cyrilzakka/clinical-trials huggingface dataset:
CBT for Spanish Speakers

The investigators are conducting a randomized clinical trial of our new web-based version of the CBT4CBT (Computer Based Training for Cognitive Behavioral Therapy) in Spanish. This program specifically designed for Spanish-speaking substance users to evaluate its effectiveness relative to standard outpatient counseling at the Hispanic Clinic. The computer-based training program (CBT4CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance use treatment.

100 Spanish-speaking substance using individuals seeking treatment at the Hispanic Clinic of the Connecticut Mental Health Center will be randomized to (1) standard outpatient counseling at the Hispanic Clinic (typically consisting of weekly group counseling), OR (2) CBT4CBT plus standard outpatient counseling. Treatments will be delivered over an 8-week period with a six-month follow-up after termination of the study treatments. The primary outcome measures will be reduction in substance use (frequency of substance use by time, confirmed by urine toxicology screens and breathalyzers). Secondary outcomes will include treatment utilization and cost, several measures intended to detect whether web-based CBT4CBT retains key characteristics of traditional clinician-administered CBT (e.g., acquisition of coping skills, use of change strategies), participant characteristics which will be evaluated as potential moderators of outcome, as well as participant satisfaction and treatment credibility.

Eligibility Criteria:
Inclusion Criteria:

* Are 18 years of age or older.
* Are applying for outpatient, non-agonist substance abuse treatment at the Hispanic Clinic.
* Meet current DSM-IV criteria for cocaine, marijuana, opioid, alcohol or other stimulant abuse or dependence.
* Are sufficiently stable for 8 weeks of outpatient treatment.
* Can commit to 8 weeks of treatment and are willing to be randomized to treatment
* Are willing to provide locator information for follow-up.
* Speak Spanish as their preferred or principal (most commonly spoken)language

Exclusion Criteria:

* Have an untreated bipolar or schizophrenic disorder.
* Who have a current legal case pending such that incarceration during 8-week protocol is likely.
* Are physically dependent on alcohol, opioids or benzodiazepines
RDEA3170 and Allopurinol Combination Study in Gout Subjects

This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.


Eligibility Criteria:
Inclusion Criteria:

* Subject meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2.
* Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL
* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject is unable to take colchicine for gout flare prophylaxis.
* Subject has a history or suspicion of kidney stones.
* Subject has an estimated creatinine clearance \< 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
* Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
* Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is stable for at least 14 days prior to study medication dosing.
* Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study.
Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol

To assess the effect of vaginal estradiol pretreatment before vaginal misoprostol on labor induction.

A prospective double blind randomized clinical trial. Conducted at Ain Shams University Maternity Hospital. Patients fulfilling inclusion and exclusion criteria will be divided into two groups. Group (A):

100 patient will receive single dose vaginal estradiol 50mcg tablet (Ethinyl Estradiol manufactured by KAHIRA Pharmaceutical company) and vaginal misoprostol 25mcg tablet (Vagiprost manufactured by ADWIA Pharmaceutical company), misoprostol alone will repeated every 6hours up to five doses.

Group (B):

100 patients will receive placebo vaginally and misoprostol 25 mcg which will be repeated every 6 hours up to five doses.

Primary Outcome

* Measure the time to cervical ripening. Secondary Outcome
* Measure the time to active labor.
* Number of misoprostol doses.
* Induction delivery time.
* Time to achieve vaginal delivery.
* Fetal outcome (Apgar score).

Eligibility Criteria:
Inclusion criteria:

* Maternal age ≥ 18 years old.
* Gestational age ≥ 37 wks to 41 wks.
* BMI between 20 kg/m2 and 35kg/m2.
* Vertex presentation.
* Singleton pregnancy.

Exclusion criteria:

* Multiple pregnancy.
* Non vertex presentation.
* Absolute or relative contraindication to vaginal delivery e.g. (Placenta previa, fibroid uterus, uterine anomalies, previous uterine surgery).
* PROM.
* IUFD.
* Fetal distress.
Evaluation of the Benefits of Individualized Advice Administration on Quality of Sleep for the Elderly Living at Home

Sleep disorder is often a complaint from the older people. Prevalence of sleep disorder increases with aging and reaches between 20 to 45% of the people of 65 years old and more. Sleep physiologically changes with aging. Sleep can also be disturbed by other factors such as intercurrent or related chronic pathologies, environmental change (institutionalized, death of a spouse...), or some medical treatments. Regardless of interindividual variabilities, normative criteria have been defined by a meta-analysis: insomnia can be diagnosed if night wakings are more than 60min and/or if sleep latency is more than 30 minutes.

Various studies have proved the major role of sleep on health and wellbeing. Sleep disorders have an impact on the quality of perception of health and on the quality of life of people and their spouse. According to the French High Health Authority recommendations, sleep diary and validated scales are the tools to use to investigate sleep disorders.

