cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Low Amplitude Electroconvulsive Therapy

The purpose of this study is to demonstrate the clinical feasibility of low amplitude electroconvulsive therapy (ECT) to reduce, and possibly eliminate the side effects of ECT by lowering the strength of the ECT stimulus from the conventional 800 mA to 500 mA. Low amplitude ECT could potentially reduce the risks associated with ECT while preserving its unparalleled efficacy. This novel development would remove key obstacles to allow for the wider adoption of ECT as a safe and effective therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects, age 18-70
2. DSM-IV-TR diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the MINI-PLUS
3. MMSE total score \> 26
4. Referred for ECT
5. Competent to provide informed consent
6. Able to read or comprehend English

Exclusion Criteria:

1. Lifetime history of schizophrenia, schizoaffective disorder, mental retardation
2. Current neurostimulation treatment (e.g., ECT, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation)
3. Current alcohol abuse or dependence within past 6 months
4. Current substance abuse or dependence within past 6 months
5. History of central nervous system (CNS) disease
6. Current diagnosis of dementia or delirium
7. MoCA total score \< 26
8. Current visual, auditory, or motor impairment that compromises ability to complete evaluations
9. Patients with intracranial implants
10. MRI contraindications: pregnancy, implanted metal, and claustrophobia
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the effectiveness and safety of JNJ 49095397 in participants with symptomatic moderate to severe chronic obstructive pulmonary disease (COPD).

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect in a clinical study), multicenter, parallel-group (each group of participants will be treated at the same time) study. Approximately 200 participants will be randomly assigned to JNJ 49095397 or placebo in the ratio 1:1. The study consists of 3 phases: screening (3 weeks), double-blind treatment (12 weeks), and follow up (4 weeks). Safety evaluations will include assessment of adverse events, vital signs, physical examination, electrocardiograms, and clinical laboratory tests which will be monitored throughout the study. The total duration of the study for each participant will be approximately 19 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of non-child-bearing potential, Global Initiative for Chronic Obstructive Lung Disease (GOLD 2 or 3), forced expiratory volume in one second (FEV1) greater than or equal to 40 less than 80 percent predicted, FEV1/ forced vital capacity (FVC) ratio less than 0.7
* Clinical history of chronic bronchitis. Either two chronic obstructive pulmonary disease (COPD) exacerbations in past two years or ability to produce a spontaneous sputum sample, treated with long-acting beta-2 agonist (LABA)/ long-acting muscarinic antagonists (LAMA), with or without inhaled corticosteroids for at least 12 weeks prior to study entry
* Smoker or ex-smoker with at least a 10 pack-year history
* No COPD exacerbation that requires change in COPD maintenance medications during the screening period
* Not experienced a significant worsening of COPD based on clinical symptoms and by investigations during screening period

Exclusion Criteria:

* Has another pulmonary disease (eg, asthma) or an active infection (eg, tuberculosis)
* Has experienced life-threatening COPD (eg, requiring intensive care unit \[ICU\] admission, intubation, or long-term non-invasive ventilation). Short-term (less than five days), non-invasive ventilation during a hospitalization for an acute exacerbation of COPD is permitted, provided that non-invasive ventilation was not continued at home
* Has right heart failure or oxygen saturation less than 90 percent at rest on room air at screening or requires oxygen therapy on a daily basis for chronic hypoxemia (deficiency of oxygen in blood)
* History of significant disease or medical illness within 12 months prior to screening - Positive serology to human immunodeficiency virus (HIV)-1 or HIV-2, hepatitis B virus, or hepatitis C virus at screening
Customer Support Response Study

The primary objective of the CUSTOM study is to respond to customer support issues (outside of the US) and to assess the impact of a particular treatment or perturbation relative to an initial control measurement. Sequential subject measurements will be analyzed to determine if a given action or condition induces a score shift, an inflation of measurement variance or elevated outlier rates.

The SCOUT DS device is not yet approved by the FDA for sale in the United States, but currently is being marketed in Canada and other countries. Customers who are using the device have contacted the sponsor with questions about testing conditions which might affect the reproducibility of measurements.

The objective is to obtain information to allow the Sponsor to address these issues. The concerns fall into three broad categories:

• Factors affecting the interface between the skin and the test sensor

These would include the effects of skin care products applied to the forearm, subject activity that changes perfusion to the skin and subject movement during the test procedure.

