cyrilzakka/clinical-trials huggingface dataset:
Substance Misuse and Family Violence Treatment Fathers

This study involves a randomized controlled trial of Fathers for Change (F4C) compared to Individual Drug Counseling (IDC) with a sample of 280 fathers enrolled in substance use (SU) treatment within community or veterans (VA) healthcare settings to (a) demonstrate F4C efficacy compared to IDC in reducing SU and family violence (FV) at end of treatment, 3- and 6-month post-treatment follow-up, and (b) document improved emotion regulation as the mechanism within F4C that results in reduced SU and FV.


Eligibility Criteria:
Inclusion Criteria:

* meet DSM-5 criteria for an SU disorder at the time of assessment at APT or VACHS;
* report FV within the last 18 months prior to screening (based on self, court, police or child protection reports);
* have at least one biological child aged 1 to 12 years with whom they live or have at least twice per month in person visits;
* are able to complete assessments in English; and
* agree to have their female coparents (mother of the youngest child) contacted for participation of their youngest child. If a participant has more than one child in the age range, the youngest will be the target of assessment and treatment.

Exclusion Criteria:

* an active full/no contact protective order pertaining to their child;
* physiological addiction to a substance that requires detoxification (such individuals may be re-evaluated following detox);
* cognitive impairment (a mini mental state score \<25);
* current untreated psychotic/bipolar disorder;
* currently suicidal or homicidal based on Brief Symptom Inventory Screening and follow-up on positive responses; or
* are currently receiving weekly individual therapy for Substance misuse or family violence
Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

Diabetic neuropathy (DN) is the most common complication of diabetes, affecting almost 50% of people with diabetes over the course of their lives. Symptoms vary from numbness to burning, aching and hypersensitivity in the lower limbs, indicative of sensory nerve loss. Motor neurons can also be affected, leading to muscle weakness and mobility issues, thus preventing patients from engaging in daily routines. Further sequelae include foot ulceration and Charcot neuroarthropathy, which are risk factors for lower limb amputation and mortality. In the United Kingdom, the annual costs of DN alone exceed £300 million, with further complications expected to cost an additional £1 billion. Currently, management strategies for DN focus on prevention and pain management. Neuromuscular electrical stimulation (NMES) is a novel nonpharmacological intervention for people with DN. NMES is the application of electrical impulses which are of sufficiency intensity to improve artificial contraction of the muscle tissue and may help with DN by improving nerve conductivity through direct stimulation of the nerves.


Eligibility Criteria:
INCLUSION CRITERIA

* Aged ≥18 (no upper limit)
* Diagnosis of type 1 or type 2 diabetes based on World Health Organisation (WHO) definition
* Diagnosis of diabetic neuropathy based on validated screening questionnaire Michigan Neuropathy Screening Instrument score of ≥4
* Access to internet at home to use the Revitive App (study smartphones will be provided)

EXCLUSION CRITERIA

* Lacks capacity to provide informed consent
* Pregnant
* Implanted electronic, cardiac or defibrillator device
* Other cause of peripheral neuropathy
* Current foot ulceration
* Severe vascular disease requiring invasive intervention
* Being treated for, or have the symptoms of, an existing deep vein thrombosis (DVT)
* Used a neuromuscular electrical stimulation (NMES) device within 1 year of randomisation
Investigating the Bactericidal Effect of Probiotics on Chromogenic Bacteria in Children An In Vivo and In Vitro Study

To investigate the bactericidal effect of probiotics (Streptococcus salivarius M18 and Lactobacillus reuteri) on two types of bacteria (Aggregatibacter actinomycetemcomitans and Actinomyces naeslundii) causing black stains of teeth in vitro.

In vitro:

An unstimulated salivary sample will be taken from patients having black stains. The two types of bacteria of each condition will be cultured, amplified, and measured in the laboratory from the saliva of these patients. After that, one type of probiotics will be applied to these bacteria separately and the same bacterial measurement will be done to evaluate the bactericidal effect of the probiotics on these bacteria, aiming to find the minimal inhibitory concentration of the probiotics.

