cyrilzakka/clinical-trials huggingface dataset:
Somatuline® Depot (Lanreotide) for Acromegaly Post-Marketing Observational Study

To assess the safety and effectiveness of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care.

The objectives of this post-marketing observational study are to assess the safety and effectiveness, as measured by insulin-like growth factor-1 (IGF-1) and growth hormone (GH) levels, of Somatuline® Depot (lanreotide) Injection when administered by a health care professional (HCP), the patient, the patient's partner or parent/guardian as part of their routine acromegaly care. Treatment convenience and acromegaly symptom relief will also be assessed through questionnaires, and demographic and medical history information will be collected.

Eligibility Criteria:
Inclusion Criteria:

* The patient must have a clinical diagnosis of acromegaly
* The patient must be treated with Somatuline® Depot (including patients newly prescribed Somatuline® Depot)
* The patient or legally authorized representative must be able to understand the protocol and give signed informed consent. Assent from the patient should also be obtained, where appropriate. Signed informed consent and assent must be obtained before any study-related activities are conducted.

Exclusion Criteria:

* Symptomatic, untreated biliary lithiasis
* Known hypersensitivity to somatostatin analogs or related compounds (e.g., octreotide)
Implementing a Comprehensive Handoff Program to Improve Patient Safety

The investigators propose to test the hypothesis that implementation of a comprehensive handoff program (CHP) - i.e., implementation of a computerized handoff tool along with teamwork training for internal medicine residents on inpatient units at Walter Reed and Madigan Army Medical Centers - will lead to reductions in resident miscommunications / medical errors and improvements in workflow and experience on the wards.

Following collection of baseline data on inpatient wards at both hospitals, teamwork training will be provided, accompanied by the introduction of a new computerized handoff tool that facilitates accurate transmission of data. The effects of this combined intervention on safety and workflow will be assessed on the intervention wards at both hospitals as compared with the historical control period.

Eligibility Criteria:
Inclusion Criteria:

* all internal medicine residents completing rotations through intervention units during data collection periods

Exclusion Criteria:

* none
Reference Values for Compound Muscle Action Potential Amplitude Obtained by Direct Muscle Stimulation

Direct muscle stimulation (DMS) method is one of the electrodiagnostic methods used in the diagnosis of critical illness myopathy (CIM) and critical illness neuropathy (CIN). The ratio of amplitude of compound muscle action potential (CMAP) obtained by nerve stimulation (nCMAP) to amplitude of CMAP obtained by DMS (dmCMAP) can be used to differentiate these two diseases. Although not certain, if the ratio is \< 0.5, the diagnosis is thought to be consistent with CIN. The ratio \> 0.5 is considered to be a finding supporting CIM. The investigators aimed to find the reference values of the ratio from healthy individuals. A monopolar needle electrode was used for DMS. The dmCMAP and nCMAP were recorded with a concentric needle. The ratio was calculated by using amplitudes of dmCMAP and nCMAP obtained from deltoid and tibialis anterior muscles.

Age, gender, height, weight, body mass index and neurological examination findings of the participants were recorded. Healthy participants were not included if they had; polyneuropathy or a disease such as diabetes mellitus that causes polyneuropathy, complaints such as weakness or paresthesia, a neurodegenerative disease, abnormal neurological examination, myopathy or hereditary polyneuropathy in family history. In addition, healthy participants were excluded if the conventional nerve conduction study and needle electromyography (EMG) findings were abnormal. Median, ulnar, posterior tibial, peroneal, superficial peroneal, sural nerve conduction studies were performed to all participants. Needle EMG and direct muscle stimulation were applied to the deltoid and tibialis anterior muscles of the healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals

Exclusion Criteria:

* Polyneuropathy
* a disease such as diabetes mellitus that causes polyneuropathy
* complaints such as weakness or paresthesia
* a neurodegenerative disease
* abnormal neurological examination
Home Management of Malaria and Pneumonia

A well-implemented community-based program of early and appropriate treatment of fevers/malaria episodes and pneumonia,will improve child survival as measured by a reduction of the less than five mortality rate.

An integrated approach of home and community management of malaria and pneumonia may increase the proportion of children receiving prompt treatment; improve child survival as measured by a reduction of the under five mortality rate. To test this hypothesis, a cluster randomised controlled trial will be performed, involving children less than 5 years of age, in Burkina Faso using a community-based supplying community health workers (CHWs), a core group of mothers (KOLs) with Coartem and cotrimoxazole specially packed in age-specific blisters containing a full course of treatment. The study will be carried out in 111 clusters of a rural district in Burkina Faso where malaria and pneumonia are two major mortality causes in under five mortality.

