cyrilzakka/clinical-trials huggingface dataset:
The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.

The Major Depression Inventory is a self-rating depression scale with 12 questions. The questionnaire has previously been investigated in a Danish population. The scale contains the 10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms are identical with the DSM-IV major depression symptoms with the exception of one symptom, low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is incorporated in the symptom of guilt. On a six-point Likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. The MDI is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument.

Patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the MDI. Patients therefore only complete the MDI once in the whole study. At the same time a Mini Mental State Examination (MMSE) and questions regarding previous illnesses and medication will be asked. Patients will not be followed up in any way.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy
* ASA I-III

Exclusion Criteria:

* Planned or ongoing preoperative chemotherapy
* Known and treated sleep apnea syndrome
* Insulin treated diabetes mellitus
* Known or previous treated depressive illness or bipolar disorder
* Known autoimmune disease
* Incompensated cirrhosis
* Other previous or ongoing cancer
* Known medically treated sleep disorder (insomnia, restless legs etc)
* Shift-work or night-work
* Daily alcohol intake of more than 5 units
* Preoperative treatment with psychopharmacological drugs, opioids or anxiolytics
* Predicted bad compliance
* Pregnant or breast feeding
* Preoperative MMSE score less than 24
Exercise Intervention Metabolic Syndrome Prostate Cancer Black Men

The main purpose of this study is to examine the feasibility of an exercise intervention on metabolic syndrome (MetS) components and biomarkers related to prostate cancer in Black men with MetS who are at increased risk of prostate cancer.

The specific aim for the proposed study is to examine the feasibility and impact of a 6-month two-arm randomized controlled trial (RCT) on MetS components and biomarkers related to prostate cancer in Black men with MetS. Due to the striking racial disparities of prostate cancer, this proposal will focus on the impact of an aerobic and resistance exercise intervention on MetS and biomarkers related to prostate cancer in Black men. Specifically, our proposed clinical trial compares an aerobic and resistance exercise intervention to an attention control group among Black men.

Eligibility Criteria:
Inclusion Criteria:

1. African-American and/or Black men;
2. between the ages of 40-70 years;
3. waist circumference \>40 inches (102 cm);
4. with at least two of the following: elevated BP (≥ 130/85 mmHg);
5. elevated fasting glucose (≥ 100 mg/dL), reduced HDL cholesterol (\<50 mg/dL), or elevated triglycerides (≥ 150 mg/dL);
6. sedentary defined as \<60 minutes of recreation or work requiring modest PA/week;
7. be able to speak and read English;
8. able to provide meaningful consent (i.e., men with severe cognitive impairment will be excluded);
9. have no physical limitations that prevent from exercising;
10. and have access to a television and DVD player.

Exclusion Criteria:

1. history of cancer except nonmelanoma skin cancer;
2. current enrollment in another clinical trial or weight loss program;
3. inability to commit to the intervention schedule. Prior to randomization, participants will be required to have a signed authorization and medical clearance from their personal physician or our nurse practitioner.
Standardized BAL Procedure for Critical Patients to Diagnose Pneumonia Pathogens

In order to improve the accuracy of the diagnosis of pulmonary pathogens and reduce the adverse impact of excessive BAL volume on patients, this study intends to explore the most optimal lavage volume in the middle lobe and the lower lobe of critical patients as well as seeking for the best way to manage BALF samples by means of detecting alveolar proteins and bacterial composition in BALF samples. The hypothesis is that the optimal lavage volume in the middle lobe and the lower lobe might be different. And to sample BALF separately through sequential lavage might be a better way to improve the accuracy of the diagnosis of pneumonia pathogens.

This is a self-control study consisted of three parts. Firstly, searching for the optimal lavage volume in the middle lobe and the lower lobe of critical patients by exploring the differences between the concentration of alveolar proteins among BALF samples of every participant. Several BALF samples are seperately collected from every single participant through sequential lavage(an initial 20 ml saline lavage at main bronchus and 5 aliquots of 20 ml saline lavage at the subsegment of the right middle lobe or 6 aliquots of 20 ml saline lavage at the lower lobe) . The concentration of Alveolar proteins including Surfactant protein B (SP-B), Surfactant protein D (SP-D) and Human typeⅠprotein (HTⅠ-56) will be determined by enzyme-linked immunosorbent assay (ELISA). Meanwhile, the amount of living cells as well as the proportion of squamous cells and columnar cells in BALF samples will be counted. Secondly, to confirm the optimal lavage volume through quantitative bacterial culture of BALF and sputum samples of participants. And BALF samples will also be tested by next generation sequencing（NGS） to identify microorganism. Thirdly, to observe the effect of BAL on respiratory and cardiovascular systems. The Vital signs, arterial gas analysis, ventilator parameters and respiratory mechanical parameters of patients before and within 24 hours after the BAL procedure will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care unit
* Mechanically ventilated patient
* 18 years old or above
* Pneumonia diagnosed by one of 1 - 4 plus 5