Eligibility Criteria:
Inclusion Criteria:

* Patients with black stains on teeth scored via modified Lobene index scores 1-3.
* Medically free patients

Exclusion Criteria:

* Stains other than black.
* Patients on antibiotic treatment or any other medication for the last 2 weeks.
* Patients allergic to prophylaxis powder.
* Parents refusing to participate
Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.


Eligibility Criteria:
Inclusion Criteria:

* Insulin naive Type 2 diabetes
* Currently treated with OADs alone or combined with other treatment for at least 3 months
* BMI below 40 kg/m2 and body weight below 125 kg
* HbA1c greater than or equal to 8%

Exclusion Criteria:

* Inability to tolerate metformin or contradictions to its use
* Pregnant, breastfeeding or intention of becoming pregnant
* Allergy to any of the trial products
* Inability or unwillingness to perform SMBG
Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Non-Small Cell Lung Cancer are allowed.


Eligibility Criteria:
Inclusion Criteria:

* Pathological confirmation of Non-Small Cell Lung Cancer (NSCLC)
* Must have been previously treated with a single platinum-based chemotherapy regimen and shown evidence of disease progression; no further limitations
* Must have normal organ function
* Must be willing to submit to blood sampling for planned PK and PD analysis
* Must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

* No other agents or therapies administered with the intent to treat malignancy
* Patients with prior exposure to obatoclax or docetaxel
* Uncontrolled, intercurrent illness
* Pregnant women and women who are breast feeding
Hyperapo B and Coronary Heart Disease

To determine the role of apolipoprotein B and apolipoprotein A1 in the etiology of coronary artery disease.

BACKGROUND:

Hyperapo B is a phenotype defined as elevated plasma level of the major apoprotein B of low density lipoproteins in the presence of a normal plasma level of low density lipoprotein cholesterol. It has been demonstrated that hyperapo B is strongly associated with coronary artery disease. In 1984 when the study began, the independence of this association with other risk factors for coronary artery disease such as cigarette smoking, hypertension, and low plasma levels of high density lipoproteins was not known. The study improved knowledge of the pathophysiology of coronary artery disease and of the genetic and biochemical defects of hyperapo B and hypoalphalipoproteinemia.

DESIGN NARRATIVE:

Interviews were conducted and clinical data collected on each index case and spouse, as well as on first degree relatives. Risk factor data included blood pressure, blood lipid levels, obesity, cigarette smoking, fasting blood sugar and diabetes, hormone use and menopause for women, physical activity, personality scores, and family history. Clinical data included the indications for coronary arteriography, history of use of lipid-lowering agents and insulin, presence of corneal arcus, xanthomata, and xanthelasma, and the electrocardiogram.

To determine if the apolipoprotein B gene and the apolipoprotein A1-C3-A4 gene cluster were independent predictors of premature coronary disease, the relation between DNA polymeric sites within the two genes and coronary disease were investigated using cloned DNA fragments as molecular probes. To determine if apolipoprotein B and apolipoprotein A levels aggregated in families and to determine if hyperapo B and hypoalphalipoproteinemia segregated as Mendelian traits, genetic analysis was conducted in the 200 index cases and the 900 first degree relatives. Studies were also conducted on the linkages between hyperapo B and haplotypes of the apolipoprotein B gene, on hyperapo B and the Ag polymorphisms, and on hyperalphalipoproteinemia and haplotypes of the apolipoprotein A1-C3-A4 gene cluster.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Phase I / II Study of Irinotecan (CPT-11) Combined With l-Leucovorin (l-LV) and 5-FU in Patients With Advanced Colorectal Cancer

We performed a phase I/II study of CPT-11/5FU/l-LV in advanced colorectal cancer, to determine the optimal dose of CPT-11 and to estimate the safety and efficacy of this regimen

A multicenter Open-label, single-arm, phase I/II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan, leucovorin plus fluorouracil. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), median survival time (MST), incidence and severity of adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of colorectral adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 18 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. No prior chemotherapy. Adjuvant chemotherapy is not defined as previous therapy.
6. No history of radiotherapy to the abdomen.
7. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
8. Predicted survival for \>3 months.
9. Able to give written informed consent.

