cyrilzakka/clinical-trials huggingface dataset:
VERIFY: Vedolizumab for the Prevention of Immune Checkpoint Inhibitor Related Diarrhea or Colitis in Patients With Cancer

The purpose of this study is to assess the prevention of immune checkpoint inhibitors (ICIs) related diarrhea/colitis using vedolizumab in participants with unresectable stage III or metastatic stage IV cancer, starting standard of care (SOC) immunotherapy

After being informed about the study and potential risks, all patients giving written informed consent will undergo up to a 2-week screening period to confirm their eligibility. Eligible patients will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Vedolizumab or placebo and given their first dose within 2 weeks of starting their SOC immunotherapy. Vedolizumab or placebo will be administered at Weeks 0, 2, 6, 14, and 22.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to initiation of any study specific activities or procedures
* Diagnosed with unresectable advanced stage III or metastatic stage IV malignancy
* Planned for initiation of SOC immunotherapy and development of prognostic biomarker evidence that predisposes to ICI diarrhea/colitis risk
* Ability to and willingness to adhere to the randomized treatment interventions (vedolizumab or placebo), administered intravenously

Exclusion Criteria:

* Condition(s) for which vedolizumab is contraindicated (e.g., hypersensitivity reaction, known allergic reaction to vedolizumab or its components)
* Current or prior use of vedolizumab or prior immunotherapy exposure for cancer
* Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis), indeterminate colitis, or microscopic colitis
* Presence of ileostomy, colostomy, or short bowel syndrome
* Presence of known luminal gastrointestinal metastases at baseline
* Presence of significant pre-existing autoimmune disease (at investigator's discretion)
* Presence of severe infection(s) or opportunistic infection(s)
* Active enteric infection with viral, bacterial, or parasitic pathogens
* Presence of untreated latent or active tuberculosis, or untreated chronic hepatitis B virus
* Baseline ECOG status grade ≥3
* Pregnancy or lactation
* Treatment with another investigational product within 8 weeks of randomization
* Requirement for baseline anti-diarrheal treatment(s) (including but not limited to loperamide, diphenoxylate-atropine, octreotide, tincture of opium), anticholinergic drug(s), or opioid-based analgesic(s) used specifically for diarrhea control within 14 days of randomization
* Any condition or diagnosis, that could in the opinion of the Qualified Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
Latent Tuberculosis in Second Generation Immigrants From High Risk Countries Compare to Low-risk Young Israeli Adults

The aim of study is to evaluate the prevalence of latent TB in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native Israelis without a family member who was born in a country with high incidence of tuberculosis. Using study questionnaire IGRA and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive IGRA test than the control native group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-25
* Men and women
* Second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000).
* Native Israelis without a family member who was born in a country with high incidence of tuberculosis.

Exclusion Criteria:

* Prior contact with a tuberculosis patient
* Working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis.
* HIV infection and any immunodeficiency condition.
* Recent live-virus vaccination
* Acute infectious disease
* Prior serious reaction to tuberculin skin test
* Pregnancy
Effect of Maternal Age and BMI on Induction of Labor Using Oral Misoprostol in Late-term Pregnancies: a Retrospective Cross-sectional Study

To evaluate the effect of maternal age and body mass index (BMI) on oral misoprostol induction of labor for late-term pregnancies.


Eligibility Criteria:
Inclusion Criteria:

* Late term pregnancies out of labor,
* Bishop score \< 7

Exclusion Criteria:

* labor (defined as presence of at least three painful uterine contractions every ten minutes),
* uterine tachysystole (\>5 contractions within 10 minutes for two consecutive 10-minute periods),
* hypertonic uterus,
* abnormal CTG,
* contraindications to vaginal delivery (fetal malpresentation such as breech presentation or transverse situation, fetal macrosomia, abnormally implanted placenta, active genital herpes infection, cervical cancer),
* patients with parity \> 4,
* medical contraindication to misoprostol (asthma, glaucoma),
* women with previous hysterotomies.
Prolonged Grief in Young Bereaved Spouses and Partners

The purpose of the research is to learn more about the experience of grief in young bereaved spouses/partners. Recent research has shown that young bereaved spouses/partners experience grief uniquely from other age groups, but it is still unclear how certain factors affect the experience of grief. The investigators research team is interested in studying how the psychological factors of trauma, personality, and meaning of the loss affect grief reactions in young spouses/partners after the loss of a spouse to cancer.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 20 years old and no older than 49 years and 11 months old.
* Participants must have lost a spouse/domestic partner to cancer 6 months to 3 years earlier.
* Participants must be able to give informed consent.
* Participants must be able to comprehend English to complete study assessments.