* General operating conditions Issues such as ambient temperature, lighting, and height of the table on which the SCOUT DS device rests have been questioned as possible factors influencing accuracy.
* Rare subject disorders

Included here would be subject skin abnormalities or physiologic changes which occur so infrequently that they were not well represented in previous data sets. Examples of such rare conditions would include scleroderma, capillary angiomata, and Raynaud phenomenon.

Eligibility Criteria:
Inclusion Criteria:

* Males and/or females greater than or equal to 18 years of age

Exclusion Criteria:

* Have received investigational treatments in the past 14 days
* Have psychosocial issues that interfere with an ability to follow study procedures
* Are known to be pregnant
* Have scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
* Have been treated on the past month with oral steroid therapy or topical steroids applied to the left forearm. Inhaled steroid therapy is not a basis for exclusion
* Are receiving medications that fluoresce (A list of excluded medications is located in Appendix H)
* Are known to have, or at risk for, photosensitivity reactions (e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)
METASARC: Patterns of Care and Outcomes in METAstatic Soft Tissue SARComa

Well-designed observational studies of individuals with rare tumors are needed to improve patient care, clinical investigations, and the education of healthcare professionals.

The patterns of care, outcomes, and prognostic factors of a cohort of 2225 patients with metastatic soft tissue sarcomas who were diagnosed between 1990 and 2013 and documented in the prospectively maintained database of the French Sarcoma Group will be analyzed with a focus on : number/frequency of systemic treatments per patient, number/frequency of patients with locoregional treatment of the metastasis, number/frequency of patients with chemotherapy, number/frequency of patients with an off-label drug.

Outcome (time-to-next treatment \[TNT\] and overall survival \[OS\]) will be reported according to histological subtype, as well as the association between TNT and OS.

Prognostic factors of OS will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* advanced soft tissue sarcoma
* age \> 18

Exclusion Criteria:

-
Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma

This is a piolt single-arm trial of Jiu-wei-zhen-xiao Granule, extracted from nine kinds of Chinese medicnie, for the treatment in patients with advanced, unresectable hepatocellular carcinoma(HCC). The primary objective is to assess its therapeutic efficacy in patients with unresectable HCC. The primary endpoint is overall survival (OS) after the use of 12-week drug. Secondary endpoints include progression-free survival (PFS) after the use of 12-week drug, the improvement of the score of the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), the changes of the liver function, coagulation function, the size of solid tumors,"Du-tan-yu-jie Zheng" in Chinese medicine, pain Visual Analogue Scale and toxicity profile of Jiu-wei-zhen-xiao Granule.


Eligibility Criteria:
Inclusion Criteria:

1. Age:18\~75 years;
2. Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:

(1) Histopathology; (2) Elevated serum alpha-fetoprotein (AFP) \>400 ng/ml and findings on magnetic resonance imaging (MRI) or computed tomography (CT) scans characteristic of HCC; (3) Findings on triple phase MRI or CT scans characteristic of HCC in patients with cirrhosis and tumors at least 1 cm or greater, without a curative treatment option (transplant, resection, or ablation).

3.The clinical staging of HCC is B or C or D staging as the Barceln Clinical Liver Cancer Classification(BCLC);

4. Patients with hepatitis B virus infection;

5. Patients with "Du-tan-yu-jie Zheng" in Chinese medicine;

6. Karnofsky score ≥60;

7. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients with unstable vital signs;
2. Any uncontrolled, severe, intercurrent illness including but not limited to ongoing or active infection, heart, brain, lung and other systemic diseases or other kinds of tumors;
3. Known history of allergy to the ingredients of this product;
4. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment;
5. Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
6. Patients who cannot take oral medication.
Effective Communication to Improve Decision Making About Health Care Plans

The overall goal of the study is to better understand how communication strategies can help people make decisions about health insurance plans.

This study aims to:

* (Aim 1) Examine currently uninsured individuals' understanding of terminology and details of health insurance plans;
* (Aim 2) Apply three recommended strategies for communicating information about health insurance plans;
* (Aim 3) Test the effects of these strategies in a randomized experiment.

First, this study will examine people's understanding of health insurance plan terminology and details through qualitative interviews with 50 uninsured individuals. These responses will then lead to the development of three communication strategies to improve understanding of health insurance plans: 1) plain language, 2) plain language plus visual displays and 3) plain language plus narratives.

