cyrilzakka/clinical-trials huggingface dataset:
Effect of Ethanol and Genetic Polymorphisms on Bupropion Metabolism

The two purposes of this study are

1. to determine what effect the chronic and moderate/heavy drinking of alcoholic beverages has

   1. on the blood level of bupropion and chlorzoxazone and their major breakdown products in the blood and
   2. on the stimulant effect of bupropion and
2. to determine what effect a normal and common (25% frequency) genetic variation of a specific liver enzyme (that breaks down bupropion) has

   1. on the blood levels of bupropion and its major breakdown products in the blood and
   2. on the stimulant effect of bupropion.

Two groups of volunteers will be recruited for this study:

1. volunteers who drink moderate to heavy amounts of alcohol frequently and
2. volunteers who usually do not drink alcohol.

Volunteers will NOT be asked to change their drinking (or nondrinking) habits during the study.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who are 21 - 55 years of age.
* Either 1) Moderate-to-heavy drinkers who drink on average more than 14 but less than 28 drinks per week; OR 2) adults who normally abstain from drinking alcohol.

Exclusion Criteria:

* Participants who are currently taking prescription medications (including oral contraceptives)
* Pregnancy
* Body mass index (BMI) greater than 30
* History of seizures or eating disorders
Stabilizing Mandibular Overdentures with a Single Implant Placed in the Canine Region of the Preferred Chewing Side

The investigators are evaluating the use of a single implant to stabilize complete dentures in the lower jaw, in the canine region of the preferred chewing side. They are conducting this study to determine whether this treatment concept gives satisfactory results, and how it compares with the standard position in the center of the lower jaw.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by the subject
* Age ≥ 60 years
* Edentulous and wearing sufficient complete maxillary and mandibular dentures or ones that can be rendered sufficient via a reline and/or renewal of the prosthetic teeth
* Healed edentulous mandible (minimum 6-8 weeks since last extraction in the anterior zone (4-4) and one year in the posterior zone (5-8))
* Physical status ASA1 and ASA2

Exclusion Criteria:

* Contraindications to the medical devices used, e.g. known hypersensitivity or allergy
* Vulnerable subjects
* Enrollment of the investigator, his/her family members, employees and other dependent persons
* Known or suspected non-compliance, drug or alcohol abuse
* Inability to perform adequate oral hygiene
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, Parkinson etc. of the subject (Dementia: clock-drawing test score ≤ 5)
* Surgical risk factors such as, but not limited to, uncontrolled diabetes, immunosuppression, radiation, chemotherapy, or antiresorptive medication (ex. Bisphosphonates)
* Heavy smoking habit: \>20 cig/d
* Reported severe bruxism or clenching habits, clinically present oro-facial pain
* Depression: Geriatric Depression Scale \> 9
* Xerostomia: SSFR ≤ 0.7ml/min
* Ridge dimensions \<6 mm (width) by 10 mm (height) in the canine or midline area
* Ridge defects requiring bone augmentation procedures
InnFocus MicroShunt Versus Trabeculectomy Study

Assess the safety and effectiveness of the InnFocus MicroShunt when used to lower intraocular pressure (IOP) in subjects with primary open angle glaucoma where the IOP is not controlled when using maximum tolerated glaucoma medications.

This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity.

Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation will be done. Annual follow up will occur up to 2 years. The primary effectiveness endpoint is 20% or greater reduction in IOP from pre-op medicated IOP at 12 months.

Eligibility Criteria:
Inclusion Criteria: - POAG on maximum tolerated glaucoma meds - Medicated ≥15mmHg and ≤40mmHg - Exclusion Criteria: - Previous conjunctival incisional ophthalmic surgery - Anticipated need for additional ocular surgery during the study - Secondary glaucoma - Any condition that prevents the device implantation or trabeculectomy in the superior region of the study eye
Effect of Intense Multi-modal Training on Bone Health and Quality of Life in Persons With Spinal Cord Injury

Bone loss is a common secondary complication of spinal cord injury (SCI), and treatments used to reverse this condition have equivocal effectiveness. The aim of this study is to determine the effect of intense multi-modal training on bone health, body fat, and quality of life in persons with SCI. Participants will complete 6 months of training during which various measures will be obtained at 0, 3, and 6 months. Control subjects are also being recruited to complete testing but not participate in training.


Eligibility Criteria:
Inclusion Criteria:

* Stable spinal cord injury below C2
* doctor's permission to participate in the study
* non-pregnant

Exclusion Criteria:

* see above
Effectiveness and Safety of Collagen Complex COLLOST in Anti-age Therapy

This study evaluates the statistics of anti-age treatment in outpatient sites in Russia (involution indicators: clinical scales; instrumental diagnostics, ultrasonic scannings, assesment of allergic state, efficacy assesment in according with GAIS scale) in routine clinical practice with focus on collagen therapy.

This non-interventional study covers 60 patients (females with involuntary changes of the face skin) from Russian sites.

The following data will be collected and analyzed after the end of treatment:

* demography
* assessment of allergic state
* safety data
* severity of aging effect
* clinical scales results before 1visit and after end of treatment
* GAIS effectiveness assessment
* instrumental diagnostic before 1visit and after end of treatment
* hydration
* elasticity
* microcirculation level
* lipofuscin level
* ultrasound scanning
* derma echo density

Eligibility Criteria:
Inclusion Criteria:

* signed Inform Consent Form
* only females
* from 35 to 65 years old
* 1-3 skin photo types
* signs of age-related skin changes
* absence of chronic disease in decompensation phase
* refusal to receive any cosmetic procedures during the study

Exclusion Criteria:

* pregnancy, lactation period
* infection process, dermatoses, censers
* systemic connective tissue diseases with skin and subcutaneous tissue damage
* taking isotretinoin drugs for the previous 6 months
* propensity to form hypertrophic and keloid scars
* exacerbation or decompensation of chronic somatic diseases; infectious and oncological diseases
* violations of blood coagulation, including iatrogenic (taking drugs that affect blood clotting)
* taking antihistamines, glucocorticoids, NSAIDs, immunosuppressants and other drugs that affect the reactivity of the skin
* hypersensitivity to the components of the studied medical device
Clinical Characteristics and Outcome of Patients Xith Spontaneous Pneumothorax

Pneumothorax occurs when air accumulates between the visceral and parietal pleura, and canbe defined as spontaneous, iatrogenic or traumatic. Spontaneous pneumothorax further classified as primary or secondary. Primary spontaneous pneumothorax (PSP) occur in the absence of underlying lung disease. Primary spontaneous pneumothorax is more common in men and in younger patients and associated with smoking. Secondary spontaneous pneumothorax (SSP) occur in the presence of underlying lung disease, most commonly chronic obstructive pulmonary disease, cystic fibrosis, pneumocystis pneumonia, lung cancer,and interstitial lung diseases (ILDs) in older adults.


Eligibility Criteria:
Inclusion Criteria:

* The study will include patients ≥18 years old with spontaneous pneumothorax admitted at Sohag University Hospital

Exclusion Criteria:

* Patients with traumatic or iatrogenic pneumothorax.
Clinical and Histological Outcomes of Allogenic Amnion Chorion Membrane in the Healing of Free Gingival Graft Donor Site

The purpose of this study is to compare an allogenic amnion chorion membrane to a collagen dressing in palatal wound healing after harvesting free gingival graft (FGG).


Eligibility Criteria:
Inclusion Criteria:

* patients attending the Clinic for Graduate Periodontics at The University of Texas health Science Center at Houston School of Dentistry who are in need of a Free Gingival Graft procedure to augment keratinized gingiva, augment ridge, or cover recession defects.
* systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Exclusion Criteria:

* size of the FGG that the patient needs bigger than the size of FGGs that have to be harvested in this study (two 8mm (width) x 10mm (length) x ≈1.5mm (thickness) FGG).
* current heavy smokers(\>10 cigarettes/day) (patients who stop smoking more than one year are eligible)
* have diabetes or other systemic diseases that may comprise healing
* take antibiotics and/or analgesics within one week before the procedure and have loss of sensation on the palate
Pharmacokinetics of Caspofungin in Burn Patients

Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. Several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. However, no pharmacokinetic data are available of caspofungin in the burn population. The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.

The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.). Blood samples are drawn just before administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after administration. Caspofungin plasma concentrations are measured by liquid-chromatography spectrometry mass tandem.The primary end-points are :

* area under the curve of caspofungin plasma concentrations over 24 hours
* mean peak level and trough concentration (24 hours after dosing)

The secondary end-points are :

* mean total clearance
* mean distribution volume These parameters will be compared to those usually observed in non burn patients. The optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients.

