cyrilzakka/clinical-trials huggingface dataset:
Comparative Efficacy of BRT and CBT-I for Insomnia

This study evaluates two behavioral treatments for patients with insomnia disorder: Bedtime Restriction Therapy (BRT) and Cognitive Behavioral Therapy for Insomnia (CBT-I). Both therapies aim to improve the clinical symptomatology of insomnia by teaching participants techniques to better manage their sleep schedule and habits. BRT is a simpler and shorter therapy focused on aligning the time spent in bed with reported sleep time. CBT-I includes additional components such as relaxation techniques and cognitive exercises. The study will compare these treatments to see if BRT is as effective as CBT-I in improving the clinical symptomatology of insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Must meet DSM-5 criteria for insomnia disorder.
* Adults aged 18 to 80 years
* Capable of giving written informed consent.
* Sufficient fluency in the study site's language (i.e., German or French) to understand all study-related information.

Exclusion Criteria:

* Unstable, progressive, or degenerative medical condition
* Acute pain or poorly managed chronic pain
* Suicidality
* Uncontrolled psychiatric condition requiring treatment outside of study
* Alcohol or drug abuse or dependency
* Diagnosis of psychosis, bipolar disorder, autism, borderline personality disorder, or antisocial personality disorder
* Clinical evidence of sleep disorders other than insomnia (e.g., sleep apnea, restless legs, periodic limb movements in sleep, parasomnia)
* Evidence of intellectual disability
* Regular intake of benzodiazepines (BZD) or benzodiazepine receptor agonists (BZDRA)
* Alteration of medication within 4 weeks prior to study treatment or planned alteration during the trial period (stable medication except BZD or BZDRA does not lead to exclusion)
* Current other psychotherapy for insomnia
* Known pregnancy or breastfeeding
* Inability to comply with study procedure
* Insufficient fluency in German or French to complete the study
Dose Confirmation Trial of AAV5-hFIXco-Padua

This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase.

The IMP AMT-061 is a recombinant adeno-associated viral vector of serotype 5 (AAV5) containing the Padua variant of a codon-optimized human FIX complementary deoxyribonucleic acid (cDNA) under the control of a liver-specific promoter. The IMP is identified as AAV5-hFIXco-Padua (AMT- 061). The pharmaceutical form of AMT-061 is a solution for intravenous infusion.

The administered dose of AMT-061 will be 2 x 10\^13 gc/kg.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. Age ≥18 years
3. Subjects with congenital hemophilia B classified as severe or moderately severe
4. \>20 previous exposure days of treatment with FIX protein

Exclusion Criteria:

1. History of FIX inhibitors
2. Positive FIX inhibitor test at screening
3. Select screening laboratory values \> 2 times upper normal limit:
4. Positive human immunodeficiency virus (HIV) at screening, not controlled with anti-viral therapy
5. Active infection with Hepatitis B or C virus at screening
6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy
A Study of Vascular Endothelial Growth Factor (VEGF) Inhibition in Patients With Unilateral Upper Extremity Lymphedema Following Treatment for Cancer

The major purpose of this study is to determine if a new drug called pazopanib decreases lymphedema in subjects previously treated for cancer. Lymphedema, or swelling of the arm, is a result of damage to the lymphatic vessels in the arm during surgery and/or radiation. The damaged vessels can not adequately drain fluid from the arm, resulting in increased pressure and swelling. Pazopanib has not previously been studied as a treatment for lymphedema.

Pazopanib inhibits the growth of blood vessels in tumors by inhibiting a protein called vascular endothelial growth factor (commonly called VEGF). Pazopanib is not currently approved by the US Food and Drug Administration (FDA) and therefore considered an experimental medication.

High levels of VEGF cause blood vessels to leak fluid, increasing the pressure in tumors similar to the increased pressure in lymphedema. Previous studies have found that treatment with pazopanib decreases the fluid pressure in tumors. That is why we think pazopanib might be an effective treatment for lymphedema.

Eligibility Criteria:
Inclusion Criteria:

* Have unilateral lymphedema of the ipsilateral arm attributed to prior surgical treatment or radiation therapy for cancer that is severe enough to warrant therapy in the opinion of the patient and treating physician.
* All patients must have greater than a 3 cm total difference in arm circumference between the affected and unaffected arm measured at five defined points (see protocol).
* Be at least 18 years of age
* Have adequate organ function as specified in the protocol.
* Agree to use effective contraceptive methods during the course of the study if the patient has child-producing potential
* Have an ECOG performance status of 0 or 1

Exclusion Criteria:

* Pregnant, lactating, or unwilling to use appropriate birth control
* Active infection
* Patients may not have clinically significant cardiovascular disease including myocardial infarction within 6 months prior to initiation of therapy, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, grade II or greater peripheral vascular disease, uncontrolled hypertension defined as SBP\>160 or DBP\>90. Patients may not have any prior history of cerebrovascular disease including TIA or stroke.
* Locally recurrent or metastatic disease
* Concurrent therapeutic anticoagulation or any history of DVT or PE.
* Major surgery within 4 weeks of starting protocol therapy (non-operative biopsy or placement of a vascular access device is not considered major surgery)
* Radiation therapy or chemotherapy within the past 6 weeks or currently undergoing radiation therapy or chemotherapy (Concurrent adjuvant hormonal therapy is allowed.)
* Altered the physical therapy regimen within the past month
* Indwelling venous device in the ipsilateral arm
* Bilateral lymphedema
* Concomitant requirement for medication classified as substrates for the CYP450 enzymes and listed as prohibited in the protocol.
Participation Restrictions in Breast Cancer Survivors

This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibilities and recreational interests and are at increased risk of developing long-term difficulties performing these valued activities (participation restrictions). Rural cancer survivors are medically underserved and due to distance and geographic isolation face significant barriers to accessing traditional rehabilitation services. Alternative rehabilitation approaches are sorely needed for this population. Based on previous research with cancer and other medical populations a working draft of a treatment manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized clinical trial, additional work must be completed. The specific aims of this study are to a. refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of BA/PS effects based on our "Self Regulation" model of functional recovery. 188 young-middle adult breast cancer survivors will be screened for participation restrictions following cancer treatment and 40 survivors with participation restrictions will receive BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness and interviewed regarding their experiences during treatment to provide information for refining the manual. The long-term objective of this line of research is to develop effective and feasible treatments for the medical and psychosocial consequences of cancer and its treatment in medically underserved cancer survivors (e.g., rural populations).


Eligibility Criteria:
Inclusion Criteria:

1. Female breast cancer patient stages I-III.
2. Age 18-59.
3. Completion of definitive breast cancer treatment (i.e., subsequent to loco-regional surgical treatment and completion of adjuvant or neo-adjuvant chemotherapy with or without radiation) within the past 3-6 months.
4. Screen positive for a moderate or worse level of participation restriction (Work and Social Adjustment Scale score \> 10) within 6 months following cancer treatment.
5. English speaking.
6. Have a land-based phone or reliable cell phone reception.

Exclusion Criteria:

1. Non-correctable hearing loss.
2. Moderate-severe cognitive impairment indicated by a score \< 3 on a 6-item cognitive screener.
3. Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder) or active substance abuse.
4. Medical record documentation of a physical disorder with associated functional impairment (e.g., Parkinson's disease, stroke, congestive heart failure, etc.).
Role of Parents Concerning Information of Adolescents About Contraception

Adolescence is a period of intensive physical and psychological changes, with notably the start of sexuality. During this period of sexual discovery, a lack or a misuse of contraception may be responsible for unwanted pregnancy.

So, sexual education and information about contraception are crucial. Teenagers often consult Internet or discuss with friends to have information but they can be not true or precise. They can also consult health professionals, however shyness and fear can hold them back. Information about contraception may also be given by their parents. The physical closeness and the trust that adolescents have in their parents can promote dialogue.

the aim of the study is to describe information about contraception given by parents to adolescents

Eligibility Criteria:
Inclusion Criteria:

* Parents (father or mother) of adolescents (boy or girl) aged 12 to 18
* agreeing to participate to the study

Exclusion Criteria:

-
A Study Using Radiation Therapy and Temozolomide to Treat Glioblastoma in Patients Over 70

In this study we propose to determine outcomes of patients age 70 or older treated with radiation over 2 weeks given with temozolomide 75 mg/m2 daily during radiotherapy and as a post radiation treatment of 150 mg/m2 - 200 mg /m2 for 6 cycles or until the disease progresses.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have histologically confirmed glioblastoma/gliosarcoma.
2. Tumor o6-methylguanine-DNA-methyltransferase promoter methylation status must be determined
3. Participants must not have had any prior therapy for glioblastoma multiforme including radiation or chemotherapy.
4. Participants must be \> 70 years of age.
5. Participants must have life expectancy greater than 6 months.
6. Karnofsky performance status \> 60 (ECOG \< 2).
7. Patients must have normal organ and marrow function

   * Leukocytes \> 3,000/microliter
   * Absolute neutrophil count \> 1,500/microliter
   * Platelets \> 100,000/microliter
   * Total bilirubin within normal institutional limits 12
   * aspartate aminotransferase test(SGOT)/alanine aminotransferase test(SGPT) \< 2.5 X institutional upper limit of normal
   * Creatinine within normal institutional limits or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal
8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Participants may not be receiving any other study agents.
2. Participants may not have had chemotherapy wafer placement at surgery.
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to temozolomide.
4. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
5. Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
6. HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with temozolomide. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
COVID-19 Wellness Survey

This study will collect data on physical activity, food consumption, stress, sleep, and alcohol consumption habits both before and after the national emergency for COVID-19 was put into place. This will help identify the health behavior changes taking place due to the COVID-19 pandemic in the United States. Data on past and current health behaviors will be self-reported by participants via a single online survey. The retrospective health behavior questions will be the same quantitative questions as the current health behavior questions so a direct comparison can be made. There will be a couple qualitative questions to assess what each participant feels are the greatest barriers or impacts to their current health behaviors. Participants will be recruited via convenient sampling.

