cyrilzakka/clinical-trials huggingface dataset:
Central Sensitization in Patients Seeking Outpatient Physical Therapy Services

This is an observational study to examine presence of CS in patients with knee osteoarthritis (OA), chronic LBP (CLBP), and chronic neck pain (CNP) seeking outpatient physical therapy (PT) services. The study will also examine if outcomes differ between patients with CS and patients without CS symptoms with standard PT interventions.

Central Sensitization (CS), defined as augmented pain processing, is common in subgroup of nearly all chronic pain conditions, including fibromyalgia, CLBP, OA, and chronic tension headache. However, current studies of CS are primarily limited to research settings, lacking the knowledge about prevalence of CS and rehabilitation outcomes in usual clinical care.

Practicing clinicians do not routinely assess for CS symptoms. Without proper screening for CS, and lack of knowledge of varying levels of nervous system involvement contributing to pain, clinicians are unable to fully identify the depth of the mechanisms and therefore unable to fully determine the best treatment strategies. This observational study addresses this gap in knowledge by screening patients for CS symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of knee, neck, or back pain
* Chronic pain as defined pain \> 3 months
* Able to read and understand English

Exclusion Criteria:

* Pregnancy
* Pain less than 3 months
American Indian Smokefree Native RCT

The aim of this clinical trial is to test the efficacy of a culturally aligned digital smoking cessation resource for American Indian persons who smoke, via a remotely conducted randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* AI race based on self-report;
* ≥ 18 years of age via photo ID confirmation;
* Average smoked cigarettes per day, ≥ 3 in the past 30 days;
* considering or willing to make a quit attempt;
* self-report having daily access to their own iPhone/Android smartphone or tablet that allows for messaging use;
* able to read and speak English.

Exclusion Criteria:

* None
Young Melanoma Family Facebook Intervention or Healthy Lifestyle Facebook Intervention in Improving Skin Examination in Participants With Melanoma and Their Families

This trial studies how well Young Melanoma Family Facebook intervention or Healthy Lifestyle Facebook intervention works in improving skin examination in participants with melanoma and their families. Young Melanoma Family Facebook intervention or Healthy Lifestyle Facebook intervention may help improve total cutaneous examinations, skin self-examinations, and sun protection among first degree relatives of young onset participants and the participants themselves.

PRIMARY OBJECTIVES:

I. To examine the efficacy of the Young Melanoma Family Facebook intervention versus the Healthy Lifestyle Facebook intervention on total cutaneous exam (primary outcome), skin self-exam frequency and comprehensiveness, and sun protection practices (secondary outcomes) of first degree relatives (FDRs) of young melanoma survivors.

SECONDARY OBJECTIVES:

I. To examine the efficacy of the Young Melanoma Family Facebook intervention on patients? skin self-exam frequency and comprehensiveness and sun protection habits.

II. To examine the mechanisms of intervention efficacy.

OUTLINE:

PHASE I: Researchers refine content for the Facebook intervention condition and conduct usability testing.

PHASE II: Participants are randomized to 1 of 2 arms.

ARM I: Participants join a secret Young Melanoma Family Facebook Group and view post messages focusing on skin cancer for 12 weeks.

ARM II: Participants join a secret Healthy Lifestyle Facebook Group and view post messages focusing on healthy lifestyle for 12 weeks.

PHASE III: Dissemination planning.

After completion of study, participants are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Diagnosed with stage 0-3 melanoma in the last 5 years
* PATIENT: Age at diagnosis 18-39 years
* PATIENT: Completed treatment at least 3 months previously
* PATIENT: Recruited from New Jersey or California State Cancer Registry or MD Anderson Cancer Center
* PATIENT: Does not have a concurrent cancer diagnosis
* PATIENT: Able to speak and read English
* PATIENT: Access to computer, internet, and has a Facebook account
* PATIENT: At least one family member consents
* FDR: Current age 18-80 years
* FDR: Does not have a personal history of melanoma
* FDR: Able to speak and read English
* FDR: Access to computer, internet, and has a Facebook account
* FDR: Has only one FDR with melanoma (patient)
* FDR: Has not had a total cutaneous examination (TCE) in the past 3 years, has done skin self-exam (SSE) fewer than three times in the past year, OR has a sun protection habits average score less than or equal to 4 (?often?)
* FDR: Patient consents

Exclusion Criteria:

