cyrilzakka/clinical-trials huggingface dataset:
Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression

This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe brain function in people with late-life depression (LLD).

Depression in older adults is a major public health problem and it often goes underdiagnosed and undertreated. A significant number of people with LLD, especially those with cerebrovascular risk factors, have subcortical grey matter and frontal deep white matter brain lesions. Some studies suggest that these lesions, or hyperintensities, may be associated with poor acute and long-term depression treatment response. Similarly, studies have shown that people with LLD frequently have functional deficits in the frontal lobe portion of their brains. This dysfunction has been shown to be associated with poor acute treatment response with a tricyclic antidepressant drug, as well as with a greater risk for depression relapse. The applicability of these findings to other classes of antidepressant medications, such as selective serotonin reuptake inhibitors (SSRIs), however, remains unknown. Additionally, more information is needed about the interaction between frontal brain lesions and executive function deficits in LLD. This study will determine the relationship between brain lesion severity, treatment response, and frontal lobe function in people with late-life depression who are being treated with the SSRI sertraline.

Participants in this open label study will first undergo neuropsychological testing to determine eligibility. All eligible participants will be treated with sertraline for 12 weeks. Dosages will begin at 25 mg per day, and will be increased to 50 mg per day after 4 days. Any other dosage modifications will depend on the participant's individual response to the medication. All participants will have an MRI scan at some point during the study. Assessments of symptoms and treatment response will occur at the study site biweekly until Week 8, and then again at Week 12.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV of major depressive disorder (MDD)
* Score of greater than 20 on the MADRS (score of greater than 17 for atypical depression)
* Score of greater than 20 on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

* Any condition that may make having an MRI medically inadvisable
* Any severe or unstable medical conditions
* Any known primary neurological disorders, including history of stroke
* Any other simultaneous Axis I disorder
* History of substance or alcohol abuse disorder within 6 months prior to study entry
* Currently at risk for suicide
* History of failed prior adequate trials of two antidepressants for the current depressive episode
* History of failed prior adequate trial of sertraline
* Current use of any other psychoactive medications (medication washout will be required)
Diffusion MRI for Quantitative Assessment of Myofascial Pain

The purpose of this study is to assess the diagnostic accuracy of diffusion MRI for evaluation of the jaw muscles for patients with masticatory myofascial pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Men and women 18-65 years of age
* Ability to give informed consent
* Symptoms meeting criteria for normal or latent/active temporomandibular myofascial pain

Exclusion Criteria:

* Contraindications to MRI scanning including severe obesity or difficulty in laying in a supine position, intracranial clips, metal implants, external metallic devices/objects/clips within 10mm of the head, suspected or confirmed metal in the eyes (history of welding or similar activity), claustrophobia, cardiac pacemaker or pacing wires
* Pregnancy or breast feeding
* Dental implants with metal on the same side of the temporomandibular pain
* Traumatic injury of masticatory muscles or temporomandibular joint within last 12 months
* Mandibular fracture within last 12 months
* Initiation of additional treatment of myofascial pain within the past 1 month
The Effects of Fenugreek Extract (Fenobet) on Metabolic Syndrome

The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. The eligible participants were allocated randomly to one of the two study groups (Fenobet, Placebo). Then, the eligible people were in one of two groups 1) receiving fenugreek extract, 2), receiving placebos and were examined for 8 weeks. At baseline and after two months of intervention, biochemical parameters, and anthropometric indices will be measured.

The current study is a three-blind, randomized clinical trial study that will be conducted on 60 people with metabolic syndrome. According to the ATP criteria, a person who has at least 3 of the following 5 components was considered as metabolic syndrome.

After providing the necessary information about the study to patients, written informed consent will be obtained from eligible volunteers.

Inclusion criteria:

* People with metabolic syndrome
* Fasting sugar above 100 mg/dL
* Both men and women
* Age range 20-60 years Exclusion criteria
* Injection of insulin or liraglutide
* People under 20 years old and over 60 years old
* having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer
* Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months
* Patients who are treated with a special diet such as vegetarianism or a special exercise program.
* Allergy
* Pregnant and lactating women The participants were allocated randomly to one of the two study groups (Fenobet, Placebo) by a random number table. Then, the eligible people were in one of two groups 1) receiving fenugreek extract (3 capsules of 500 mg, 1 capsule half an hour before meals), 2), receiving placebos (3 capsules of 500 mg, 1 capsule half an hour before meals) and were examined for 8 weeks. It is worth noting that the participants were asked not to change their physical activity and diet during the study and to report any changes in the type and dosage of the drug to the researchers. The capsule and container intended for the placebo will be exactly the same size and color as the fenugreek capsule and a dark container will be chosen for the capsules. At baseline and after two months of intervention, biochemical parameters (fasting blood sugar, HbA1C, lipid profile, C-reactive protein), and anthropometric indices (weight, body mass index, waist circumference, Hip circumference) will be measured.