The strategies will the be pilot tested with 30 individuals to assess readability, clarity of language, and layout. The revised communication strategies will be tested with 280 individuals in a randomized experiment. Individuals will be randomly assigned to either a plain language condition alone, a plain language + visual displays condition, and a plain language + narrative condition.

Eligibility Criteria:
Inclusion Criteria:

* Must be without health insurance currently
* Must have been without health insurance at some point in the past 12 months
* Must speak English

Exclusion Criteria:

* Currently has health insurance and has not had any lapses in coverage in the past 12 months
* Does not speak English
Treatment of Primary Hyperoxaluria Type 1 With Nedosiran

The purpose of this program is to provide participants with access to an investigational drug, nedosiran, for treatment of primary hyperoxaluria type 1 (PH1). Eligible participants may receive nedosiran in this program until the drug is commercially available or until Novo Nordisk terminates the program, whichever comes first. Novo Nordisk may terminate the program at any time for any reason, including if the drug receives regulatory approval and becomes commercially available, or if the drug does not receive regulatory approval. Nedosiran will be given once a month with a thin needle in the thigh or abdomen. The study doctor will ask the participant to come to the clinic monthly. The study doctor may allow participant to take nedosiran at home for self-administration. The participant should let the doctor know if they are unable to make a visit so it can be rescheduled. Participants to inform the study doctor of any medications they are taking, including over the counter medicines, vitamins, and herbal medicines. If any medications change in dose, or new medications are added, participants should inform the study doctor. Study doctor should be informed of any new or continued health problems or any changes in the participant's health.


Eligibility Criteria:
Early Access Eligibility Criteria:

* Written, signed, and dated informed patient/parent consent; and for patients who were minors, age-appropriate assent (performed according to local regulations)
* Male or female patients at least 2 years of age
* Genetically-confirmed diagnosis of PH1
* Accessible for treatment and follow-up and be able to comply with treatment monitoring requirements
* Not eligible for an ongoing RNAi therapy trial and not participating simultaneously in any interventional clinical research study
* Patients with PH1 that are not satisfactorily treated with current standard of care; i.e., 24-hour urinary oxalate (Uox) excretion ≥ 0.7 (millimoles) mmol for participants 18 years and older, or greater or lesser than (≥) 0.7 mmol per 1.73 metre square (m\^2) body surface area (BSA) for participants less than 18 years of age
* Estimated GFR at screening ≥ 30 millilitres per minute (mL/min) normalized to 1.73 m\^2 BSA
* No renal or hepatic transplantation; prior or planned within the treatment period
* No documented evidence of clinical manifestations of systemic oxalosis (including pre existing retinal, heart, or skin calcifications, or history of severe bone pain, pathological fractures, or bone deformations)
* Patient not currently on dialysis
* Plasma oxalate ≤ 30 micromoles per litre (μmol/L)
* Female patients not breastfeeding or pregnant
* The potential benefit for the individual patient justifies the potential risks of treatment as per prescribing physician judgment
Determination of ED90 of Intrathecal Lidocaine for Adequate Anesthesia for Elective Cervical Cerclage Surgery

Cervical incompetence complicates approximately 1 in 500 pregnancies . Those women with cervical incompetence are at risk for second trimester spontaneous abortion and preterm labor. Cervical cerclage reduces these risks but must be performed under general or neuraxial anesthesia. Some anesthesiologists prefer neuraxial anesthesia, as it reduces fetal exposure to medications and avoids the risks associated with loss of maternal airway reflexes under general anesthesia. Spinal anesthesia, in particular, has the added advantage of being technically simple while still providing a rapid, dense sensory block. For cerclage placement, patients require a sensory block from the T10 to S4 dermatome in order to cover sensation from the cervix as well as the vagina and perineum. Patients presenting for cerclage under spinal anesthesia pose a dosing challenge given the physiologic changes associated with pregnancy. As women progress with their pregnancy, they require lower doses of intrathecal local anesthetic to achieve similar block level. Multiple studies have demonstrated that these changes start during the second trimester. Inadequate sensory coverage with a spinal anesthetic typically necessitates conversion to general anesthesia, causing additional time wasted and added risk to the patient and fetus. Anecdotally, this is the reason why some anesthesiologists choose general anesthesia for patients undergoing cerclage over a spinal anesthetic. As there is currently no literature determining the correct dosage for these patients, we propose a dose-response study to determine the ED90 of intrathecal lidocaine for adequate anesthesia for elective cervical cerclage placement.The findings of this study will help determine the minimum dose of intrathecal lidocaine necessary to provide adequate spinal anesthesia for cervical cerclage for 90% of women. This will help decrease the frequency of inadequate anesthesia for cervical cerclage.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who is at least 18 years old
* ASA physical class I or II
* BMI \<40 kg/m2,
* Presents for elective cervical cerclage during their first or second trimester of pregnancy will be eligible to participate.

