cyrilzakka/clinical-trials huggingface dataset:
Dyadic Text-Messaging Micro-Intervention

The purpose of this study is to develop, refine, and pilot test a text-messaging micro-intervention focused on improving communication skills for couples in which one partner has gastrointestinal cancer.

For the pilot testing portion of the study, couples will be randomized (1:1) to receive the text-messaging communication micro-intervention or to a waitlist control group. All couples will be asked to complete questionnaires before randomization and 30 days post-randomization. Couples in the waitlist control group will be offered the text-messaging micro-intervention after completing the second set of surveys (30-days post-randomization).

A cancer diagnosis requires patients and their intimate partners to communicate effectively to navigate illness-related challenges. Research indicates that couples who use effective communication strategies have better individual psychological adjustment and higher relationship satisfaction. However, many couples have difficulty communicating about cancer-related issues which can lead to poorer individual, relationship, and patient health outcomes.

While dyadic interventions to improve couple communication have proven efficacious, they are often time intensive and have limited reach. The challenges of recruiting couples into dyadic interventions are well-documented, with low recruitment rates especially among underserved couples.

Micro-interventions, which consist of brief educational materials and short activities delivered via text message or a mobile application, have significant potential to increase reach and participation in diverse groups of couples by increasing flexibility and reducing barriers to access. Previous studies have found micro-interventions to be effective in promoting health behavior change in a wide range of individuals and in enhancing dyadic functioning in community couples.

The proposed project aims to develop, test, and examine the feasibility, acceptability, and efficacy of a text-messaging communication micro-intervention for couples coping with advanced GI cancer.

Eligibility Criteria:
Inclusion Criteria:

1. In a committed relationship
2. Both members of the couple must read and speak fluent English
3. One partner must be diagnosed with advanced (Stage III or IV) gastrointestinal cancer and undergoing systemic therapy (e.g., chemotherapy)
4. One or both partners must score ≥1.0 on the holding back screen

Exclusion Criteria:

1. Patient or partner who is unable to provide informed consent as assessed by the oncologist or research staff
2. Patient or partner is physically impaired in such a way that precludes the use of a mobile device
3. Patient or partner who do not have a mobile device
4. Patient or partner who is too sick to participate, as judged by the oncologist or research staff.
Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety. Disorder.

1. In this study, ultrasound-guided Stellate Ganglion Block(SGB) will be used in the treatment of anxiety disorders, combined with relevant scales, HRV indicators and resting state functional magnetic resonance data, to explore the safety and effectiveness of SGB in the treatment of anxiety disorders, and to explore whether its mechanism of action is related to the excitability of sympathetic nervous system and the activity changes of insular cortex.
2. Verify the following hypothesis:

(1) SGB is a safe, well-tolerated and acceptable treatment technique; (2) After SGB treatment, the anxiety symptoms of the patients were relieved to a certain extent and the psychological function was restored; (3) The sympathetic excitability of patients after SGB treatment is reduced, and this effect can be monitored by heart rate variability; (4) The activity of insular cortex decreased after SGB treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-60 years old
2. Diagnosed with various types of anxiety disorders according to the DSM-5, and meet the diagnostic criteria for pain disorders
3. Right-handed
4. Voluntarily join the study and sign the informed consent.

Exclusion Criteria:

1. Suicidal thoughts and behaviors
2. serious physical disease
3. diseases of the nervous system or other mental diseases
4. Contraindications for MRI examination
5. During pregnancy or lactation
6. Allergy to narcotic drugs
7. Contraindications with stellate ganglion block
PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

This is a randomized, open-label, 2-arm, controlled, phase 2, multi-center, estimation clinical trial of docetaxel and cisplatin combination chemotherapy with and without panitumumab in the first-line treatment of subjects with metastatic or recurrent head and neck cancer, as well as a cross-over second-line panitumumab monotherapy of subjects who fail the chemotherapy only arm. This study will be conducted in the United States. Approximately 150 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed metastatic and/or recurrent Squamous Cell Carcinoma of Head and Neck (SCCHN) determined to be incurable by surgery and/or radiation therapy.
* Measurable disease by CT scan
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Age: 18 years or older
* Adequate hematologic, renal, metabolic, hepatic \& thyroid function