Eligibility Criteria:
Inclusion Criteria:

People with metabolic syndrome

* Fasting sugar above 100 mg/dL
* Both men and women
* Age range 20-60 years

Exclusion Criteria:

* Injection of insulin or liraglutide
* People under 20 years old and over 60 years old
* having chronic cardiovascular diseases, chronic liver and kidney diseases, uncontrolled thyroid disorders and malignancies including cancer
* Taking herbal medicines or herbs to control blood sugar and fat in the last 6 months
* Patients who are treated with a special diet such as vegetarianism or a special exercise program.
* Allergy
* Pregnant and lactating women
Safety and Efficacy Study of CNOP Chemotherapy in Diffuse Large B Cell Lymphoma

The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.

Mitoxantrone Hydrochloride Liposome Injection is a kind of anthraquinone compounds, and its antineoplastic effect has been viewed in preclinical tests. The investigator´s phaseⅠstudy has shown that the drug´s toxicity is manageable and the tolerable does is 20 mg/m2. The purpose of this study is to determine whether Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Mitoxantrone Hydrochloride Liposome Injection plus Cyclophosphamide,Vincristine and Prednison(CNOP)is safe and effective in the treatment of Diffuse Large B Cell Lymphoma.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to study specific screening procedures;
* Favorable index of curative effect of Diffuse Large B Cell Lymphoma confirmed by histological analysis;
* ≥ 18 and ≤ 70 years of age, male or female;
* Advanced Lymphoma and standard treatments failed;
* May benefit from anthracycline-based drugs;
* ECOG performance status of 0-2;
* More than 4 weeks from the last chemotherapy, more than 4 weeks from the last biotherapy, more than 4 weeks from the last clinical trial drug therapy;
* Life expectancy of more than 3 months;
* Sexually active women of childbearing potential must use a medically acceptable form of contraception;
* Adequate hepatic, renal, cardiac and hematologic functions: leukocyte≥3.5×10\^9/L,neutrophils≥2.0×10\^9/L,platelets≥100×10\^9/L, hemoglobin≥90g/L,creatinine clearance rate≤1.5×ULN, serum bilirubin≤1.5×ULN, ALT≤2.5×ULN(5×for liver metastasis),AST≤2.5×ULN(5×for liver metastasis), alkaline phosphatase≤200 IU/L,Electrocardiogram appeared to be essentially normal, ejection fraction of Heart Doppler ultrasound appeared to be normal.

Exclusion Criteria:

* Pregnant or lactating women;
* Patients with Multiple sclerosis;
* Suffering from serious internal disease, including serious heart attack, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension,uncontrolled infection, Active peptic ulcer;
* Mitoxantrone has been used before;
* The cumulative does of doxorubicin and epirubicin before inclusion have surpassed 360 mg/m2 and 600 mg/m2, respectively;
* Heart disease was caused after Anthracycline-based drugs used;
* Other antineoplastic drugs need to be used in this study;
* History of Anthracycline-based drug allergy or liposome drug allergy;
* Uncontrolled primary brain tumor or brain metastases;
West Sweden Parkinson Objective Measurement Registry Study

WestPORTS will recruit a randomly selected population consisting of 25% of all individuals with Parkinson's disease (ICD G209) that have visited any of the seven major outpatient neurology or geriatrics clinics in West Sweden (population 1.7M) during a predefined 12 month period between Sept 2016 and April 2018.

Baseline clinical and demographic data will be collected along with a 6 x 24h accelerometry recording using the Parkinson Kinetigraph (Global Kinetics). Repeated data collections will be made with regular intervals of up to 2 years as long as subjects are alive and willing.