  1. purulent endotracheal secretions or increasing oxygen requirements;
  2. body temperature exceeds 38.0 ℃;
  3. potentially pathogenic bacteria be isolated from the endotracheal secretions;
  4. leukocyte count exceeds 10×10\^9 per liter or less than 4×10\^9 per liter;
  5. new or persistent radiographic features of pneumonia without another obvious cause.

Exclusion Criteria:

* considered to be unsuitable for bronchoscopy by attending physician;
* underwent bronchoalveolar lavage within the last 48 hours;
* medical history of lobectomy
* airway bleeding or pulmonary edema
* refuse to sign the informed consent
COVID-19 (Coronavirus Disease-2019) Psychiatric Outcomes

The goal of this longitudinal and observational study is to better understand the psychiatric consequences of COVID-19 over time. Psychiatric outcomes like mood, anxiety, stress, and cognitive symptoms in patients who underwent inpatient hospitalization at NewYork-Presbyterian Hospital/Weill Cornell Medicine for COVID-19 will be assessed at 6 months or later post-discharge.


Eligibility Criteria:
Inclusion Criteria-COVID-19 group:

* Men and women age 18-89.
* Past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 PCR test in electronic medical record
* English speaking
* Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.

Inclusion Criteria-Comparison group:

* Men and women age 18-89
* English speaking
* Previously hospitalized at NYP/WCM between March 1 2020 and six months prior to enrollment for a minimum of three days.
* Underwent hospitalization secondary to a medical diagnosis that was not COVID-19

Exclusion Criteria--COVID-19 group:

N/A

Exclusion Criteria--Comparison group:

* Past diagnosis of COVID-19
* Admitted to inpatient hospitalization due to, or past history of, a primary central nervous system relation etiology such as stroke, brain tumor, encephalitis, traumatic brain injury, multiple sclerosis, or Parkinson's disease.
Urine Interleukin-37 as a Biomarker of Mortality Risk in Patients With Sepsis

This study aims to evaluate the efficacy of IL-37 as a biomarker to predict mortality risk in adults with sepsis.

Sepsis patients admitted in the Department of Critical Care Medicine, Zhongnan Hospital will be included.

There are three groups of patients in this study: control group, sepsis group and septic shock group.

The interleukin-37 (IL-37) concentration in urine was analyzed in the day 1, 2, 4, 6.

Additionally, IL-37 concentration between blood stream infection groups and non-infection groups were analyzed. IL-37 concentration between survivors and non-survivors were also compared. IL-37 concentration were followed from day 1, 2, 4, 6.The correlation between the concentration of IL-37, IL-1β, IL-6、IL-10 and TNF-α were analyzed. Furthermore, the investigators will determine the correlation between the concentration of IL-37, sepsis associated organ dysfunction, 28-day mortality. Lastly, the predictive value of IL-37 to sepsis associated organ dysfunction and prognosis were explored.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Expected length of stay\>24 hours in intensive care unit (ICU)
3. Sequential organ failure assessment (SOFA) score ≥ 2 on ICU admission with a suspicion of infection

Exclusion Criteria:

1. anuria
2. ICU readmission in 28 days
A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects with Androgenetic Alopecia

To investigate the efficacy of HMI-115 compared to placebo in treating Androgenic Alopecia patients for 24 weeks


Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
2. Male subjects, between 18 and 65 years of age, inclusive, at the time of signing informed consent.
3. Clinical diagnosis of androgenetic alopecia. Male subjects who meet Norwood-Hamilton scales III vertex, IV and V .
4. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions, including having a small circle about 1 cm2 of hair clipped to approximate 1 mm in length and micro-dot-tattoo on the scalp of target area.
5. Subjects who are willing to keep the same hair color, refrain from hair weaving, and hair growth therapy and supplement (except for protocol specified IMP) during the study.
6. Subjects agree to use required birth control methods from signing the consent until 3 months after the last dose of IMP or complete whole study period whichever is longer.

