cyrilzakka/clinical-trials huggingface dataset:
Substance Abuse Self-Help Group Referral: Outcomes and Services Use

Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.

Background:

Self-help groups (SHGs) have become an important component of the system of care for patients with substance use disorders (SUDs). SUD patients' participation in SHGs has been linked to lower relapse rates and less use of additional treatment services.

Objectives:

The first objective was to implement and validate procedures to help counselors make effective referrals to SHGs for SUD patients. This project randomly assigned SUD outpatients to a standard referral or an intensive referral condition. We are determining the extent to which intensive referral increased patients' SHG attendance and involvement in comparison to standard referral. The second objective is to determine whether patients who received intensive referral to SHGs have better substance use and functioning outcomes over the 1-year follow-up period, and less use of formal treatment services, thereby reducing costs for VA, than those who received standard referral. The long-term goal is to develop and implement guidelines to facilitate SUD patients' participation in SHGs and thereby improve their quality of life and decrease their use of VA's specialized SUD treatment services.

Methods:

This project used a randomized design in which 345 patients entering VA outpatient SUD treatment were randomly assigned to either standard or intensive referral to SHGs. Standard referral consisted of the counselor recommending SHG participation. The keys to intensive referral included the counselor facilitating direct contact between the patient and a member of the SHG, and counselor follow-up on the recommendation for self-help. Patients were followed at 6 months and 1 year to determine whether intensive referral resulted in more self-help attendance and involvement; in better substance use and functioning outcomes (using the Addiction Severity Index); and in less use of VA services and lower treatment costs (using methods of the VA Health Economics Resource Center). To make these determinations, we are conducting analyses at each follow-up, and then will use hierarchical linear modeling to examine the benefits of intensive referral over time.

Status:

Project work is ongoing.

Eligibility Criteria:
Inclusion Criteria:

Consecutive substance use disorder outpatients at VA PA HCS and is not cognitively impaired.

Exclusion Criteria:

Cognitive impairment
Hyperthermia Enhanced Re-irradiation of Loco-regional Recurrent Tumors

This study investiagates deep-regional or superficial hyperthermia to enhance radiotherapy or chemoradiation in patients that suffer recurrent disease after previous radiotherapy.

patients that present a relapse within the previously irradiated volume can be included in this trial. These patients will receive re-irradiation according to clinical guidelines and hyperthermia as study intervention. According to tumor location hyperthermia can either be performed by microwave or by capacitive devices.

The primary endpoint of this study is non-inferiority of re-irradiation compared to the initial course of radiotherapy (calculated as time to local failure).

Eligibility Criteria:
Inclusion Criteria:

* prior radiotherapy of the treatment side with a treatment dose \> 30 Gray (Gy) EQD2 (calculated with alpha/beta value of 9)
* local/ regional / or oligometastatic tumor recurrence. Maximum number of three macroscopic tumor lesions with at least one of them receiving prior radiotherapy
* macroscopic tumor recurrence
* side of recurrence is amenable to hyperthermia (abdomen, pelvis, extremities, spine, cervical lymphnodes)
* planned re-irradiation dose of at least 40 Gy EQD2 (calculated with alpha/beta value of 9)

Exclusion Criteria:

* \>3 macroscopic tumor lesion
* brain metastases
* recurrence is amenable to local ablative radiotherapy (brachytherapy or stereotactic radiotherapy)
* recurrence region is not amenable to hyperthermia (lung, liver, mediastinum)
* contraindications for hyperthermia (serious cariovascular disease, ICD or larger implants at the treatment site)
* psychiatric disorders that impede proper informed consent
* serious comorbidities with very limited prognosis quo ad vitam
Long-term Effect of The Mother Infant Transaction Program (MITP)

The purpose of this study is to investigate if a cost and time effective intervention in a previous RCT for preterm infants and their parents can reduce the parents experience of concern and stress, and improve the childrens development in various aspects at three years of corrected age.

Hypothesis 1: The preterm born children of parents who were enrolled in the earlier RCT have a higher developmental level then preterm children of parents who received the usual treatment.

Hypothesis 2: Parents who who were enrolled in the earlier RCT will have a lower level of stress and concern then parents who received treatment as usual.

A previous RCT by Ravn (NCT00245843) investigated if the MITP could sensitize the mothers toward the babies signals and thereby increase the quality of joint attention. The study followed the children for 1 year.

