cyrilzakka/clinical-trials huggingface dataset:
A Mobile Health Intervention to Achieve Appropriate Gestational Weight Gain in Overweight/Obese Women

The aim of this trial is to investigate the effectiveness of a mobile health (mhealth) intervention to help overweight and obese women achieve appropriate gestational weight gain (GWG) for their pre-pregnancy body mass index (BMI). The goal of the intervention is to help women achieve GWG within the range recommended by the Institute of Medicine. The investigators propose an adaptive intervention that begins with an effective, yet low resource-intensive treatment and then provides incremental support and resources only to patients who need them. The intervention includes: 1) an mHealth tool allowing data to be automatically transmitted to a mobile website; 2) personalized text messages; and 3) personalized 1:1 telephone coaching sessions. The latter more intensive components are reserved for patients whose GWG is not within the IOM guidelines. The lifestyle intervention will be delivered through 1 telephone counseling session with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and weekly e-mails of core lifestyle intervention sessions. Personalized text messages and 1:1 telephone coaching sessions will be given to those who are not meeting the GWG guidelines. The lifestyle intervention will be compared to usual medical care. Maternal outcomes will be assessed shortly before delivery and at 6 weeks postpartum. Infant birthweight and weight at one year will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Women receiving prenatal care at Kaiser Permanente San Francisco and Oakland and whose obstetric care clinicians consent to participate;
* Pregravid BMI 25 to \<40 (as determined from a measured pregravid weight in electronic medical record);
* Has access to a smartphone and Wi-Fi;
* Provides informed consent to participate.

Exclusion Criteria:

* Multiple births;
* Planning to move out of the area during the study period;
* Inability to speak, read, or understand English;
* Placed on bed rest at time of enrollment; -\>15 weeks' gestation at enrollment.
Study of TPI 287 Administered Every 21 Days in Patients With Advanced Malignancies

Tapestry Pharmaceuticals, Inc. has developed a novel taxane analog, TPI 287. TPI 287 is synthetically manufactured from naturally occurring taxanes extracted from yew starting material. The synthesis involves modification to the taxane side chain to overcome multidrug resistance and to achieve mutant tubulin binding. This study will be a multi-center, dose escalation, sequential group, Phase 1 study evaluating the intravenous administration of TPI 287 on an every 21 day cycle.

The primary objective of this study is to determine the maximum tolerated dose of TPI 287 administered every 21 days for Phase II clinical trials.

Eligibility Criteria:
Inclusion Criteria:

Patients must be/have:

* Histological evidence of malignancy
* Advanced solid tumors that have recurred or progressed following standard therapy
* Failed one prior therapy or have no standard therapy available
* Ambulatory with ECOG of 0-1 and estimated life expectancy of \> 3 months
* If female, negative pregnancy test
* If of childbearing years, agree to use birth control
* If patient with prior radiation therapy for brain metastases, on steroids, must have been stable for 1 month

Exclusion Criteria:

Patients will be excluded if they are or have had:

* Prior radiation within 4 weeks
* Active medical condition or organ disease which may compromise safety or interfere with the study
* Clinically significant cardiac co-morbidities or pulmonary impairment
* Concomitant therapy needs
* Treated with any investigational drugs within 30 days
* Tumors involve major artery or vein
* Prior or concurrent central nervous system (CNS) disease
* Less than 4 weeks since major surgery
* Known to be positive for HIV, hepatitis B or C
* Concurrent use of aspirin
* Use of thrombolytic agents
* Uncontrolled hypertension
* Grade II-IV peripheral vascular disease
* Pregnant or lactating
* Prior allergic history to compounds of similar chemical composition
* Inpatients
* Grade II-IV peripheral neuropathy
IMT Outcomes in Sufferers of Severe Walking Disabilities and Intensive Care Unit Acquired Weakness

Intensive care unit-acquired weakness (ICU-acquired weakness) may be caused by a variety of different causes. Several studies have shown that ICU-acquired weakness occurs in up to 30% of critically ill patients. It affects daily activities, walking, and functional performance

Forty ICU-acquired weakness elderly patients will be randomly assigned to group A and group B, 20 elderly for each. Both groups will receive chest physiotherapy (cough training, vibration, percussion, rib springing, and postural drainage), 30 minutes of resisted training on upper- and lower-limb muscles (15 min on upper limb and 15 min on lower limb), and 30 minutes of neuromuscular electrical stimulation of lower- and upper-limb muscles (triceps and wrist extensors, dorsiflexors, and quadriceps). sessions will be executed 5 times weekly). Group A only will receive 3-set IMT (two sessions daily via threshold IMT, the set contain 10 repetitions) 5 times weekly. The study duration will be 1 month.

