cyrilzakka/clinical-trials huggingface dataset:
Remote Fetal Monitoring in High Risk Pregnancies

Antenatal nonstress tests (NSTs) are performed to assess fetal health and are used as a cost-effective test that can be widely administered. However, an NST is operator-dependent due to the nature of Doppler ultrasound and is primarily performed in a clinic and hospital setting.

The ability to conduct a clinically valuable test at home would address access to care issues faced by numerous women in the United States and reduce the workload on healthcare clinicians facing a shortage of human resources.

This pilot study aims to assess the feasibility and acceptability of home NST monitoring in order to determine whether femomTM could be utilized as an adjunct to routine prenatal care.

Patients with high risk pregnancies who are recommended to undergo at least once weekly at 32 weeks testing by the obstetrician will be recruited for participation in this study. Participants will be asked to perform three 30 minute monitoring sessions weekly starting at 32 weeks for 6 weeks.

Measuring fetal heart rate (FHR) through various methods is essential for assessing fetal wellbeing antenatally. This enables clinicians to identify patterns that could indicate fetal hypoxia.

Cardiotocography (CTG), which uses Doppler ultrasound, is the gold standard for non-invasive FHR monitoring. This technology detects movement in the cardiac structures and approximates the FHR from this and requires signal modulation and auto-correlation to provide accurate quality readings of FHR. This method of external FHR monitoring is prone to signal loss, maternal fetal ambiguity where the maternal heart rate is confused for FHR, and signal artefacts (e.g., double-counting, and half-counting), during both antenatal and intrapartum monitoring, and must be performed by an obstetric provider.

Non-invasive fetal electrocardiography (NIFECG) is a form of electrocardiography (ECG), which captures simultaneous maternal and fetal PQRST waves. NIFECG has the theoretical benefits of minimizing maternal-fetal heart activity confusion, is not affected by maternal adiposity, and delivers no energy to the patient, which permits prolonged periods of fetal monitoring with safety. To date, NIFECG has mostly been limited to research use due to low fetal signal-to-noise ratios. Despite technical challenges, NIFECG may be the most promising method of ambulatory self-applied FHR monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Intrauterine pregnancy greater than 32 weeks gestation
* Recommended for at least once weekly antenatal fetal testing by their obstetrician
* English-speaking

Exclusion Criteria:

* Under age 18 years of old
* Non-english speaking
Easy Way of Choosing Rectangular Expander and Getting Maximum Benefit From Expanded Tissue

Background: Tissue expanders are widely used for reconstruction of tissue defects. The choice of expander and planning the flap is complicated for the inexperienced surgeon.

Objective: To demonstrate the choice of expander sizes proper for the tissue defect and maximum advancement technique during the defect coverage.

Methods: The present study included 19 patients who were operated between January 2013 and January 2017. The expander projection was chosen in the manner that it would be more than the half length of the defect to be occurred and the expander width was chosen as wide as possible based on the area of its placement. After the expansion was completed, advancement method was used to cover the defect.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with rectangular tissue expanders.
* Patients who attended to at least postoperative six months control.

Exclusion Criteria:

* Patients treated with tissue expanders other than rectangular expanders.
* Patients who did not attend to postoperative controls.
Entheogen Resurgence

For the purpose of this anonymous, observational pilot survey, the investigators will define "entheogens" as substances, generally derived from plants, that are ingested in order to impact one's consciousness for therapeutic, religious, or spiritual purposes. This survey will focus on the naturalistic use of entheogens and other substances including kambo, ayahuasca, hapé, bufo, and sananga typically used in specific cultural and spiritual contexts for healing. There are substantial limitations to what the healthcare community knows about the intentions, motivations, experiences, health behaviors, and demographics of people who decide to participate in entheogen therapy centers or retreats and their willingness to participate in future research studies.

The primary goal of this observational pilot survey is to collect self-reported, anonymous data from people who have opted to participate in entheogen therapy centers and retreats during the last five (5) years on the topics of their initial intentions, motivations, experiences, demographics, and willingness to participate in future entheogen research.

With the support of established therapy and retreat centers, the research team will aim to collect 100 survey responses from unique, unidentified individuals who have participated in some form of entheogen therapy or treatment during the last five (5) years. Those who choose to fill out the survey will be at least 18 years of age, fluent in English, and self-reporting participation in therapy or a retreat which utilized entheogens in a naturalistic setting in the past five (5) years.


Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Fluent in English
* Self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years

Exclusion Criteria:

* Inability to provide informed consent
* Inability to complete the online questionnaire
* No self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years
* Self-reported participation in therapy or a retreat in naturalistic setting that incorporated the use of entheogens greater than five (5) years ago
Double-blind Comparative Study of TAK-875

The purpose of this study is to evaluate the efficacy and safety of treatment with TAK-875 in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
Imaging Biomarker for Early Detection of Treatment Efficacy During Breast Cancer Neoadjuvant Chemotherapy

This is a single-arm, single-institution pilot study that will collect preliminary data to be used in the design of a subsequent study to assess whether changes in fDM (Functional Diffusion Maps) derived from primary breast cancer diffusion weighted MRI images can serve as an early predictor of response to treatment, and whether the magnitude of the change correlates with the effectiveness of treatment.

This trial has a two-step, sequential design, with continuation to the second part of the trial being dependent on the positive results in the first part. In Part One of the trial, the investigator will compare intrapatient variability in fDM performed at two timepoints prior to chemotherapy (chemotherapy will be chosen by the treating physician and will not be assigned as part of this study), with the change in fDM before and approximately one week after a dose of chemotherapy, to establish that treatment-related changes in fDM will occur in this clinical setting. If there are positive results in Part One, then the investigator will proceed to the second half of the trial. In Part Two, the investigator will examine changes in fDM that occur one week after each type of chemotherapy is administered, which will be compared to pathologic response, radiological response, and clinical response.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a primary measurable, biopsy proven, invasive breast carcinoma with the primary tumor intact. The tumor should be staged clinically as T2-T4 (minimum size \>2.0 cm).
* Patients must have a breast tumor that is resectable or potentially resectable following neoadjuvant chemotherapy and be willing to undergo resection, if indicated, after chemotherapy.
* Patients may not have received prior chemotherapy or radiation therapy for their current breast cancer.
* Patients may not have had a clip placed into the tumor that is not compatible with MRI.
* Patients must be deemed eligible for neoadjuvant chemotherapy, as assessed by the clinical investigator.
* Age \> 18 years.
* Patients must have an ECOG performance status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.) of 0 - 1.
* Patients must not be pregnant or breast-feeding. Patients with reproductive potential must consent to the use of effective contraception while on the study.
* Patients must have no contraindications to MRI (Magnetic Resonance Imaging) exams. Patients who require sedation with general anesthesia to complete an MRI are not eligible for the study.
* Patients may have no ferrous metal implants or medical devices which would exclude MRI.
* Patients must be capable of lying flat in an MRI magnet for 30-60 minutes on 4 occasions.
* Weight must be less than 275 pounds.
* Patients must have the ability to understand and willingness to sign a written informed consent document.
Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. Cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. Cohort I was injected with EC and TB-PPD in both arms, and cohort II was injected with EC only

Assessment of effectiveness:

In cohort 1, the injection site reaction was examined at 0min, 24h, 48h and 72h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.

In cohort 2, the injection site reaction was examined at 0min and 48-72 h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. Any blisters, necrosis, lymphangitis should be faithfully recorded.

Safety assessments:

The safety assessment included all expected and unexpected medical events that occurred during the observation period of the clinical trial (within 72 hours after the skin test) and were related or unrelated to the injection of the investigational drug. These included specific reactions such as redness, induration, blister, necrosis, and lymphangitis at the injection site (palmar forearm). Common and occasional adverse reactions include:

Local adverse reactions: injection site pruritus, injection site pain, injection site rash;

Systemic adverse reactions included fever, headache, nausea, fatigue, myalgia, diarrhea, vomiting, paresthesia.

Eligibility Criteria:
Inclusion Criteria:

* People aged 6 months and above (≥6 months).
* Normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above).
* I or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol.