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.
Self-Management in Young Adults With Type 1 Diabetes

Type 1 Diabetes (T1D) affects 1.6 million Americans, and only 14% of young adults age 18-25 years achieve glycemic targets (glycosylated hemoglobin A1C \<7.0%). Achieving glycemic targets is associated with reduced risk for both micro-and macrovascular complications, better neurocognitive function, and better diabetes quality of life. In lab studies, sleep deprivation led to impaired glucose tolerance and insulin sensitivity in adults without chronic condition and in one study of adults with T1D. Extending sleep in natural environments contributes to improved insulin sensitivity and glucose levels, neurocognition, and psychological symptoms in young adults without chronic conditions. Modifiable dimensions of sleep health (appropriate sleep duration, stability, and timing) are associated with better glycemic control in adults with T1D. Therefore, improving sleep duration, stability, and timing may be potential therapeutic targets to improve glucoregulation and clinical outcomes (diabetes self-management, neurocognitive function, and symptoms) in this high-risk population.

The overall objective is to test and compare the effects of a cognitive-behavioral sleep self-management intervention (sleep extension and consistency in sleep timing) compared to an attention control condition (habitual sleep duration + diabetes self-management education) on improving sleep duration, stability, and timing, and glycemia (glycemic control and glucose variability) in short-sleeping young adults with T1D in a pilot randomized controlled trial.

This is a two-arm randomized controlled trial, with participants assigned to either the Sleep Self-Management arm or the attention control arm (Diabetes Self-Management Education). The Sleep Self-Management condition involves an initial 50-minute face-to-face consultation with brief 5-10 minute weekly follow-ups in a format TBD by aim 1 (e.g., call, text, video conference) with 3-week booster sessions in person. The Sleep Self-Management intervention activities are provided in addition to "usual care."

Eligibility Criteria:
Inclusion Criteria:

* 1) Age range: from 18 to 26 years
* 2) Diagnosed with T1D for at least 6 months
* 3) No other major health problems (e.g., chronic medical condition or major psychiatric illness
* 4) Not currently participating in any intervention studies
* 5) Read/speak English
* 6) Have a most recent A1C or eA1C value ≥ 7%.

Exclusion Criteria:

* 1) Previous OSA diagnosis/high-risk sleep apnea
* 2) Current pregnancy
* 3) Night shift workers
* 4) Habitually sleep \> 7 hours on work or school days.
Single-Incision Gasless Endoscopic Total Thyroidectomy Via Subclavian Approach Versus Open Surgery for PTC

Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.

Historically, performing a contralateral thyroid lobectomy and lymph node dissection via the subclavian approach was considered challenging. This study aimed to evaluate the safety and feasibility of single-incision gasless endoscopic total thyroidectomy and central compartment neck dissection via the subclavian approach (SCA) in comparison to conventional open surgery for the treatment of papillary thyroid carcinoma (PTC) retrospectively.

Eligibility Criteria:
Inclusion Criteria:

* (1) thyroid neoplasm \&lt;3.0 cm;
* (2) well differentiated papillary thyroid carcinoma.

Exclusion Criteria:

* (1) extrathyroidal extensions estimated in ultrasonography scan;
* (2) enlarged lymph nodes in lateral neck compartment on palpation, or US scan;
* (3) suspected distant metastases;
* (4) previous history of neck radiation therapy and/or surgery.
Deutsches Dual Therapy Stent Register

The DTS.DE registry is an initiative for the collection of high quality process and historical data of implantations with the COMBO Dual Therapy Stent in Germany. DTS.DE was designed as a national, non- randomized, prospective, multicenter registry without a comparison group.

The responsible Steering Committee is of the opinion that the Combo stent qualifies for further documentation of treatment results in the form of a German registry, based the CE certification of the COMBO Dual Therapy stent in 2013 and its clinical and scientific investigation in the context of the REMEDEE study program, as well as company independent externally initiated studies with the COMBO Dual Therapy Stent.

It is expected that by mid- 2015, at least 1,000 patients will be enrolled and documented in the DTS.DE registry with the COMBO Dual Therapy Stent. A clinical follow-up is performed after 6 weeks and 12 months.