Eligibility Criteria:
Inclusion Criteria:

* sufferers with intensive care unit acquired weakness
* Older sufferers patients with severe walking disability detected by Modified Functional Ambulation Category test,

Exclusion Criteria:

* lower limb amputations
* orthopedic or spinal disc disorders
Safety and Efficacy Evaluation of iAPA-DC/CTL Combined Gemcitabine Therapy on Advanced Pancreatic Cancer

The aim of this study is to evaluate the safety and efficacy of iAPA-DC/CTL combined gemcitabine therapy on advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced Pancreatic cancer patients with histological pathology confirmation
2. Both gender, aged 18-70 year-old
3. Bone marrow functioned well
4. Renal function normal
5. Liver function normal
6. patients are voluntary, and willing to sign informed consent
7. expected lifetime was at least 3 months

Exclusion Criteria:

1. With acute inflammation
2. Accompanied with primary malignant tumor other than pancreas
3. with autoimmune disease
4. using corticosteroid or other suppress immune hormone treatment
5. had transplant operation of vital organs
6. active hepatitis
7. HIV positive
8. dysfunction in blood coagulation
9. serious diseases in circulatory and respiratory systems
10. pregnancy or breast-feeding women
Airway Management and Weight in Children

The investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in overweight/obese children is lower than that associated with endotracheal intubation (ETT).


Eligibility Criteria:
Inclusion Criteria:

* sex-specific body mass index (BMI) is ≥85th percentile
* elective surgical outpatient peripheral or lower abdominal procedures
* Surgery length estimated to last between 30 and 120 minutes

Exclusion Criteria:

* Active gastro-esophageal reflux, possible difficult intubation or planned asleep fiber optic intubation, cardiac disease, thoracic deformities, upper abdominal, and thoracic or airway surgeries.
* Children with active asthmatic attack or those considered to be "full stomach" will also be excluded.
* Laparoscopic surgical procedures and those requiring extreme head-down tilt will also be excluded.
* Children with a physiology or other condition requiring a certain type of airway for the procedure will also be excluded
* Children whose anesthesiologist is not agreeable to randomization of airway management choice will also be excluded.
Obese Patients With or Without Comorbidities (RIO-North America)

To assess the effects of weight loss and weight maintenance over a period of two years when prescribed with a hypocaloric diet in obese patients with or without comorbidities


Eligibility Criteria:
* Stable weight (variation of less than 5 kg within 3 months prior to screening visit)
* BMI (Body Mass Index) of 30 or greater in patients with or without comorbidities, or BMI greater than 27 in patients with treated or untreated hypertension and/or treated or untreated dyslipidemia
A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia

The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 74 years at Screening
* Hypercholesterolemia (LDL-C ≥ 70 mg/dL and \< 190 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening
* Satisfies one of the following:

  1. Female patients of childbearing potential must have used appropriate and highly effective contraception (a regimen which results in a failure rate of \<1% per year) with their partners for 4 weeks prior to Screening, and remain compliant during the treatment phase and until 4 weeks after the last dose of investigational product
  2. Male patients must use an acceptable and highly effective contraceptive method during the treatment phase and until 4 weeks after the last dose of investigational product
* Body mass index (BMI) ≤45 kg/m2

Exclusion Criteria:

* History of any major cardiovascular event (stroke, TIA, MI, PTCI, CABG, hospitalization due to heart failure) within 6 months of Screening
* Type I diabetes mellitus or use of insulin
* Active peptic ulcer disease or a history of muscle disease or myopathy
Midkine Role With Deregulated Oxidative and Immune Milieu in Induction of Preeclampsia

Preeclampsia (PE) is a hypertensive pregnancy-related disorder that endangers maternal and fetal outcomes and accounts for 9-10% of maternal mortalities with its early-onset phenotype is the most dangerous, but its etiology is still not fully elucidated.

Midkine (MDK) is a multifunctional protein that plays a unique role in the development of hypertension (HTN), via its proatherogenic effect and induction of overexpression of angiotensin converting enzyme. Oxidative stress (OS) upregulates the expression of MDK and MDK induces propagation of neoangiogenesis and acts as chemotactic for neutrophils.


Eligibility Criteria:
Inclusion Criteria:

* Newly pregnant normotensive (NT) women with singleton fetus;
* Free of the Exclusion Criteria.

Exclusion Criteria:

* Women with history of complicated pregnancy;
* Had manifest essential hypertension, Diabetes Mellitus or chronic kidney diseases;
* Had multiple gestational sacs, morbid obesity with Body Mass Index at time of pregnancy diagnosis over 35 kg/m2;
* Had genetic disorders, coagulopathy, autoimmune diseases or maintained on immunosuppressive therapy.
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI

The goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an AI assisted scenario.