This study is a follow-up to the above mentioned RCT. It investigates whether the effect of the RCT is present at three years corrected age.

The research questions are:

1. Can a psychoeducative program like the MITP influence the childrens' development in various aspects?
2. How did the MITP influence the parents experience of concern and stress three years later?
3. Were there any differences by the groups? a) Preterm intervention group b)Preterm control group c) Full term control group

The questionnaires to be used in this observational study are:

Ages and Stages

Eligibility Criteria:
Inclusion Criteria:

* All parents of children who participated in Ravn's RCT and who said yes to be asked for participation in an eventually later study will be asked.
Weight Change with Controlled Ankle Movement (CAM) Boot Use

The purpose of the study is to determine if patients wearing a CAM boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines and perform upper body exercises.

The study objectives include: 1) Determine if patients wearing a CAM (Controlled Ankle Movement) boot have a change in weight compared to patients who wear a CAM boot and are provided nutritional guidelines at the time the CAM is dispensed and perform upper body exercises through the treatment period. 2) Determine, if weight is gained or lost, the average amount gained/lost over the treatment period. 3) To qualitatively explore if the intervention helped to prevent gain weight during post-operative recovery when CAM boot is used

Eligibility Criteria:
Inclusion Criteria:

* Age greater or equal to 18 years
* Participants with foot or ankle injury who are prescribed a CAM boot as standard of care
* Participants willing to have height and weight measured at the time of enrollment and final visit
* Participant is able to provide voluntary, written consent
* Fluent in written and spoken English
* Participant in the opinion of the Principal Investigator, is able to understand the clinical investigation

Exclusion Criteria:

* Age less than 18 years
* Pregnant women
* Participants with vertigo or other balance issues
* Participants unable to provide informed consent
* Participants with foot or ankle injury who will not be wearing a CAM boot
* Participants unable/unwilling to perform upper body exercises and follow nutrition recommendations
The Treatment of Purulent Flexor Tenosynovitis

This study evaluates the effect of postoperative intermittent closed-catheter irrigation on the recovery from the purulent flexor tenosynovitis. One group of patients suffering from acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the other group having both intra- and postoperative irrigation.

The foundation of the successful management of purulent flexor tenosynovitis is the surgical debridement followed by an intravenous antibiotic treatment. Several surgical methods have been described to remove the purulent debris from the flexor tendon sheath. Closed-catheter irrigation involves irrigation of the tendon sheath from proximal to distal direction facilitated by two small incisions; one proximal to A1 pulley and one distal to A4 pulley. Lille et al. (J Hand Surg Br. 2000;25(3):304-307) conducted a retrospective study that implied that intraoperative closed-catheter irrigation without postoperative irrigation might be as effective as the combination of intra- and postoperative irrigation.

The hypothesis of this prospective randomized trial is that the intraoperative closed-catheter irrigation alone is as effective as the combination of intraoperative and postoperative intermittent closed-catheter irrigation in the treatment of purulent flexor tenosynovitis.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of purulent flexor tenosynovitis with all four positive Kanavel's signs:

  * symmetric swelling of the entire digit
  * exquisite tenderness along the course of the tendon sheath
  * semiflexed posture of the digit
  * pain with attempted passive extension of the digit
* age over 18 years
* patient's willingness to participate in the study

Exclusion Criteria:

* High-pressure, foreign body or chemical injuries, which require open debridement
* prisoner, military serviceman, mental retardation or other factors which may affect one's decision making
Single Rising Dose Study Investigating the Safety, Tolerability and Pharmacokinetics of Spray Dried BIBN 4096 BS After Inhalation Administration in Healthy Male and Female Volunteers

The purpose of the present study was to obtain information about the safety, tolerability and pharmacokinetics of BIBN 4096 BS after single inhalation administration of rising doses of spray-dried powder in healthy male and female volunteers. According to the original protocol, the primary objective was to investigate the safety and tolerability of single doses of a new spray-dried inhalation formulation of BIBN 4096 BS (SD I). Following implementation of Amendment 2, this objective was extended to the second spray-dried inhalation formulation SD II with and without concomitant administration of lactose


Eligibility Criteria:
Inclusion Criteria:

Subjects could be included in the study if they met the following criteria:

* Healthy male or female volunteers
* Written informed consent in accordance with Good Clinical Practice (GCP) and the local legislation prior to admission to the study
* Age 21 - 50 years
* Body mass index (BMI): 18.5 - 29.9 kg/m2