It is the objective of the DTS.DE registry to capture the documentation of all patients who have been treated with a Combo Dual Therapy Stent in Germany, and who have been properly informed and consented with regards to their participation in the registry. All of these patients will be registered in the electronic data capturing system (eCRF) of the DTS.DE registry and will be followed and documented for a period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients has at least one coronary lesion, suitable for PCI treatment with the Combo stent in accordance with European Society of Cardiology Guidelines and local Guidelines of the Deutsche Gesellschaft für Kardiologie for drug eluting stents

Exclusion Criteria:

* Patient has previously received murine therapeutic antibodies and exhibited sensitization through the production of Human Anti- Murine Antibodies (HAMA)
* Patient in whom anti-platelet and/or anticoagulant therapy is contraindicated
* Patient in whom a complete inflation of the angioplasty balloon or correct stent placement is thought to be inhibited
The Effect of Pre-rehabilitation and Rehabilitation Period on Functional Status in Inpatient Stroke Patients

Patients who underwent inpatient rehabilitation for the last 5 years were retrospectively scanned. The pre-rehabilitation and rehabilitation periods of the patients were determined. At the beginning and end of rehabilitation, patients were evaluated with the Brunsstrom, Barthel and Stroke Impact Scale. The effect of the specified durations on these scales was investigated.


Eligibility Criteria:
Inclusion Criteria:

* 40-90 years old
* Have hemodynamic stability to participate in rehabilitation
* Having had an ischemic or hemorrhagic stroke

Exclusion Criteria:

* Having a serious comorbidity that may preclude rehabilitation
* Malignancy
* Aphasia
* Having a serious perception problem or psychiatric illness
* Having a history of stroke
Closed-loop Functional Spinal Cord Stimulation in Patients With Spinal Cord Injury

The purpose of this experiment is to evaluate the efficacy of Closed-loop Functional Spinal Cord Stimulation on Walking Rehabilitation in Patients after Spinal Cord Injury

The whole course will last around 12 months, during which there will be: Pre-implant evaluations and standard rehabilitation (6-10 weeks), Stimulator implantation and stimulation optimization (4-8 weeks), Rehabilitation training with stimulation (6 months). At the end of the protocol, the study aims to make the patients walk better and faster.

Eligibility Criteria:
Inclusion Criteria:

* Age 18\~70
* Spinal cord injury staging(AIS) A,B,C or D
* Level of lesion is T10 and above
* Distance between lesion and conus \>60mm
* Injured Time \> 3 months
* Capable of participating rehabilitation program
* Agree to comply with all conditions of the study and to attend all required study training and visits

Exclusion Criteria:

* With Obvious psychiatric disorder that cannot complete relevant questionaires
* Cognitive impairment
* Severe autonomic reflex disorder
* Severe muscle atrophy and joint contracture
* Cannot participate in spinal cord stimulation surgery or follow-up visits
* Life expectancy less than 12 months
* Abnormal blood or other physiological examinations that cannot conduct surgery, such as blood coagulation disorder or kidney/liver abnormalities
* Uncontrollable hypertension, heart diseases, respiratory diseases or took related medicine in last 3 months
* Unsuitable candidates in PI's perspective
Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.

In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status grade I and II infants (1-12month).
2. undergoing elective cataract surgery in one eye under general anesthesia.

Exclusion Criteria:

1. infection of the orbit,
2. increased intraocular pressure(IOP),
3. history of allergy to local anesthetics,
4. history of previous eye surgery,
5. cardiovascular or clotting disorders,
6. full stomach,inner ear disorders or other conditions predisposing to vomiting
7. airway abnormalities
8. compromised sclera.
ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19

The purpose of this study is to evaluate the feasibility, acceptability and effectiveness of a brief, telehealth intervention (the Emotional Support Plan), intended to support autistic adults to cope with their negative emotions during and/or after the COVID-19 pandemic. The first objective is to develop and refine a brief telehealth-delivered treatment, the Emotional Support Plan (ESP), to help promote adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic. The second objective is to assess the feasibility and effectiveness of the ESP to support autistic adults to implement emotion regulation strategies during periods of acute distress. The last objective is to yield preliminary data to apply for extramural grants to validate these methods to monitor and support mental health of autistic adults during key transitions (e.g., starting college).


Eligibility Criteria:
Inclusion Criteria Adults 18 years or older with previously established diagnoses in ASD will be invited to participate. Adults who have a verbal IQ above 70 or who are students admitted to a college or university will be included in the study.

