cyrilzakka/clinical-trials huggingface dataset:
Genetic Determinants of the Hypokalemic and Hyperglycemic Effect of Albuterol Inhalation

Several studies have indicated that albuterol administered either intravenously or by inhalation can significantly reduce plasma potassium concentration in patients suffering from chronic renal failure.In conjunction with the decrease in potassium concentration a modest rise in glucose concentration is usually noted. These metabolic effects are characterized by rapid onset occurring as early as 3-5 minutes following salbutamol administration and lasting for at least 1 hour.

The role played by ß2AR polymorphisms in determining the bronchial and vascular response to ß2AR agonist drugs, have been confirmed by several studies.

The purpose of the present study is to examine possible causal relationships between genetically based alteration in the structure of ß2AR and the metabolic effects of inhaled albuterol.


Eligibility Criteria:
Inclusion Criteria:

* patients regularly attending the nephrological clinic or the dialysis unit
* persistent potassium concentration above 5 mEq/L

Exclusion Criteria:

1. Patients suffering from active ischemic heart disease
2. Patient with a recent history of arrhythmia
3. Patients treated regularly with ß blockers
4. Patients treated regularly with salbutamol or other ß2AR agonists
5. Patients suffering from persistent tachycardia (pulse \> 100 beats/min)
6. Patients who are hemodynamically unstable
7. Patients suffering from any acute illness
How Hormones and Exposure and Response Prevention (EX/RP) Affect the Brain of People With OCD

Studies show that hormones affect the brain's fear extinction network, which is relevant for therapy involving exposure and response prevention (EX/RP), a first-line treatment for obsessive compulsive disorder (OCD). This study will examine the effect of delivering EX/RP to women during different phases in their menstrual cycle to determine the effects of hormones on the fear extinction network and on their OCD symptoms.

This study involves neuroimaging and a brief EX/RP protocol. The investigators will recruit both male and female participants. All participants will complete neuroimaging, hormonal assays and symptom ratings before and after a brief course of EX/RP. Female participants will be randomized to complete brief EX/RP during distinct phases of their menstrual cycles. This design will allow the investigators to study the effects of hormonal variation during the menstrual cycle and sex on the fear extinction network and on EX/RP outcome. The long-term goal is to optimize EX/RP for individuals suffering from OCD. Men will also be recruited for this study to further explore biological sex differences. The results will elucidate treatment mechanisms and could lead to personalized treatment recommendations for women with OCD.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) Diagnosis of OCD;
2. Male and female subjects aged between 18- 45;
3. Women must be menstruating and regularly cycling
4. Ability to tolerate a treatment-free period;
5. No psychotropic medication in the past 12 weeks
6. At entry, at least moderate severity OCD
7. Willingness and ability to give written informed consent after full explanation of study procedures.

Exclusion Criteria:

1. Use of birth control (oral contraception or IUD) that affects the menstrual cycle, or menopause.
2. Pregnancy. Women of childbearing potential will be required to sign a statement indicating their intention to avoid pregnancy during the study.
3. Neurologic or medical condition that would prevent safe participation in the full study protocol.
4. Any contradiction to magnetic resonance imaging (e.g., metallic implants or devices).
5. Comorbid psychiatric conditions that significantly elevate the risks associated with study participation or confound results.
6. Patients with prominent suicidal ideation or with a recent suicide attempt.
7. Current psychotherapy
Study of the Use of Orthopulse Photobiomodulation

This PMCF study evaluates the safety and performance of OrthoPulse photobiomodulation to accelerate tooth movement during alignment with fixed appliances.

The purpose of the current clinical investigation performed in form of a post-market clinical follow-up (PMCF) study is to evaluate the performance of OrthoPulse by means of confirming the hypothesis that Subjects in the interventional group (group 1) will have a statistically significant average faster rate of tooth movement during the alignment phase than the average of subjects in the control group (group 2) (estimated 1.8x faster tooth movement) and to substantiate the clinical data for the application of OrthoPulse in case of fixed appliances (brackets).