Eligibility Criteria:
Inclusion Criteria:

* living in one of the study cluster (villages)
* no story of allergy to any of the study drugs
* history of fever or body temperature \>= 38.5°C

Exclusion Criteria:

* signs of severity/complications like impaired consciousness, convulsions, fast breathing etc
Frequently Asked Questions for ICU Patients' Families

The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in ICU, intubated and mechanically ventilated during the first 48 hours of the stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ

Half of the families of ICU patients do not understand the information provided by doctors and nurses. Receiving clear, loyal and appropriate information is one of their main expectations. We have previously reported that relatives had difficulty asking questions that allow them to improve their understanding regarding ICU issues. In a preliminary study, we developed a list of questions considered as important by families, ICU doctors and nurses.

The aim of this prospective, randomized and controlled trial is to test the effectiveness of a list of frequently asked questions to relatives of ICU patients on their understanding of the provided information.

The intervention consists of the delivery of a list of 21 questions to the relative of each patient admitted in intensive care, intubated and mechanically ventilated in the first 48 hours of ICU stay. A formal interview is scheduled for relatives at Day 3 of inclusion. The information comprehension at Day 5 (± 1) will be compared between families that received the list of "FAQ" and families that received information as usual (without providing the list of FAQ).

Eligibility Criteria:
Inclusion Criteria:

The subjects that will be included are relatives of patients. The patients must be

1. Adults
2. Receiving invasive mechanical ventilation
3. Intubated in the first 48 hours of ICU admission
4. For an expected duration of mechanical ventilation \> 48 hours
5. With a life expectancy of at least 5 days and a SAPS 2 at baseline \< 75
6. Who received a visit within 24 hours after intubation. Only one relative will be included.

Exclusion Criteria:

* person unable to read French
French Prospective, Observational Cohort Study of Patients With Fabry Disease Treated With Migalastat

This is a noninterventional cohort study to evaluate the effects of migalastat, on long-term safety, effectiveness, and quality of life (QOL) in patients with Fabry disease.

Occurrence of key indicators of safety and effectiveness will be evaluated, such as cardiac, cerebrovascular and renal events, and overall survival. The study is designed to provide effectiveness and safety data by Q2 2023 which will cover a period up to 5 years after the migalastat launch date.

This will involve a retrospective data collection up to migalastat initiation (for patients already receiving migalastat) and a prospective follow-up from 1 to 3.5 years (depending on the time of enrollment) in migalastat-treated patients with Fabry disease who have a GLA mutation amenable to migalastat.

All visits will be scheduled and conducted according to the clinical site's standard of care. Standard of care is defined as a diagnostic and customary clinical treatment/practice process that a clinician chooses according to their clinical judgement for a Fabry disease patient. There are no study- required visits, tests or clinical assessments.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Fabry disease aged 16 years or older
* eGFRCKD-EPI \> 30 mL/min/1.73 m2
* treated with migalastat, or who are starting migalastat upon enrollment
* Patients with Fabry disease and/or parents/guardians (when applicable) who are able to understand and have provided a signed non-opposition form.
* Equipped with a web connection via a computer or tablet

Exclusion Criteria:

* Patients who are participating in a clinical trial of any investigational medicinal product or device at the time of enrollment.
* Patients already included in the present study
Analysis of Ameliorative Effects of Oral Probiotics on Bacterial Vaginosis

The purpose of this study is to analyze the ameliorative effects of oral probiotics on bacterial vaginosis.

To analyze the oral Lactobacillus rhamnosus with Lactobacillus acidophilus or Lactobacillus rhamnosus with Lactobacillus plantarum could be ameliorative effects for bacterial vaginosis.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form.
* Subjects with bacterial vaginosis and Nugent score as 4-10
* Subjects in age of 20-55 years old
* Regularly menstruating premenopausal women (normal menstrual function (Eumenorrhoea) shall mean regular menstrual bleeding pattern every 28 plus/minus 10 days)
* Forbidden sexual behavior was required 72 hours before all visits

Exclusion Criteria:

