cyrilzakka/clinical-trials huggingface dataset:
Integrating Support Persons Into Recovery

INtegrated Support Persons Into Recovery (INSPIRE) is a 4-year research project that tests whether integrating a patient's support person into a patient's treatment with Buprenorphine/Naloxone can improve outcomes. The study will examine whether a counseling program called CRAFT for a support person, such as a family member, spouse or friend, can improve patient outcomes.

Opioid use disorders (OUDs) have reached an all-time high and have devastating effects on the individual, family, and community. While medication treatment for OUD saves lives, rates of treatment drop out are very high. In addition, existing OUD treatments neglect the impact of untreated OUD on the family, and ignore the potential role family members and support persons (SPs) could have on encouraging long-term recovery. Incorporating the patient's support system may be an important way to improve treatment retention. The proposed study evaluates a counseling program for concerned family members, spouses, and friends called Community Reinforcement and Family Training (CRAFT), which is successful at engaging and retaining patients in substance use treatment. While promising, no studies have evaluated whether CRAFT can help patients remain on medication treatment for OUD, provided by community health clinics. If effective, this could save lives and help both patient and family member health outcomes. Patient and SP pairs will be recruited from community health clinics throughout northern and southern California. Patients taking OUD medication treatment will be recruited and randomly assign half of the SPs to receive CRAFT; the other half would receive treatment-as-usual. Patients and SPs will be interviewed three and twelve months later to evaluate whether patients with CRAFT SPs stay in OUD treatment longer, and whether patient and SP health outcomes improve.

Eligibility Criteria:
Patient inclusion criteria:

* 18 and older
* on buprenorphine treatment for OUD
* has an eligible support person that participates

Support person inclusion criteria:

* 18 and older
* frequent contact with the patient
* willing and available to try CRAFT

Patient exclusion criteria:

* \< 18 years and older
* not currently receiving buprenorphine
* not able to provide consent

Support person exclusion criteria:

* \< 18 years and older
* currently has a problem with heroin or opioid pills
* not able to provide consent
* actively using other substances such that their presence in group would be contraindicated
TAP Block With Magnesium Sulfate Added to Local Anesthetic in Abdominal Hysterectomy

Major abdominal surgeries are associated with severe abdominal pain, which can affect respiratory and cardiac functions, if insufficiently managed. This increases the incidence of post-operative morbidity.

The objective of this study was to detect the efficacy and safety of magnesium sulphate as an adjuvant to the analgesia offered by local anesthetic in ultrasound guided TAP block in patients undergoing total abdominal hysterectomy.


Eligibility Criteria:
Inclusion Criteria:

* weight: 50- 85 kg.
* ASA score: I-III
* scheduled for total abdominal hysterectomy

Exclusion Criteria:

* history of relevant drug allergy.
* coagulation disorders.
* opioid dependence.
* sepsis.
* psychiatric illnesses that would interfere with perception and assessment of pain.
Smoking Cessation in Patients With COPD (SMOCC) in General Practice

Background: Smoking cessation is the key element in the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). The role of the general practice in assisting these patients with successful quitting smoking was suboptimal. Therefore we evaluated the effectiveness of two smoking cessation programs (counseling and nicotine replacement) for smokers with COPD in routine general practice, one with (CNB) and one without (CN) the combination with bupropion-SR, compared to usual care (UC) and explored the role of COPD symptoms in successful smoking cessation.

Method: RCT with 667 patients with COPD, 68 general practices were randomly allocated. The usual care group (UC) consisted of 148 patients (22 practices), the first intervention group (counseling plus nicotine replacement (CN) of 243 patients (21 practices) and the second intervention group of 276 patients (25 practices. Main outcome measure was (biochemically verified) point prevalence.


Eligibility Criteria:
Inclusion Criteria:

A software program using Anatomical Therapeutical Chemical (ATC) prescription codes and International Classification of Primary Care (ICPC) diagnosis codes selected potential patients with COPD. Criteria: age \>35 years and a diagnosis recorded as COPD or as ICPC code R95/96, or a prescription of at least three times of bronchodilators (ATC code R03a/bc) and/or prescription of at least two times of inhaled anti-inflammatory medication in the past year (ATC code R03). General practitioners (GPs) had to confirm the diagnosis of the selection. Patients were eligible to participate if they met the following criteria:

* Current smoking
* Suffering from COPD according to the GP's diagnosis
* In command of the Dutch language.