Eligibility Criteria:
Inclusion Criteria:

* Age: at least 18 years
* Indication for an orthodontic treatment with fixed appliances
* Presence of a written declaration
* Permanent dentition
* Class I-III malocclusion
* Between 4-10mm of crowding (estimated traditionally) in anterior teeth in mandibular arch (This will depend on the time we choose for the endpoint)

Exclusion Criteria:

* Simultaneous participation in another clinical investigation or study
* Prior participation in this study
* Persons who have been placed in an institution as a result of an administrative or judicial order
* Persons who are dependent on the sponsor, Investigator or the investigation site
* Anterior cross bite
* Spaces between anterior teeth
* Extractions or missing permanent teeth (except for third molars)
* No anticipated requirement of auxiliary appliances and/or elastics during treatment during alignment phase
* Acute oral infection or periodontal disease
* Active caries
* Pregnant patients or patients planning to become pregnant
Safety and Performance of the Glyconics-SX System

The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or assumed clinical status of the participants and as controlled by values of an internal biomarker indicative of glycaemia, HbA1c, as measured with validated, comparator device.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy adults (≥18 years of age) with known or unknown T2DM status willing to participate in and provide a written consent for the study
* willingness to undertake assisted assessment of glycaemia by both the NIR spectra measurement, and HbA1c by finger prick test
* Individuals with two visually assessed apparently healthy, undamaged, and intact fingernails, one in both right- and left-hand middle fingers

Exclusion Criteria:

* Individuals with any known medical conditions impacting either of the assessment methodology for glycaemia, such as

  * anaemia (iron deficiency sickle cell anaemia or similar)
  * haemoglobinopathies or atypical haemoglobin subtypes not detectable by regular assays,
  * severe renal impairment (CKD stage III-IV) or decompensated hepatic disease
  * severe Vitamin D deficiency
  * known severe immunodeficiency such as HIV, malignancy or other chronic condition significantly impacting assessment of glycaemia
  * eating disorders (as per clinical assessment)
  * Recent (within 28 days) blood donation
* Any structural, deviating and visually detectable deviations in the appearance of the nails potentially impacting the spectra measurement, including

  * nail dystrophy or deformity
  * severe nail infections (onychomycosis causing visual changes in the appearance of the nail)
  * rare hereditable conditions impacting the structure of keratin
  * mechanical damage or marks on the surface of the nail after removal of nail polish
  * use of acrylic or gel nail decoration and polish, which cannot be removed
* Any systemic or topical medication known to modify either the surface or structure of the nail or accuracy of HbA1c value.
Registration of Children With CML and Treatment With Imatinib

Newly diagnosed pediatric patients (age \< 19 years) with bcr-abl-positive CML will be treated with imatinib. Serial monitoring of treatment response is performed in one month intervals during the first three months of treatment and in three months intervals thereafter. Patients with non-response, poor response (either molecular, cytogenetic, or hematologic non-/poor response) or progress of the disease while under imatinib treatment will stop imatinib and undergo stem cell transplantation. All responders to imatinib treatment with an HLA matched donor will undergo stem cell transplantation not later than 2 years after diagnosis.

Indication:

Newly diagnosed pediatric patients with bcr-abl-positive CML.

Design:

Multicenter, non-randomized, open, prospective clinical trial.

Objectives:

Primary:

- assessment of antileukemic activity of imatinib in children and adolescents with Philadelphia chromosome-positive chronic myeloid leukemia

Secondary:

* assessment of the time-to event-efficacy variables
* correlation of the quality of haematological, cytogenetical and molecular remission in children and adolescents with CML on ongoing imatinib therapy with survival
* safety of imatinib

Endpoints:

Primary:

- rate of haematological, cytogenetical and molecular remissions

Secondary:

* time to progression
* duration of chronic phase
* time to loss of response
* overall survival
* assessment of treatment-related toxicities in children and adolescents.

