cyrilzakka/clinical-trials huggingface dataset:
Sleep Loss and Energy Metabolism in People With Family History of Type 2 Diabetes.

The use of energy from food changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the amount of energy that people who have a relative with type 2 diabetes (parent, sibling, or grandparent) use to perform their daily activities. This study is being done to test the hypothesis that the daily use of energy in people who have a history of type 2 diabetes in their family will be different after they have slept short hours for 16 days in comparison to when they have slept longer hours for 16 days.

Study participants will complete two 16-day inpatient stays in the sleep laboratory of the University of Chicago Clinical Resource Center that will be scheduled at least 4 weeks apart. Bedtime duration will be set at 5.5 hours per night during one of these stays and at 8.5 hours per night during the other. No daytime naps will be allowed. Study participants will be served regular daily meals including breakfast, lunch, dinner, and a bedtime snack. On weekdays all participants will engage in simulated "office work" in the sleep laboratory. During the rest of the time participants will maintain their usual indoor and outdoor activities as much as possible within the limits of the University of Chicago campus. At the beginning of each inpatient stay, study participants will drink a glass of water containing harmless non-radioactive dense forms of oxygen and hydrogen, small amounts of which are found in natural water. Several urine samples will be collected before and after the participants drink the water and again 14 days later in order to measure the amount of energy that was used by them during this time. At the end of each stay participants will also undergo measurements of their body composition (lean tissue, bone and fat) and their metabolic rate at rest and after a standard meal, and will complete tests to determine how much insulin does their body produce in response to an intravenous glucose infusion and how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Eligibility Criteria:
Inclusion Criteria:

* regular sleep habits
* BMI 20 to 27 kg/m2
* at least one parent, sibling or grandparent with type 2 diabetes
* must exercise regularly

Exclusion Criteria:

* active smoker
* night or shift work
* have highly variable sleep habits
* have a hormonal disorder
* have a sleep disorder
* have an active medical problem
* women only: use of birth control pills
* women only: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep
Multimodal Assesment of Alzheimer Patients

The goal of this study is to learn more about the changes in the brains of patients with cognitive impairment (MCI) and Alzheimer's Disease (AD).

The main questions the study aims to answer are:

1. What findings can be used to earlier detect patients that will develop Alzheimers?
2. Which differences are seen between healthy and cognitively impaired patients?
3. Which differences are seen between patients with Alzheimers disease?

Participants will undergo:

* Cognitive tests
* Magnetic resonance imaging (MRI)
* Electroencephalography (EEG)
* Blood sample collection
* Fecal sample collection
* A randomized group will undergo polysomnography analysis.

The projects aims to map brain changes in patients with mild cognitive impairment (MCI) and Alzheimer's Disease (AD) by combining different assesment modalities.

In the MRI, researchers will get the opportunity to analyse both structural and functional brain changes. In the EEG, changes in elctrical activites will be measured. The blood samples allow researchers to analyse specific dementia and inflammation proteins, while fecal speciments can be used to assess bacterial composition. Additionally, the cognitive testing allow to assess the specific part of cognitive function which is affected.

Eligibility Criteria:
Inclusion Criteria:

* MCI and AD according to relevant ICD-criterias.
* Control cohort is age and gender matched with other cohorts.

Exclusion Criteria:

* Uneligibility for any of the planned neuroimagery devices (MRI, EEG)
* AD diagnosis before the age of 65 (Early-onset AD).
* Brain tumor
* Traumtic head injury
* Earlier neurosurgery
* Other neyrodegenerative diseases (i.e Parkinson and ALS)
* Diseases related to inflammation and auto-immunity (i.e MS)
Light Sleep: Screen Use and Sleep Health

The Phone Sleep Study is being done to find out whether wearing blue light-blocking glasses in the evening improves subsequent sleep. This is a 21-day study and participants will be asked to wear a sleep-monitoring "actiwatch", a heart tracker, and an activity monitor, as well as to provide screenshots of participants' smartphone's screen time app for three weeks. Participants will also be asked to wear a blood pressure cuff on their arm for three days during each week, for a total of nine days.


