cyrilzakka/clinical-trials huggingface dataset:
Ketamine for Methamphetamine Use Disorder

This study aims to determine whether treatment response with IV ketamine is superior to treatment response with IV midazolam in adults with moderate to severe MUD.

The study design is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV midazolam, delivered over six weeks in 120 adults with moderate to severe methamphetamine use disorder (MUD).

Effective management for methamphetamine use disorder (MUD) remains elusive, despite widespread misuse of this stimulant. Psychological interventions have demonstrated modest benefits, and relapse rates are high. There are currently no Food and Drug Administration (FDA)-approved pharmacotherapies for MUD. This study explores the efficacy, safety, and feasibility for intravenous (IV) ketamine as a treatment for MUD and will help to determine the effect size for a larger, multi-site trial of intravenous (IV) ketamine in MUD.

Participants will receive either IV ketamine (0.50mg/kg) or IV midazolam (0.02mg/kg) over 45 minutes per infusion for a total of eight (8) infusions over six (6) weeks. Medical management sessions with a study clinician will be provided to all participants once weekly (from Weeks 1 through 6).

The use of IV ketamine in this trial is consistent in dose (0.5 mg/kg) and duration of infusion (45-minute-long) to other studies of ketamine for psychiatric disorders (such as major depressive disorder and post-traumatic stress disorder, both of which are often comorbid in individuals with MUD) and substance use disorder. However, IV ketamine has not been directly evaluated as mono-pharmacotherapy in those with MUD yet.

Additionally, participants will be asked to participate in cognitive behavioral therapy (CBT) sessions once weekly (from Weeks 1 through 12) on a non-infusion day.

Eligibility Criteria:
Inclusion criteria

Study participants must:

1. Be 18 to 65 years old
2. Be able to sufficiently understand, speak, and read English
3. Be interested in reducing or stopping methamphetamine use
4. Meet criteria for methamphetamine use disorder
5. Use acceptable methods of contraception during participation in the study

Exclusion criteria

Study participants must not:

1. Have been in a research study of pharmacological or behavioral treatment for addiction within 6 months prior to written informed consent
2. Be currently in jail, prison, or inpatient overnight facility as required by court of law
3. Have upcoming surgery planned or scheduled
4. Be currently pregnant, breastfeeding, or planning on conception, if biologically female

Additional inclusion and exclusion criteria will be assessed by the study investigators at the screening visit.
A Carotid Stenting Boston Scientific Surveillance Program

CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.


Eligibility Criteria:
Inclusion Criteria:

* Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.
* Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR
* Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.
* Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System.
* Subject is willing and able to comply with all follow-up requirements.
* Subject has provided a signed informed consent prior to participation in the Registry.

Exclusion Criteria:

* Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
* Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
* Patients with uncorrected bleeding disorders
* Lesions in the ostium of the common carotid artery.
Effects of OMT on Interoception

Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain
* written informed consent signed

Exclusion Criteria:

* congenital disease
* acute pain
* subject below 30 and above 50
* co-morbidities associated with low back pain
* surgical patients
* cardio-vascular, respiratory, gastro-enteric disease
* obese subjects
* diabetics
* dizziness
* subjects into pharmacological prophylaxis
* drug addicted subjects
* subjects undergoing physiotherapy
* subjects with experience in osteopathic treatment
Clinical Evaluation of a Self-etch Adhesive Using a Selective Etch Technique

Study hypothesis: Etching the enamel followed by use of a self-etching adhesive on enamel and dentin is as effective as a one-step etch and rinse approach.

There is scant evidence available on the performance of self-etching dental adhesive systems. This study aims to clinically evaluate a self-etch adhesive used either with an extra enamel etching step, or in a self-etch stand alone technique with no extra enamel etch.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* written informed consent
* regular dental attender, can return to clinic for study recalls
* good medical health
* normal saliva flow
* has one or two pairs of back teeth that require a Class I or II restoration of appropriate size
* study teeth that are vital

Exclusion Criteria:

* currently in an evaluation of other dental materials
* an irregular dental attender
* has unacceptable oral hygiene standards
* has chronic periodontitis or rampant caries
* has teeth with signs of periapical pathology
* has history of pulp problems, and/or needs pulp treatment
* women who are pregnant or breast-feeding
* has known allergy to resin composite or latex
* has serious chronic disease requiring hospitalization
* has oral soft tissue pathologies
* takes medications which, in the opinion of the investigator, could interfere with the conduct of the study
* has current or recent history of alcohol or other substance abuse
* is an employee of the sponsor or the study site, or members of their immediate family
* has had any restorative treatment of teeth involved in the study in the last twelve months
Interfacial Injection in Low Back Pain

Its effect on thoracolumbar fascia and low back pain has been investigated in different studies.These studies suggest that the anatomical and histological features of the fascia may have an effect on low back pain. This study aimed to investigate the effectiveness of interfacial injection in patients with chronic back pain.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain for more than 6 months;
* Presence of MR findings radiologically diagnosing LDH;
* Numeric rating scale (NRS) \> 5

Exclusion Criteria:

* Spinal stenosis;
* Spondylolisthesis;
* Previous lumbar
* Spinal surgery
Substance Abuse Treatment to HIV Care (SAT2HIV): The Implementation & Sustainment Facilitation Experiment

A cluster randomized experiment focused on testing the extent to which the organization-focused Implementation \& Sustainment Facilitation (ISF) strategy is an effective adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.