Inclusion criteria:

Newly diagnosed Ph+ or bcr-abl-positive CML- Male and female patients aged 0 to 18 years- Written informed consent

Exclusion criteria:

* CML without bcr-abl rearrangement detectable by PCR
* Pretreatment with Interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of CML). However, these patients may be registered as observational patients.
* Any other severe underlying disease beside CML.
* Age \> 18 years
* Pregnant or lactating women
* Subjects unlikely to comply with the requirements of the protocol

Number of patients to be enrolled: 150

Recruitment period: 5 years

Treatment period: 2 years

Planned start of study: 2007

Planned end of study: 2013

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed Ph+ or bcr-abl-positive CML
* Male and female patients aged 0 to 18 years
* Written informed consent

Exclusion Criteria:

* CML without bcr-abl rearrangement detectable by PCR
* Pretreatment with Interferon alpha or any other cytostatic drug with the exception of hydroxyurea or anagrelide (Note: anagrelide is not approved in Germany for treatment of CML). However, these patients may be registered as observational patients.
* Any other severe underlying disease beside CML.
* Age \> 18 years- Pregnant or lactating women
* Subjects unlikely to comply with the requirements of the protocol
Acquisition and Analysis of Relationships Between Longitudinal Emotional Signals Produced by an Artificial Intelligence Algorithm and Self-questionnaires Used in the Psychiatric Follow-up of Patients With Mood and/or Anxiety Disorders: a Real-Environment Study.

The worldwide prevalence of anxiety and depression increased massively during the pandemic, with a 25% rise in the number of patients suffering from psychological distress. Psychiatrists, and even more so general practitioners, need measurement tools that enable them to remotely monitor their patients' psychological state of health, and to be automatically alerted in the event of a break in behavior.

In this study, the investigators propose to collect clinical data along with longitudinal measurement of patients' emotions. Emobot proposes to analyze the evolution of mood disorders over time by passively studying people's emotional behavior. The aim of EMOACQ-1 is to acquire knowledge and produce a quantitative link between emotional expression and mood disorders, ultimately facilitating the understanding and management of these disorders.

Through this study, could be developed a technological solution to support healthcare professionals and patients in psychiatry, a field known as the "poor relation of medicine" and lacking in resources. Such a solution would enable better understanding, disorders remote \& continuous monitoring and, ultimately, better treatment of these disorders.

The investigators will process the data by carrying out a number of analyses, including descriptive, comparative and correlation studies of the data from the self-questionnaire results and the emotional signals captured by the devices.

Finally, the aim will be to predict questionnaire scores from the emotional signals produced.


Eligibility Criteria:
Inclusion Criteria:

* Persons over the age of 18 who volunteer to take part in research
* Must have access to a computer with an Internet connection,
* Written comprehension of French.

Exclusion Criteria:

* N/A
Effect of Intercessory Prayer in Patients With Breast Cancer in Radiotherapy Treatment: Clinical Trial

Living with breast cancer and forms of treatment, among them radiation therapy can cause both side effects such as pain, fatigue and skin changes that affect the well-being, as anxiety, feelings of isolation and changes in routine, which generate existential conflicts and allow the origin of the spiritual anguish phenomenon, which in turn, aggravates the physical and emotional symptoms and the ability to fight the disease. Thus, this study aims to evaluate the effect of intercessory prayer on levels of spiritual distress, religious / spiritual coping, psychological morbidity (anxiety and depression) and amylase levels salivary present in patients with breast cancer radiotherapy.