Eligibility Criteria:
Inclusion Criteria:

1. Fluent English speaker and reader
2. Capable of providing one's own informed consent
3. Age 18 to 29 years old
4. Healthy, sighted individuals
5. Own an iOS smartphone (iPhone)
6. Willingness to update smartphone to access the current version of the Screen Time or StayFree application, depending on smartphone operating system
7. Willingness to participate in surveys, wear health monitoring devices, and provide screenshots of their smartphone's screentime application throughout the entire study

Exclusion Criteria:

1. Younger than 18 or older than 29 years
2. Individuals who are blind or wear corrective lenses
3. Taking prescribed medications that affect sleep
4. Recent shift work
5. Sleep disorder diagnosis or any cardiovascular disease
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, age 18 years and older
* Presence of hepatitis C infection, genotype 1a or 1b
* Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
* Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

Exclusion Criteria:

* Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
* Patients with cirrhosis
* Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
* Co-infection with hepatitis B or human immunodeficiency virus (HIV)
* History or evidence of chronic liver disease other than hepatitis C
Limits of Stability in Sitting in Healthy Controls and Participants Post Stroke

In this cross-sectional study we will compare the limits of stability in non-ambulatory participants post stroke compared to healthy controls. This will be done by placing participants in a seated position on a force platform, that will measure centre of pressure displacements during a leaning task in multiple directions. The results of the limits of stability test will be compared to standard clinical Measures of trunk control and functional balance, to see if there is a relationship between both ways of measuring. And how balance and trunk control are affected in the subacute stroke population.


Eligibility Criteria:
Inclusion Criteria Participants post Stroke:

* a stroke with clear hemiplegia (a previous stroke is accepted when complete recovery was achieved)
* being a patient at the UZ Pellenberg
* Functional Ambulation Catergory of two or less
* to be able to sit independently for 2 minutes
* to be cooperative enough to fulfill multiple Evaluations and tests
* to be able to understand simple instructions and be able to execute those.

Exclusion Criteria Participants post Stroke:

* to have musculoskeletal and/or other neurological disorders that could influence the protocol
* severe communication, memory or language disorders that could disturb the understanding of the research protocol.
* no signed informed consent

Inclusion criteria healthy controls:

* Age above 50
* to be able to stand independently for 2 minutes

Exclusion criteria healthy controls:

* a disorder that could influence balance capabilities
* Berg Balance Scale less than 50 Points
* no signed informed consent
Clinical & Radiographic Evaluation of Neo MTA Versus White MTA in Revascularization of Non-Vital Immature Permanent Teeth

* To evaluate and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.
* Evaluation of the effectiveness of Neo MTA as coronal plug in revascularization of immature teeth with necrotic pulp.

The new formulation of MTA (NeoMTA) does not contain bismuth oxide, will be used in revascularization of nonvital immature permanent anterior teeth.

to evaluate the effectiveness of Neo MTA as coronal plug and compare the degree of tooth discoloration in tooth crowns induced by Neo MTA versus white MTA over time.

Eligibility Criteria:
Inclusion Criteria:

* Age of patients: 7-15years old.
* Free from any systemic diseases that may affect the normal healing process.
* Tooth with immature root apex.
* Traumatically or cariously exposed non vital permanent anterior tooth.
* Pulp space not needed for post and core for final restoration.
* Compliant patient/parent

Exclusion Criteria:

* Patients having allergy to medicaments and antibiotics necessary to complete procedure.
* Tooth with vital pulp or complete root formation.
* Teeth with internal or external root resorption.
* Un-cooperative patients.
* Luxative injuries.
* Teeth with a root fracture
* Alveolar fracture
* Subjects with chronic systemic illness.
* Subjects with poor oral hygiene.
* Compromised remaining tooth structure as teeth with extensive loss of coronal tissue will require restoration with a post that will occupy the space required for blood clot formation.
Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume

During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis.

Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable low tidal volume for intraoperative oxygenation and protection against PPCs.

Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in adults.

We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs.

Patients will be randomly assigned to one of two groups:

FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers

VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.

Lung separation will be performed by DLT technique. Mechanical ventilation will be applied in volume-controlled mode. During two-lung ventilation, VT will be set at 8 mL/kg predicted body weight. During one-lung ventilation, in GroupFix VT will be decreased to 6 mL/kg PBW with 5 cmH2O PEEP.