The following data will be collected at baseline:

Date of birth Handedness Family history of Parkinson's disease Time of first motor symptom onset Laterality of symptom onset Time of diagnosis Time of first pharmacological intervention (if applicable) First antiparkinsonian drug

The following data will be collected at every visit/update Current living conditions Current non motor complications Current medications Hoehn and Yahr staging Clinical Impression of Severity Index in Parkinson's disease (CISI-PD)

Patient self assessments: PDQ8, NMS-Questionnaire, EQ5D-5L, Patient Reported Outcome in Parkinson's Disease (PRO-PD)

Parkinson Kinetigraph (PKG) accelerometry based recording of spontaneous movement patterns over a 6x24h period. The following indices will be extracted: median bradykinesia score (BKS), median dyskinesia score (DKS), Fluctuation Dyskinesia Score (FDS), Percent daytime with Immobility (PTI%), Percent daytime with tremor (PTT%).

The primary analysis will be descriptive and include demographic composition of the population, clinical characteristics and objective measurement data. In addition to indices a standardized qualitative assessment of PKG recordings will be made to identify motor fluctuations. Correlations between clinical ratings, patient reported outcomes, disease duration, age, medication and objective measurement indices will be studied

In the prospective phase of the study the development of objective movement recordings will be studied along with the development of clinical ratings and patient reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Medical record with a G209 (Parkinson's disease) diagnosis
* A visit to one of the participating outpatient clinics in West Sweden within the last 6 months
* Informed consent

Exclusion Criteria:

* Diagnosis revised before visit.
Evaluate Protein C Levels in Severe Sepsis Patients on Drotrecogin Alfa (Activated)

In this trial, patients with severe sepsis and low protein C levels will receive drotrecogin alfa (activated) at the normal, approved dose and time of administration \[24 microgram/kilogram/hour (mcg/kg/hour) for 96 hours\] or will receive the normal, approved dose or higher doses than the approved dose for a longer administration time. After the drug administration is complete, the protein C levels from the patients receiving the normal, approved dose will be compared to protein C levels from patients receiving the normal, approved dose or higher dose for a longer duration to determine if the protein C levels improve faster if given higher dose and/or longer administration time.

Note: The protocol was amended to remove the option of shorter infusion durations.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years or older
* Must have a suspected or proven infection
* Must have two or more sepsis-associated organ dysfunctions

Exclusion Criteria:

* Documented multiple organ dysfunction greater than 24 hours prior to start of study drug
* Actual body weight less than 30 kg or more than 135 kg
* Platelet count less than 30,000/mm\^3
* Active internal bleeding or at increased risk of bleeding
* Not expected to survive 28 days given the patient's pre-existing uncorrectable medical condition
Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease

This research study will help us learn more about how chronic graft-versus-host disease affects the skin, hair and nails. We are interested in knowing if hair and nail problems predict worse disease. This information may help us treat patients like you in the future.

* At the initial visit, participants will have a complete examination of their skin, hair and nails. We will also test muscle strength and movement by moving the participant's arms, legs and neck. Photographs will be taken of the skin, hair and nails of they are abnormal. Blood tests will be done to check the liver and blood cell count. The participant and their legal guardian will answer questions about how the participant feels and about their health.
* Participants will then be scheduled for follow up visits at 3 months, 6 months, and 12 months. At each subsequent visit the following will be done: A complete examination of the skin, hair and nails; a test of muscle strength; photographs will be repeated; blood tests to check liver and blood cell counts; and questions about how the participant feels and about their health.

Eligibility Criteria:
Inclusion Criteria:

* Received hematopoietic stem cell transplant
* Meet the diagnostic criteria for cutaneous cGVHD

Exclusion Criteria:

* Previous HSCT (other then the current HSCT)
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.

This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.


Eligibility Criteria:
Main Inclusion Criteria:

* Written Informed Consent has been obtained
* OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
* Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary

Main Exclusion Criteria:

* Daily voiding frequency less than 5
* Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
* Uroflow indicative of pathology other than OAB
* Maximum voided volume (morning volume excluded) \> expected bladder capacity for age \[(age +1) x 30\] in ml or a maximum voided volume (morning volume excluded) above 390 ml
* Post Void Residual (PVR) \> 20 ml
* Monosymptomatic enuresis
* Polyuria defined as \> 75 ml/kg/b.w./24 hours
* Dysfunctional voiding
* Congenital anomalies affecting lower urinary tract function
* Current constipation
* Current Urinary Tract Infection (UTI)
* Catheterization within 2 weeks prior to screening
Behaviour Intervention to Decrease Melamine Exposure

One source of melamine exposure in the modern life is from the use of melamine tableware. This study examines whether the use of stainless steel containers can decrease melamine exposure in the daily life. The investigators hypothesize that, compared to those without use of stainless steel containers, university student volunteers with use of stainless steel containers excrete significantly lower melamine levels in urine.

