cyrilzakka/clinical-trials huggingface dataset:
Research on Outpatient Adolescent Treatment for Comorbid Substance Use and Internalizing Disorders

Adolescent substance abuse results in significant negative outcomes and extraordinary costs for youths, their families, communities, and society. Moreover, rates of psychiatric comorbidity among substance abusing youth range from 25% up to 82%, and youths with a dual diagnosis are more than twice as costly to treat compared to those with no comorbidity. The applicant principal investigator recently completed a pilot project funded by the National Institute on Drug Abuse focused on developing and piloting a psychosocial treatment specifically for youth presenting for outpatient treatment with co-occurring substance use and internalizing (i.e., mood and/or anxiety) problems. Results were promising with the experimental group exhibiting significantly less substance use and more rapid reductions in anxiety and depressive symptoms compared to the control group. The proposed research is a randomized clinical trial (RCT) to compare the experimental treatment (OutPatient Treatment for Adolescents; OPT-A) to an "active placebo" on key clinical indices from pre-treatment through 18 months. The proposed RCT (n = 160) employs the treatment manual, quality assurance protocol, and therapist training protocol developed and successfully tested in the pilot study, to evaluate the efficacy of OPT-A for youth referred to outpatient treatment of co-occurring substance use and internalizing problems. The following outcomes will be evaluated: drug use; mental health; behavioral, school, peer, and family functioning; and consumer satisfaction. The intervention addresses one of the more prevalent and most challenging, costly, and understudied presenting problems among adolescent outpatients. If successful, this research could provide a considerable contribution in the treatment field for youth with co-occurring substance use and internalizing disorders.


Eligibility Criteria:
Inclusion Criteria:

* 10 to 17 years of age
* Residing with at least one adult caregiver who serves as a parent figure
* In need of treatment for a Substance Abuse or Dependence Disorder
* In need of treatment for an Axis I Mood Disorder and/or Anxiety Disorder

Exclusion Criteria:

* Pervasive Developmental Disorder
* Active Psychotic Disorder
* Severe or profound mental retardation
Study Examining Stress During Pregnancy

Researchers at UVa Health System are interested in how women experience and deal with stress during pregnancy. Participants will be randomly assigned either to engage in coping strategies on one's own or to receive 6 weeks of relaxation training. Researchers will examine how coping strategies affect the course of the pregnancy and the health of the infant

Participants will be asked to fill out questionnaires and complete some tasks that require concentration as heart rate and other biological signals are monitored. Participants will also be asked to provide samples of saliva a few times during 1 day. These tasks will be repeated 3 times during pregnancy and participants will be asked to complete questionnaires at 6 months postpartum

A stress-reduction workshop will be offered to all participants at the completion of the study.

Participants will be paid for study completion

Eligibility Criteria:
Inclusion Criteria:

* beginning of the 2nd trimester of pregnancy
* feel stressed or overwhelmed
* do not yet have any children

Exclusion Criteria:

* more than 1 miscarriage
* currently receiving medication for anxiety or depression
Validity of Elastography During Pregnancy

Non invasive methods are the only available methods to stage liver fibrosis during pregnancy. The safety of elastometry - ultrasound based - is obvious, as medical supervision of pregnancy is based on ultrasonography, both methods using same wavelengths. Therefore, this method is sometimes used in pregnant women with recent diagnosis of chronic viral hepatitis infection, whereas its validity in pregnant women has never been studied. This lack of data justifies our study.

One measurement during the third trimester of pregnancy will be compared to a second measurement, 3 months after childbirth.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Followed in Obstetrics Dpt
* HBV or HCV chronic hepatitis
* After information and written consent

Exclusion Criteria:

* None
A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies

The study is designed to investigate whether paracetamol from a hot remedy reaches the plasma faster than standard paracetamol tablets. The study will also assess the gastrointestinal transit of two oral cold and influenza ('flu') formulations using gamma scintigraphy. It is postulated that paracetamol in solution, such as from cold and 'flu' hot remedies, provides a greater early exposure compared to standard paracetamol tablets. In addition, the pharmacokinetic (PK) profile of paracetamol in the two formulations will be investigated.


