cyrilzakka/clinical-trials huggingface dataset:
BTX-A Treatment for Palmar Hyperhidrosis

Primary focal hyperhidrosis (excessive sweating) is a debilitating condition affecting approximately 3% of the population in the United States. Not only that it is a major social embarrassment to affected individuals, it also has significant negative impacts on career, school, and relationship. Botulinum toxin A (BTX-A), a sterile neurotoxin purified from Clostridium bacteria, was approved by the U.S. Food \& Drug Administration in 2004 for the treatment of severe focal axillary hyperhidrosis that does not respond to topical antiperspirants. It is becoming a promising treatment for many patients suffering this condition. Over the past decade, the medication has also been used effectively for many other forms of focal hyperhidrosis such as the hands, feet, forehead, scalp and groin. Unfortunately, BTX-A injection for primary focal hyperhidrosis of the palms and soles are often limited by pain and post treatment muscle weakness associated with the procedure. Recent studies have demonstrated that BTX-A can be delivered across the skin via electric current using a medical device, called iontophoresis (FDA 510(k) clearance # K042590 or Phoresor IIPM700). Studies with limited number of patients have demonstrated promising results with this new treatment.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female
* Age 16 and older
* If \<18, parent/legal guardian willing to sign consent and accompany to visits
* Diagnosis of hyperhidrosis disease with a severity score (HDSS) of 3 or 4
* Treatment types of topical antiperspirants, iontophoresis, or systemic anticholinergics have failed to treat
* Able to come to 5 clinical visits during the study period

Exclusion Criteria:

* Diagnosis of neuromuscular disease such as peripheral motor neuropathic diseases (e.g. amyotrophic lateral sclerosis, or motor neuropathy)
* Diagnosis of neuromuscular junctional disorders (e.g. myasthenia gravis or Lambert-Eaton syndrome)
* Diagnosis of dysphagia
* Individuals with surgical implants such as pacemakers, orthopedic hardware, etc.
* Individuals who are Immunocompromised
* Systemic infectious illness or infection at the injection site(s)
* Known hypersensitivity to any ingredient in the formulation of the drug
* Organic cause of hyperhidrosis
* Known allergy to the ingredients in the general anesthesia
* Diagnosis of cardiac/pulmonary issues or disease
* Women who are pregnant or suspected to be pregnant
Etoposide+Cytarabine+PEG-rhG-CSF for Hematopoietic Stem Cell Mobilization in Patients With Hematological Malignancies

This is a single-arm, multicenter, exploratory clinical study to evaluate the safety and efficacy of the combination of etoposide, cytarabine and PEG-rhG-CSF (EAP regimen) on hematopoietic stem cell mobilization in poor mobilization patients with hematological malignancies. All eligible patients will receive EAP regimen treatment, then the number of CD34+ cells and white blood cells will be monitoring. When the collection standard is met, hematopoietic stem cell collection will be started.


Eligibility Criteria:
Inclusion Criteria:

1. According to the diagnostic criteria of the Italian transplantation working group, patients with multiple myeloma or lymphoma diagnosed as "confirmed poor mobilization" or "predicted poor mobilization".
2. Patients with auto-HSCT indication.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~2.
4. Patients should be within age range of ≥18 and ≤75 years old.
5. Life expectancy ≥ 3 months.
6. Patients must be able to sign informed consent.

Exclusion Criteria:

1. Patients with severe cardiac, hepatic or renal insufficiency, such as:

   * Cardiac function class II or higher or severe arrhythmia;
   * Serum direct bilirubin (DBIL)\>2× upper limit of normal (ULN);
   * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2× ULN;
   * Serum creatinine clearance rate≤50%.
2. Patients with active infection.
3. History of allergy to Etoposide (VP-16), Cytarabine (Ara-C), or PEG-rhG-CSF.
4. Women who are pregnant or breastfeeding.
5. Have received live vaccine and attenuated live vaccine within 4 weeks before enrollment.
6. For any other reasons, the patients are believed not suitable for participation in this study by investigators
Psychophysiological Effects of Probiotic Supplementation

This is a pilot exploratory study to investigate the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.