Exclusion Criteria

* Individuals who are younger than 18 years old or who does not have diagnosis of ASD will excluded from the study as the purpose of the current research is to evaluate the validity of ESPs in adults with autism.
* Adults who are unable to understand English will be excluded because the instruments being investigated are currently only validated in English and the study team is not sufficiently fluent in other languages to provide assurance that informed consent could be obtained (or intervention provided) in a language besides English.
* Subjects without access to a compatible iOS and Android smartphone (nearly all phones from the past 10 years are compatible) will be excluded because the study requires subjects to record responses on a smartphone app. Individuals will not be excluded from the study based on race, ethnicity or gender.
* Subjects who have a verbal IQ below 70 will be excluded as this is a study that requires self-report and engagement in a one-on-one intervention.
* If the PI's clinical judgment is that it would not be in the adult's best interest to be enrolled, they may also be excluded.
Procalcitonin Test for Differentiation of the Cause of Pneumonia

The purpose of this study is to evaluate the usefulness of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.

Serum procalcitonin test is currently used as the biomarker for bacterial infection. Especially, procalcitonin test has been reported to be helpful in differentiating bacterial pneumonia from viral pneumonia, acute exacerbations of interstitial pneumonitis or chronic obstructive lung disease. However, it is not known whether procalcitonin test can help distinguish bacterial pneumonia from non-bacterial pneumonia such as radiation pneumonitis or chemotherapy-induced pneumonitis in patients with cancer.

The aim of this prospective cohort study is to observe the clinical benefits of procalcitonin test for differentiation of the cause of pneumonia in patients with cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Patients who have symptoms and suspected imaging findings compatible with pneumonia

Exclusion Criteria:

* Patients who have been treated with antibiotics or steroid therapy.
Technology-Enabled Collaborative Care for Youth

The overall objective is to develop scalable interventions to address the physical health needs of patients affected by early psychosis. The objective of this project is to conduct a feasibility study of a high intensity technology-enabled collaborative care model (CCM) compared to lower intensity self-help modules and email support for early identification and treatment of cardio-metabolic risk factors in youth, ages 16-29, affected by early psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Ages 16 - 29 years
* Clinician diagnosis of early psychosis (diagnosed in last 5 years)
* Prescribed psychiatric medication, stable for 4 weeks
* Access to telephone or internet through computer or mobile

Exclusion Criteria:

* Unable to provide consent
* Unable to understand English
Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes

Glycemic variability has been associated with mortality in hospitalized patients with hyperglycemia. However, it is unknown how modulation of glycemic variability would impact outcomes. One possibility is that glycemic variability could impact autonomic tone. In particular, heart rate variability (HRV) measurement is a sensitive marker for measuring autonomic tone, and aberrations in HRV have been associated with mortality. The current randomized pilot study will compare the effects of continuous intravenous (IV) insulin and subcutaneous basal bolus insulin on glycemic variability and autonomic tone in hospitalized non-critically ill patients with diabetes. Non-critically ill patients who are hyperglycemic or are requiring at least 20 units of insulin per day will be included. Patients with conditions that preclude accurate HRV readings (such as atrial fibrillation or paced rhythms) will be excluded. Patients randomized to intravenous insulin will receive the therapy for 24 hours according to our standard hospital guideline. Patients randomized to subcutaneous (SQ) insulin will receive basal bolus therapy using insulin analogues. All therapies will begin between 8 and 10 AM. Patients will undergo repeated heart rate variability recordings during the 24 hour period. Blood draws will be collected at baseline and at 24 hours for measurement of catecholamines, insulin, and c-peptide. Glycemic variability will be measured using a continuous subcutaneous glucose monitor and reported as coefficient of variation. The primary outcome measure is low frequency-to-high frequency power spectrum ratio of heart rate variability.

1. Glycemic variability is associated with unfavorable changes in autonomic tone, as assessed by low frequency (LF)/high frequency (HF) HRV ratio, independent of changes in overall glycemia.
2. Short-term increases in glycemic variability, followed by more prolonged glycemic stability are observed in generalized hospitalized patients treated with intravenous insulin compared to standardized basal bolus therapy. LF/HF HRV differs among subjects receiving intravenous compared to subcutaneous insulin.
3. Glycemic variability differs among subjects receiving intravenous compared to subcutaneous insulin


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Admitted to a general medicine or medicine subspecialty service
* Insulin use (\>20 units/day) or hyperglycemia. Hyperglycemia is defined as glucose greater than 180 mg/dL on at least 2 occasions separated by at least 4 hours apart.

Exclusion Criteria:

* Type 1 diabetes
* Hospital stay expected less than 48 hours
* Inability to consent
* Pregnancy
* Prisoners
* Previous participation
* Autonomic neuropathy
* Conditions that preclude accurate heart rate variability monitoring: atrial fibrillation, frequent ectopy, congestive heart failure, paced heart rhythms
* Conditions which require lower dose insulin algorithms: end stage renal or liver disease