The main questions it aims to answer are:

* will the experimental pathway be non-inferior to the standard pathway?
* will the experimental pathway be economically superior to the standard pathway?

Participants will receive screening mammograms, as part of the breast cancer screening program. Researchers will compare the interpretation made by the second reader in the standard pathway with the AI assisted interpretation made by a different reader in the experimental pathway.

All mammograms eligible for a second reading, and included in the study, go through 2 arms:

* Conventional second reading by a radiologist accredited to do second reading in France (L2 control arm),
* Second reading assisted by the AI (L2-AI experimental arm): mammograms will be read by the AI first and only if deemed suspicious, a radiologist accredited to do second reading in France will review them.

The most pejorative assessment among the two arms is used as the final decision: if both arms consider the mammogram as negative, the participant won't be recalled, if one arm consider the mammogram as positive, the participant will be called back for further examinations.

Clinical performances and economical impacts of both scenarii will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Affiliated to the French social security system
* Whose mammograms meet the following characteristics: 4 (2 per breast, CC and MLO) meeting local regulatory standards and with correct DICOM metadata,
* Whose mammograms have been determined to be normal or to have benign lesions by the radiologist who performed the first reading of the images (L1) in the framework of the organized breast cancer screening program
* Having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration of their participation,
* Having completed and signed the informed consent form.

Exclusion Criteria:

* Woman with breast implants,
* With clinical symptoms of breast cancer,
* With a history of breast surgery (breast reduction or surgery for benign lesion),
* Pregnant or breastfeeding,
* With medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent,
* Deprived of liberty by judicial or administrative order,
* Participant whose mammogram images have at least one of the following defects: poor quality of the images, non-standard mammography (projection, magnification, compression), ML/LM/SIO/XCCL or XCCM view.
Ocular Changes With Alpha-2 Receptor Agonist.

selective alpha-2 receptor agonists cause changes in intraocular pressure and pupillary size thus may affect patient quality of life.

In this research, we will analyze the effect of selective alpha-2 receptor agonists on the human eye and investigate ocular changes over 6 months after its topical use.

Eligibility Criteria:
Inclusion Criteria:

* Glaucoma suspect cases.
* post-refractive surgery cases.

Exclusion Criteria:

* Cases with prostatic hyperplasia or diabetics that may alter the measurements of pupillary diameter.
* Cases with previous history of any retinal intervention or other drugs that may alter intraocular pressure measurements.
Study of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture

The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture.

The four techniques are：

* balloon dilation
* balloon dilation plus cryotherapy
* balloon dilation plus spiculiform electrosurgery
* balloon dilation plus mitomycin C injection


Eligibility Criteria:
Inclusion Criteria:

* tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis
* the degree of stenosis is above 50%
* estimated survival duration is longer than 3 months
* recieved no treatment one month before
* can understand the statement informed consent
* agree to enroll in the study

Exclusion Criteria:

* older than 70 years or younger than 18 years
* not fibrotic stenosis
* not central airway stenosis
* existence of lumina collapse or twisting
* severe arrhythmia, myocardial ischemia or hypertensive crisis
* coagulation disorders
* existence of severe organ disfunction
* allergic to anesthesia drugs
* refuse to participate the study
Long-Term Follow-Up of Patients Undergoing Catheter Ablation

The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at the OU Medical Center.

The purpose of this study is to assess the long-term effects of catheter ablation procedures performed at this institution, including recurrence of the ablated arrhythmia and any late complications.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing catheter ablation at the OU Medical Center

Exclusion Criteria:

* Prisoners
* Refusal to participate
Feasibility and Effectiveness of Telehealth in Patients With Chronic Obstructive Pulmonary Disease in Taiwan

Recent studies have demonstrated the promising potential that telehealth has in management of chronic disease. For COPD patients, implementation of telehealth reduced readmissions, emergency room visits, and exacerbations and was cost-effective. Telehealth as a method of delivering healthcare to remote, resource-deprived areas is not lacking in evidence of benefit; however, the situation about its more widespread use for monitoring purposes is much less clear. To date, most of the studies dealing with telehealth in COPD were conducted in countries covering vast territories. Therefore, it needs to be investigated whether telehealth conveys similar advantages for COPD patients in a small island country.


Eligibility Criteria:
Inclusion Criteria:

* Admissions for chronic obstructive pulmonary disease
* Age 20 or more

Exclusion Criteria:

* Discharge against medical advice
* Enrolled in other trials
* Not being discharged to home
* Unconsciousness
Effect of Rifampicin on the Pharmacokinetics of Apatinib

The primary purpose of this study is to investigate potential pharmacokinetic interaction in healthy volunteers when apatinib is administered in combination with rifampicin. Secondary objective is evaluating the safety and tolerability of apatinib alone and when co-administered with rifampicin.