The purpose of the study is to explore the effects of a probiotic Bifidobacterium longum NCC3001 intake on physiological and psychophysiological parameters related to stress in healthy individuals with mild to moderate stress level.

The objectives is three:

* Measure the effects of a 6-week supplementation with NCC3001 on psychological and physiological parameters in response to an acute experimental stress;
* Measure the effects of a 6-week supplementation with NCC3001 on chronic stress level, gastro-intestinal symptoms and sleep quality;
* Explore changes in the profiles of biological parameters associated with ingestion of NCC3001; including changes in hormones, neurotransmitters, circulating immune and microbiome-derived molecules and changes in the microbiome itself

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and sign the informed consent
2. Healthy adult men and/or women aged 25 to 65 years old
3. Mild to moderate stress, defined as a score in the range of 15 to 25 on the validated Depression, Anxiety and Stress Scale (DASS-42)
4. Proficiency in French and/or English
5. Normal visual acuity and hearing with or without correction (self-reported)
6. BMI in the range of 18.5 to 29.9 kg/m2

Exclusion Criteria:

1. Diagnosed food allergies
2. Currently participating or having recently participated in a clinical study with products potentially interfering with the results as judged by the investigator
3. Organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids
4. Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
5. Concurrent diagnosed systemic chronic disease (e.g., endocrine, cardiovascular, metabolic, liver, celiac)
6. Willing to avoid the consumption of probiotic-containing products (including yogurts containing probiotics) i.e. any commercially available product specified as containing Lactobacillus, Bifidobacteria, Streptococcus or Saccharomyces for the 2 weeks prior to randomization visit
7. Willing to avoid the use of antibiotics in the 4 weeks prior to randomization visit
8. Adherence to an overly unbalanced diet such as vegan, paleo, ketogenic, low carbohydrate, raw diets
9. Conditions that may affect mood
Web-based Psychological Intervention to Coronary Artery Heart Disease Patients

The purpose of this study is to evaluate medical cost-effectiveness, reduce the psychological risk factors( including hostility, anxiety, depression, and perceived stress) in coronary artery disease (CAD) patients and enhance the regulation of the autonomic nervous system (including respiration rate, heart rate, distal blood vessel pulse, and finger temperament) through web-based cognitive -behavioral group therapy.

Cognitive-behavioral therapy (CBT) is effective in reducing the level of anger, hostility and depression present in coronary artery disease (CAD) patients.In Taiwan, Weng et al. also confirmed the eight-week group CBT program not only diminished the emotion disturbances including anger, hostility and depression of CAD, but also significantly prolonged the coagulation time, thus reducing the rate of thrombosis formation. Even though the therapeutic effect of the CBT program was valid, this program is still not accessible for some patients in need because they are not aware of it, or they are restricted by time and transportation. Internet-based therapeutic intervention can overcome the obstacles to access this program at any time and in any place. Presently, structured CBT intervention is provided through the Internet and used widely by patients with physical or psychological problems such as smoking, obesity, or headaches, but not by CAD patients. Therefore, the purpose of this research is to evaluate the effects to reduce the psychological risk factors of a web-based group CBT program in CAD patients. Follow-up assessments will be performed after 3 and 6-month durations. The investigators expect that, after an eight-week group intervention, there will be significant decrease of the psychological risk factors. Moreover, the therapeutic effects can be maintained during the three- and six-month follow-up.evaluate In addition, web-based cognitive -behavioral group therapy will significantly reduce indirect medical costs (travel time and money).