Exclusion Criteria:

Subjects were not allowed to participate if any of the following applied:

* Any finding of the medical examination (including blood pressure, pulse rate, Respiratory rate, body temperature and ECG) deviating from normal and of clinical relevance
* Raw \> 3 cm H2O • s • L-1 or FEV1 \<80% of predicted
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system, psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts,
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which was deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug before enrolment in the study
* Use of any drugs which might influence the results of the trial (within 1 week prior to administration of investigational drug or during the trial)
* Participation in another trial with an investigational drug (within 2 months prior to drug administration or during the trial)
* Smoker (\>10 cigarettes/day or \>3 cigars/day or \>3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\>60 gram/day)
* Drug abuse
* Blood donation (≥100 mL within 4 weeks prior to administration of investigational drug or during the trial)
* Excessive physical activities (within the last week before the study)
* Any laboratory value outside the reference range and of clinical relevance
* For female subjects:

  * Pregnancy
  * Positive pregnancy test
  * No adequate contraception e.g. oral contraceptives, sterilization, intrauterine device
  * Inability to maintain this adequate contraception during the whole study period,
  * Lactation period
CAR-T Cell Therapy Targeting to CD19 for R/R ALL

Refractory and relapsed (R/R) acute lymphoblastic leukemia (ALL) patients with active disease always have a dismal outcome. Chimeric antigen receptor (CAR) T-cell therapy targeting to Cluster of Differentiation Antigen 19 (CD19) has been proved as a potent approach to attain remission in B-cell R/R patients. Therefore, the investigators conduct atrial to evaluate the the efficacy and safety of locally producing CAR T cells targeting CD19, and to analyze the outcome of enrolled B-cell ALL patients with active disease or persistent residual disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as CD19+ B-cell acute lymphoblastic leukemia;
* Fail to achieve remission, or with persistent residual disease after at least 2 cycles of consolidation;
* With an estimated survival of higher than 3 months (according to investigator's judgement);
* Sufficient organ function: left ventricular ejection fractions≥ 0.5 by echocardiography, creatinine \< 1.6 mg/dL, aspartate aminotransferase/aspartateaminotransferase \< 3 x upper limit of normal, bilirubin \<2.0 mg/dL;
* Karnofsky performance status ≥ 60 or ECOG ≤ 2.

Exclusion Criteria:

* Intolerant to immunosuppressive chemotherapies;
* With active infection or other uncontrolled complications;
* With history of seizure;
* Active hepatitis B or hepatitis C infection and HIV infection;
* Pregnant or lactating women, or patients refusing to take effective contraception measures;
* Other contraindications that considered inappropriate to participate in this trial (according to investigator's judgement).
Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)

1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.


Eligibility Criteria:
Inclusion criteria:

* Newly prescribed treatment with Pradaxa® (dabigatran etexilate)/VKA in the indication "Stroke prevention in non-valvular atrial fibrillation" (AF) respecting the indication and contraindications as described in the respective Summary of Product Characteristics for Pradaxa® 110 mg or 150 mg hard capsules or the appropriate VKA (patients are eligible for both Pradaxa® and VKA therapy).
* Treatment with dabigatran etexilate or VKA is given in accordance with the respective Summaries of Product Characteristics. The routine diagnostic procedures and treatment that would be undertaken irrespective of the study are unaffected.
* Only patients who are eligible both for therapy with Pradaxa® and for therapy with VKA in accordance with the respective Summaries of Product Characteristics will be documented (patients eligible for VKA and Pradaxa®)
* Patients must have signed the patient consent form prior to inclusion in the Non-Interventional Study (NIS).

Exclusion criteria:

* Patients with the general and special contraindications mentioned in the packaging leaflet or Summary of Product Characteristics must not be included.
* Patients participating at the same time or within the last 30 days in another Non-Interventional Study (NIS) or an interventional clinical trial must not be included.
* Patients treated with anticoagulants for a condition other than non-valvular atrial fibrillation must not be included.
* Pradaxa® and VKA should not be used during pregnancy and lactation. Pregnant or breastfeeding women must therefore not be included in the NIS.
A Study Testing A Radioactive Compound Given Through A Vein With And Without The Non-Radioactive Compound, Given By Mouth, To Characterize Tissue Distribution Using Positron Emission Tomography Scanning

In this study, radioactive PF-06427878 will be administered, through a vein, alone and with 2 different oral doses of non-radioactive PF-06427878 to healthy, adult, male subjects. Positron emission tomography will be used to characterize tissue distribution. The study will also characterize how the study drug behaves in the body, its safety, and how the body tolerates it.