Results from previous studies brought us to consider sleep complaint more specifically and adjust to the heterogeneous population of the investigator's hospital with a subjective approach. This work intends to offer a program of individualized advice to older patients with no cognitive impairment, or with a mild or moderate cognitive impairment, who complain about their sleep quality. Patients with a moderate cognitive impairment who have a caregiver at home can also join the study. The main objective of the study is to evaluate the impact of individualized care for sleep disorders on quality of sleep using the Pittsburgh Sleep Quality Index which validity was demonstrated among the elderly.


Eligibility Criteria:
Inclusion Criteria:

1. Patient giving a signed informed consent
2. Patient complaining about their sleep
3. Patient living at home
4. Patient with a Mini Mental State Examination score of 10 or more If the Mini Mental State Examination score is between 10 and 20, caregiver living at home able and willing to be in charge of a sleep calendar
5. Patient able to fill in questionnaires

Exclusion Criteria:

1. Patient living in a senior living facility
2. Patient legally protected
3. Patient with a psychotic decompensation
4. Patient with a sleep pathology
5. Patient with a Lewy body disease at the time of enrollment
6. Patient with no health insurance
Efficacy of Oral Hygiene Instructions Carried Out Using an Intra-oral Scanner

In the relationship between the dental hygienist and the patient, communication plays a key role in ensuring the quality of care, the patient's well-being, and adherence to oral hygiene recommendations. The professional must therefore consider the challenges and limitations of effective communication.

The dental hygienist is a healthcare professional who plays a crucial role in the prevention and promotion of oral health. These specialists assist and educate patients on oral hygiene practices. In order to communicate effectively, especially in today's modern society, it is essential to use increasingly advanced communication tools. The hygienist's task is to explore new technologies and communication methods to motivate patients.

Through empathetic, respectful, and personalized communication, a lasting relationship is often established between the hygienist and the patient. This is because their interactions are generally more frequent than those between the patient and the dentist. While professional oral hygiene sessions are recommended at least once a year for everyone, "fragile" patients-those with periodontal disease or other conditions-may require more frequent visits.

In everyday practice, it has been observed that patients tend to feel more comfortable discussing their doubts, concerns, and issues with dental hygienists rather than with dentists.

To achieve effective communication, various communication methods may be necessary. It will be interesting to determine whether technology can become a useful tool in dental hygienists' practice and positively influence patients' oral hygiene with long-lasting effects.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 80 years
* with good systemic health

Exclusion Criteria:

* Patients with conditions related to increased gingival bleeding
* Patients on drug therapy related to increased gingival bleeding
* Patients with cognitive and/or manual and/or sensory deficits
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
* Ann Arbor Stage II, III, or IV

Exclusion Criteria:

* Not a candidate for treatment with rituximab as a single-agent
* Evidence of transformation to a high grade or diffuse large B-cell lymphoma
* Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids
* Any prior treatment with rituximab
* Active, uncontrolled infection
Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.

Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.

In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.


Eligibility Criteria:
Inclusion Criteria:

1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
2. Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
4. Metastatic melanoma AJCC stage IV, completely resected.
5. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
6. Melanoma can be of either mutant or wild-type B-RAF.
7. Karnofsky performance status over 80 (Normal activity with effort).
8. No active cardio-respiratory disease.
9. Hematocrit over 25% and WBC over 3000.
10. Informed consent of the patient.

Exclusion Criteria:

1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
2. Active brain metastases requiring cortico-steroids.
3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
4. Active serious infection.
5. Allergy to penicillin.
6. Patient's wish to withdraw from the study at any stage.
Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia

This study was conducted to investigate the effects of daily supplementation of hydrolysed red ginseng extract on improvement of Hyperglycemia.

This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group. Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were assessed before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-80 years with fasting glucose 100-140 mg/dL

Exclusion Criteria:

* Weight less than 48 kg or weight decreased by more than 10% within past 3 months
* Have clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatic biliary system, kidney and Urinary system, neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies, gastrointestinal disorders, etc.
* Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months
* Blood sugar improvement or healthy functional food within past 1 month
* Under antipsychotic medication therapy within past 2 months
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test by show the following results

  * aspartate aminotransferase, alanine aminotransferase \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dl
* Pregnancy or breast feeding
* If a woman of childbearing doesn't accept the implementation of appropriate contraception
* Principal Investigator judged inappropriate for participation in study because of Laboratory test result, etc.
Ketone Supplementation in Cystic Fibrosis

This study will examine the effects of a novel ketone monester supplement on patients with cystic fibrosis experiencing an acute pulmonary exacerbation requiring hospitalization. Patients will undergo standard testing along with blood sampling to examine concentrations of inflammatory markers. Patients will then receive the ketone supplement for 5 days followed by post-testing to examine changes in pulmonary function and inflammatory markers