Eligibility Criteria:
inclusion:

1. coronary artery disease
2. regular medication

exclusion:

1.Psychiatric diseases
Minocycline as an Adjunctive Therapy for Schizophrenia: a Randomized Controlled Study

Double - Blind, Randomized, single centered study. The purpose of this study is to assess the feasibility of minocycline vs. placebo, added to atypical antipsychotic medications, for positive symptoms in adults suffering from schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 20-65 years of age.
* Primary DSM-IV diagnosis of Schizophrenia based on SCID for schizophrenia and confirmed by two senior psychiatrists.
* Patients who scored "moderate" (4) or higher on at least three of seven positive items in PANSS
* Initiated on treatment with atypical anti-psychotic medication.
* Capable and willing to provide informed consent
* Able to adhere to the treatment schedule
* Able to read, hear, write and speak the local language.
* Has signed a written informed consent to participate in the study

Exclusion Criteria:

* Patients with acute, unstable, significant, or untreated medical illness besides schizophrenia including alcohol and drug dependence, or depression.
* Current suicidal ideation or history of a suicide attempt in the past 3 years
* Known or suspected pregnancy or women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse. or women who are breastfeeding
* Subjects who were taking a known contraindication to minocycline treatment.
* Subjects who had received treatment with minocycline or β-lactam antibiotics in the preceding half year before study entry.
* Subjects who were under compulsory hospitalization.
Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes

The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).

The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - \<65 years, 2) body mass index (BMI) ≥ 24 kg/m2 \[7\], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of pancreatitis, coronary artery disease, liver function impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases (emphysema and cor pulmonale), infectious disease, hematological disease, systemic inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.

Eligibility Criteria:
Inclusion Criteria:

* age 20 - \<65 years,
* body mass index (BMI) ≥ 24 kg/m2,
* HbA1c ≥ 7% (53mmol/mol).
* diabetes antibodies (-)
* diagnosed with T2D within the previous 3 months

Exclusion Criteria:

* anti-diabetic drugs or diet therapy before participation
* pancreatitis
* coronary artery disease
* liver function impairment
* renal function impairment
* intestinal surgery
* chronic hypoxic diseases (emphysema and cor pulmonale)
* infectious disease
* hematological disease
* systemic inflammatory disease
* cancer
* pregnant, possibly pregnant
* ingesting agents known to influence glucose or lipid metabolism
Post-ERCP Pancreatitis Prevention by Stent Insertion

The presented study is designed to analyze the efficacy of pancreatic stent insertion in patients undergoing ERCP with accidental cannulation of the pancreatic duct.


Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing ERCP with unintended cannulation or opifiacation of main pancreatic duct
* age \> 17 years
* signed informed consent

Exclusion Criteria:

* intention to intervene main pancreatic duct
* age \< 18 years
* pregnancy
* absent of signed informed consent
Electrocardiographic and Electrophysiologic Changes After Percutaneous Closure of Atrial Septal Defect

Primary outcomes :

Determining the incidence of SAN and AVN dysfunction before and after percutaneous ASD closure Comparing ECG and EP parameters of SAN and AVN before and after percutaneous ASD closure

Secondary outcomes :

Assessing clinical, echocardiographic and procedural risk factors affecting the AVN function after ASD closure device implantation Determining the incidence of supraventricular arrhythmia inducibility before and after percutaneous ASD closure

Atrial septal defects (ASDs) are one of the most common types of acyanotic congenital heart diseases, comprising 6-10% all congenital heart defects. They represent the most common congenital heart disease diagnosed during adulthood. Secundum ASD is a defect in the fossa ovalis (septum primum), or the superior limb of the septum secundum and is the most common type of ASD (80% of all ASDs).

ASD closure for secundum ASD is recommended regardless of symptoms in patients with evidence of right ventricular (RV) volume overload and no pulmonary arterial hypertension (PAH) or left ventricular (LV) disease. Percutaneous device closure has become the first choice for secundum defect closure in presence of a feasible morphology with a reported low risk of serious complications (≤1% of patients).

Subclinical electrocardiography (ECG) abnormalities, sinoatrial node (SAN) and atrioventricular node (AVN) conduction abnormalities have been reported in patients with ASDs. . The reported incidence of AVN block following ASD device closure varies widely from none up to 6.1%. High-grade AVN block after device closure typically occurs in the first 24-hour post-procedure and may mandates device removal for resolution of heart block.