Reflection on the existence and the meaning of life, common among people with breast cancer radiotherapy generates a suffering that, when directed to the spiritual dimension, results in spiritual distress. In addition, combined with the presence of this phenomenon can flourish during this phase psychological morbidity such as anxiety and depression. In order to face this situation, each person uses cognitive and behavioral strategy according to their beliefs and their meaning of life (religious / spiritual coping). The use of intercessory prayer, where an individual asks a higher being for the benefit of someone seen as receiver, is a strategy that can help people cope with the situation of illness and restore your health. Prayer is one of these activities in the nursing intervention "spiritual support" (5420) proposed by the Nursing Interventions Classification (NIC). a complementary alternative therapy is considered and can be used as an adjuvant in radiotherapy. Therefore, the aim of this study is to verify that the intercession of prayer cause positive effects on levels of spiritual distress, religious coping / spiritual and psychological morbidity (anxiety and depression) present in patients with breast cancer radiotherapy. Thus, a clinical trial will be used randomized controlled and mascaraed. Intervention group will receive the prayer of intercession and control groups (positive and negative) usual care. The data will be analyzed using the Statistical Package for the Social Sciences version 20.0 and will be adopted as the reference value p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with breast cancer in adjuvant and neoadjuvant radiotherapy treatment;
* Both female and male participants are being studiedolder;
* Minimum age of participants is 18 years.

Exclusion Criteria:

* Not being with consciousness, memory and orientation preserved;
* Patients with clinical conditions that affect the continuity in the study or express request not to continue participating in the study.
Protocol Optimization in CT for the Quantification of BMD

Bone mineral density is an important measurement to detect osteoporosis.

The goal of this clinical trial is to compare bone mineral density measurements in CT examinations and DXA scans. The main question it aims to answer is:

* How good is the measurement of bone mineral density in the new photon-counting CT in comparison to DXA
* How can we optimize the CT scan for bone mineral density

Participants will undergo:

* Clinically indicated CT scan on day of inclusion
* Study related DXA scan on a separate appointment


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent signed by the subject
* Referral to a regular clinically indicated CT examination covering the lumbar area (e.g., Abdomen, Thorax + Abdomen, Neck + Thorax +Abdomen)
* Informed written and oral consent (interpreter present in case of foreign language patients)
* No contraindication to the clinically indicated CT examination

Exclusion Criteria:

* Patients \< 18 years
* Pregnant women
* Vulnerable subjects
* Contraindications to the clinically indicated CT scan
* Multiple Myeloma
* Diffuse bone metastasis
* Fixateur interne in the lumbar spine
* Kyphoplasty in the lumbar spine
* Enterally administrated contrast agent
* Obtaining informed consent is not possible
* Withdrawal of consent orally or in writing
* Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
* Immobility (patients confined to a wheelchair or to bed)
Validate the Difficulty Scoring System and Develop a Novel Scoring System for Laparoscopic and Robotic Liver Resections

To validate the Iwate difficulty scoring system and Institut Mutualiste Montsouris (IMM) scoring system (Appendix 2) in both laparoscopic and robotic liver resections

Minimally-invasive liver resections (MILR) are increasingly conducted world-wide today. Several international consensus meetings were convened to enable the safe dissemination of laparoscopic and robotic liver resections. The Iwate difficulty scoring system (Appendix 1) was formulated in Japan to grade the difficulty of liver resections. This was to allow beginners to adopt a stepwise approach to safely perform MILR according to their experience and competency level. Although this system has been recently validated in a recent Japanese multicenter study, it has not been externally validated in a large cohort of patients. Thus far, it has only been validated in several small single center studies. Furthermore, its utility for robotic liver resections has not been well-studied.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients operated at a single institution during a fixed period
* Most recent operation date allowed (up till December 31, 2020, to allow three months follow-up).
* All minimally invasive hepatectomy approaches can be included, including lap- assisted (hybrid), hand-assisted, robotic-assisted and pure laparoscopy.
* The data of all patients including those that had repeat liver resections, concomitant surgeries (e.g. colectomies, hilar lymph node dissection, enbloc resections) may be included
* Patients with no "liver tumors" such as recurrent pyogenic cholangitis/ gallbladder may be included
* The site of the "lesion/ pathology" will be considered as the tumor site, size will be considered less than 3 cm unless tumor invades the liver.