Exclusion Criteria:

* Any patient who is not a candidate for neuraxial anesthesia (including coagulopathy,
* Local skin infection, uncorrected hypovolemia)
* Allergy to lidocaine or fentanyl
* Chronic opioid user
* History of failed neuraxial anesthesia or analgesia,
* Had prior spine surgery
* Can not assume a sitting position for spinal anesthesia due to risk of amniotic membrane rupture
A Phase IIa Study Assessing the Effects of AZD1236 on Biomarkers in Chronic Obstructive Pulmonary Disease (COPD) Patients

The primary aim of this study is to investigate the effects of AZD1236 compared with placebo ("inactive substance") in COPD patients by analysing biomarkers for inflammation and tissue degradation in blood, urine and sputum.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD for 1 month
* Men or postmenopausal women
* Spirometry values indicating symptomatic patients
* Smoking history equivalent to using 20 cigarettes a day for 10 years.

Exclusion Criteria:

* Any current respiratory tract disorders other than COPD
* Requirement for regular oxygen therapy
* Acute worsening of COPD (exacerbation) 1,5 month prior to study drug administration
* Use of oral or parenteral glucocorticosteroids within 30 days and use of inhaled steroids 14 days prior to the study
Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy

To compare the effects of intravenous paracetamol and ibuprofen on postoperative pain and morphine consumption in patients undergoing hysterectomy surgery and the side effects associated with opioids.

All surgical procedures are associated with acute pain and inflammation, varying degrees of severity for the patients, causing significant stres and discomfort. Effective postoperative pain management in hysterectomy can reduce complications and improve postoperative care. In postoperative pain, multimodal analgesic techniques are used to provide synergistic effects through different nociceptive mechanisms.

Hysterectomy is the second most common gynecological surgery performed after cesarean section. It is known that effective postoperative analgesia management decreases complications and increases patients' comfort.

Various analgesics are used for pain. Opioids, frequently used for postoperative pain, are the most frequently used drug group. The combination of opioids with adjuvant agents may reduce the opioid consumption used systemically. Side effects such as sedation, respiratory depression, nausea, vomiting, rash and urinary retention that develop secondary to opioids may also be reduced by the combination of supplemental analgesics.

Adjuvant agents, including nonsteroidal antiinflammatory drugs (NSAID), may be used in combination with opioids. NSAIDs do not only reduce pain, but also control the underlying inflammatory process. In addition, combining NSAIDs and opioids can help reduce the side effects by reducing administration of total opioid consumption.

Intravenous ibuprofen is the first and only intravenous NSAID approved in the United States for both pain and fever control in adults. It has been reported in multicenter, randomized, double-blind, placebo-controlled studies that IV ibuprofen is safe and effective in postoperative pain management for abdominal hysterectomy and orthopedic surgeries.

Intravenous paracetamol is an analgesic and antipyretic agent used as a first step drug for pain and fever control in adults and children. It has been clearly shown that IV paracetamol, with analgesic efficacy and safety profile, reduces analgesic requirements for pain management. It has also been shown that it provides better analgesic efficacy and reduces the opioid consumption when used in combination with opioids.

The investigators aimed to compare the effects of intravenous paracetamol and ibuprofen on postoperative pain and morphine consumption in patients undergoing hysterectomy surgery and the side effects associated with opioids.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists scores 1-3
* 18-65 years

Exclusion Criteria:

* American Society of Anesthesiologists scores IV,
* Under the age of 18,
* Over the age of 65,
* Peptic ulcer disease,
* Hepatic and renal dysfunction,
* Severe cardiovascular and pulmonary disease,
* Allergic history to propofol, fentanyl, rocuronium, paracetamol, ibuprofen and morphine,
* Emergency surgery,
* Refused informed consent form