Study subjects:

Two tiers:

1. Recruit 88 student volunteers from two university buildings and collect their morning one-spot urine specimens for 3 consecutive days (44 students in each building (Building A and Building B)
2. Select appropriate study subjects with high excretion of urinary melamine and with consuming melamine tableware containing hot water or hot soup by questionnaire in the past 3 days for intervention.

Study protocol:

This is a cluster randomized crossover intervention. We will conduct this study for 9 days and each experimental step lasts for 3 days. We randomly assign one building with 8 appropriate study subjects to a serial of control-intervention-intervention steps and another building with also 8 appropriate study subjects to a serial of control-control-intervention steps. Intervention step means study subjects will carry one big bag containing two stainless containers, one stainless spoon, and one stainless chopstick and use them for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal). Control means study subjects will carry one big bag without those stainless container, spoon, and chopstick and only use the containers provided by vendors for each meal during the trial (Some subjects will need to take pictures randomly and email back before the meal to check their adherence). Collect 24-hr urine samples for 9 days for melamine levels.

Inclusion criteria: 20-30 healthy students Exclusion criteria: Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, including urinary tract infection, or renal stones; Family history of renal stones; Body weight less than 50 kg.

Eligibility Criteria:
Inclusion Criteria:

* 20-30-yrs healthy students

Exclusion Criteria:

* Subjects with cancer, hypertension, diabetes, chronic hepatic or renal diseases, renal stones;
* Family history of renal stones;
* Body weight less than 50 kg.
Early Feasibility Study to Assess Safety and Device Performance of AcoustiCare™

AcoustiCareTM is a non-invasive clinical tool used for the detection of intracardiac pressures using heart sounds in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects between the ages of 18 - 80 years
2. Willing and able to sign informed consent form
3. Normal subjects without a history of heart disease who are recruited from the surrounding community
4. Subjects with heart failure undergoing treatment in a hospital setting

Exclusion Criteria:

1. Hemodynamic instability (Systolic BP\>180 or \<90 and Diastolic BP\>90 and \<60)
2. Acute coronary syndrome
3. Prior heart transplant recipients
4. Subjects who are pacemaker dependent
5. Severe obesity (body mass index \> 40 kg/m2)
6. Subjects who are pregnant
Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease

The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.


Eligibility Criteria:
Inclusion criteria:

* Subjects and their caregivers must provide informed consent prior to study entry.
* Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with a documented 6-month history of AD symptoms
* Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status.
* Female subjects of child-bearing potential must agree to pregnancy testing and approved form of birth control.

Exclusion criteria:

* Diagnosis of possible, probable or definite vascular dementia.
* History/evidence of any other CNS disorder that could be interpreted as a cause of dementia
* History of known or suspected seizures, loss of consciousness or significant head trauma
* Subjects with ECG, blood pressure and laboratory values outside of protocol criteria are excluded.
* Subjects with known photosensitivity
* Subjects with a history of previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.
Silver Nitrate Vs. Triamcinolone for Treatment of Hypergranulation Tissue

This randomized controlled trial aims to compare the efficacy of silver nitrate, triamcinolone, and a successive use of both treatments in managing hypergranulation tissue in traumatic wounds. Conducted over a four-year period at UPMC Mercy, the study will involve patients presenting with hypergranulation tissue. Participants will be randomly assigned to receive either topical silver nitrate, topical triamcinolone, or a combination of the two in succession. The study will assess treatment outcomes based on the reduction or resolution of hypergranulation tissue, with the goal of identifying the most effective therapeutic approach. This research will provide valuable insights into optimizing treatment strategies for hypergranulation tissue in traumatic wounds.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years or older.
* Patients must be admitted to the institution with non-infected, traumatic wounds exhibiting hypergranulation tissue.
* Patients must provide consent to participate in the study.
* Eligible wounds include superficial or partial-thickness wounds.
* Wounds will be categorized based on size and depth, with variations controlled for in the statistical analysis.

Exclusion Criteria:

* Patients with known allergies or contraindications to silver nitrate or triamcinolone.
* Patients with wounds that do not exhibit hypergranulation tissue.
* Patients with wounds not primarily due to traumatic injury (e.g., surgical wounds, pressure ulcers).
* Full-thickness, infected, or complex wounds will be excluded, as these may require different management strategies.