Exclusion Criteria:

* Prior systemic treatment for metastatic and/or recurrent SCCHN
* CNS metastases, or nasopharyngeal carcinoma
* History of interstitial lung disease
* History of another primary cancer
* Any co-morbid disease that would increase risk of toxicity

  * Active infection requiring systemic treatment
  * Prior anti-Epidermal Growth Factor receptor (anti-EGFr) antibody therapy
P. Falciparum Infection Dynamics and Transmission to Inform Elimination

In the current study, three experimental approaches aiming at reducing malaria transmission will be tested. The study will cover two transmission season (2019 and 2020) and the interventions will vary by season. More specifically, in the 2019 transmission season (June-December) (Year 1), community case management of malaria (CCM) will be implemented in all eight villages as improved standard of care; in the 2020 transmission season (Year 2), the eight study villages will be divided into 4 study arms. CCM will continue in all villages; two villages will continue with CCM only (Arm 1, control); the three other pairs of villages will receive active fever screening and treatment (Arm 2); monthly mass screening and treatment (MSAT) (Arm 3); and mass drug administration (MDA) during the last 3 months of the dry season (April-June) (Arm 4). For MDA, the whole population (except for those not fulfilling the entry criteria) will be treated with a full course of dihydroartemisinin-piperaquine (DP) (320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet) per manufacturer's guidelines (once daily for 3 days and according to body weight). The MDA treatment will be repeated 3 times at monthly intervals.

In the current study, the investigators will first improve access to care in all villages by implementing community-based clinical case management (CCM) (year 1). In this year, the investigators will quantify gametocyte carriage and transmission from clinical cases passively recruited by CCM, and gametocyte carriage and transmission from asymptomatic infections detected in community surveys. These data will support the interpretation of the main study outcomes in year 2 when the investigators will directly compare the effect of CCM on the human reservoir of infection as compared to three different approaches, namely i) active fever screening and treatment that should detect symptomatic infections for early treatment; ii) Mass Screening and Treatment (MSAT) that will systematically screen, using point-of-care diagnostics, the whole population, with infected individuals immediately treated; and iii) mass drug administration (MDA) that will treat the whole population with a full course of an antimalarial treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Resident in the village.
2. Willingness to participate in repeated assessments of health and infection status and to donate a maximum of 30 mL (milliliter) of blood (children \<5 years of age), 37 mL (milliliter) of blood (children \<10 years of age) or 52 mL (milliliter) of blood (older individuals) during an 18-month period.

Exclusion Criteria:

1. Any chronic illness that would affect study participation.
2. Pre-existing severe chronic health conditions
3. History of intolerance to artemether-lumefantrine.
4. Participants \< 6months old and pregnant women in the first trimester (only for Arm with MDA-DP treatment).
5. Hypersensitivity to DP (only for Arm with MDA-DP treatment).
6. Taking drugs that influence cardiac function or prolong QTcorrected interval (only for Arm with MDA-DP treatment).
FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:

* Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
* Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
* Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors
2. Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors
3. Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tumors
4. Available related donor who is CMV+ and HLA-haploidentical or better but not fully HLA-matched
5. Presence of measurable disease by RECIST 1.1
6. Life expectancy of at least 3 months.
7. Provision of signed and dated informed consent form (ICF).
8. Stated willingness to comply with study procedures and duration.

Exclusion Criteria:

1. Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
2. Eastern Cooperative Oncology Group (ECOG) performance status \>2.
3. Evidence of insufficient organ function as determined by the protocol.
4. Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
5. Have central nervous system disease (CNS) as follows:

   1. Dose Escalation Cohorts: Active CNS disease, including history of CNS metastases.
   2. MTD/MFD Expansion Cohorts: CNS disease, including history of CNS metastases, that was not stable during the last 6 months.
6. Myocardial infarction (MI) within 6 months of Screening Visit.
7. Severe asthma.
8. Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
9. Uncontrolled infections.
10. Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
Interferon-gamma With Interferon Alpha and Ribavirin for Hepatitis C Non-responders

