the QoL questionnaires
* Child-Pugh C, not eligible for liver transplantation (TXP), surgical resection, ablation, locoregional or systemic therapy
* Child-Pugh C, eligible for systemic chemotherapy (Sorafenib), not eligible for TXP, surgical resection, ablation or locoregional therapy
* Child-Pugh A or B, not eligible for surgical resection or ablation (\>3 lesions or 2 lesions with one being \>5cm)
* Child-Pugh A, not eligible for TXP, surgical resection, ablation or locoregional therapy

Exclusion Criteria:

* Primary modality of treatment is potentially curative TXP, surgical resection or ablation as deemed by GI MDC
* Child-Pugh A or B (up to 2 lesions \< 5cm in size)
* Medical (e.g. severe encephalopathy), psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
* Any medical condition (acute myocardial infarction or stroke) that could jeopardize the safety of the patient and his/her compliance in the study
* Vulnerable population (inmates in jail or prison)
* Non-English or Non-Spanish Speaking patients.