Exclusion Criteria:

1. Subject with history of scalp radiation or surgery which could interfere study assessment (e.g., hair transplantation surgery).
2. Subject with history of scalp laser treatment within 6 months prior screening, including but not limited to, low level laser, and fractional laser, etc.
3. Subject with history of hair weaves within 3 months prior screening.
4. Subject has a current history of hyperthyroidism or uncontrolled hypothyroidism.
5. Subject has, in the Investigator's opinion, uncontrolled hypertension (systolic blood pressure \[SBP\] \> 159 mmHg, diastolic blood pressure \[DBP\] \> 99 mmHg).
6. Subject has any of the following conditions within 6 weeks prior to Screening:

   1. Myocardial infarction, stroke, unstable angina, or transient ischemic attack.
   2. Heart failure with classified as being in New York Heart Association Class III or IV.
7. Subject has high fever, major surgery, or ten percent or more weight decrease within three months before screening.
8. Subject with history of active malignancy (with or without systemic chemotherapy), except treated basal cell carcinoma of the skin (besides scalp).
9. Subject plans to schedule elective surgery during the study.
Digital Voice Analysis in Patients With Schizophrenia

There is a differences in voice frequency of schizophrenic patients compared to patients with other mental diseases and compared to mentally healthy people.


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenic patients
* Other mental disease patients
* Healthy people
* People above age 18

Exclusion Criteria:

* None
A Study to Evaluate Seroprevalence and Seroconversion of Antibodies to Adeno-Associated Virus (AAV) in Patients With Hemophilia A

To quantify the seroprevalence of antibodies to AAV5, AAV6, and AAV8 and the seroconversion rate over varying follow-up intervals in subjects with hemophilia A

This is a single-center, decentralized, patient-centered, prospective, observational study utilizing biospecimen samples collected from hemophilia A subjects across the United States to evaluate and characterize seroprevalence and the rate of seroconversion of antibodies against AAV serotypes and exploratory vectors, and to investigate the associated factors that may influence the vector titers.

Relevant medical findings will also be collected from the subject, as well as symptoms related to hemophilia A. The collection of medical history may include major illnesses, diagnoses, and surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Subjects diagnosed with Hemophilia A
* Subjects aged 18years or over at time of entry

Exclusion Criteria:

* Currently participating in an interventional study of any investigational product, device or procedure.
* Subjects who have been previously treated with AAV vector gene therapy
Single and Multiple Ascending Dose Study of NGM120 in Healthy Adult Subjects

The purpose is to evaluate the safety, tolerability, and PK of NGM120 in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Normal ECG findings

Exclusion Criteria:

* Significant history or clinical manifestation of any allergic, dermatological, hepatic, renal, hematological, pulmonary, metabolic, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
Effect of 10mg Domperidone on Gastric Emptying of a High-fat Meal and Appetite Sensations in Healthy Adults

The purpose of this study is to determine whether domperidone was sufficient to accelerate gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult population.

This study aims to investigate the effect of domperidone on gastric emptying and appetite sensations in healthy subjects. Domperidone is a dopamine 2 (D2) receptor antagonist with claims of gastrointestinal tract pro-kinetic activity. Accelerated gastric emptying (GE) may lead to reduced satiation, increased food intake and is associated with obesity and diabetes mellitus. It is hypothesized that domperidone will increase gastric emptying rate and reduce satiety responses to a high-fat meal.

The effect of acute oral administration of 10 mg domperidone on gastric emptying of a high-fat pancake test meal, and subjective appetite sensations by visual analogue scale will be measured for six hours postprandially in a randomized, placebo-controlled, single-blinded manner in 13 healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-40 years

Exclusion Criteria:

* History of gastrointestinal-related conditions, diabetes mellitus or cardiovascular disease
The Effects of Autonomy and Perceptions on Resistance Training Outcomes

120 participants will be randomized into one of two groups that will perform resistance training at a gym three time per week for three months. One group will follow common resistance training guidelines, whereas the other will exercise according to their preferences and perception of effort. The groups will be compared on the following primary outcomes after six and 12 weeks: body composition, physiological and performance tests. The groups will be compared on the following secondary outcomes every two weeks: enjoyment and satisfaction levels. Adherence rates will be measured throughout the intervention.