When administered simultaneously, interferon-alpha 2b + interferon-gamma result in dramatic antiviral synergy.Ribavirin has shown to enhance interferon-gamma levels in patients with chronic hepatitis C treated with interferon-alpha. Enhancement of immune responses, especially those related to type-1 T helper cell activity, may contribute to better efficacy in combining ribavirin with IFN-alpha for treatment of chronic hepatitis C. The aim of the present study is to evaluate the efficacy and safety of a triple regimen, a combination treatment with Interferon gamma, Interferon alfa-2b plus Ribavirin in patients who have not previously responded to interferon alpha in combination of ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Non-responders and relapsers to previous interferon and ribavirin therapy given for six months
* HCV genotype 3
* Compensated liver disease
* Hb ≥10 g/dl (females),≥11 g/dl (males)
* Platelets count ≥ 100,000 / cubic mm
* Neutrophils count ≥1,500/cubic mm
* ≥18 years to ≤ 70 years.
* At least one abnormal ALT value in the last year.
* TSH level within normal limits.
* Non pregnant adult females.
* Absence of drug or alcohol abuse.
* Informed consent given by the patient

Exclusion Criteria:

* Patient younger than 18 yrs and older than 70 yrs.
* Hepatitis B or HIV co-infection.
* Severe renal dysfunction or creatinine clearance less than 50 ml/min
* Pregnant women or breast feeding women.
* Suspected hypersensitivity to Interferon alpha, gamma or ribavirin.
* Decompensated liver cirrhosis.
* History or any other evidence of other causes of CLD other than hepatitis C infection ( like hemochromatosis,, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposure, Wilson's disease,Drug induced liver disease)
* Active malignant disease.
* Any known pre-existing medical condition that could interfere with subject's participation or completion of study such as psychiatric condition, seizures disorder requiring medications, co existing heart diseases, lung diseases, poorly controlled diabetes, auto immune diseases, gout)
* History of interferon and/or ribavirin intolerance
Influence of Semaglutide on Pharmacokinetics and Pharmacodynamics of Warfarin and Pharmacokinetics of Metformin in Healthy Subjects

This trial is conducted in Europe and Asia. The aim of the trial is to investigate the influence of semaglutide on pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of warfarin and pharmacokinetics of metformin in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 23 and 30 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearingpotential and not using adequate contraceptive methods for the duration of the trial and for 5 weeks following the last dose of semaglutide. Adequate contraceptive measures are implants, injectables, combined oral contraceptives, hormonal intrauterine device, sexual abstinence or vasectomised partner
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
* Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal products, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2
* Smoking, drug or alcohol abuse
PEMF Effects on Pain After Abdominal Body Contouring

Body contouring surgery has a higher potential for postoperative pain and wound healing complications. The purpose of this study is to determine if pulsed electromagnetic field (PEMF) devices can reduce the pain and complications associated with this type of surgery.

Pulsed electromagnetic field (PEMF) devices have been shown to be effective treatments to decrease healing time in nonunion fractures and pressure ulcers, and to reduce pain in whiplash injuries, persistent neck pain, and chronic lower back pain. These devices have been FDA approved for treatment of pain and edema (510(k) number: K070541). More recently, PEMF devices have been shown to decrease postoperative pain and narcotic use in breast augmentation patients. This study seeks to determine if PEMF will also cause similar effects in the more complex procedures performed on body contouring patients. The specific aims of this study are:

1. Evaluate if adjunct PEMF therapy will accelerate the rate of postoperative pain reduction in abdominal body contouring patients.
2. Evaluate if adjunct PEMF therapy will decrease the postoperative use of narcotic pain relievers in abdominal body contouring patients.

PEMF devices have been shown to be effective in reduction of pain and pain medication use in breast augmentation patients. No literature has shown if PEMF is an effective adjunct to decrease pain or pain medication use in the abdominal body contouring patient. A decrease in pain would result in a better experience for patients and a reduction in pain medication may decrease complications associated with these medications. The PEMF therapy device being used in this study is a non-significant risk device because it is noninvasive and does not present a potential for serious risk to the health, safety, or welfare of a subject.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years and older and able to provide informed consent
* Eligible for and have agreed to be scheduled for elective abdominal body contouring surgery
* Willing and able to comply with all study procedures.