Eligibility Criteria:
* Healthy male volunteers
* Body mass index between 18.0-29.9 kg/m\^2
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)

Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain for previous 3 months and majority of days in last month
* Regular use of acetaminophen or NSAID to treat low back pain in past month
* Judged to be in otherwise good health

Exclusion Criteria:

* Low back pain that is due to secondary causes
* Radicular/myelopathic pain
* Surgery for low back pain within the past 6 months
* Active lawsuit or claim pertaining to their low back pain
* Disease that may confound the results of the study or pose risk to the patients
* Corticosteroid use in past month
* Previous participation in MK0663 study
A Study of LY900014 Administered in Participants With Type 1 Diabetes Using an Insulin Pump

This study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes LY900014, a new blood sugar lowering insulin, and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump
* Have a screening body mass index (BMI) of greater than 18.5 to 33.0 kilograms per meter squared (kg/m²), inclusive
* Have medical and laboratory test results that are acceptable for the study
* Have had no episodes of severe hypoglycemia (requiring assistance in treatment by a second party) in the past 6 months
* Have venous access sufficient to allow for blood sampling
* Have provided written consent and are willing to follow study procedures and commit to the study duration

Exclusion Criteria:

* Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
* Had blood loss of more than 500 milliliters (mL) within the last month
* Have known allergies to LY900014, insulin lispro, related compounds or any components in the study drug formulations
* Have previously participated or withdrawn from this study
* Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Efficacy of Silk - Like Bedding Fabric Pillow Case in the Treatment of Acne Vulgaris

The purpose of this research study is to better understand how this study pillowcase works when people use it to treat acne. Most people, including people with acne, sleep six to eight hours each night in direct contact with bedding fabrics that provide no benefit to the healing process associated with acne. The fabric in this study pillowcase may be able to reduce bacteria on the skin. This study would evaluate how acne is affected by this silk-like pillowcase. This type of study has not been done before.

This is a pilot study of subjects with mild to moderate/severe facial acne vulgaris with an assessment of 2-4 on the Investigator Global Assessment (IGA) scale . We will enroll 40-60 subjects in order to obtain 40 evaluable subjects. Evaluable subjects will be defined as those that complete the protocol, or those that fail to complete due to an adverse event related to the study. One-half of subjects will be assigned to sleep on the study product, which is a standard size pillowcase made of a silk-like fabric. The other half will be assigned to sleep on the placebo pillowcase made of 100% cotton. Each subject will be instructed to sleep on this pillowcase every night for 12 weeks. Investigators will be blinded to the type of pillowcase used by the study subject. The distribution of placebo and study product pillowcases will be randomized 1:1. The study period will last for 12 weeks. Subjects will be evaluated at baseline, weeks 2, 6 and 12.

Eligibility Criteria:
Inclusion Criteria:

* Male or female with facial acne vulgaris, 12 years of age or older, that agree to participate and provide written consent
* Greater than 5 superficial inflammatory lesions with less than 3 nodules on the face
* A score of 2-4 on the Investigator Global Assessment
* Women of childbearing potential will be allowed to participate in the study, and these subjects will be required to use at least one form of birth control
* Female subjects will have a urine pregnancy test if applicable.

Exclusion Criteria:

* Use within 4 weeks of baseline of systemic anti-inflammatory medication, which may influence study outcome, such as systemic corticosteroids
* Application or use within 2 weeks of baseline of topical acne or rosacea medications or topical anti-inflammatory medication, which may influence study outcome
* Presence of a concurrent medical condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments
* Subjects who have taken isotretinoin within the past 6 months
* Subjects with known allergy or sensitivity to polyester or nylon fibers in fabric
* Pregnant women and women who are breastfeeding
An Observational Study on Patients With Rheumatoid Arthritis Treated With MabThera (Rituximab)

This observational study will assess the execution, efficacy and safety of treatment with MabThera in patients with rheumatoid arthritis. Data from patients receiving MabThera according to local treatment guidelines will be collected for 29 months. Target sample size is 100-200 patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>/= 18 years of age
* rheumatoid arthritis
* treatment with rituximab

Exclusion Criteria:

* unable/unwilling to give informed consent to data collection
EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET

Study 1:

The purpose of this study is to evaluate safety and efficacy of Photon infusion sets (PIS) with new PFAS-free cannula (catheter) in adult patients with Type 1 diabetes for up to 10 days and 6 hours.

This is a 1-center, prospective, open-label, 1-arm study with type 1 patients with diabetes on 780G insulin pump therapy with Guardian™ 4 Continuous Glucose Monitoring (CGM). All subjects will be instructed to change infusion sets every 246 hours (10 days \& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.

After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.