Exclusion Criteria:

* Too ill
* Under control of a chest physician
* Serious physical or psychological comorbidity
Mechanisms of Affective Touch in Chronic Pain

This study compares how different types of touch found in massage therapies impact pain perception, and whether these effects differ in individuals with and without chronic pain. This study also examines psychological factors that may predict differences in touch perception in individuals with chronic pain. This research will improve our understanding of whether and how massage therapies can benefit pain and health, and whether this differs in people who suffer from chronic pain.


Eligibility Criteria:
Inclusion Criteria:

1. ages 18-65
2. fluent in English
3. physician diagnosis of Fibromyalgia but no other chronic pain conditions (patients) or no evidence of chronic pain (healthy volunteers)

Exclusion Criteria:

1. Sensory, motor, or anatomic differences or injuries relevant to study procedures
2. Known anomalies of the central nervous system (including stroke, dementia, aneurysm, or personal history of psychosis)
3. Pregnancy
4. Inability to rate pain or sensations
5. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
6. History of blood clots or first-degree family members with clotting disorders
7. Current use of opiate medication(s)
8. Contraindications to MRI if participating in pilot MRI study
9. Unable to identify a heat stimulus 50C or lower that generates a rating of a 7 on our VAS scale
10. History of fainting or seizures
11. History of frostbite
12. Open cut or sore on hand to be immersed in cold water bath
13. Fracture of limb to be immersed
14. History of Reynaud's phenomenon (hands get white, then blue on exposure to cold, then red on warming)
CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma

Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells.

Eligible patients will be screened for study entry and proceed to cell procurement at local sites with collection of peripheral blood mononuclear cells (PBMC) for CD30+ CAR T-cell manufacturing at UNC. Patients will then have autologous stem cells collected (PBSC) and stored for future AutoHSCT.

After another screening for MAC+AutoHSCT, patients who meet criteria will receive BEAM conditioning followed by AutoHSCT. About 21-42 day after the autologous stem cell infusion, patients will receive their autologous CD30+ CAR T-cell infusion, if they meet subsequent pre CD30+ CAR T-cell eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

* Age between ≥ 6 and ≤ 29.99 years at the time of consent.
* Lansky OR Karnofsky score of ≥ 60% (see Appendix VI)
* Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following:

Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd)

* Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry.
* Risk Factors: Patient must meet 2 or more of the established risk factors:

Performance score (Karnofsky/Lansky) \<;90% Time from diagnosis to first relapse of \<1 year Extra nodal involvement at the time of relapse/progression High baseline metabolic tumor volume (MTV, \>60mL) by 18F-fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT) Chemo resistant disease (Deauville 4-5) after the first re-induction

Exclusion Criteria:

* not meeting the inclusion criteria
Percutaneous High Frequency Alternating Current Stimulation in Healthy Volunteers With 30kHz

High-frequency alternating currents of greater than 1 kHz applied on peripheral nerves has been used in animal studies to produce a motor nerve block. It has been evidenced that frequencies higher than 5 kHz are necessary to produce a complete peripheral nerve block in primates, whose nerve thickness is more similar to humans.

The previous studies with transcutaneous and percutaneous HFAC, suggest high-frequency stimulation (10 and 20 kHz) have an inhibitory effect over muscle strength and somatosensory threshold.

However, the 30 kHz frequency has never been applied, and the hypothesis is that it can produce a greater blockage at the sensitive level and be a more comfortable application for the patient. The purpose of the present work is to determine if a greater blockage of the sensory component of the nerve occurs with this frequency and is to reduce the amount of current intensity needed using a percutaneous approach by apply two acupuncture needles near the nerve as electrodes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Ability to perform all clinical tests and understand the study process, as well as obtaining informed consent.
* Tolerance to the application of electrotherapy.
* That they have not diagnosed any pathology.
* They do not present a contraindication to puncture and / or the application of electric currents.

Exclusion Criteria:

* Neuromuscular disease.
* Epilepsy.
* Trauma, surgery or pain affecting the upper limb
* Osteosynthesis material in the upper limb.
* Diabetes.
* Cancer.
* Cardiovascular disease.
* Pacemaker or other implanted electrical device.
* Take any drug (NSAIDs, corticosteroids, antidepressants, analgesics, antiepileptics, ...) during the study and in the previous 7 days.
* Presence of tattoos or other external agent introduced into the treatment or assessment area.
* Pregnancy
Drain After Elective Laparoscopic Cholecystectomy

The trial aims to assess the value of drains in elective laparoscopic cholecystectomy.