Data collected in this study will show a decline in at least one healthy behavior after the United States national emergency for COVID-19.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Under the age of 18 and anyone who does not currently reside in the United States
A Study of Lasmiditan and Propranolol in Healthy Participants

This study will assess the effects on heart rate and blood pressure when a single dose of lasmiditan is administered with a daily dose of propranolol. This study will also measure how much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it together with propranolol. The study will also look at how well both drugs are tolerated. Information about any side effects that may occur will be collected.

This study will last approximately 45 days including screening. This study will require 13 days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment approximately 7 days after the last dose. Screening is required within 28 days prior to the start of the study.

This study is for research purposes only and is not intended to treat any medical condition.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females, as determined by medical history and physical examination
* Have a body mass index (BMI) of 19 to 35 kilograms per meter squared (kg/m²) inclusive, at the time of screening

Exclusion Criteria:

* Have known allergies to lasmiditan, propranolol, related compounds or any components of the formulation of lasmiditan or propranolol
* Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias, sick sinus syndrome/sinoatrial block, or second or third-degree heart block, or have any other abnormality in the 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have an abnormal supine blood pressure, defined as systolic blood pressure less than (\<) 95 or greater than (\>) 140 millimeters of mercury (mmHg) or diastolic blood pressure \<65 or \>90 mmHg at screening
* Have a supine pulse rate of \<50 or \>90 beats per minute (bpm) at screening
* Have an estimated glomerular filtration rate (eGFR) of \<60 milliliter per minute (mL/min) per 1.73 meter squared (m2)
* Show evidence of significant active neuropsychiatric disease (for example, manic depressive illness, schizophrenia, depression)
* Show a history of central nervous system (CNS) conditions such as strokes, transient ischaemic attacks, significant head trauma, CNS infections, migraines, brain surgery or any other neurological conditions that, in the opinion of the investigator, increases the risk of participating in the study
* Are women with a positive pregnancy test or women who are lactating
Increasing Condom Use in People at Risk for HIV Infection

This study will evaluate a new program designed to increase condom use in both women and men.

As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.

Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.

Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

Eligibility Criteria:
Inclusion Criteria

* HIV uninfected
* Sexually active
* At risk for HIV (as determined by study officials)
* Speaks English
* Seen at a participating clinic

Exclusion Criteria

* Pregnant
Treatment With Nutritional Eating Plan and Dietary Fibers in Adult Patients With HIV/AIDS

To evaluate if nutritional treatment with nutritional supplementation of dietary fiber reduces cholesterol levels and triglycerides (dyslipidemia) in patients with HIV/AIDS receiving antiretroviral therapy (HAART).


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected patients
* Adults (≥ 19 years old)
* On highly active antiretroviral therapy (HAART)

Exclusion Criteria:

* Pregnancy
* Breastfeeding
* Opportunistic disease
Duloxetine for the Treatment of Generalized Anxiety Disorder

This is a 15 week study comparing how well duloxetine and placebo treatments improve generalized anxiety disorder


Eligibility Criteria:
Inclusion Criteria:

* Psychiatric Diagnosis of generalized anxiety disorder (GAD)
* Outpatients
* Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis for GAD
* Clinical Global Impression (CGI) of Severity Score of at least moderate
* Sheehan Disability Scale (SDS) Global Functioning Impairment Score \>= 12

Exclusion Criteria:

* Pregnancy or breast feeding
* Serious medical illness
* Other primary psychiatric diagnoses, such as major depressive disorder or substance abuse disorder within the past 6 months
* panic disorder, post-traumatic stress disorder (PTSD), or eating disorder in the last year
* lifetime history of bipolar or psychosis
* Any unstable serious medical condition for which duloxetine would not be allowed
* Any use of medications that are not allowed
Combined Treatment of Manual Therapy and Therapeutic Exercise in Patients With Low Back Pain

MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.

SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.

HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.

METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.

The patients will be randomized and divided into two groups A (control) and B (experimental).

Group A will undergo an exercise protocol.

Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.

Eligibility Criteria:
Inclusion Criteria:

* Legal age
* Non-specific Low-Back pain
* Pain more 3 months

Exclusion Criteria:

* subjects with lumbar herniation.
* Spine canal stenosis
* Subjects with neurological disease.
* Lumbar surgery
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.

Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).


Eligibility Criteria:
Inclusion criteria:

1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.
2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.
3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment.

Exclusion criteria:

1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment
2. Treatment with other investigational drugs or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study.
3. Patients unable to comply with the 1199.26 protocol.
4. Pregnancy or breast feeding.
5. Active alcohol or drug abuse.
6. Women of child bearing potential, or men who are able to father a child, unwilling to use a medically acceptable form of contraception during the study period.