* Physical Activity Readiness Questionnaire (Thomas, et. al., 1992): This 7-item scale will be used to screen out individuals who will need to consult a physician for medical clearance before engaging in physical activity. If a participant checks off any of the items, the investigators will ask for a physician clearance before consenting to study
Glucagon Responses During Oral- and iv Glucose in Patients With Type 1 Diabetes

In order to evaluate the potential role of the gastrointestinal (GI) tract in the postprandial hyperglucagonemia, which characterizes type 1 diabetes mellitus (T1DM) (as well as type 2 diabetes mellitus (T2DM)), we wish to investigate the secretion of glucagon in patients with T1DM without residual beta-cell function during 50-g oral glucose tolerance test (OGTT) and during isoglycemic iv glucose infusion. By evaluating C-peptide negative patients with T1DM we aim to describe the glucagon response to glucose (+/-stimulation of the GI tract) independently of the potentially very important regulation of glucagon secretion by endogenous insulin secretion. A more detailed understanding of the inappropriate glucagon secretion in T1DM is highly needed in order to establish new intervention strategies in the future treatment of the growing numbers of T1DM patients.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian over 18 years with T1DM (diagnosed according to WHO's criteria) treated with long-acting insulin
* No residual beta-cell function (arginine test without increment in plasma C-peptide - see below)
* BMI \<30 kg/m2
* Normal haemoglobin
* Informed consent

Exclusion Criteria:

* Residual beta-cell function (increment in plasma C-peptide during arginine test - see below)
* Known liver disease or affected liver enzymes (ALAT/ASAT \> 2 x upper normal limit)
* Diabetic nephropathy (se-creatinin \> 130 µM and/or albuminuria)
* Proliferative diabetic retinopathy (anamnestic)
* Treatment with medication that cannot be discontinued for 14 hours
HIV- Risk Reduction Behavioral Intervention for Commercial Sex Workers in Yerevan Armenia

This pilot study will test the efficacy of a behavioral intervention in reducing HIV related risk behaviors among sex workers in Yerevan, Armenia.

The purpose of this pilot study is to evaluate the efficacy of an intervention to reduce sexual risk behaviors and enhance HIV-preventive behaviors among female sex workers (FSWs) in Yerevan, Armenia. The study design is a randomized controlled trial of 120 FSWs aged 18 and over recruited through Hope and Help NGO. Participants will complete an interviewer administered questionnaire collected at baseline, 3- and 6-month follow-up.

Subsequently, participants will be randomly assigned to either the intervention condition or a wait-list control. Those randomized to the intervention condition will receive a 2-hour one-on-one intervention session emphasizing HIV knowledge, self-efficacy, and condom use behaviors. They will also receive a 10-15 minute booster session at 3-month follow-up. The comparison condition is wait-listed, but have the choice of participating in the intervention program upon completion of the study.

The main outcome measure includes consistent condom use, defined as condom use during every episode of vaginal intercourse with clients. Other outcome measures are condom application by FSW and HIV- preventive behaviors such as condom use self-efficacy, knowledge of HIV transmission dynamics,perceived barriers to condom use and condom use errors.

Results from this pilot study are expected to inform a larger trial to be implemented with FSWs in Armenia, in an effort to devise gender and culturally relevant intervention programs to prevent HIV transmission in this vulnerable population.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* traded sex for money in the past 7 days
* cognitive ability to participate in assessment and intervention

Exclusion Criteria:

* younger than 18 years of age
* did not trade sex for money in the past 7 days
* cognitively unable to participate in assessment and intervention
Evaluation of Ocular Surface Inflammatory Mediators Effected by Lotemax

The purpose of this study is to evaluate the effects of an anti-inflammatory drug (Lotemax®) on the surface of the eye and tear film (a film that coats the eye which is made up of oil and water).


Eligibility Criteria:
INCLUSION CRITERIA:

* Age 50-70
* Diagnosed with Sjogren's Disease
* Good general health (defined by medication use that has not changed within the last 2 months and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
* Ability to give informed consent
* Willing to spend time for the study; approximately one hour for a screening visit and between 60-90 minutes for each of the measurement visits
* Either gender
* Any racial or ethnic origin

EXCLUSION CRITERIA:

* Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
* Current acute eye disease that affects the surface of the eye such as, but not limited to blepharitis, ocular allergy, and infection.
* Subjects who have had cataract surgery less than one year ago
* Use of soft or hard contact lenses.
* Female subjects may not be pregnant or lactating (subjects will be asked to self-report these conditions).
* Inability to provide analyzable data
The Clinical Comparison of Narafilcon A and Stenfilcon A Contact Lenses

This study aims to compare the clinical performance and subjective acceptance of the narafilcon A lens with the stenfilcon A lens when used on a daily wear, daily disposable basis.