After laparoscopic gallbladder removal patients are randomized to have a suction drain positioned in the subhepatic space or to have a sham drain in the subhepatic space. The primary outcome measure will be the presence of subhepatic fluid collection at ultrasonographic examination on the first postoperative day. Secondary outcome measures will be postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting and morbidity

Eligibility Criteria:
Inclusion Criteria:

* elective laparoscopic cholecystectomy

Exclusion Criteria:

* acute cholecystitis, cholangitis, or pancreatitis
* no contraindication for the laparoscopic
* no other additional procedure
Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers

This study will examine whether an Internet-based Acceptance and Commitment Therapy (ACT) intervention is effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers. In our study, we will compare 1) the experimental Internet-based ACT group to 2) standardized institutional rehabilitation carried out in rehabilitation centers and to 3) support provided by voluntary family caregiver associations

It is well-known that stress, low quality of life and depression are relatively common problems among family caregivers. The proportion of elderly family caregivers is rapidly increasing which emphasizes the need for new support systems. Internet-delivered psychological interventions are one possible approach, offering benefits as they are more easily to achieve for family caregivers who often are home-bound with their relatives.

This study will examine whether an Internet-based Acceptance and Commitment Therapy intervention would be effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers.The family caregivers' depressive symptoms, perceived burden, anxiety, quality of life, psychological flexibility, personality and physical performance will be studied by a quasi-experimental study design comparing three groups of family caregivers (Group 1, experimental: Internet-based ACT intervention; Group 2, active comparator: Standardized institutional rehabilitation in a rehabilitation center; Group 3, other: Support given by voluntary family caregiver associations). Data collection will be performed at three time points: pre, 4 months and post (10 months).

Secondly, we also aim to examine demographics and psychological variables that could predict change in depression and perceived burden over time (pre, 4 months and post (10 months). A further aim of the study is to examine potential mediators on the effect of the interventions including psychological flexibility and suppression of thoughts. Moreover, we aim to study user experiences and satisfaction of the Internet-based program, i.e., how the family caregivers experience and accept the web-based ACT intervention.

Eligibility Criteria:
Inclusion Criteria for all groups:

* family caregiver
* at least 60 years of age

Inclusion Criteria for the experimental and active comparator group - depressive symptoms and/or psychological distress

Exclusion Criteria for all groups:

* parallel psychological treatment
* severe mental disorder

Additional inclusion criteria for the experimental group:

- computer and Internet connection or willingness to use a tablet provided by the study
Pharmacogenetic Analysis of Korean Pediatric Patients With Acute Lymphoblastic Leukemia

This study is to find out distribution of genetic polymorphisms and genes related to the chemotherapeutic drugs of ALL.

Cure rate of pediatric ALL dramatically improved over 80%. Resistance to drug and hematologic relapse are remaining problem in ALL treatment. One of the explanations of drug resistance and toxicities is the pharmacogenetic effect. Germline polymorphisms in genes that code for proteins involved in the pharmacokinetics and pharmacodynamics of antileukemic agents are various, and inter-patient variability is the main factor for pharmacogenetic difference. Since multiple chemotherapeutic agents are involved in treating ALL, many genes related to the metabolic pathways of those drugs have an effect on the pharmacokinetics of patients with ALL. In Korea, pharmacogenetic study including multiple genetic loci for pediatric ALL has not been reported.In this study, the distribution of genetic polymorphisms and genes related to antileukemic drugs were analyzed, and their relations to the outcome of treatment and relapse rates were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute lymphoblastic leukemia
* In case of informed consent and assent

Exclusion Criteria:

* Paients or parents refusal
Seroquel Long-Term NIS for Schizophrenia Patients

To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder


Eligibility Criteria:
Inclusion Criteria:

* The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
* The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR
* The patient is between 18 and 65 years old(extremes included)
* On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy
* If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation

Exclusion Criteria:

* The patients who have known hypersensitivity to quetiapine
Medical Office Intervention for Adolescent Drug Use

The goal of this study is to assess the efficacy of a new intervention based on motivational enhancement therapy among adolescents with a history of substance use.