Up to 25 hospitalized patients with cystic fibrosis will take part in this study at UAB. Patients will be randomly assigned to receive either an exogenous ketone or placebo supplement. Participants will take the ketone or placebo for 5 days during hospitalization. Participants will drink one 60 mL bottle twice daily of either the ketone or placebo. On day 1 and day 5, before the patient drinks the ketone (or placebo) the patient will be asked to fast overnight for 8 hours. Following administration of the first morning dose of ketones (or placebo) blood samples will be obtained from a finger stick before (time 0 min) and following (15, 30, 60, 90, and 120 min) after they drink the supplement. A commercially available ketone meter (Keto-Mojo, Napa, CA) that provides instant assessment of circulating ketone concentrations will be used to measure ketone concentrations in the blood. Medical history history will be obtained at hospitalization. The study team will also examine the body for any abnormal signs and symptoms. Sputum and blood will be collected prior to and following the ketone supplement or placebo. The hypothesis is that ketone supplementation will reduce inflammation via a well known inflammatory pathway to improve outcomes in patients with cystic fibrosis experiencing an acute pulmonary exacerbation

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF
* Age \>19
* Colonization with P. Aeruginosa
* Acute pulmonary exacerbation requiring inpatient care

Exclusion Criteria:

* Concurrent or recent (within 28 d of enrollment) use of corticosteroids
* Inability to produce sputum
* Acute respiratory failure
* Chronic liver or renal disease
* Pregnancy
Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss

Anorexia and weight loss are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Community-dwelling patients ≥ 18 years of age with incurable, histologically diagnosed cancer.
* Involuntary loss of body weight of ≥ 5 % within the past 6 months

Exclusion Criteria:

* Presently hospitalized or in a nursing care facility.
* Inability to increase food intake from secondary causes.
* Liver disease
* If female-pregnant, breast-feeding or of childbearing potential.
Evaluation of the Effect of Drug-Related Problems in Pulmonary Embolism

Pulmonary embolism (PE) presents notable risks of morbidity and mortality, underscoring the need for customized anticoagulant treatment. There is a scarcity of research examining drug-related issues (DRPs) in PE. This research endeavor seeks to assess how addressing DRPs affects the clinical outcomes of PE patients receiving outpatient care, offering valuable insights to bolster patient safety measures.

This study will conduct a randomized controlled trial on PE patients in Istanbul, Turkey, from January 15, 2022, to January 15, 2023. The intervention group (IG) will receive clinical pharmacist (CP) recommendations for DRPs, while the control group (CG) will undergo observation only. Evaluations will occur at 90- and 180-days post-discharge, focusing on DRPs, CP interventions, and patient outcomes. Data will be systematically recorded and analyzed, adhering to ethical standards and employing the PCNE v9.1 classification system.

Pulmonary embolism (PE) involves the blockage of the pulmonary artery or one of its branches by materials like thrombus from elsewhere in the body. This condition is linked to increased mortality and morbidity rates, and if left untreated, it can result in recurring episodes. Additionally, using anticoagulant therapy poses a significant risk of severe bleeding.

Recent guidelines recommend customizing the duration of PE treatment based on the type of underlying risk factor, distinguishing between transient and persistent factors. Prolonged treatment without a persistent risk factor may heighten the risk of bleeding. Hence, selecting appropriate treatment options tailored to individual patient needs is crucial.

The main goal of our study is to evaluate how managing drug-related problems (DRPs) in pulmonary embolism (PE) outpatients influences their clinical outcomes. This research aims to provide valuable insights into the effectiveness of interventions targeting DRPs within the framework of PE management .

Eligibility Criteria:
Inclusion Criteria:

1. A confirmed diagnosis of pulmonary embolism (ICD-10 code: I26.0)
2. Patients visited the chest diseases outpatient clinic for post-discharge follow-up
3. Being 18 years or older.
4. Patients who could be evaluated by the clinical pharmacist for at least 24 hours within the intervention group.

Exclusion Criteria:

1. Being under 18 years old.
2. Lost follow up in 90th day after pulmonary embolism.
Motor Learning for the Lumbar Spine Using Sensor-based Postural Feedback: a Randomized Controlled Trial

A large subgroup of patients with chronic non-specific low back pain have motor control impairments. During motor control exercises, different forms of external feedback can be used to support training. This randomized controlled trial will investigate the effectiveness of different forms of external feedback during the learning phase of a motor control task for the lumbar spine in healthy subjects and patients with chronic non-specific low back pain (CNSLBP). Both healthy subjects and patients with CNSLBP will be randomized into three groups: one group will receive feedback from motion sensors, one group from a mirror and one group will receive no feedback (control group). A single session intervention with measurements at baseline and immediately post-intervention will be used.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific low back pain
* Age 18-65
* Able to understand Dutch

Exclusion Criteria:

* Subjects that received lumbar stabilization exercises in the past year
* Spinal surgery in the past
* Pregnancy
* Serious underlying pathologies (e.g. multiple sclerosis, tumors,...)
* Signs or symptoms of nerve root involvement
* Any physical condition at the moment of testing that can interfere with activities of daily living (e.g. serious knee pain)
* Known skin-allergy for tape
* BMI \> 30kg/m²
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery

A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. \& Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males/Females aged over 20 years
2. Patients with over 2 impacted wisdom teeth in the upper and lower jaws
3. Pain VAS Value over 50 mm evaluated as 100mm VAS
4. Subjects who voluntarily or legal guardian agreed with written consent

Exclusion Criteria:

1. Patients with severe heart disease, uncontrol hypertension, diabetes
2. Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
3. Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
4. Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
5. Patients with severe respiratory depression