This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross comparison. Seventy subjects will use each lens type for a week in a random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. They are of legal age (18) and capacity to volunteer.
  2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  3. They are willing and able to follow the protocol.
  4. They agree not to participate in other clinical research for the duration of this study.
  5. They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
  6. They have a spectacle cylindrical correction of -0.75D or less in each eye.
  7. They can be satisfactorily fitted with the study lens types.
  8. At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
  9. They currently use soft contact lenses or have done so in the previous six months.
  10. They are willing to comply with the wear schedule (at least six days per week and for at least eight hours per day).
  11. They own a wearable pair of spectacles.

Exclusion Criteria:

* Subjects will not be eligible to take part in the study if:

  1. They have an ocular disorder which would normally contra-indicate contact lens wear.
  2. They have a systemic disorder which would normally contra-indicate contact lens wear.
  3. They are using any topical medication such as eye drops or ointment.
  4. They have had cataract surgery.
  5. They have had corneal refractive surgery.
  6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  7. They are pregnant or breast-feeding.
  8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  9. They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  10. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
  11. They currently wear either the stenfilcon A lens or narafilcon A lens.
The Allurion Digital Behaviour Change Intervention

The proposed study is a prospective, non-randomized, pilot study to test the impact of the Allurion Digital Behaviour Change Intervention (DBCI) in participants who have been treated with the Allurion™ Gastric Balloon System. The study will include a nested qualitative and quantitative evaluations of the intervention from both the participant and Allurion provider perspective.

The study consists of the following:

* Screening and enrolment period (prior to or day of Allurion Gastric Balloon System treatment)
* All participants will take part in the Allurion DBCI for 6 months following study enrolment
* All participants will complete a 6-month follow-up assessment after completion of the Allurion DBCI

Eligibility Criteria:
Inclusion Criteria:

* Allurion Gastric Balloon System placement in accordance with the approved Indications for Use
* Age 18 to 65 years of age
* BMI ≥ 27
* Weight \< 180 kg
* Owns an Android or Apple smart phone
* Willing to download the Allurion App
* Willing to wear the Allurion Health Tracker Watch for the duration of the study
* Willing to use the Allurion Scale
* Proficient in reading the English language

Exclusion Criteria:

- Any condition contraindicated for the Allurion Gastric Balloon System as specified in the Instructions for Use
Study of Maggot Therapy in Diabetic Foot Ulcers

This study was a Kind of clinical trial with equal randomization, that have been done from January 2009 to June 2011 in the AFZALIPOOR hospital endocrine ward in Kerman-Iran on 128 diabetic patient who had foot wounds.Replacement of conventional therapy by new methodes is one of the more important aims for health professional specially for nurses.One of this new treatment is maggot therapy.


Eligibility Criteria:
Inclusion Criteria:

* Have a chronic illness more than 7 weeks.
* The age of the patients between 40- 90 years old.
* Not having capillary disease (Blockage of artery, Rinold).
* Not user of anticoagulants and corticosteroids drugs.
* Patients without history of allergy to drugs and foods.
* Having diabetic type 2

Exclusion Criteria:

* patients who refer to critical clinical care unit
* patients who have amputation
Treating Intention In Aphasia: Neuroplastic Substrates

The purpose of this study is to determine if an "intentional act" improves treatment response for patients with nonfluent aphasia. The treatment involves naming pictures and saying members of categories. The "intentional act" requires initiating picture naming or category member trials with a left-hand movement sequence. Nonfluent aphasia is a disorder of language production in which patients with damage to the brain's language system have trouble initiating and maintaining spoken communication. All patients participating in the study take part in functional MRI scans to determine how treatments affect brain systems.

A new treatment manipulating intention substrates for language production in "nonfluent" aphasia patients was developed. The intention component involves initiating word-finding trials with a complex left-hand movement. The study addresses (1) whether or not the intention manipulation (complex left-hand movement) makes a unique contribution to treatment outcome and (2) whether or not the intention manipulation helps to shift word production mechanisms from the left to the right frontal lobe. All study participants take part in functional magnetic resonance imaging (fMRI) scans of word-finding before and after treatment and at 3-month follow-up to measure changes in lateralization of frontal lobe activity during word finding. Only patients with a substantial degree of left frontal activity on the pre-treatment fMRI scan can participate. There are three specific aims: (1) to determine if repetitive initiation of word production with a complex left-hand movement leads to increased right-hemisphere lateralization of frontal activity and if these changes can be attributed to the intention component of treatment, (2) to determine whether activity in posterior perisylvian cortices that is entrained to right frontal activity shows a greater increase in right-hemisphere lateralization from pre- to post-treatment fMRI when the intention component is included in treatment, and (3) to determine whether onset of hemodynamic responses (HDRs) in right motor/premotor cortex becomes more closely associated with the temporal onset of participants' spoken responses across treatment when the intention component is included in treatment. If successful, the treatment can provide a new treatment vehicle for increasing language function in patients with "nonfluent" aphasia.