In GroupVar VT will be 6 ml/kg predicted body weight ±33% with 5 cmH2O PEEP. Respiratory rate will be adjusted to maintain same minute ventilation as during two-lung ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring OLV (no emergency surgery)
* BMI \< 35 kg/m2
* Age ≥ 18 years
* Expected duration of surgery \> 60 min
* Expected duration of anesthesia \> 90 min

Exclusion Criteria:

* COPD GOLD 3+4, lung fibrosis, documented bullae, severe emphysema, pneumothorax
* uncontrolled asthma
* NYHA 3+4, CCS 3+4
* previous thoracic surgery
* ARDS (Berlin definition)
* documented pulmonary arterial hypertension \> 40 mmHg syst
* documented or suspected neuromuscular disease (thymoma, myasthenia)
* planned mechanical ventilation after surgery
* bilateral procedures
* lung separation with other method than DLT (eg diff. airway, tracheostomy)
* surgery in prone position
* persistent hemodynamic instability, intractable shock
* intracranial injury or tumor
* enrollment in other interventional study or refusal of informed consent
* pregnancy (excluded by anamnesis and/or laboratory analysis)
Effect of Physical Therapy on Breast Cancer Related Lymphedema

The objective of this study is to investigate if Complete Decongestive Therapy is equally effective whether it includes manual lymphatic drainage or not in the treatment of lymphoedema among patients with breast cancer.

Physical therapy treatment of patients with lymphoedema includes treatment based on the principles of 'Complete Decongestive Therapy' (CDT). CDT consists of following components; skin care, manual lymphatic drainage, bandaging and exercises. Regarding what type of treatment of treatments is most effective, the scientific evidence is sparse. Studies have focused on the time-consuming manual lymphatic drainage, but the scientific evidence is not consistent.

A randomized, single-blind, equivalence trial. A total of 160 breast cancer patients with lymphoedema will be recruited from 3 hospitals and randomised into one of two treatment groups: A: Complete Decongestive TherapyA (incl. manual drainage) or B: Complete Decongestive TherapyB (except manual lymphatic drainage

Eligibility Criteria:
Inclusion Criteria:

* The diagnose breast cancer regardless of date for operation and identified lymphoedema
* Precede ultrasonic scanning of axilla in order to exclude local relapse
* Lymphoedema \> 2 cm i.e. stage II-III
* Completed radiotherapy and/or chemotherapy at least 2 months prior inclusion

Exclusion Criteria:

* Relapse of breast cancer
* Untreated infection
* Untreated heart failure
* Untreated renal failure
* Untreated deep venous thrombosis in the arm
* Unable to participate in physiotherapy treatment and/or not able to understand instructions
A Study of Medication With or Without Psychotherapy for Complicated Grief

The major goal of this 4-site, double blind, placebo-controlled intervention trial is to assess the efficacy of medication (Citalopram) alone or with psychotherapy (Complicated Grief Therapy) to treat the symptoms of complicated grief.

Complicated grief (CG) is a debilitating condition that is estimated to affect millions of people in the United States alone. We conducted the first randomized controlled study to address this condition (MH60783) and confirmed efficacy of a targeted psychotherapy, complicated grief treatment (CGT). Participants in our prior study continued stable antidepressant medication while receiving CGT or Interpersonal Psychotherapy (IPT). Individuals taking antidepressants had better outcome in both treatments, though CGT was superior to IPT when administered with (60% responders v. 40%) or without (42% v.19%) antidepressants. Studies of antidepressant medication alone have shown mixed results with SSRIs appearing to be promising. However, there has been no randomized controlled study of SSRIs for CG. Determining the efficacy of SSRI treatment for CG, when administered with and without CGT, is of great public health importance.

We assembled 4 groups of investigators with strong track records in bereavement research and extensive experience with intervention studies and multicenter projects, to conduct a study of citalopram (CIT) efficacy. We plan to enroll participants with a primary diagnosis of Complicated Grief and randomly assign them (n=480; 50 at Columbia) to receive treatment with CIT, Placebo (PBO), CIT + CGT or PBO + CGT over a period of approximately 16 weeks. We want to determine whether citalopram shows a better response than placebo, when administered either with or without CGT. We will also address the question of whether CIT performs as well when administered alone as it does when administered with CGT.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Complicated Grief and this is the patient's most important (primary) problem
* Ability to give informed consent
* Fluent in English
* Willingness to have sessions audiotaped
* Willingness to undergo random assignment

Exclusion Criteria:

* Diagnosis of one or more of the following disorders: Schizophrenia or other psychotic disorder, current (past 6 months) substance abuse, Bipolar Disorder, current manic episode, Dementia
* Pregnant or lactating women and women of childbearing potential not using medically accepted forms of contraception
* Acute, unstable or severe medical illness such as (but not limited to) stroke, epilepsy, or other neurodegenerative disorders, metastatic or active cancer, hepatic disease, or primary renal disease requiring dialysis
* Prior intolerance of citalopram
* Pending or active disability claim or lawsuit related to the death
Analysis of BPA Concentration in Serum in Women of Reproductive Age With Autoimmune Thyroid Disease

The aim of the study is to assess the relationship between the concentration of bisphenol A in serum and selected parameters of thyroid function in women of reproductive age with thyroid dysfunction - Hashimoto's disease and Graves' disease.