The mechanism of AVN block after ASD device occlusion could be due to mechanical pressure on the AV node or edema related to trauma. Young age and large defect/device size may be a risk factor for AVN block. Deficient rims of the ASD may also have an impact on development of AVN block.

Whether or not there is a direct impact of ASD device closure on the functional properties of AVN and SAN is not well elucidated. Testing the electrocardiographic and electrophysiologic (EP) parameters of AVN and SAN before and after the procedure could obviously help understanding the real risk

Eligibility Criteria:
Inclusion Criteria:

* All patients presented with secundum ASD eligible for percutaneous transcatheter ASD closure at Assiut university heart hospital

Exclusion Criteria:

* No exclusion
Image Guided Radiation Therapy For Prostate Cancer

During the 7 to 8 weeks of conformal radiotherapy for prostate carcinoma, the prostate has an intra-pelvic motion which is not detectable by the conventional portal imaging. This prostate motion may lead to a mistargeting, which possibly decreases the local control. On the other hand, the new 3D on board imaging (3D OBI) allows to localize the target but is expensive. The cost/effectiveness ratio is not well established, as well as the frequency of using such imaging during the course of radiation.


Eligibility Criteria:
Inclusion Criteria:

* prostate adenocarcinoma
* intermediate / high risk group
* N0 or N -
* treatment by conformal radiotherapy (including or not IMRT), with or without androgen deprivation

Exclusion Criteria:

* pelvic irradiation
* metal objects in the pelvis
Rehabilitation After Breast Cancer

The aim of the study is to evaluate whether a screening-based individually tailored nurse navigator intervention compared to standard care significantly reduce psychological and physical symptoms among women being treated for breast cancer who had moderate-to-severe distress (score ≥ 7 on the distress thermometer).

During a 2-year period, 758 patients newly diagnosed with breast cancer will be screened for inclusion at the Section of Breast Surgery at Rigshospitalet, Copenhagen. Of these 324 participants enter the randomized controlled trial (RCT) and are randomized in a computer-generated sequence of 1:1 to the intervention (nurse-navigation) or control group (standard care). A total of 432 participants will enter an observational questionnaire study. All participants are followed for 1,5 years.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with breast cancer (i.e. prior to surgery), scheduled for breast cancer surgery at Section of Breast Surgery at Rigshospitalet, 18 years or above, Danish citizen, read, understand and speak Danish, female gender,signed written informed consent. Those who experience high psychological distress (score ≥ 7 on the distress thermometer) will enter the RCT whereas those who experience low psychological distress (score \< 7 on the distress thermometer) will be followed in an observational questionnaire study.

Exclusion Criteria:

* no severe cognitive problems or dementia, no severe psychiatric disease requiring treatment, e.g. schizophrenia, alcohol or narcotic dependence,
Mobile Behavior Change Program for Weight Loss in Breast Cancer Survivors

The purpose of this study is to evaluate the preliminary efficacy of a Noom Breast Cancer Weight Loss Program on weight loss outcomes, quality of life, and physical activity. Also, to qualitatively determine acceptability of this novel program among breast cancer survivors with overweight or obesity.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and provide informed consent
* 18 years and older
* Overweight or obesity (BMI ≥ 27.5)
* Not 6 months postpartum
* Not planning to become pregnant in the next 7 months
* Have a smartphone that is compatible with Noom's mobile app
* Breast cancer survivor with stage I, II, or III
* Completed active treatment (e.g, surgery, chemo, radiation, etc.) \> 6 months ago

Exclusion Criteria:

* Inability or unwillingness of a participant to give written informed consent
* Currently pregnant or \< 6 months postpartum
* Plans to become pregnant within the next 7 months
* Stage IV, metastatic cancer or DCIS
* Currently taking insulin
* Uncontrolled hypertension
Testing the Effect of Press Guides on Health Journalists

The purpose of this study is to test the effect of adding a "press guide" to standard materials that journalists routinely receive regarding research published in medical journals.

