cyrilzakka/clinical-trials huggingface dataset:
Effect of Low vs Moderate-intensity Endurance Exercise on Physical Functioning Among Breast Cancer Survivors

The purpose of this study is to evaluate the effect of two exercise programs: 1) one program will be at low intensity; 2) the other program will be at moderate intensity. One hundred forty two women who are breast cancer survivors will be recruited. Participants will be educated on a home exercise program to be performed at either low or moderate intensity, according to group assignment. Evaluations to participants will consist of function and quality of life.

Improvements in early diagnosis and treatment for breast cancer in women have resulted in increased survivorship. An unintended consequence of increased survival, however, is that more women are living with the negative sequelae associated with cancer treatment, including decreased physical function. Exercise has been beneficial in arresting these sequelae, but adherence to exercise guidelines continues to be a challenge. As most breast cancer survivors are middle-aged and older, an alternative to enhance exercise engagement and adherence might be providing a low intensity exercise program. The overall purpose of this study is to assess the impact of a low intensity versus moderate intensity endurance exercise program on physical functioning on breast cancer survivors. It is hypothesized that participants of the low intensity exercise program will demonstrate similar physical functioning as participants in the moderate intensity exercise program. The Theory of Planned Behavior will serve as framework for the intervention. A convenience sample of 142 women, residents of Puerto Rico, age 50 or older, with a diagnosis of breast cancer, stage 0 thru III, who have received surgical treatment for breast cancer, with or without adjuvant therapy, will be randomly assigned to a low intensity or moderate intensity endurance intervention. Both interventions will be home-based, have a duration of 6 months, and be provided by physical therapists. An evaluator blinded to group assignment will assess participants at baseline and at completion of the intervention. Primary outcome measures will consist of physical functioning, and health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Fifty years of age or older
2. Be a resident of the San Juan metropolitan area of Puerto Rico (PR)
3. Diagnosed with breast cancer
4. Be classified in breast cancer stage grouping 0 to III according to the American Joint Committee on Cancer Classification of Malignant Tumors (TNM) Staging System (2013)
5. Have completed adjuvant curative therapy at least two months to 5 years prior to recruitment

Exclusion Criteria:

1. Women who have contraindications to exercise, such as extreme fatigue or anemia, unstable cardiac disease; uncontrolled diabetes; uncontrolled hypertension; coagulopathies; inability to ambulate independently
2. Women with metastasis or secondary cancers
3. Women who already meet the national standard for exercise (≥ 150 minutes per week of moderate exercise).
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003

The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136 (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.

This is a multicenter, long-term study of sirukumab (CNTO 136) that will be conducted in two groups of participants at the same time (parallel-group study). The maximum duration of participation in this study is 208 weeks, followed by approximately 16 weeks of safety and efficacy follow-up after the administration of the final study agent injection of sirukumab. Participant safety will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003
* Signed an informed consent form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
* Signed an informed consent form (ICF) for pharmacogenetics research (how a person's genes may affect a drug's effects) in order to participate in the optional pharmacogenetics component of this study. Refusal to give consent for this component does not exclude a participant from participation in this clinical study

Exclusion Criteria:

* Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or CNTO136ARA3003
* Is pregnant
* Has active diverticulitis
* Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (eg, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
rTMS and Functional Paralysis

Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy, physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always satisfactory with persistent symptoms after long-term follow-up. In a preliminary retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ± 16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an immediate or quasi-immediate recovery in 73% of patients (n=51).

We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to the restoration of an appropriate cerebral connectivity by activating a suppressed motor cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.

A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized examination), 2- the number and gravity of side effects.

If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be considered a useful early therapeutic option.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 14 years old
* Psychogenic paralysis according to the DSM-IV-R

Exclusion Criteria:

* Contra-indication of rTMS
* Pregnancy or breast-feeding
* Previous history of epilepsia
* Previous session of rTMS (for any indication)
Evaluation of the Satisfaction of Patients Coming "on Foot" in the Operating Room

Ambulatory surgery is currently experiencing unprecedented growth and is becoming the standard of care compared to traditional hospitalization. Without mentioning the obvious financial gains, the benefits of ambulatory care essentially lie in optimised perioperative comfort. This comfort is due to a limited period of stay (\< 12 hours) and to the proactive action of the care providers.