Photon infusion sets with 6-mm and 9-mm cannula length will be supplied for this study, with selection based on subjects' needs and doctor's recommendation. Subjects will change insulin reservoirs at least every 7 days (the labelled wear duration of the Extended reservoir). The infusion set(s) or reservoir(s) can be replaced independent of each other. The date and time of each infusion set insertion will be recorded in a Daily Log (Diary) which will include the causes of early removal, if occurs.

Study 2: If Study 1 is successful, the same study designed as illustrated in Figure 1 may be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year
2. Using a MiniMed™ 780G Insulin pump with Guardian sensor
3. Age 18 to 80 years
4. Hemoglobin A1c level less than or equal to 10%
5. Not currently known to be pregnant, nor planning pregnancy during the study.
6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
2. Pregnant or lactating females
3. Subject has Glycosylated hemoglobin (HbA1c)\< 10 % at time of screening.
The Effects of Chiropractic in Adults With Metabolic Syndrome

The purpose of this study is to assess the feasibility of our study procedures/protocols and to look at the potential effects of chiropractic care on people with metabolic syndrome.

After providing informed consent, individuals will undergo 6 weeks of chiropractic care. Throughout these 6 weeks there will be three assessments (Day 0, Week 2, and Week 6) that each include the following:

1. Seated resting recording
2. Auditory oddball task
3. Isometric hand grip
4. Postural challenge
5. Treadmill walking
6. Patient-reported outcome surveys

Each assessment will consist of the following recordings:

1. Electroencephalography \[EEG\]
2. Electrodermal activity \[EDA\]
3. Impedance cardiography \[ICG\]
4. Electrocardiogram \[ECG\]

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18
* Individuals who can wear an EEG net for 30 minutes
* Individuals who can sit quietly for at least 15 minutes
* Individuals who can walk unassisted for up to 10 minutes
* Individuals who can provide informed consent
* Individuals who meet 3 of the 5 following criteria:

  * Elevated waist circumference (\>40 in/102 cm if male and \>35 in/88cm if female)
  * Elevated triglycerides (\>150 mg/dL) or drug treatment for elevated triglycerides
  * Reduced HDL-cholesterol (\<40mg/dL if male and \<50 mg/dL if female) or drug treatment to increase HDL-C
  * Elevated blood pressure (\>130 mm Hg systolic BP or \>85 mm Hg diastolic BP) or drug treatment to reduce blood pressure
  * Elevated fasting glucose (\>100 mg/dL) or drug treatment to reduce blood glucose

Exclusion Criteria:

* Individuals with a known disorder resulting in syncope/fainting during postural changes (e.g., POTS, orthostatic hypotension)
* Individuals with impaired function of the dominant hand
* Individuals with malignant hypertension
* Individuals with a known heart condition such as arrhythmia that results in an aberrant ECG recording
* Individuals with any implanted devices (i.e., pacemakers)
* Individuals with brain aneurysms
* Individuals with a history of epilepsy or stroke that would influence EEG readings
* Individuals with a diagnosed externalizing or thought disorder (i.e., anti-social disorder, any major personality disorder such as borderline personality disorder, or schizophrenia)
* Individuals who are on short-acting benzodiazepines which include midazolam \& triazolam
* Individuals with any serious injury or surgery to the head or torso, or lower body in the last 6 months
* Individuals with a hearing impairment or hearing aids (due to the auditory stimulus recording being performed)
* Individuals who are currently pregnant
* Individuals with current litigation related to a physical, health-related injury
* Individuals who have been diagnosed with rheumatoid arthritis, osteoporosis or instability of the neck.
* Individuals with moderate to severe pain on a daily basis
* Pain on the day of testing rated greater than 3/10 on a visual analog scale (VAS)
The Comparison of Single Catheter and Double Catheter Adrenal Vein Sampling Methods Based on the Upper Limb Approach

Primary Aldosteronism (PA) is a clinical syndrome characterized by the autonomous overproduction of aldosterone by the adrenal cortex's zona glomerulosa, leading to hypertension, elevated aldosterone levels, and suppressed renin activity as the primary manifestations. Studies have shown that the prevalence of PA in an unselected hypertensive population ranges from 5% to 11% , while the prevalence in patients with resistant hypertension is approximately 20% . PA is one of the most common causes of secondary hypertension , and its prevalence increases with rising blood pressure levels. Due to the adverse effects of PA on the heart, arterial walls, and kidneys, it contributes to the occurrence of cardiovascular events, with atrial fibrillation being the most common . In summary, PA is characterized by rapid onset, significant symptoms, obscurity, and severe complications, making early diagnosis and targeted treatment essential for prevention.