Eligibility Criteria:
Inclusion Criteria:

* Nonfluent aphasia caused by stroke
* Moderate to severe word-finding problems
* 6 or more months post stroke
* Right handed prior to stroke
* All strokes in left hemisphere
* Native English speaker
* Capable of following verbal directions

Exclusion Criteria:

* Severe impairment of word comprehension
* Brain injury or disease in addition to stroke
* Drug or alcohol abuse within past 6 months
* Schizophrenia or other psychiatric disorder necessitating hospitalization
* History of learning disability
* Claustrophobia
* Cardiac pace-maker
* Ferrous metal implants not attached to bone, metal fragments in body
* Profound hearing loss
Safety Study of Sorafenib Following Combined Therapy of Radiation and TACE for Liver Cancer

Patients with liver cancer will receive interventional therapy plus radiotherapy. Maintenance Sorafenib will be taken after the completion of radiotherapy. Hypothesis of the current study is that Sorafenib as a maintenance therapy is safe and superior to radiotherapy combined with interventional therapy in terms of survival in comparison to historical data.

Patients with solitary lesion (bigger than 5 cm in diameter) histologically or cytologically confirmed HCC receive TACE (1-3 cycles) plus 3DCRT/IMRT 4-6 weeks later. Maintenance Sorafenib will be administered only for the patients with non-progression disease 4 to 6 weeks after the completion of radiotherapy. The dose will be 400 mg, p.o., twice a day. Sorafenib will be continuously given for 12 months unless intolerable toxicities and/or tumor progression. Hypothesis of the current study is that Sorafenib as a maintenance therapy after combined therapy of 3DCRT/IMRT and TACE is safe and superior to radiotherapy combined with TACE alone in terms of time to progression (TTP), progression-free survival (PFS) and overall survival (OS) in comparison to historical data.

Eligibility Criteria:
Inclusion Criteria:

1. Age of equal or older than 18 years and not over 75 years with a life expectancy of at least 12 weeks;
2. Karnofsky performance status (KPS) of ≥70;
3. Histologically or cytologically confirmed HCC;
4. BCLC stage B, solitary lesion (bigger than 5 cm in diameter) with tumor burden less than 50% of total liver volume;
5. Liver function of Child-Pugh A;
6. Technically unresectable, medically inoperable, or surgery declined by the patient;
7. Normal renal function and adequate bone marrow reservation;
8. Signed informed consent must be obtained prior to any study specific procedure.

Exclusion Criteria:

1. Presence of intrahepatic and/or extrahepatic metastases
2. Previous received systemic therapy for liver cancer;
3. History of radiotherapy to the liver;
4. Indistinct tumor boundary on CT/MRI images;
5. Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix or superficial bladder tumors \[Ta, Tis and T1\];
6. History of cardiac disease: congestive heart failure \> NYHA class 2, active CAD, cardiac arrythmias requiring anti-arrhythmic therapy or uncontrolled hypertension within the last 12 months;
7. Concurrent uncontrolled medical conditions;
8. Pregnancy or breast feeding;
9. Investigational drug therapy outside of this trial during or within 4 weeks of study entry;
10. Psychiatric or medical unstable conditions that compromise the patient's ability to give informed consent.
A Study in Healthy Men to Test How Well Different Doses of BI 1569912 Are Tolerated

The main objectives of this trial are to investigate (1) safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising doses of BI 1569912; (2) tolerability of BI 1569912 in an up-titrating dosing scheme.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* MRD- and POSO-part: Age of 18 to 45 years (inclusive); ELDERLY-part: Age of 65 to 80 years (inclusive)
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

  * Use of adequate contraception, e.g. any of the following methods (of female partners) plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device
  * Sexually abstinent
  * Surgically sterilised (including hysterectomy of female partner)
  * Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion Criteria:

* Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetres of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm)
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) after repeated measurements
* Any evidence of a concomitant disease assessed as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures/ convulsions or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or unexplained blackouts