Exclusion Criteria:

* Patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases
* A pure protein derivative or similar product was used within 3 months prior to the initiation of this trial.
* Participated in other new drug clinical trials within 3 months prior to clinical trials.
* Any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.
Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal

Chronic Obstructive Pulmonary Disease \[COPD\] is a major cause of chronic morbidity and mortality worldwide. COPD is characterized by persistent progressive airflow limitation that adversely affects the ventilation/perfusion (V/Q) matching and mechanics of the respiratory muscles and leads to hypoventilation and reduced gas transfer. COPD was identified as a significant comorbidity associated with increased incidences of postoperative pulmonary complications and prolonged hospital stay. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. MgSO4 either intravenous or inhalational has been shown to promote bronchodilation and to improve lung function in asthmatic patients. Administration of MgSO4 in patients with stable COPD was associated with reduced lung hyperinflation and improvement of respiratory muscle strength. This randomized control trial is designed to assess the effect of intravenous MgSO4 infusion on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications and length of hospital stay in patients with COPD undergoing cancer larynx surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cancer larynx surgery (partial laryngectomy, total laryngectomy with or without neck dissection).
* Age more than 40 years old
* ASA physical status II and III.
* Diagnosed as having COPD by preoperative spirometry. The classification is bases on the post-bronchodilators forced expiratory volume in the first second (FEV1). Mild COPD is diagnosed when FEV1 is \> 80% of predicted while moderate COPD is diagnosed when FEV1 is \< 80% and \> 50% of predicted and sever COPD is diagnosed when FEV1 is \< 50% and \> 30% of predicted

Exclusion Criteria:

* o Patients with heart failure.

  * History with arrhythmias or treatment with antiarrhythmic drugs.
  * Patient with heart block or on beta blockers or calcium channel blockers.
  * Patients with impaired renal function (creatinine \> 2)
  * Patients with impaired liver function (ALT more than 2 folds).
  * Patient with combined restrictive and obstructive pulmonary disease.
  * Patients with preoperative tracheostomy.
  * Patients with huge mass obstructing \> 50% of the view. (due to its influence on the spirometry measurements).
Pre-exposure Prophylaxis for SARS-Coronavirus-2

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

The current standard of care is observation and quarantine after exposure to COVID-19. There is no approved treatment or prophylaxis for COVID-19.

As of March 6, 2020, the CDC estimates that the transmission of SARS-CoV2 after a U.S. household close contract is 10.5% (95%CI, 2.9 to 31.4%). Among all close contacts, the SARS-CoV2 transmission rate is estimated at 0.45% (95%CI, 0.12 to 1.6%) by the CDC. These estimates are based on monitoring of travel-associated COVID19 cases. Conversely, in a setting with community transmission, the secondary attack rate in China was 35% (95%CI, 27-44%) based on 48 transmissions among 137 persons in 9 index patients.

Chloroquine or Hydroxychloroquine may have antiviral effects against SARS-COV2 which may prevent COVID-19 disease or reduce disease severity. It is not known at what dosing hydroxychloroquine may be effective for pre-exposure prophylaxis.

Eligibility Criteria:
Inclusion Criteria:

- A healthcare worker at high risk for COVID-19 exposure (defined below):

* Persons primarily working in emergency departments (physicians, nurses, ancillary staff, triage personnel)
* Persons primarily working in intensive care units (physicians, nurses, ancillary staff, respiratory therapists)
* Persons performing aerosol generating procedures (i.e. anesthesiologists, nurse anesthetists (CRNAs)
* First responders (i.e. EMTs, paramedics)

Exclusion Criteria:

* Active COVID-19 disease
* Prior COVID-19 disease
* Current fever, cough, shortness of breath
* Allergy to chloroquine or hydroxychloroquine
* Prior retinal eye disease
* Known Chronic Kidney disease, Stage 4 or 5 or dialysis
* Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
* Weight \<40 kg
* Prolonged QT syndrome
* Current use of hydroxychloroquine, chloroquine, or cardiac medicines of flecainide, amiodarone, digoxin, procainamide, or propafenone
* Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen, or methotrexate.
Acupuncture for Relieving Chronic Pelvic Pain

Individuals with chronic pelvic pain will be identified, consented and enrolled in this study in which acupuncture will be offered in addition to current standards of care. The primary outcome will assess if there is a reduction of pain intensity from the baseline to 6 months as a result of treatment.

Chronic pelvic pain as defined by the American College of Obstetricians and Gynecologists is "noncyclic pain of 6 or more months duration that localizes to the anatomic pelvis, anterior abdominal wall at or below the umbilicus, the lumbosacral back or the buttocks and is of sufficient severity to cause functional disability or lead to medical care". This has devastating consequences both monetarily as well as emotionally and can lead to opioid addiction, depression and even suicide.