This study aims to explore a quasi-selected prospective randomized controlled method to compare the clinical efficacy differences between single-catheter and dual-catheter adrenal sampling via the right upper limb approach. The study seeks to clarify the effectiveness and safety of single-catheter sampling from the upper limb, providing a more efficient and cost-effective solution for the subtype diagnosis of patients with Primary Aldosteronism (PA).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70 years with hypertension.
* Initial screening shows a standing aldosterone/renin ratio (ARR) \> 3.7, a baseline aldosterone level \> 10 ng/dl, aldosterone level \> 6 ng/dl after a saline load test, or aldosterone decrease of less than 30% after a captopril suppression test, consistent with a diagnosis of primary aldosteronism.
* Voluntary participation in the trial, with signed informed consent.

Exclusion Criteria:

* Patients with an allergy to iodinated contrast agents.
* Patients who are pregnant, breastfeeding, or planning to become pregnant.
* Patients with severe comorbidities, such as renal failure, liver cirrhosis, metastatic tumors, or those who have had an acute stroke or acute myocardial infarction, as well as patients with a history of surgery within the past month.
* Patients suspected of having adrenal cortical carcinoma.
Greater Occipital Nerve and Cervical Region Injection in Patients With Trigeminal Neuralgia

The aim of this study is to investigate the efficacy of greater occipital nerve block and cervical injections with lidocaine

After being informed about the study and potantiel risks, all patients giving informed consent will undergo randomization in 1:1 ratio to 1% lidocaine or 0.9% saline groups

Eligibility Criteria:
Inclusion Criteria:

* Classical Trigeminal Neuralgia

Exclusion Criteria:

* Secondary Trigeminal Neuralgia
Identification of Complete Lymph Node Removal by Application of Near Infrared Fluorescence Imaging in Laparoscopic and Robotic Gastrectomy

Lymph node dissection in gastric cancer surgery is a very important factor not only for exact acquisition of stage but also proper treatment. Realistically, it is impossible to identify complete removal of lymph node in dissected nodal station by naked eye. The investigators can assess the route of lymphatic drainage and identify residual lymph nodes in dissected area. In the field of gastric cancer treatment, ICG and near infra-red fluorescence imaging was used only detection of sentinel lymph nodes. However, this novel concept can help to understand lymphatic drainage and make surgeons to perform D1+ or D2 lymph node dissection completely.


Eligibility Criteria:
Inclusion Criteria:

1. Males or Females, aged≥20 years and ≤80 years
2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry
3. American Society of Anesthesiolosists (ASA) score of 1 to 3
4. Histologically confirmed adenocarcinoma in stomach
5. Clinical stage I (T1N0M0, T2N0M0, T1N1M0)

5. The patient has curatively resectable disease 6. The patient has given their written informed consent to participate in the study

Exclusion Criteria:

1. M1 status
2. Experience of previous gastric resection
3. Complication due to gastric cancer, such as complete obstruction or perforation
4. History of anti-cancer therapy (chemotherapy or radiotherapy) for current gastric cancer
5. History of surgery, chemotherapy or radiotherapy for primary carcinoma of other organ in 5 years
Sitafloxacin and Ertapenem Treatment for Acute Urinary Tract Infection Caused by E. Coli or K. Pneumoniae in Post-kidney Transplantation Patients

This study evaluates oral antimicrobial agents for the treatment of non-bacteremic acute urinary tract infection caused by Extended Spectrum Beta Lactamase producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Patients are treated with intravenous (IV) antibiotics follow by oral sitafloxacin or IV ertapenem.

A prospective randomized controlled trial of patients with a presumptive diagnosis of acute urinary tract infection caused by Extended Spectrum Beta Lactamase-producing Escherichia coli or Klebsiella pneumoniae in Post-kidney transplantation. Intravenous (IV) antibiotic is initially given to all patients. After day 3, patients were randomized to receive either oral sitafloxacin (100 mg twice daily) or intravenous ertapenem. The course of treatment will complete within 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Acute urinary infection by definitions
* Positive urine culture for Extended Spectrum Beta Lactamase E. coli or K. pneumoniae ≥105 colony forming unit/mL
* Post-kidney transplantation
* Voluntarily consented to be enrolled in the study

Exclusion Criteria:

* Sepsis
* Positive blood culture
* Mixed organism of urine culture
* Immunocompromised conditions other than post-kidney transplantation
* Pregnancy or lactation
* Previous urinary tract infections within 4 weeks
* Contraindicated for fluoroquinolones and carbapenems