A cluster randomized experiment with 39 AIDS service organizations located across the United States. The overarching goal is to test the extent to which the organization-focused Implementation \& Sustainment Facilitation (ISF) strategy is an effective adjunct to the staff-focused Addiction Technology Transfer Center (ATTC) strategy.

Eligibility Criteria:
Inclusion Criteria:

* AIDS service organizations have to

  1. serve a minimum of 100 individuals living with HIV/AIDS per year,
  2. have at least two frontline staff who were willing and able to be trained in the Motivational Interviewing-based Brief Intervention (MIBI) Experiment's MIBI for substance use, and
  3. have at least one leadership staff (i.e., supervisor, manager, director) willing and able to help ensure case-managers were given sufficient time for project participation.

     Exclusion Criteria:
Reliability and Validity of the Turkish Version of General Sleep Disturbance Scale (GSDS-T) in Multiple Sclerosis

The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale have been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis

The GSDS-T was developed by Lee KA to assess difficulty falling asleep, waking up during sleep, sleep quality, and daytime alertnes. The Turkish validity and reliability of the scale has been conducted on stroke patients but not on multiple sclerosis patients. The aim of this study is to investigate the validity and reliability of the Turkish version of general sleep disturbance scale (GSDS-T) in patients with multiple sclerosis. GSD has 21 questions. This study will be conducted on patients with multiple sclerosis (MS). 126 participants will be included in the study. In order to evaluate the validity of the GSDS-T, the Pittsburgh Sleep Quality Index (PSQI) which can evaluate sleep quality and has been validated in Turkish, will be used. Scales will be repeated after 15 days to assess test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Individuals over the age of 18 who have been diagnosed with Multiple Sclerosis for at least two years,
* Those with an EDSS score \>2.
* Those without symptoms of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria
* Individuals whose native language is Turkish and who have the ability to speak and understand.

Exclusion Criteria:

* Those with severe spasticity,
* Those with vision and hearing problems,
* Those with a known mental illness (major depression, schizophrenia, psychosis, etc.),
* Those in an acute relapse phase,
* Those using dietary supplements,
* Those using tranquilizers or immunosuppressants.
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, 18-80 years of age
* Moderate to severe active rheumatoid arthritis
* Inadequate response to a single previous or current treatment with an anti-TNF agent
* Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

Exclusion Criteria:

* Previous treatment with MabThera
* Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
* Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
* Active infection, or history of serious or chronic infection
Electroacupuncture for Postoperative Ileus After Laparoscopic Rectal Cancer Surgery

Postoperative ileus remains a significant medical problem after colorectal surgery that adversely influences patients' recovery. The investigators previous study demonstrated that electroacupuncture (EA) at Zusanli, Sanyinjiao, Hegu, and Zhigou reduces the duration of postoperative ileus and hospital stay after laparoscopic resection of colonic and upper rectal cancer. Patients with mid/low rectal cancer undergoing laparoscopic total mesorectal excision (TME) or abdominoperineal resection (APR) were excluded. However, these complex cases are more likely to develop prolonged ileus and morbidity after surgery, and it is uncertain whether EA will be beneficial to them. The investigators therefore propose to conduct a prospective cohort study to evaluate the efficacy of EA in preventing prolonged ileus after laparoscopic surgery for mid/low rectal cancer. Fifty consecutive patients with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion will be recruited. All patients will undergo 1 session (20 minutes) of EA daily from postoperative day 1 till day 4. These patients will be compared with a matched historical control group (1:2) who underwent laparoscopic TME or APR without EA. The primary outcome is the incidence of prolonged ileus, which is defined as the inability to tolerate fluid diet by 4 days after surgery, associated with the need for nasogastric decompression and/or parenteral nutrition support. Secondary outcomes include time to defecation and duration of hospital stay. Results of this study will help clarify the efficacy of EA in preventing prolonged ileus after laparoscopic rectal surgery, and may provide the basis for planning a larger randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients (aged between 18 and 80) with mid/low rectal cancer undergoing laparoscopic TME or APR without the need of conversion
* Patients with American Society of Anesthesiologists grading I-III
* Informed consent available

Exclusion Criteria:

* Patients undergoing simultaneous laparoscopic resection of rectal cancer and other coexisting intraabdominal diseases
* Patients undergoing laparoscopic resection of rectal cancer with en-bloc resection of surrounding organs
* Patients who developed intraoperative problems or complications (e.g. bleeding, tumor perforation) that required conversion
* Patients with intestinal obstruction
* Patients with previous history of abdominal surgery
* Patients with evidence of peritoneal carcinomatosis
* Patients who are expected to receive epidural anesthesia or analgesia
* Patients with cardiac pacemaker
* Patients who are pregnant
* Patients who are allergic to acupuncture needles
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.