* Subjects are pregnant, lactating or planning to become pregnant.
* Allergy to test products (raw material components included: Anhydrous glucose, Magnesium stearate, Fructooligosaccharides, Microcrystalline cellulose, Lactobacillus, etc.)
* Bleeding from genital tract of unknown aetiology.
* Congenital and acquired immunodeficiencies.
* Diabetes
* Mental illness
* Malignant tumor
* Application of NuvaRing hormonal contraceptive vaginal ring
* Application of mechanical contraceptives, such as: diaphragms, intrauterine contraceptive insert, except condom
* Application of hormonal preparations, such as: Vagifem, Ovestin and vaginal estrogens in reproductive period.
* Mycotic vaginitis
* Antibiotic(unless indicated by PI) and steroids therapy during this trial.
* Use of oral or vaginal probiotic products (sachet, capsule, or tablet) four weeks before V1.
* Participation in another clinical study.
A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function

The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

General criteria

* Signed informed consent prior to any study-mandated procedure
* Body mass index of 18.0-30.0 kg/m2 (inclusive) at Screening
* Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at Screening and on Day -1 of the first Period
* 12-lead ECG: QT interval corrected using Fridericia's formula (QTcF) \<450 ms for male subjects and \< 470 ms for female subjects, QRS interval \< 110 ms, PR interval ≤ 200 ms, and heart rate (HR) ≤ 90 bpm without clinically relevant abnormalities using a 12-lead ECG measured after 5 min in the supine position at Screening and on Day -1 of the first Period

Study-specific criteria

* Women of non-childbearing potential
* Male subjects must accept to use a condom and not to procreate for the duration of the study and for 3 months thereafter

Exclusion Criteria:

General criteria

* Previous exposure to clazosentan or to moxifloxacin within 3 months prior to Screening
* Known hypersensitivity to any of clazosentan excipients or to moxifloxacin or any of its excipients
* Any contraindication to moxifloxacin treatment
* Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the study
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions if considered clinically significant by the investigator
* Veins unsuitable for i.v. puncture on either arm (e.g., veins that are difficult to locate, access, or puncture, veins with a tendency to rupture during or after puncture)
* Participation in a clinical study involving study treatment administration within 3 months prior to Screening or in more than 4 clinical studies within 1 year prior to Screening
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Study-specific criteria

• History or presence of rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, second- or third-degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation)
Real-World Use of Selinexor, Daratumumab and Dexamethasone in Chinese Patients With Multiple Myeloma at First Relapse

This is a single-arm, prospective, non-interventional, real-world study to observe and evaluate the efficacy and safety of selinexor in combination with daratumumab and dexamethasone in patients with multiple myeloma at first relapse.

This is a non-interventional, prospective, observational post-marketing surveillance study of selinexor, daratumumab and dexamethasone in participants with multiple myeloma (MM).

The study will assess the safety and effectiveness of selinexor in combination with daratumumab and dexamethasone (XDd) for first relapse MM patients under real-world conditions.

The study will enroll approximately 34 participants. The data will be prospectively collected, at our center from medical files and recorded into electronic case report forms (e-CRFs).

The overall duration of the study will be approximately 3 years. Data will be collected over and up to a 12 months-surveillance period (per participant) once enrolled.

Eligibility Criteria:
Inclusion Criteria:

1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
2. Subjects must have previously received 1 anti-myeloma regimens. Subjects must have documented disease progression
3. Age ≥18 years;
4. Life expectancy \> 6 months;
5. patients should provide available clinical case files and/or detailed records of medical history, diagnosis and treatment information, and cooperate with clinical management;
6. Fertile women and men whose partner is of childbearing potential or pregnant should agree to practice complete abstinence or to use a condom during therapy and dose interruptions and for 90 days after the last treatment.

Exclusion Criteria:

1. Patients who are contraindicated as per product label of XDd;
2. Known positive for HIV or active hepatitis B or C or other infectious diseases;
3. Pregnancy or lactation;
4. Patients with a history of malignant tumor that may affect the implementation or results analysis of this study (except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, intramucosal carcinoma of the gastrointestinal tract in situ, and localized prostate cancer);
5. Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results;
6. Patients who are unsuitable for this study judged by clinicians.
Rapid HIV Testing and Counseling in Drug Abuse Treatment

This is a randomized controlled clinical trial in which adults receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV risk behaviors.