The news media has a powerful influence on public perceptions about health and health care; and much of what people -- including many physicians -- know and believe about medicine comes from the print and broadcast media. Several studies, however, have raised questions about how well the press covers medical issues, pointing out errors and omissions in coverage and misleading presentations of statistics. The goal is to help train journalists to better understand and cover medical research, and to help improve communication between journalists and medical journals.

Journalists traditionally write newspaper articles about medical research using information from press releases and the medical journal article's abstract or full text. The objective is to test whether the addition of a 'press guide' (a one-page summary of the study findings) in addition to these other materials improves comprehension of facts about the study article and the overall judgment of the newsworthiness of the study.

Eligibility Criteria:
Inclusion Criteria:

* All journalists attending the 2009 NIH/Dartmouth/VA Medicine in the Media Symposium will be invited to participate in the study.
* The symposium, which is held annually, is open to journalists across the country and from abroad.

Participants who are Health Journalists at the Health Journalism 2010 conference will be invited to participate in the study. This annual conference is being held in Chicago, IL at the Hyatt Regency McCormick Place During April 22, 2010-April 25, 2010.
The Effect of an Acute Bout of Exercise on Pain Sensitivity and Clinical Pain in Adults With Chronic Low Back Pain

The goal of this interventional study is to investigate the efficacy of an acute bout of exercises on pain sensitivity (primary aim) and clinical pain intensity (secondary aim) among adults with Chronic Low Back Pain. The following question will be answered in this research Q1: Is acute bout of exercise effective in reducing pain among adults with Chronic Low Back Pain?

Participants who agree to participate and sign the informed consent will be randomized to one of three groups:

Group 1: Isometric exercise with neutral language and no verbal suggestion consisting of 1 rep of wall squat, 3 min or to volitional fatigue at 100° knee angle;(n=30).

Group 2: Isometric exercise with neutral language and no verbal suggestion consisting of 3 reps of wall squat, 3 min or to volitional fatigue at 100°degree knee angle, 30-sec rest between rep, ;(n=30).

Group 3 (Control group): true control (do nothing);(n=30).


Eligibility Criteria:
Inclusion Criteria:

1. aged 18 years or older; and
2. diagnosed with chronic non-specific LBP (lasting for more than 12 weeks).
3. Able to perform physical therapy exercises.

Exclusion Criteria:

1. pregnancy.
2. patients who have neurological compromise (e.g., cauda equine syndrome or spinal nerve compromise).
3. Patients who have spinal pathologies (e.g., fracture, ankylosing spondylitis)
4. Uncontrolled diabetic.
5. who has any history of heart disease (e.g., myocardial infarction, embolism)
6. Orthopaedic impairment (e.g., balance problems)
Promoting Breast Cancer Screening in Women Who Survived Childhood Cancer

The purpose of this study is to empower women to improve their health in two very important areas: breast and heart health. This twelve-month study will compare two methods of informing participants about potential health risks and ways to stay healthy.

The EMPOWER Study has been designed for adult women who were treated for a childhood cancer with chest radiation.


Eligibility Criteria:
Inclusion Criteria:

* Participant in the CCSS cohort
* Diagnosed with a childhood cancer prior to 21 years of age
* Treated with \> 20 Gy of chest radiation (mantle, mediastinal, lung, or chest)
* Age 25-49 years at time of enrollment into the study
* Interval from chest radiation to the time of enrollment of \> 8 years
* No mammogram or other breast imaging study in the 24 months prior to enrollment
* English-speaking - The University of Colorado AMC Denver and MSKCC group are not capable of or equipped for conducting a brief motivational interviews by telephone in another language.

Exclusion Criteria:

* Diagnosed with breast cancer
* Participated in the Project VISION feasibility study (exposed to part of the intervention)