Eligibility Criteria:
Inclusion Criteria:

* healthy males
* body mass index 17.5-30.5 kg/m2 ; body weight \>50 kg
* signed and dated informed consent document
* willing and able to comply with study requirements

Exclusion Criteria:

* tobacco/nicotine containing products \> equivalent of 5 cigarettes per day
* history of cumulative ionizing radiation exposure in the past year, including anticipated exposure in this study, and subjects with current, past or anticipated exposure to radiation in the workplace
* severe claustrophobia
* unable to lie still for the required period to acquire images
Pharmacokinetics, Safety and Tolerability of AGO178C in Subjects With Renal Deficiencies Compared With Healthy Subjects

This study will assess the pharmacokinetics, safety and tolerability of a single dose of AGO178C in subjects with mild, moderate, severe renal impairment and end-stage renal disease with that in healthy matched control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Mild, moderate, severe renally impaired or ESRD patients.
* Healthy male or female subjects to match renally impaired patients in BMI (±15%), age (± 7 years) and gender (in this order). Smoking status (yes or no) will also be used as a final criterion, if deemed feasible by the Investigator.

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study as defined in the protocol.
* Smokers, smoking 10 cigarettes or more per day from screening to study completion
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study
* Co-medication for healthy subjects

Other protocol-defined inclusion/exclusion criteria may apply
Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)

This study will:

* Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.

  * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.
* Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.

This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.

Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with clinically definite MS according to the McDonald criteria
* Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse
* Age 18-65
* Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of \>9 T2 lesions in addition to 1 Gd lesion)
* Have EDSS scores less than or equal to 5.5
* Have disease duration of 3 months to 30 years
* None of the exclusion criteria

Exclusion Criteria:

* Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)
Azelnidipine Anti-Coronary Atherosclerotic Trial in Hypertensive Patients by Serial Volumetric IVUS Analysis(ALPS-J)

In patients with hypertension who undergo elective PCI, the effects of long-term administration of Calblock (azelnidipine) on plaque volume will be determined quantitatively by 3D-IVUS and compared with those of amlodipine besilate (Norvasc or Amlodin).

Clinical studies have demonstrated that calcium antagonists can reduce cardiovascular events in patients with coronary artery disease. Recently, suppression of the development of coronary atherosclerotic plaque by calcium antagonists has been reported as one of the mechanisms involved. Thus, calcium antagonists have been promising strategy for preventing the progression of the coronary atherosclerosis. Various calcium antagonists are clinically available at present and these drugs may differ from each other with respect to the anti-atherosclerotic effects. Consequently, we plan to perform the ALPS-J study to compare the effects of two long-acting calcium antagonists, azelnidipine and amlodipine, on plaque quantitatively by IVUS. In this study, azelnidipine (16 mg/day) or amlodipine besilate (5 mg/day) will be administered to patients with hypertension for 48 weeks after elective PCI. The plaque volume will be measured in each patient by IVUS at the time of PCI and 48 weeks after PCI. Percent change in plaque volume from the baseline value will be used as the primary endpoints for evaluation of efficacy. We plan to enroll 100 patients in each group for a total of 200 patients.

Eligibility Criteria:
Inclusion Criteria:

* Age: Between 20 and 79 years (at the time of giving informed consent).
* Sex: Either sex.
* Admission status: Outpatients.
* Patients requiring treatment for hypertension according to the JSH 2004 hypertension therapy guidelines before beginning this study
* Patients who have not used any calcium antagonists for at least 4 weeks before the beginning of this study.
* Patients who are scheduled to undergo elective PCI.

Exclusion Criteria:

* Patients with acute coronary syndrome (ACS).
* Patients who have experienced Q-wave myocardial infarction within 4 weeks before beginning this study.
* Patients with renal dysfunction (serum creatinine \>2.0 mg/dL).
* Patients in whom PCI is unsuccessful.
* Patients with cardiogenic shock.
* Patients with moderate or severe congestive heart failure.
* Patients with 50% or more stenosis of the main trunk of the left coronary artery.
* Patients with other problems whom the investigator considers unsuitable for this study.