Eligibility Criteria:
Inclusion Criteria

* Healthy infants able to attend all study visits
* Parent(s)/legal representative able to read, understand, and complete study questionnaires

Exclusion Criteria

* History of congenital or acquired immunodeficiency
* Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
* History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
* Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
* Has any chronic illness that could interfere with study conduct or completion
* Received any immune globulin, blood, or blood-derived products since birth
* Received a dose of hepatitis B vaccine prior to the study
* Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
* Fever within 24 hours prior to enrollment
* Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
* Has a coagulation disorder
* Has developmental delay or neurological disorder
* Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity
* History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection
The Effect of NLP on Pain Before Uterine Curettage Due to the Fetal Demise

Pregnancy termination is a difficult and painful procedure can be done by medically or uterine curettage. Studies have been conducted to reduce the anxiety of women undergoing pregnancy termination, but there are no publications on topics such as anxiety, pain perception, and pain catastrophizing.

Neuro Linguistic Programming (NLP) has been called "the art and science of personal excellence", "the study of subjective experience". NLP helps us understand the difference between our actions that produce mediocre results or failure and those that require success or excellence.

NLP: "How do I do something I do well?", "How can I do it better?", "How can I gain skills that I admire in others? It addresses questions like ". It is important to note that NLP is not limited to observable behavior. Our way of thinking, that is, all experience and it also includes the mental processes that control our actions. By dealing with the entire structure of a person's experience (in fact, their motivation), it tries to shape the thought processes, emotions and beliefs that result in a behavior. It is especially about our communication with ourselves as well as with others.

No study was planned on pain and pain perception during pregnancy termination by uterine curettage by teaching the NLP technique to the patients.

In this randomized controlled study, the group of patients who underwent uterine curettage with the indication of pregnancy termination in the Septic Service of the Department of Gynecology and Obstetrics of Şanlıurfa Training and Research Hospital will be divided into two groups and NLP training will be given before uterine curettage in a double-blind manner and VAS (visual pain scale) after uterine curettage. Evaluation will be made using the fear of pain scale-3 and the pain catastrophizing scale. NLP training will be given for approximately 20 minutes, and the group that will not receive NLP training will remain silent for 20 minutes. The results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age, non-pregnant, with an indication for pregnancy termination; Those who agreed to participate in the study, patients who understand and can speak Turkish

Exclusion Criteria:

* Patients who do not meet the inclusion criteria or who have had a previous pregnancy termination
The Role of Lactate in Viral and Bacterial Infection

Acute upper respiratory tract infection(AURI) is common in children, and viral infection is the main cause. However, several children with viral infection are easy to suffer from secondary bacterial infection, and the mechanism is unclear.

Lactate is an important molecule in the spread and metastasis of tumor by suppressing the innate immune response. As is known, the immune system is not mature in children and it is reverse related to the age of children. An reasonable hypothesis is that the lactate is a independent risk factor in the children with viral infection progress to bacterial infection. Here, our aim is to test the hypothesis.

Eligibility Criteria:
Inclusion Criteria:

* child's age is from 0 to 18 years
* a child is at least diagnosed with viral infection

Exclusion Criteria:

one of the following conditions appeared:

* congenital heart disease or other abnormalities
* respiratory failure
* hereditary and/or metabolic disease
Topical Composition Therapy for the Treatment of Cutaneous Mastocytosis

The purpose of this study is to determine the effectiveness and tolerability of a novel topical preparation for the treatment of cutaneous lesions of mastocytosis.


Eligibility Criteria:
Inclusion criteria

* Biopsy proven cutaneous mastocytosis with or without evidence of systemic disease
* Male and female patients 18 to 80 years of age
* No UVB treatment of the skin for 6 months prior to study entry
* No use of topical or systemic corticosteroids for 1 month prior to study entry
* Good general health as confirmed by medical history
* Female patients of child-bearing potential with negative urine pregnancy test who agree to use effective methods of birth control or remain abstinent during treatment. Participants must use birth control for the entire study and for at least 1 week after the last application of the study formulation. Acceptable methods of birth control include ongoing hormonal contraception methods, (such as birth control pills, patches, injections, vaginal ring, or implants), barrier methods (such as a condom (for men) or diaphragm used with a spermicide), intrauterine devices, tubal ligation, or abstinence.
* Patients who are willing and capable of cooperating to the extent and degree required by the protocol; and
* Patients who read and sign an approved informed consent for this study

Exclusion criteria

* Vulnerable study population
* Exposure to ultraviolet B (UVB) radiation to any region of the skin surface for 6 months
* Regular use of skin lightening agents within 1 month of study entry, including

  * Topical corticosteroids
  * Topical bleaching products
  * Topical retinoids
* Use of systemic preparations within 1 month of study entry, including:

  * Systemic corticosteroids
  * Systemic cyclosporine, interferon
  * Systemic acitretin, etretinate, isotretinoin
  * Systemic methotrexate,
  * Systemic photoallergic, phototoxic and/or photosensitizing drugs
* UV light therapy and sunbathing
* Inability to communicate or cooperate with the Principal Investigator and/or Investigators due to language problems, poor mental development or impaired cerebral function
* Pregnant or nursing women
* Women planning a pregnancy within the study period