Exclusion Criteria:

* • Patients \< 18 years of age

  * Patients with liver transplant living donor hepatectomies
Subcostal TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Donor Nephrectomy Patients: A Prospective Study

The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

The primary objective of this study is whether one local anesthetic, liposomal bupivacaine, provides improved pain control and decreased opioid use compared to bupivacaine when injected during a transversus abdominis plane block for donor nephrectomy patients.

Background and treatment procedure: Liposomal bupivacaine is a multi vesicular formulation of bupivacaine that has been shown to provide up to 72 hours of analgesia compared to bupivacaine which provides up to 24 hours of analgesia post injection. These two medications have been compared using a infiltration or injection at the site of incision but have yet to be compared when used during a TAP block. A TAP block is an injection of local anesthetic under the covering of the transversus abdominis muscle layer. This layer is found using an ultrasound which is a beam of high frequency sound that allows one to visualize images in the body. Then using this ultrasound we can see our needle as it pierces the covering of the transversus abdominis muscle layer and watch as the local anesthetic is injected into this plane. This is done on both sides of the abdomen to provide analgesia to the skin, muscle, and fascial layers of the abdomen.

Population: Adult patients who are undergoing a donor nephrectomy Rationale: It will be useful to determine if one formulation or the other provides better and longer lasting pain control for patients undergoing abdominal procedures.

Eligibility Criteria:
Inclusion Criteria:

* presenting for donor nephrectomy

Exclusion Criteria:

* non english speaking
* chronic pain condition
* taking chronic opioids
MyLife MyStyle Evaluation Project

The purpose of the MyLife MyStyle Evaluation Project is to determine whether the MyLife MyStyle group-level intervention reduces HIV sexual-risk behaviors among 18- to 29-year-old African American men who have sex with men (MSM). Specifically, the project will test whether participants of the MyLife MyStyle program will report at least a 15% absolute decrease in frequency of unprotected anal sex with male partners at three and six months post-intervention compared with the wait-list control participants.

In Los Angeles County, as well as nationally, the primary mode of HIV transmission for African American men is sexual contact with another man. According to national data from 45 states with name-based HIV surveillance in 2006, the majority of all new HIV infections among African American males were associated with sex with other men. The disproportionate impact of HIV in AAMSM in Los Angeles County is also observed in provisional HIV surveillance data. Between 2002 and 2004, AAMSM composed 16.3% of the new HIV diagnoses among males in Los Angeles County, with an average annual HIV diagnosis rate 2.0 and 2.5 times greater than the rates of new HIV diagnosis for White and Latino MSM, respectively. In addition to demonstrating the highest HIV prevalence and incidence estimates, AAMSM also had the highest proportion of previously unrecognized HIV infection (67%) compared with all other racial/ethnic groups. Given significant and continuing disparities in HIV infection among African Americans in the United States, and specifically among AAMSM, more intervention programs must be planned, implemented, and tested in order to reduce the heavy toll of HIV/AIDS in this population. Components of these intervention programs must be culturally competent and should include promotion of HIV counseling and testing to reduce the high prevalence of unrecognized HIV infection in AAMSM. Interventions should also take into consideration the many co-factors that may hinder AAMSM from addressing their HIV risk such as racism, poverty, stigma, and homophobia. The MyLife MyStyle Evaluation Project aims to implement and evaluate the efficacy of a "homegrown" group-level intervention to reduce HIV risk (unprotected anal sex with male partners) among young African American MSM in Los Angeles County, CA.

Eligibility Criteria:
Inclusion Criteria:

* Identify as African American or Black
* Identify as male
* Age 18 to 29 years
* Reside within Los Angeles County
* Self-reported anal sex with a male partner in the past 12 months
* Has not participated in an HIV prevention intervention in the past 3 months
* Able to complete ACASI and MyLife sessions in English

Exclusion Criteria:

* Identify as a transgender female
* Plan to move out of Los Angeles County before the end of their follow-up period (within 7 months)