Eligibility Criteria:
Inclusion Criteria:

* Graves' disease or Hashimoto's disease (positive thyroid autoantibody)
* Control group: thyroid autoantibody negative, normal thyroid function
* Women aged 18 to 45 in both the control group and experimental group

Exclusion Criteria:

* Pregnancy and lactating women
* Previous or planned treatment with 131I or thyroidectomy
* The use of drugs affecting the thyroid function (lithium, amiodarone, interferon a, sodium nitroprusside, sunitinib, sorafenib, iodine contrast, antibiotics / antifungals / antivirals (for at least 4 weeks prior to recruitment to the study), which do not result from the treatment of thyroid disease (levothyroxine, thyreostatic drugs, glucocorticoids)
* Active malignancy
* Other autoimmune diseases
* Other endocrine diseases
* Patients with severe liver, kidney or heart failure
Defining Endpoints in Becker Muscular Dystrophy

This is a 24-month, observational study of 50 participants with Becker muscular dystrophy (BMD)

Becker Muscular Dystrophy (BMD) is most frequently due to in-frame mutations in the dystrophin gene that are associated with reduced levels of frequently shortened dystrophin, though other mutations may be related to the Becker phenotype. There is wide variation in the age of onset and degree of progression, ranging from childhood to late adulthood. The more severe form of dystrophinopathy, Duchenne muscular dystrophy, has a more characteristic rate of progression and overall natural history. The wide variation in severity of progression has led to challenges in the design and conduct of approaching therapeutic trials. There is a need for a more rigorous natural history study to assist in the design of these promising therapeutic trials.

Eligibility Criteria:
Inclusion Criteria:

For ages 6-12

1. Clinically affected (defined as weakness on bedside evaluation in a pattern consistent with BMD)
2. Genetic confirmation of an in-frame dystrophin mutation
3. Ambulatory
4. Willing and able to give informed consent and follow all procedures and requirements

For ages 13 and older

1. Clinically affected (defined as weakness on bedside evaluation in a pattern consistent with BMD)
2. Genetic confirmation of a dystrophin mutation
3. Willing and able to give informed consent and follow all procedures and requirements

For participants in the MRI substudy:

1. Ambulatory, defined as able to walk 10 meters without assistive devices (orthotics allowed)

Exclusion Criteria:

For ages 6-12

1. Out of frame dystrophin mutation
2. Use of chronic corticosteroids at baseline, defined as greater than 6 months of chronic use, will be limited to 20% of the overall population
3. Non-ambulatory, defined as the inability to walk 10 meters without assistive device (excluding orthotics)
4. \>16 hours of ventilatory support
5. Any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator.
6. Under the age of 6 at time of enrollment
7. For MR Cohort: Have contraindications to MRI or MRS (e.g., non-MR compatible implanted medical devices or severe claustrophobia)

For ages 13 and older

1. Loss of ambulation prior to age 16
2. Use of chronic corticosteroids, defined as greater than 6 months of chronic use, will be limited to 20% of the overall population
3. Less than 30% of the overall population will be non-ambulatory, defined as the inability to walk 10 meters without assistive device (excluding orthotics)
4. \>16 hours of ventilatory support
5. Subjects aged 13-16 only: time to rise \>10 seconds
6. For MR Cohort: Have contraindications to MRI or MRS (e.g., non-MR compatible implanted medical devices or severe claustrophobia)
Closure of Anastomotic Leaks in the Stomach and Esophagus by Endoscopic Suturing

Patients with suspected leakage at the specified surgical anastomoses undergo an immediate diagnostic endoscopy as part of current clinical routine. Consenting patients meeting the inclusion criteria will undergo closure of the defect by endoscopic suturing in addition to standard surgical care.


Eligibility Criteria:
Inclusion Criteria:

* leakage at anastomosis within 2 weeks after upper gastrointestinal (GI) resection

Exclusion Criteria:

* tubular ischemia of the upper GI tract
* inability to provide informed consent