This is a randomized controlled clinical trial in which individuals receiving drug abuse treatment will be recruited to participate in a multi-center HIV testing and counseling study. The purpose of this study is to assess the relative effectiveness of three HIV testing strategies on increasing receipt of HIV test results: (1) on-site HIV rapid testing with brief, participant-tailored prevention counseling, (2) on-site HIV rapid testing with information only, and (3) referral for off-site HIV testing. The study will also assess the effectiveness of the three testing strategies in reducing HIV sexual risk behaviors. Injection drug risk behavior will be a secondary outcome. Participants will complete a baseline assessment to report their demographics, HIV testing history and sexual and drug-using risk behaviors, and will be randomized to one of three groups. At one month post-randomization, participants will complete a follow-up assessment to determine whether or not they received their HIV test results. At six months post-randomization, participants will complete a follow-up assessment to assess any changes in their HIV sexual risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* HIV-negative or HIV status unknown
* No receipt of results from HIV test initiated within last 12 months
* Be able to communicate in English
Erector Spinae Plan Block (ESPB) with Dexmedetomidine and Dexamethasone in Lumbar Spine Fusion

This study wants to understand if using a pre-operative anesthetic injection could contribute to better pain relief after the surgery. This injection is referred to as an erector spinae plane block (ESPB, or "Block" for short). In the past, blocks have been commonly used to alleviate different types of pain, including pain following lumbar spine surgery, but our investigators are curious to study if adding two additional commonly used drugs could improve pain relief following surgery when used together. This possibility for improvement in pain management is important for our doctors to study because they want to find ways to reduce the amount of pain medication required after surgery.

We try to assess if one treatment is better than the other by looking into the amount of pain medication used immediately after the surgery (up to five times within the first 2 days; this is usually done by reviewing progress notes) and by asking patients if they can share with us their pain experienced at different times during their stay at the hospital and at 2-weeks after their procedure.

Regional anesthetic techniques, including interfascial plane blocks, have demonstrated success in postoperative pain control and improved patient satisfaction. Erector spinae plane blocks (ESPB) are a relatively new regional anesthetic modality, which have shown potential for perioperative pain control in lumbar spinal surgery. This study aims to investigate whether adding dexmedetomidine and dexamethasone as adjuncts to bupivacaine in ESPB improves analgesia and reduces opioid usage in lumbar spinal fusion patients receiving multimodal pain regimens. It will also assess the impact of these adjuncts on postoperative nausea and vomiting (PONV) and anti-emetic medication requirements. The study employs a randomized, double-blind design, with participants divided into two groups: ESPB without adjuvants (Group A) and ESPB with dexmedetomidine and dexamethasone (Group B). Primary outcomes include opioid consumption at 24 hours postoperatively, while secondary outcomes involve opioid consumption at various time points and visual analog scale (VAS) pain scores. The results of this investigation will provide valuable insights into the efficacy of ESPB with adjuncts in postoperative pain management in lumbar spinal fusion patients.

Eligibility Criteria:
Inclusion Criteria:

* Medically optimized patients undergoing 1-3 level lumbar fusion surgery for treatment of degenerative lumbar spinal pathologies
* Aged 18 years or older
* English-speaking patients

Exclusion Criteria:

* Patients with surgical indications for infection, malignancy, or trauma
* women who are pregnancy or breastfeeding
* Patients with respiratory compromise
* Patients who are smokers
* Patients with allergies to local anesthetics, and/or opioid medications
The Effectiveness of Cancer Pain Management in Siriraj Outpatient Pain Clinic

-Background: Cancer is one of the most common cause of death. Cancer pain is often cited as one of the most feared in cancer patients. Although, WHO guidelines have been provided to improve pain outcome, the results are still unsatisfied. In order to improve cancer pain management we consider to contribute a new guideline which includes interdisciplinary approach, early doing the pain interventions, breakthrough pain, education, high quality of pain assessment and contribute the effectiveness follow-up system

* Objectives:Primary outcome is study the effectiveness of new approach and closed follow up system by relief pain intensity 30% at 3 month up to 80% of all new cancer pain patients in OPD setting Secondary outcomes are quality of life (BPI,ESAS), side effect of treatments and the contributing factors that impact on the outcomes
* Study design:A prospective observational study
* Sample size : 150
* Data collection: General information: age, gender, body weight, height, religion, residence, care giver, occupation, income, education, medical problem Clinical pain information: primary diagnosis, staging, cancer site, current medications Clinical assessment: at three study time points: baseline (initial assessment) and the three subsequent follow-ups (FU1, FU2 and FU3)

Eligibility Criteria:
Inclusion Criteria:

* Cancer pain patients
* more than 18 years old

Exclusion Criteria:

* Clinical instability
* Cannot read and write
* Do not know the diagnosis