Exclusion Criteria:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Diarrhea (watery stools).
6. Uncontrolled ischemic heart disease.
7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
8. Active multiple cancer.
9. Severe mental disorder.
10. Pregnancy, possible pregnancy, or breast-feeding.
11. Flucytosine treatment
12. Gilbert's syndrome.
13. Judged to be ineligible for this protocol by the attending physician.
Get-a-Grip Lifestyle Management Programme

The primary aim of this study was to examine weight reduction in primary care in obese or overweight subjects with a comorbidity that would benefit from weight loss during 1-year comprehensive lifestyle management programme including medical examinations, personalized dietary and exercise advice, guidance on shopping behaviour and food preparation, and group discussions.

Obesity is associated with altered glucose and lipid metabolism, and elevated blood pressure (BP) increasing the risk of cardiovascular morbidity and mortality. Obesity-induced complications are increasingly encountered in the health care system and especially in primary care. Thus, there is a growing need for individually tailored weight management programs aiming to permanent lifestyle and dietary changes for the prevention and treatment of obesity-related health hazards.

The study investigated weight reduction during 1-year comprehensive lifestyle programme in 134 obese or overweight subjects (BMI\>30, or BMI\>25 with a comorbidity including diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea). The participants were recruited from the local diabetes centre and health care providers. The programme aimed at 5-10 % weight reduction utilizing exercise program supervised by personal trainer, advice on diet and on-location shopping behavior by a registered dietician, hands-on cooking classes by a professional chef, examinations by a medical doctor, and group discussions. The efficacy of the program was followed by measuring change in weight, BMI, waist circumference, fat and muscle percentage, visceral fat, and systolic and diastolic BP.

The study protocol has been approved by the ethics committee of the Pirkanmaa Hospital District (R12099).

Eligibility Criteria:
Inclusion Criteria:

* BMI \>30
* BMI\>25 with a co-morbidity that would benefit from weight loss (diabetes, hypertension, arthrosis, asthma, chronic obstructive lung disease, sleep apnoea)

Exclusion Criteria:

* physical condition that prevented exercise
* abuse of alcohol or drugs
* medical history suggesting poor adherence
* severe concurrent disease
* moderate to severe dementia
Biofeedback for Dyssynergic Constipation

Constipation affects 4% of adults in the United States (U.S.). An estimated half of constipated patients are unable to relax pelvic floor muscles during defecation, a type of constipation called pelvic floor dyssynergia (PFD). Biofeedback has been recommended for the treatment of constipation because uncontrolled studies over the past 10 years suggest that these treatments are as effective as medical or surgical management and involve no risk. However, placebo-controlled trials are still lacking. The aims of this study are:

* to compare biofeedback to alternative therapies for which patients have a similar expectation of benefit;
* to identify which patients are most likely to benefit; and
* to assess the impact of treatment on quality of life.

This study is a long-term prospective, single-blind study comparing biofeedback for pelvic floor dyssynergia to a skeletal muscle relaxant drug (diazepam 5 mg two hours before attempted defecation) and to placebo medication. Prior to randomization, patients will first receive medical therapy (laxatives and education) for 4 weeks and only those remaining constipated will be randomized. Physiological tests of anal canal pressure during straining to defecate and ability to pass a 50-ml air filled balloon will be tested before and after treatment. Patients will keep a diary throughout baseline and treatment, and they will be reassessed at 3, 6, and 12 months follow-up. Treatment will consist of 6 clinic visits at 2-week intervals. The investigators will develop a detailed treatment manual for this disorder which would permit other investigators to replicate their study.

Eligibility Criteria:
Inclusion Criteria:

* Males or females ages 16 or above who have symptoms of constipation due to pelvic floor dyssynergia

Exclusion Criteria:

* Pregnancy (because of the possibility of randomization into the diazepam group)
* Prior history of biofeedback treatment for pelvic floor disorders
CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation

Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels planned.

Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually for years 2 and 3.

Patients will receive escalating doses of 4G7-CARD T-cells (after pre-conditioning with Fludarabine and Cyclophosphamide), paralleling clinical standard of care with unmanipulated donor lymphocytes. Intra-patient dose escalation will proceed at intervals of not less than 8 weeks, dependent on development of toxicity or evidence of efficacy and confirmation by the Trial Management Group.