In many parts of the U.S. adolescent substance abuse treatment is scarce. Several studies have shown that brief interventions increase the likelihood of patients' completion of referrals to alcohol counseling or treatment. Other studies have shown a direct effect of brief interventions on patients' alcohol consumption. Although brief interventions have been widely recommended for adolescents, fewer studies have been conducted in this age group. If the current study confirms the effectiveness of the Motivational Enhancement Therapy approach, this will add another outpatient treatment option for adolescent patients with drug problems.

The specific aims of the project are to:

1. Test the effect of the brief intervention on drug use. We hypothesize that, among 12-18 year old medical patients who use drugs, the experimental intervention (two 60-minute motivational interviewing sessions) administered by a trained clinician will be at least 25% more effective than "standard care" (assessment/referral only) in decreasing drug use as measured by a 90-day Timeline Followback (6) (TLFB) calendar.
2. Test the effect of the brief intervention in increasing engagement in substance abuse treatment. We hypothesize that, among 12-18 year old patients who are referred to drug counseling or other treatments, the experimental intervention administered by a trained clinician will result in at least 25% more patients entering treatment compared to standard care, as measured by the numbers of patients who complete referrals to treatment providers.
3. Test the effect of the intervention on other substance-related outcomes. We hypothesize that the intervention will result in similar reductions in alcohol use, as measured by the TLFB, and in driving/riding while impaired (DRWI) risks as measured by the score of a 4-item self-reported scale. Other outcomes of interest include readiness to change, school performance, and experience of other harmful consequences of substance use and associated risk behaviors.
4. Identify factors that moderate and/or mediate the effect of the experimental intervention on our outcomes of interest (drug use, engagement in treatment), and estimate their effect sizes. Identifying moderating variables will help us to identify subgroups of optimal responders to the brief intervention. Based on our previous experience, we theorize that girls may respond more strongly to the intervention than boys, and that those who participate in other treatments (outpatient counseling) and/or a laboratory drug testing program will also have greater response.

Eligibility Criteria:
Inclusion Criteria:

* 12-21 years old
* Use of alcohol, marijuana or other drugs 6 times in last 3 months
* CRAFFT score of 1 or greater
* Have completed evaluation at Adolescent Substance Abuse Program at Children's Hospital Boston

Exclusion Criteria:

* Can not read or understand English at a 6th grade reading level
* Needs immediate hospitalization
Late Onset Postoperative Nausea and Vomiting

The purpose of this trial is to study the effects of different combinations of antiemetics on the incidence of late onset postoperative nausea and vomiting.

The authors will study the effect of many antiemetics on the occurrence of nausea and vomiting following strabismus surgery in pediatrics.

Eligibility Criteria:
Inclusion Criteria:

* children undergoing elective strabismus surgery under general anesthesia

Exclusion Criteria:

* children experienced retching or vomiting
* children who have taken anti-emetic medications, antihistaminics, steroids, or psychoactive drugs within 24 hours before surgery
Efficacy and Safety of Bilateral Theta Burst Stimulation for the Treatment of Auditory Hallucinations

First clinical studies indicate an effect of repetitive transcranial magnetic stimulation(rTMS) in the treatment of auditory hallucinations (AH). However, effect size, optimal stimulation site and parameters are unclear. With this randomized, placebo-controlled clinical trial we test the efficacy and safety of bilateral continuous theta burst stimulation (cTBS), a patterned form rTMS, against auditory hallucinations. The treatment will be applied add-on to individual antipsychotic and behavioral therapy. Patients will be treated for 6 weeks each weekday (30 sessions) with 40s of cTBS (halfway between T3/P3 and T4/P4). For weeks 1-3, half of the subjects will be randomized to a sham-stimulation (coil tilted 45°). During weeks 4-6, all subjects receive real cTBS.


Eligibility Criteria:
Inclusion Criteria:

* auditory hallucinations at least once a week
* Schizophrenia (DSM-IV)
* stable treatment setting (in- or out-patient)
* no change of antipsychotics during and at least 1 week before treatment initiation

Exclusion Criteria:

* epilepsy
* benzodiazepines \> 1,5mg lorazepam / d
* pregnancy
* metal parts in the brain
* cardiac pacemaker
* deep brain stimulation