Acupuncture has been used to treat pain in China for millenniums and was one of the more effective ways to treat pain before morphine was discovered. Acupuncture is feasible, economic and a safe way to treat chronic pain.

Patients with chronic pelvic pain will be identified and offered participation in the study. After the consent process is completed, patients will undergo a brief physical exam to rule out acute symptoms. The patient will be asked to complete a baseline pain inventory and genitourinary pain index survey before proceeding with acupuncture treatment. Qualified patients will be requested to accept acupuncture treatments twice weekly for 12 consecutive weeks. Each week the patient will be asked to report their current medications and changes in the dosage as well as their narcotic (opioid) doses and any changes in the dosages. Patients will be followed up monthly for up to 3 months after treatment completion by phone to record their pain inventory as well as their genitourinary pain index survey.

Eligibility Criteria:
Inclusion Criteria:

* Chronic pelvic pain persisting for at least 6 months
* English speaking
* Able to provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
* Pregnant
* Prisoners
* Morbid obesity (BMI \>40, or \> 36 associated with hypertension and diabetes)
* Severe cardiac disease
* Active chemotherapy or radiation therapy
* Skin infections or lesions
* Severe COPD
* Neuropathy
* Previous stroke
* Paralysis
* Needle phobia
Exercises With Elastic Bands and Stability in Proprioception and Strength in Female Athletes of Taekwondo

Strength and proprioception exercises are used to improve the strength and unipodal balance of lower limbs in Taekwondo players. The moments of unipodal support in Taekwondo require a great demand that is necessary to adapt the athlete through the development of strength and proprioception.

The main objective of the study is to assess the effectiveness of strength work with elastic bands and balance exercises in increasing strength and unipodal proprioception in taekwondists aged 18 to 30 years.

Randomized, single blind clinical study 30 taekwondists will be randomized to the two study groups: experimental (strength training and proprioception) and control (without intervention). The intervention will last 4 weeks, with 2 weekly sessions each session will be approximately 15 minutes each. The study variables will be: unipodal muscle strength (jump test), and lower limb balance (Y-Balance test). The sample distribution will be calculated using a Kolmogorov-Smmirnof analysis. The changes after each evaluation will be analyzed with the t-student test and with an ANOVA of repeated measures the intra and intersubject effect will be observed. The effect size will be calculated using Cohen's formula.

After the training period it is intended to obtain improvement in the strength of the lower limbs, as well as an increase in balance during unipodal support during the execution of a movement.


Eligibility Criteria:
Inclusion Criteria:

* Female Taekwondo players
* Age range of 18 to 30 years
* More than 2 years of sports practice of taekwondo, federated
* Currently participate in regional or national competitions.

Exclusion Criteria:

* Participants who have some type of musculoskeletal lesion in the lower limbs
* That are belts below the color green
* Have not competed in the last year in any regional or national competition.
* Have not signed the informed consent document
Church-based Intervention to Improve Physical Function

This is a 12-month multi-level behavioral cluster randomized trial testing a church-based intervention to improve physical function (PF) in Americans with PF limitations.


Eligibility Criteria:
Inclusion Criteria:

Churches (Community-level):

* Membership of 300 or more adults
* Located in Cook, Lake, Dupage, Will, McHenry, Kane, or Kendall counties

Participants (Individual-level):

* Age 40 or older
* Have mobility limitations (defined as SPPB score of ≤9)
* Ambulatory, defined as able to get out of a chair and walk without assistance without using a straight cane
* Able to speak and read English
* Attend recruitment church; and
* Safe to begin an exercise program, which will be determined using the Exercise Assessment and Screening for You (EASY) Tool.

Exclusion Criteria:

Participants (Individual-level):

* Severe cognitive impairment, defined as five or more errors on the Short-Portable Mental Status Questionnaire
* Unable to consistently attend group classes at a scheduled time due to lack of reliable transportation, schedule conflicts, travel, plans to relocate, upcoming surgery, etc.
* Participating in a medically supervised rehabilitation program such as cardiac rehab
* Inpatient treatment for a psychiatric condition within the past 6 months, or currently receiving treatment for schizophrenia or other serious psychiatric illness
* Contraindications to exercise determined using the EASY/healthcare follow-up
* Congestive heart failure New York Health Association (NYHA) Class I or higher; unstable angina; heart attack or stroke within past 6 months
* Visual or hearing impairment.