Three dose cohorts levels are planned, and dosing will be according to total CD3+ T- cell dose as this correlates with toxicity in the unmanipualated donor lymphocyte setting:

* Dose Level 1: 1x10\^6 CD3+ T-cells/kg (starting dose for all patients)
* Dose Level 2: 3x10\^6 CD3+ T-cells/kg
* Dose Level 3: 1x10\^7 CD3+ T-cells/kg

The inter-patient dosing for the first 3 patients was at least 28 days, following TMG confirmation.

Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. During the long term follow up phase of the study (years 2-3 post-final 4G7-CARD T-cell infusion) patients will be followed-up annually for overall survival, disease status and safety.

All patients will enter long term follow up until 3 years post-final 4G7-CARD T-cell infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Age 16-70 years
2. Confirmed diagnosis of CD19+ malignancy relapsing following allogeneic transplantation
3. Agreement to have a pregnancy test, use adequate contraception for 12 months post-final 4G7-CARD T-cell infusion
4. Karnofsky performance status \>60
5. Written informed consent

Exclusion Criteria:

1. Women who are pregnant or lactating
2. Prior history of ischaemic heart disease, dysrhythmias, abnormal ECG (LBBB), Multi Gated Acquisition Scan (MUGA) left ventricular ejection fraction (LVEF\<40%) (if performed)
3. Known involvement of the central nervous system or cerebral vascular accident within prior 3 months
4. Patients receiving corticosteroids at a dose of \> 10mg prednisolone per day (or equivalent)
5. Active graft versus host disease requiring immunosuppression
6. Use of rituximab within the last 2 months prior to ATIMP infusion
7. Known allergy to albumin or dimethyl sulfoxide (DMSO)
8. Patients who have experienced significant neurotoxicity following blinatumomab treatment
Feasibility of High Intensity Interval Training in Knee Osteoarthritis

The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based high intensity interval training program (HIIT) to improve physical function in patients with knee osteoarthritis (OA).

All participants will be assigned to the single-arm of the study in which all participants will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms ranging from mild to severe. The investigators will determine adherence to and tolerability of HIIT, acceptability, and recruitment and retention rates during the 12 week program. Additional outcomes will include physical function, knee OA symptomatic burden (pain), static standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and body composition.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 40 and 75 years old
* body mass index of 18.5-50 kg/m²
* exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.

Exclusion Criteria:

* individuals diagnosed with a cardiovascular condition restricting exercise
* individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes per week
* individuals currently doing HIIT
* individuals currently participating in physical therapy for knee OA
* individuals currently participating in another OA intervention study
* received a corticosteroid or hyaluronic acid intra-articular injection in the knee during the previous 3 weeks or scheduled for during the intervention
* diagnosis of gout in the knee
* diagnosis of rheumatoid arthritis
* diagnosis of fibromyalgia
* other systemic rheumatic disease
* severe dementia or other memory loss
* active diagnosis of psychosis or uncontrolled substance abuse disorder
* hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 3 months
* total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months
* on a waiting list for total joint replacement
* severely impaired hearing or speech
* pregnant or planning to become pregnant while enrolled in the study
* inability to speak English
* serious or terminal illness as indicated by referral to hospice or palliative care
* nursing home residence
* inability to ride a stationary bike
* any other health problems that would prohibit safe participation in the study
* EKG results EKG suggesting the individual would not be able to safely participate in this study
Validation of a Patient Decision Aid for Type 2 Diabetes

The objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a Patient Decision Aid and those who receive usual care.

This study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. The intervention is a Patient Decision Aid (PDA) video delivered via the internet.

Eligibility Criteria:
Inclusion Criteria:

1. Type 2 diabetes
2. Age 18 or older
3. English speaking
4. Currently taking metformin
5. Inadequate glycemic control in the opinion of the investigator
6. Is considering additional medication options on the advice of their physician
7. Can provide a valid email address
8. Access to the internet and able to read and respond to internet questionnaires

Exclusion Criteria:

1. Participation in a clinical trial of a diabetes medication within 1 year
2. Currently taking more than two (2) medications for diabetes
3. Has been exposed to diabetes medications from more than three (3) drug classes
4. Adults unable to consent
5. Individuals who are not yet adults (infants, children, teenagers)
6. Pregnant women
7. Prisoners