Eligibility Criteria:
Inclusion Criteria:

* female of non-childbearing potential or male;
* age 18-45 years;
* body mass index 19-24 kg/m2 with total body weight;

Exclusion Criteria:

* clinically significant medical or surgical conditions with the potential to interfere with the absorption, distribution, metabolism or excretion of the study drugs;
* history of alcohol abuse; smoker;
* electrocardiogram(ECG) abnormality;
* blood pressure \>140/90 mmHg;
* treatment with an investigational drug or any known CYP450 enzyme inducing/-inhibiting agents or herbal supplements within 14 days prior to first dose of study medication;
* Subjects were to abstain from using prescription and non-prescription drugs (other than acetaminophen as deemed necessary), vitamins and dietary supplements within 14 days prior to the first dose of study medication and throughout the study.
Sleep for Stroke Management and Recovery Trial

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Sleep SMART has a prospective, randomized, open-label, blinded-endpoint (PROBE) design. It is a multi-site, parallel-group superiority trial that compares 6 months of OSA treatment to usual care. The study includes two trials: a prevention study with an embedded recovery trial. 3062 subjects will be randomized over 5 years at 110 sites within the NINDS-funded StrokeNet clinical trials network.

Eligibility Criteria:
Current Inclusion Criteria, as of 6/28/2024:

1. Ischemic stroke within the prior 7 days.
2. NIH Stroke Scale Score ≥1 at the time of enrollment

Previous Inclusion Criteria, prior to 6/28/2024:

1. Ischemic stroke or TIA with ABCD ≥4, within prior 14 days.

Exclusion Criteria (for entire time period):

1. pre-event inability to perform all of own basic ADLs
2. unable to obtain informed consent from subject or legally authorized representative
3. incarcerated
4. known pregnancy
5. current mechanical ventilation (can enroll later if this resolves) or tracheostomy
6. current use of positive airway pressure, or use within one month prior to stroke
7. anatomical or dermatologic anomaly that makes use of CPAP interface unfeasible
8. severe bullous lung disease
9. history of prior spontaneous pneumothorax or current pneumothorax
10. hypotension requiring current treatment with pressors (can enroll later if this resolves)
11. other specific medical circumstances that conceivably, in the opinion of the site PI, could render the patient at risk of harm from use of CPAP
12. massive epistaxis or previous history of massive epistaxis
13. cranial surgery or head trauma within the past 6 months, with known or possible CSF leak or pneumocephalus
14. recent hemicraniectomy or suboccipital craniectomy (i.e. those whose bone has not yet been replaced), or any other recent bone removal procedure for relief of intracranial pressure
15. current receipt of oxygen supplementation \>4 liters per minute
16. current contact, droplet, respiratory/airborne precautions
Combined Application of Pulsed RF and Steroids to the DRG for PHN

Recently, the use of pulsed radiofrequency has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. Transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. We hypothesize that the combined use of pulsed RF and steroid injection applied to the DRG may achieve better outcomes than the use of epidural steroid injection alone.

Varicella-zoster virus reactivates in sensory ganglia as the dorsal root ganglion (DRG). The DRG contains many receptor channels and is an important region for pain signal transduction. Sustained abnormal electrical activity to the spinal cord via the DRG in acute herpes zoster can result in neuropathic conditions such as postherpetic neuralgia (PHN). Postherpetic neuralgia (PHN) is the final stage of varicella-zoster infection and is manifested as severe refractory neuropathic pain. Preventing the transition of herpes zoster-related pain to PHN is a very important therapeutic principle for patients at an early stage, especially for older patients. The exact discriminative time point for PHN has not yet been standardized. Various criteria have been used, from 30 days to 180 days after zoster onset. If pain persists for more than 180 days after zoster onset, the likelihood of pain reduction is very low and such a condition is considered "well established" PHN. Therefore, it is advisable to actively attempt various treatment modalities for pain control before the condition progresses to a recalcitrant state. Pulsed radiofrequency (PRF) is a variant of thermal radiofrequency that applies pulsed current to limit heat generation to less than 42˚C, creating a little risk of thermal or nerve injury. Recently, the use of PRF has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. Transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. We hypothesize that combined use of pulsed RF and steroid injection applied to the DRG may achieve a better outcome than use of epidural steroid injection alone.

Eligibility Criteria:
Inclusion Criteria:

* patients with ASA I\&II status
* Thoracic zoster related pain
* less than three months duration from the appearance of shingles

Exclusion Criteria:

* coagulopathy
* local infection
* patient refusal
* Diabetes Melliteus