Develop and test the non-inferiority of a new RT prescription model, entitled The Autonomy and Perceptions Approach to Resistance Training (APART). This approach is simple to follow, individualized, and autonomy supportive. Accordingly, it may assist trainees to overcome some of the limitations of the standard RT prescription approach. Under APART, trainees choose the loads they lift for each exercise according to their preferences, and then complete as many repetitions as required until reaching a specific rating of perceived effort (RPE) value on a 0 (no effort) to 10 (maximal effort) scale (e.g., 8/10). For this non-inferiority randomized controlled trial, the investigators will recruit 120 healthy, sedentary participants, between the ages of 18 and 45, who will be block-randomized by gender and age (18-27, 28-45) to either the APART or the standard groups. Following two baseline-testing sessions and two guided familiarization sessions, participants will independently complete three RT sessions per week for 12 weeks. The following primary outcomes will be assessed after six and 12 weeks: (ⅰ) body composition including fat free mass; (ⅱ) performance measures, including maximal strength and strength endurance; and (ⅲ) physiological measures, including blood profile and hemodynamics. The following secondary outcomes will be measured every two weeks: (ⅳ) psychological measures, including self-efficacy, autonomy, and enjoyment; and (ⅴ) adherence measures, which will be monitored throughout the intervention. If APART will be found to be non-inferior to the standard RT prescription, it can provide a simple and easy to follow alternative to the standard RT prescriptions, which also highlights trainees' preferences and individual abilities. This, in turn, might contribute to future participation and adherence to RT.

Eligibility Criteria:
Inclusion Criteria:

* No health issues preventing resistance training
* Body mass index (BMI) between 18.5 ("normal") and 29.9 ("overweight")
* Body weight \> 50 Kg
* Without RT experience or with little experience (i.e. less than once a week in the past 12 months).

Exclusion Criteria:

* Participants who responded positively to any of the health sections and did not provide medical clearance
* Pregnant women or less than six months after childbirth
* BMI values outside of the specified range
* Body weight \< 50 Kg
* RT experience exceeding the specified cut-off (see above)
The School SPIT Study - COVID-19 Testing in Secondary Schools

This study will conduct an evaluation of a program that is being implemented SickKids / Toronto Public health that provides take-home saliva testing kits in schools. Operationally, there is a planned randomization so that all schools have an equitable chance to receive the intervention at various time periods during the planned operational roll-out, which will require a staggered implementation consistent with the stepped-wedge study design. The study will leverage this chance implementation to do a robust evaluation of the public health intervention. Schools that are not being rolled out to week one, will begin in the "control phase" (testing at an assessment center) and transition to the program "intervention phase" (take home saliva kits available at schools) at a randomly assigned time (wedge) over a 6-week period with all schools receiving the program by the end of the study. The investigators will evaluate the impact of the program on SARS-CoV-2 case identification in schools.

This is a prospective evaluation of a program that is being implemented using a stepped-wedge, cluster randomized design.

Eligible secondary public schools in Toronto Region will be randomized. The study will occur over a 7-week period with a minimum of one-week of baseline data (control phase - testing at an assessment center, primary care or acute care center) and then schools will start the program in a stepwise manner (10 crossovers per week) with take-home saliva being available to all 60 schools by the end of the study period. The primary objective of the study is to assess whether the availability of take home saliva kits at schools for symptomatic PCR testing leads to increased diagnosis of COVID-19 cases in the school.

Eligibility Criteria:
Secondary schools will be included in the evaluation if they are:

* Considered a secondary school by the school board
* Open for in-person learning during the study period
* They have at least 100 students
* Offer Grades 9-12 (secondary)

Exclusion Criteria:

Schools that are middle schools only, that are not open for in-person learning, have fewer than 100 students or are not a complete secondary school (i.e. adult learning schools, schools offering independent courses, prep schools with 1-2 grades, secondary schools with \< 4 grades) will be excluded.
Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections (otitis media).

Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media during the first year of life. Following acute otitis media, middle ear fluid effusions can persist for weeks to months. Approximately 40% of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion, and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion. Since antibiotic use has become widespread, concern has emerged regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of complementary alternative medical (CAM) approaches for prevention of otitis media has not been widely quantified. This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent