cyrilzakka/clinical-trials huggingface dataset:
Dextromethorphan, Memantine Monotherapy, or Combined Use of Dextromethorphan and Memantine in Amphetamine Addiction

The investigators will conducted a randomized double-blind placebo-controlled study to investigate the treatment outcomes of add-on low dose dextromethorphan (DM), memantine (MM), or dextromethorphan and memantine combination (DM+MM) in amphetamine-type stimulants use disorder patients.

The investigators will conducted a randomized double-blind placebo-controlled study to investigate the treatment outcomes of add-on low dose dextromethorphan (60mg/day, DM), memantine (5 mg/day, MM), or dextromethorphan (60mg/day) and memantine (5mg/day) combination (DM+MM) in amphetamine-type stimulants use disorder patients. The investigators will recruit 120 patients with ATSUD in three years and allocate participants to add-on DM, MM, DM+MM or placebo group in a 1:1:1:1 ratio (participants will also undergo usual psychosocial interventions).The investigators will follow up the participants for 12 weeks and measure the treatment responses, urine drug tests, craving scales and side effects to evaluate the therapeutic effects of add-on DM, MM, or DM+MM. Neuropsychological assessments, tests for inflammatory parameters and neurotrophic factors, and brain functional magnetic resonance imaging (fMRI) will also be evaluated during 12-weeks follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent by patient or legal representative.
2. Male or female patient aged ≧20 and ≦65 years.
3. A diagnosis of ATSUD according to DSM criteria made by a specialist in psychiatry.
4. Patient or a reliable caregiver can be expected to ensure acceptable compliance and visit attendance for the duration of the study.

Exclusion Criteria:

The presence of any of the following will exclude a patient from study enrollment:

1. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study.
2. Females who are pregnant or lactation.
3. Other major Axis-I DSM-IV diagnosis other than ATSUD, except for tobacco use disorder, ATS induced mood or psychotic disorders.
4. Current evidence of an uncontrolled and/or clinically significant medical condition, e.g., cardiac, hepatic and renal failure that would compromise patient safety or preclude study participation.
5. History of allergy or intolerable side effects of DM or MM.
6. Suicidal attempts or risks during screen or study period.
7. Presence of active infectious or autoimmune disease.
A Study of TAK-881 and HyQvia in Healthy Adults

The main aim of this study is to understand how the body absorbs, processes, and removes (known as pharmacokinetics or PK) TAK-881 and HyQvia, after they are given as a single injection under the skin in healthy adults.

Study participants will receive a single dose of TAK-881 or HyQvia on Day 1.

During the study, participants will need to stay at the clinic for 8 days followed by 8 ambulatory follow up visits till Day 85.


Eligibility Criteria:
Inclusion Criteria:

1. Men and Women between 18 and 50 years can participate.
2. Must be a non-smoker, with no use of nicotine or tobacco products.
3. Must have Body Mass Index (BMI) between 18.0 and 30.0, and body weight under 120 kilograms (kg).
4. Must be medically healthy.
5. Must follow protocol-specified contraception guidance.

Exclusion Criteria:

1. Any current or past medical history of blood/clotting disorder, liver, lung, heart, kidney, immune, skin, or brain or psychiatric condition.
2. History of alcohol or drug abuse within 2 years before dosing.
3. History or presence of hypersensitivity or severe allergic reactions to blood or blood components.
4. History or presence of thrombotic/thromboembolic events, or venous thrombosis.
5. Pregnant or breastfeeding.
6. Unable to refrain from taking prescription and non-prescription medications, herbal remedies, homeopathic preparations, or vitamin supplements.
7. Recently donated blood or blood products.
8. Participated in another clinical trial involving immunoglobulin products within 12 months of screening.
9. Has taken biologic agents within 12 weeks of screening.
10. Has used an investigational product within 30 days or 5 half-lives, whichever is longer, prior to screening.
11. Has received any vaccine (including live attenuated vaccines and COVID-19 vaccines) during the last 30 days before dosing.
Telephone-Delivered Interventions for Smoking Cessation

The purpose of this study is to demonstrate that Acceptance and Commitment Therapy's (ACT) implementation outcomes are at least as good as those of traditional cognitive behavioral therapy (CBT).


Eligibility Criteria:
Inclusion Criteria:

1. ages 18 and older
2. smokes at least ten cigarettes per day (to be eligible for NRT) and has done so for at least the past 12 months
3. wants to quit smoking in the next 30 days
4. if concurrently using any other nicotine or tobacco products wants to quit using them within the next 30 days
5. willing to be randomly assigned to either group
6. willing and able to speak and read in English
7. willing and medically eligible to use NRT
8. resides in the U.S., and expects to continue for at least 12 months
9. not participating in other smoking cessation interventions (including our own intervention trials)
10. has regular access to a telephone.

Exclusion Criteria:

The exclusion criteria are opposite of the inclusion criteria listed above.

In addition we will exclude:

1. anyone who is pregnant or breast feeding
2. has had a heart attack in the past 30 days
3. has unstable angina
4. has evidence of arrhythmia in the past 6 months
5. has a history of severe skin reaction to adhesive patches.
Transversus Abdominis Plane Block Versus Spinal Morphine After Caesarean Section : A Comparison Study

Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.

Intrathecal morphine (ITM), administered as a part of spinal anesthesia for caesarian section, can produce significant post-operative analgesia for several hours. The Tranversus Abdominis Plane (TAP) Block can also provide prolonged post-operative pain control. A small number of published studies comparing analgesic outcomes after cesarian section with ITM or TAP block have reported variable results.Moreover, these studies have been conducted in countries with extensive post-operative nursing care.

Many counties in sub-Saharan Africa have very limited post-operative nursing capacity, and relatively little data have been published about post-operative maternal pain control in these settings. Cesarean section is the most common type of major operation at our institution, Mbarara Regional Referral Hospital (MRRH), in south-western Uganda.Nursing ward staffing capacity is low, with much basic nursing care provided by families and friends of patients. The investigators conducted a study to examine the impact of ITM versus TAP block in a setting of limited formal nursing oversight.

Eligibility Criteria:
Inclusion Criteria:

1. Women between the age of 18-45;
2. Greater than 50 kilograms in weight;
3. Routine spinal anesthetic without sedation for an uncomplicated caesarean delivery via a low, transverse abdominal incision (Pfannenstiel);
4. In good health with no major medical problems including gastric ulcers, liver or renal dysfunction
5. Able to communicate freely with a provided non-family member interpreter fluent in the patient's language so that informed consent may be obtained

Exclusion Criteria:

1. Patients with allergies to bupivacaine, paracetamol, or diclofenac;
2. Patients undergoing a surgical approach is other than a low, transverse abdominal incision (Pfannenstiel);
3. Pre-eclampsia, uterine rupture, placental abruption with this pregnancy;
4. Prior complicated abdominal surgery;
5. Medical history of gastric ulcers, liver or kidney dysfunction; and
6. Patient refusal to be involved in the study. Failure to attain informed consent from the patient due to age or level of consciousness
7. Voluntary or involuntary withdraw from the study
8. Referral to another health centre or Hospital for further management.
A Study to Evaluate the Safety and Efficacy of Paricalcitol Capsules in Reducing Serum Intact Parathyroid Hormone Levels in End Stage Renal Disease Subjects on Peritoneal Dialysis

To determine the safety and efficacy of paricalcitol capsules as compared to placebo for treatment of secondary hyperparathyroidism by decreasing serum intact parathyroid hormone levels in end stage renal disease subjects on peritoneal dialysis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is greater than or equal to 18 years.
* Subject is diagnosed with ESRD and must be on continuous PD 7 days per week for at least 2 months prior to Screening Phase.
* If female, subject is either not of childbearing potential or is of childbearing potential and practicing one of the recommended methods of birth control.
* If female, subject must have a negative serum pregnancy test prior to treatment.
* If female, subject is not breastfeeding.
* Subject is undergoing full PD regimen and is expected to remain on this PD regimen for the duration of the study.
* For those subjects who have been taking a phosphate binder prior to therapy, the subject has been on a stable type of phosphate binder at least 4 weeks prior to the Pre-Treatment Phase.
* For entry into the Pretreatment Phase the subject must have: Calcium level less than or equal to 10.5 mg/dL and Ca x P level less than or equal to 65.
* For entry into the Treatment Phase the subject must have: iPTH greater than or equal to 300 pg/mL, calcium level of 8.0 to 10.5 mg/dL, inclusive, and Ca x P less than or equal to 65.
* Subject has voluntarily signed and dated an IRB approved informed consent.

Exclusion Criteria:

* Subject has history of an allergic reaction or significant sensitivity to drugs similar to the study drug
* Subject has had active peritonitis within 1 month prior to screening phase.
* Subject has had more than one episode of peritonitis within 4 months prior to screening phase.
* Subject has received a partial parathyroidectomy within 1 year prior to screening phase.
* Subject has had acute renal failure within 3 months of screening phase.
* Subject has chronic gastrointestinal disease.
* Subject has taken aluminum-containing phosphate binders for greater than 3 weeks in the last 3 months prior to the screening phase or will require these medications greater than 3 weeks in the study.
* Subject has a current malignancy or clinically significant liver disease.
* Subject has a history of drug or alcohol abuse within 6 months prior to screening phase.
* Subject has evidence of poor compliance with diet, medication, or PD.
* Subject has participated in any investigational drug or device study within 4 weeks prior to the treatment phase.
* Subject is taking maintenance calcitonin, glucocorticoids, or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy.
* For any reason, subject is considered by the investigator to be an unsuitable candidate to receive paricalcitol capsules.
* Subject is known to be HIV positive.
Anti-pollution Effects of AP Green Tea Extracts

The objective of this clinical trial is to evaluate the anti-pollution effects of AP green tea extracts in subjects with discomforts related to the respiratory system by prolonged exposure to particulate matter in air pollution


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 19 years or over
* Subjects with discomforts related to the respiratory system by prolonged exposure to particulate matter in air pollution
* Subjects who voluntarily decide to participate in this clinical study and sign the informed consent form on their own or through their representatives

Exclusion Criteria:

* At the screening visit, subjects who were diagnosed with acute or chronic respiratory disease and undergoing medication.
* Subjects who were diagnosed with ventricular associated disease, unstable and uncontrolled chronic medical disease, or active malignant tumor and undergoing medication within 4 weeks prior to the first administration of the investigational product
* Subjects who show a level of ALT/AST of 2 times or more the upper limit of normal as a result of a screening test and have acute or chronic hepatitis or known liver cirrhosis
* In addition to the above, subjects who are determined to be ineligible to participate in the clinical study according to the investigator's medical opinion
Non-invasive Measuring of Cerebral Perfusion After Severe Brain Injury With Near-infrared-spectroscopy and ICG

The purpose of this study is to show if it is possible to detect secondary ischemic events in patients with severe brain injury or cerebral haemorrhage with the help of non-invasive near-infrared spectroscopy (NIRS) by using the indocyanine green measuring of cerebral perfusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* onset of clinical symptoms of subarachnoid or intracranial haemorrhage or trauma suffered less than 72h
* indication for implanting a tissue oxygen and intracranial pressure probe
* A signed informed consent by the patient or legal guardian

Exclusion Criteria:

* Persistent epidural, subdural or subcutaneous hematoma in planned area of the NIRS optode
* Open injuries in the area of the planned optodes
* Malignant primary disease under chemotherapy
* pregnancy
* bleeding disorder
* In the short term unfavorable prognosis (eg, bilateral wide and light-fixed pupils)
* Patients with pacemakers or where no MRI compatibility is due to non- removable metal parts
* contraindications for contrast media in CT (eg, iodine allergy)
* Untreated hyperthyroidism
* End Stage Renal Disease
* severe psychomotor agitation
Type 1 Diabetes and Diabetes Distress

The goal of this clinical trial is to reduce diabetes distress in emerging adults (18-35 years) with type 1 diabetes and moderate-to-severe diabetes distress.

The expectation is that a group-based psychological intervention (ACTnow) will not only reduce diabetes distress but also improve psychological well-being and glycemic outcomes.

The intervention involves a multidisciplinary team, including nurses, psychologists, and physicians, and is designed in a format that can easily be integrated into future standard care.

The main research questions are:

* Does a group-based psychological intervention reduce diabetes distress?
* Does a group-based psychological intervention improve psychological well-being and glycemic outcomes?

Researchers will compare the group-based psychological intervention (arm 1) with a waitlist control group, which will receive the intervention after three months (arm 2).

Participants will first attend a virtual screening interview with a psychologist or nurse to identify if they are eligible to participate in the study. After randomization, the intervention group receives six bi-weekly sessions, each lasting two hours, led by a psychologist and nurse. Each session includes a mindfulness exercise, a review of the previous session, a new topic, individual homework assignments, and a conclusion.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes for at least 6 months
* Age between 18 and 35
* T1-DDS score ≥ 2, or T1-DDS subscale score ≥ 2
* Treated in a diabetes clinic in the Region of Southern Denmark
* Proficient in Danish

Exclusion Criteria:

* Psychiatric diagnosis: diagnosed with substance abuse, alcohol abuse, psychosis, schizophrenia or any other psychiatric diagnosis that may compromise participation in the intervention
* Cognitive disorders such as brain injury
* Complex challenges best suited to individual treatment
* Current therapeutic treatment for depression, anxiety or stress
* Not stable medication for anxiety/depression for the past two months or planned change in medication for anxiety/depression during the project period
Accuracy of Maxillary Repositioning During Orthognathic Surgery

Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned using clinical, radiological and dental cast data. The result of this planning are occlusal splints. Orthognathic surgery had improved in the last decade with 3 dimensions computerized tomography scan (3D CT-Scan) planning and osteosynthesis implants. However the accuracy of the operative results compared to the planned ones has rarely been measured.

Orthognathic surgery aims to correct jaw position taking into account esthetic and functional criteria (dental occlusion, lip position, breathing...). These surgeries are planned only after the end of the growing period and in association with orthodontics. It is necessary to wait the end of facial growth to expect a stable result especially concerning mandibular. The age limit seems to be around 15 to 16 years old for retromandibular deformities and around 18 years old for premandibular deformities.

These surgeries are planned using clinical, radiological and dental cast data. Occlusal splints are made using all these results; these occlusal splints are used during the orthognathic surgery to maintain bones in the planned position.

Since 1993, a navigation system (Orthopilot™) is used, which allow to track jaw position, in real time, with an accuracy around one millimeter and one degree, during orthognathic surgery. This system is routinely used for condyle repositioning after mandibular sagittal split osteotomies; but it is also useful for maxillary navigation and positioning.

The investigator propose to measure the accuracy of the operative results compared to the planned ones, using the Orthopilot™ system.

Eligibility Criteria:
Inclusion Criteria:

* patients needing orthognathic surgery with mobilization of the maxilla via a Le Fort I osteotomy, alone or associated to a mandibular osteotomy, whatever the indication (poor occlusion, sleep apnea, temporo-mandibular dysfunction...)
* patient over 16 years old
* having not expressed any opposition to the collection of his/her personal data for this study (patient him/herself or holder of parental authority in case of patients younger than 18)

Exclusion Criteria:

* pregnancy
* patients deprived of liberty
* protected adult
* patients needing maxillary disjunction
Does Quality of Life Decline During the COVID-19 Pandemic and Can we Change Behaviour to Improve Poor Quality of Life?

The response to COVID-19 means social isolation/distancing for the majority of the UK. This has the potential to negatively affect all domains of quality of life (QoL). QoL can be improved by giving feedback on gaps between someone's perceived QoL in a domain and how important it is to them (plus prompting reflective questions). However, interventions that are designed to improve QoL may increase the effectiveness of this as optimised behaviour change techniques can be used. This study aims to develop and test a quality of life intervention during social isolation/distancing.

The response to COVID-19 means social isolation/distancing for the majority of the UK. This has the potential to negatively affect all domains of quality of life (QoL). QoL can be improved by giving feedback on gaps between someone's perceived QoL in a domain and how important it is to them (plus prompting reflective questions). However, interventions that are designed to improve QoL may increase the effectiveness of this as optimised behaviour change techniques can be used. This study aims to develop and test a quality of life intervention during social isolation/distancing.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18+ years
* Living in United Kingdom during COVID-19 pandemic.

Exclusion Criteria:

* English language - all participants are required to be able to read and understand English to participate.
A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer

This survey study is looking to determine if patient reported outcomes(using the PROMIS survey) will vary according to the presence of recurrent or metastatic lung or esophageal cancer.

A patient-centered approach to lung cancer surveillance following resection needs to incorporate patient reported outcomes. The Patient Reported Outcomes Measurement Information System (PROMIS®) was designed to revolutionize the assessment of patient reported outcomes by establishing a national resource for the measurement of patient-reported symptoms and other health outcomes.

The PROMIS Assessment Center, the management tool within the larger PROMIS system, will be used to securely store de identified data, provide automated accrual reports and data export for this specific study. This study will have it's own study specific website.

Patients seen at the University of Virginia Cancer Center will be identified and invited to participate in an assessment of their reported outcomes over multiple domains available in PROMIS. Collecting this information on lung cancer survivors may provide a robust platform to design a patient-centered surveillance strategy following resection.

The study team hypothesizes that patient reported outcomes will vary according to the presence of recurrence or metastasis of lung or esophageal cancer. The study team also believes including patient reported outcomes into routine post-treatment surveillance will improve patient satisfaction and improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Suspected or Known diagnosis of lung or esophageal cancer
* Willing and able to complete questionnaires

Exclusion Criteria:

* Subjects unwilling to provide informed consent
* Subjects unwilling or unable to answer the questionnaires