Exclusion Criteria:

* Inability to provide informed consent
* Patients having multiple procedures concurrently except liposuction.
* Current use of oral steroids as determined through patient history and medical record review
* Current narcotic use as determined through patient history or medical record review
* Current nerve or pain disorder.
* Recent (1 month) coronary stent or implanted medical device (e.g. pacemaker).
* Pregnancy (demonstrated by a positive result of a urine pregnancy test)
* Based upon surgeon judgement and the results of screening procedures, patient is not a suitable candidate for surgery.
Efficacy of Aerobic Exercise Added to Alprazolam in Panic Disorder Treatment

The purpose of this study is to determine whether the combination of aerobic physical exercise and alprazolam in patients with panic disorder has a better therapeutic response than the treatment with alprazolam alone.

We have observed in our clinical practice that patients who practiced aerobic physical exercise had faster remissions and better improvement in their treatments that those who did not. There are also some scientific studies that included physical exercise in the treatment for panic disorder and compared them to other single pharmacological treatments.

So our objective will be to compare the efficacy of a pharmacological monotherapy (alprazolam), that is one of the options for the pharmacological treatment of panic disorder, with other treatment such as the combination of aerobic physical exercise and alprazolam, and to determine if this combination results in a better therapeutic response.

Eligibility Criteria:
Inclusion Criteria:

* Patients with panic disorder scored between 20 and 30 by the Hamilton Anxiety Rating Scale/14. (Baseline scale scores were measured during the first interview and diagnoses were made by a psychiatrist using the Structured Clinical Interview for DSM IV).
* Good physical health and normal results determined on a previous physical examination and routine laboratory tests (renal, hepatic, hematological and thyroid function).
* Patients who completed a written informed consent form (which was obtained from every included patient and had been fully explained before the procedure).

Exclusion Criteria:

* A history of some kind of recent somatic disease.
* Diagnosis of some other type of associated or psychiatric disease of axis I of DSM IV, such as affective disorders, drug dependency.
* Hamilton Anxiety Scale lower than 20 points or higher than 30.
* Use of some other type of medication or treatment (including psychotherapy) or having received it during last past 3 months.
* Patients who could not complete the clinical examination
* Patients who have not accepted to complete or sign the written informed consent.
* Pregnant patients or in lactation. (A pregnancy test was performed for women in fertile age)
* Patients with history of rejection to the used drug.
Chronic Low Back Pain: A Multidisciplinary Approach

Introduction: Non-specific chronic low back pain (CLBP) is one of the most frequent causes for patient disability and a general recurrent cause for medical consultation with high costs to public health. From rehabilitative medicine, physiotherapy is commonly offered. Although this treatment is aimed to reduce disability, pain severity and pain-related anxiety-depressive symptoms, many patients report partial improvement and recurrent intensive and disabling pain episodes. Therefore, a new approach in the treatment and rehabilitation of this pathology that takes into account psychosocial aspects that might be modulating pain is necessary.

Material and methods: This project aims to assess the efficacy of two complementary interventions to standard physical therapy, such as relaxation techniques and cognitive-behavioral intervention, to improve health-related quality of life (HRQoL) among patients with CLBP. It is hypothesized that groups receiving these complementary interventions will significantly improve their adherence to physiotherapy and the control of their pain and, ultimately, these aspects will facilitate a decreasing of pain intensity and better HRQoL.

For these purposes, a pre-post longitudinal design will be carried out, with follow-up assessments at 6 and 12 months in a sample of 66 participants. This sample will be divided into: control group (physiotherapy), intervention group 1 (physiotherapy and relaxation techniques-sophrology) and intervention group 2 (physiotherapy and cognitive-behavioral intervention).

Expected impact: Study results are not available yet. However, if working hypotheses are confirmed, a multidisciplinary model of care for CLBP will be empirically justified. This approach is expected to benefit HRQoL among these patients implying a significant short-mid term reduction of public health costs.


Eligibility Criteria:
Inclusion Criteria:

* Non-specific chronic (\> 6 months of evolution) low back pain diagnosis
* Ability to read and speak in Spanish

Exclusion Criteria:

* Addictive behaviors (DAST-10 \> 3, alcoholism, drug addiction or other drug abuse)
* Psychiatric contraindications (BDI \> 15 or other severe psychiatric disorder not stabilized)
* Neurological impairment
* No mental competence (MEC \< 23)
* Fibromyalgia and/or chronic fatigue