Eligibility Criteria:
Inclusion Criteria:

* 18 - 60 years old
* burn surface : 20-60% total body surface area
* delay of injury time : 8-15 days
* lack of fungal infection
* delay of hospitalization : \> 5 days
* written informed consent
* last biological picture in 24 hours before inclusion

Exclusion Criteria:

* survival inferior to 5 days
* surgical intervention planned in the next five days following inclusion
* moderate or severe hepatic impairment according to Child Plug B \> 9
* pregnancy
* allergy to caspofungin or excipients (saccharose, mannitol and frozen acetic acid)
* patient already included in other study
* concomitant administration of CYP450 inducers : rifampicin, efavirenz, phenobarbital, phenytoin, carbamazepine
* withdrawal of consent
* event (during the first 48 hours following administration) susceptible to modify pharmacokinetic parameters
* Investigator decision
* no social security insurance
The Effect of Intracameral Carbachol and Epinephrine on Choroidal Thickness

81 eyes of 81 patients undergoing cataract surgery were included in this prospective interventional study. During cataract surgery, intracameral carbachol was applied to 27 eyes, intracameral epinephrine was administered to 20 eyes and 34 eyes were the control group. Macular choroidal thickness measurement was performed before, 1 day, and 1 week after phacoemulsification surgery in all patients using optical coherence tomography.

This study consisted of three groups: epinephrine group, carbachol group, and control group. Intracameral carbachol and epinephrine was not used for complication management. In the epinephrine group, 0.2 mL of epinephrine (1:5000 solution) was used immediately after making the clear corneal incision. In the carbachol group, a 0.5 ml dose of 0.01% carbachol solution (Miostat®, Alcon Laboratories, Inc., Fort Worth, TX) was given intracamerally immediately after viscoelastic matter removal following IOL implantation. The control group was given neither epinephrine nor carbachol.

Mydriasis was induced using combined 2.5% phenylephrine and 1.0% tropicamide topical drops before surgery. All surgeries were performed by the same surgeon (HBK) using a similar technique, under topical anesthesia (0.05% proparacaine HCL), and with a 2.8 mm temporal clear corneal incision. After making the incision, 0.2 mL of preservative-free epinephrine (1:5000) was injected into the epinephrine group only. A combination of 1.6% sodium hyaluronate and 4% chondroitin sulfate (ophthalmic viscosurgical device, Discovisc, Alcon Laboratories, Inc.) was used during capsulorhexis in all three groups, and Alcon Infiniti System (Alcon Laboratories Inc.) was used for phacoemulsification. A continuous curvilinear capsulorhexis of 4.5-5.5 mm was created. After complete hydrodissection, the nucleus was removed using the stop and chop technique. Phacoemulsification time (range: 30-60 s) was similar in all patients, while the phacoemulsification strength was set to 35%-40% for all operations. The cortex was aspirated in irrigation/aspiration mode. Before implanting a one-piece foldable hydrophobic acrylic IOL into the capsular bag, 1% sodium hyaluronate (ophthalmic viscosurgical device, Healon) was injected into the capsular bag. After removal of the viscoelastic material, only the carbachol group was given 0.5 ml of 0.01% carbachol solution intracamerally. Hydration with balanced salt solution was used to close the corneal incisions. Topical moxifloxacin, nepafenac, and prednisolone acetate eye drops were given to all patients six times a day for the first week. Prednisolone acetate was then reduced and discontinued 4 weeks after the operation.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* patients with cataracts

Exclusion Criteria:

* hypertension and diabetes
* ocular problems such as uveitis, glaucoma, amblyopia
* maculopathy, retinal dystrophy
* any previous ocular surgery
* eye trauma
* congenital cataracts
The Roles of Exosomal Circ-LRBA and 451/CRTC2 Signaling Axis in Colorectal Cancer

Colorectal cancer (CRC) is one of the most common malignant tumors in the world. Most of the patients with colorectal cancer were diagnosed in poor stage. Although 40% to 50% patients of colorectal cancer can be cured by surgery, but most patients have undergent metastasis or recurrence, and eventually death. In recent years, molecular targeted therapy has shown significant efficacy in specific patients. It was necessary to detect the corresponding molecular targets of tumors before selecting appropriate targeted drugs in clinic. The changing state of related gene molecules in colorectal cancer played a key role in drug selection, there were few effective targets so far. At present, metastasis and recurrence still be the most difficult problems in treatment. Therefore, investigators should deeply study the occurrence and development of colorectal cancer at the gene level and look for new biomarkers to predict the prognosis. Furthermore, the study can clarify the exact molecular mechanism of colorectal cancer. These will be important clinical significance for targeted therapy of colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1.18-80 years old.

2.18.5 \< BMI \< 27.9.

3. The surgical methods are radical resection of rectal cancer, resection of right colon cancer, resection of left colon cancer and radical resection of sigmoid colon cancer.

Exclusion Criteria:

1. Those who refuse to collect samples.
2. Patients with severe dysfunction of coagulation, hepatorenal dysfunction or severe cardiopulmonary diseases.
3. Patients who has a history of neoadjuvant radiotherapy or chemotherapy.
4. Combining with distant multiple metastases of tumor
Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults With ADRD

The purpose of the study is to test if Acceptance and Commitment Therapy (ACT), a behavioral intervention designed to increase psychological flexibility in the face of challenges, reduces anxiety associated psychological distress in dementia caregivers compared to the control group who will receive self-help and educational materials. This version of ACT is delivered over the phone in six primary sessions and one booster session.


Eligibility Criteria:
Inclusion Criteria:

* Listed in ADRD patient's chart as primary caregiver or self-identifies as ADRD patient's primary caregiver
* Intends to continue caregiving for ≥12 months
* Clinically-significant anxiety (score ≥10 on GAD-7)
* 21 years or older
* Able to communicate in English
* Able to provide informed consent

Exclusion Criteria:

* Caregiver is a non-family member
* Care recipient is in an assisted living or nursing home (at baseline)
* Has ADRD or other serious mental illness diagnosis such as schizophrenia as determined by ICD-10 code or self-report
* Caregiver is enrolled in an existing ADRD collaborative program at Eskenazi Health, IU Health or the VA.
* Caregiver is enrolled in another IU study that is testing a ADRD caregiver intervention
Pain Multidisciplinar Intervention in Major Trauma Patients

In Spain, major trauma continues to be the leading cause of death among young people. However, mortality rates represent only a relatively small part of the impact of trauma injuries on the health of the population. Pain and anxiety are two of the most poorly controlled factors that have a huge impact on a patient's quality of life.The type of therapy that has been shown to be most effective in treating post-traumatic pain is one that involves different specialists, given its multicausality, care should be multidisciplinary.

This investigation project consists in an observational study performed by a multidisciplinary team in our center. Major trauma patients with moderate, severe or incapacitating pain will be referred to consultations specialized in chronic pain and psychology. One year after the trauma, patients will be evaluated in terms of quality of life.

The aim of this study is to determinate the impact that multidisciplinary treatment of post-traumatic pain has on the perception of quality of life in severely injured patients.


Eligibility Criteria:
Inclusion Criteria:

* Major trauma patients with moderate, severe or incapacitating pain (according to EQ-5D-5L scale).

Exclusion Criteria:

* Death in the first 30 days after the trauma.
* Transferred to another center.
Hand and Arm Motor Recovery Via Non-invasive Electrical Spinal Cord Stimulation After Stroke

The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke.

Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery.

The aims of the study are:

1. to determine the improvements in hand and arm function that result from the combined application of non-invasive spinal stimulation and activity-based rehabilitation. Surface electrodes placed over the skin of the neck will be used for non-invasive electrical stimulation of the spinal cord. Functional task practice will be used for activity-dependent rehabilitation,
2. to evaluate long-lasting benefits to hand and arm function that persist beyond the period of spinal stimulation.


Eligibility Criteria:
Inclusion Criteria:

* Radiologically documented single ischemic stroke resulted in hemiplegia/hemiparesis
* At least six months post-stroke
* Upper Extremity Fugl-Meyer Assessment score "moderate" or "moderate-mild" (29-53 inclusive out of 66) at the screening visit
* Medically and neurologically stable, as determined by medical history and documented physical examination
* For women of childbearing potential, a negative over-the-counter pregnancy test at study entry and willingness to practice adequate contraception during the study
* Ability to attend sessions three times per week
* Adequate social support to participate in all intervention and baseline, follow-up assessment sessions throughout eight months.
* Ability to read, comprehend and speak English

Exclusion Criteria:

* Hemorrhagic stroke
* History of multiple strokes
* Active implanted stimulator (e.g., pacemaker, vagus nerve stimulator, cochlear implant, etc.) or baclofen pump
* Aphasia or any other deficit in communication that interferes with reasonable study participation
* Moderate to severe cognitive impairment
* Presence of neglect (inability to perceive or awareness of, or loss of attention to the weaker half of the body)
* Severe spasticity in the upper limb
* Taking baclofen more than 30 mg/day
* Change in baclofen dose within four weeks before enrollment
* Receiving benzodiazepines, dantrolene, tizanidine, anticoagulant, or antiepileptic medication
* Botulinum toxin injection to the upper limb muscles within six months before enrollment
* Severe joint contractures in the affected hand and arm
* History of spontaneous seizure that had occurred one month or longer after the stroke