In this context, the optimization of the whole patient's journey during the perioperative period has been reviewed and adapted to personalized management within healthcare facilities. For more than a year now, multimodal approaches such as early rehabilitation have been undertaken, including

* morning admission with an innovative principle of "3D" patient (standing, dignified, relaxed)
* no premedication, wearing glasses and wigs,
* Drinking on the morning of the intervention (2H before admission),
* Walking to the block on foot (or in a wheelchair), return adapted to the wheelchair and no longer in a stretcher,
* fast resumption of feeding.

Currently, in the investigator's various institutions, several modes of transport to the operating theatres coexist. The purpose of this observational study is to evaluate this optimization of perioperative management "3D mode", in particular the mode of transport.

The main objective is to determine the level of patient satisfaction with this management using a standardized quality questionnaire: the "EVAN" questionnaire. This questionnaire contains 22 items allowing a global analysis of patient satisfaction. This questionnaire is already routinely conducted in many institutions. The EVAN questionnaire will be supplemented by questionnaires assessing the level of perioperative anxiety. They will be initiated into the anesthesia consultation, and finalized on the day of the surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 yars
* Consent to participate

Exclusion Criteria:

* Emergency surgery
* ASA \>4
* Difficulties in French reading, incapacity to complete questionnaire
* patient in a wheelchair or stretcher or having difficulty walking alone
QP ExCELs: MultiPole Pacing (MPP) Sub-Study

The objective of this MultiPole Pacing (MPP) sub-study of the QP ExCELs study is to demonstrate that the MPP feature is effective by converting a percentage of cardiac resynchronization therapy (CRT) non-responders to responders. The MPP sub-study is a single-arm, multi-center, prospective trial within the ongoing QP ExCELs study (NCT02290028).


Eligibility Criteria:
Inclusion Criteria:

* Currently enrolled in the ongoing QP ExCELs study
* Successfully implanted with a BIOTRONIK Ilivia 7 HF-T QP family CRT-D system, or future-marketed CRT-D system with the MPP feature. Successful implantation is defined as having at least two LV pacing vectors with a measured pacing threshold of ≤ 5.0 V @ any pulse width (allowing for a minimum 2.5 V safety margin) without phrenic nerve stimulation at the final programmed pacing output at the time of enrollment into the MPP sub-study.
* CRT Responder Assessment classification as "Worsened" or "Unchanged"
* Standard continuous biventricular (BiV) pacing from implant until the 6-Month QP ExCELs follow-up visit. (Implant to 3-Month QP ExCELs follow-up who qualify due to a Heart Failure (HF) hospitalization event)
* Able to understand the nature of the sub-study and give informed consent
* Available for an additional follow-up visit specific to the MPP sub-study at the investigational site
* No evidence of non-compliance to their ongoing commitment in the QP ExCELs study

Exclusion Criteria:

* Have a life expectancy of less than 6 months
* Expected to receive heart transplantation or ventricular assist device within 6 months
* Chronic atrial fibrillation
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Received MPP pacing prior to enrolment into the MPP sub-study
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis

This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients with angina or evidence of myocardial ischaemia
* Patients with restenotic lesions in a previously DES area of a coronary artery
* Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
* The stent diameter of DES-ISR is 2.5mm to 4.0mm
* Target lesion length \< 30mm
* Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic

Exclusion Criteria:

* Patients with acute myocardial infarction with 1 week
* Patients with evidence of extensive thrombosis in the target vessel
* Patients with left main coronary artery disease
* Patients with cardiogenic shock, left ventricular ejection fraction \< 40%,significant renal dysfunction and severe heart valve disease
* Patients who had cerebral stroke within 6 months before PCI
* Patients with a life expectancy \< 1 year
* Patients not able to adhere to follow-up visits
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation (FMT) for Gastrointestinal Dysfunction in Children Following Hematopoietic Cell Transplant (HCT).

The study participant is being asked to take part in this clinical trial, a type of research study, because the participant has Gastrointestinal (GI) symptoms following a Hematopoietic Cell Transplant (HCT).

Primary Objective

* To determine the safety and feasibility of FMT for treating a GvHD of the gut following HCT.
* To determine the safety and feasibility of FMT for treating HCT induced gut dysfunction.

Secondary Objectives

* To assess the potential efficacy of FMT for treating a GvHD of the gut following HCT.
* To assess the potential efficacy of FMT for treating HCT induced gut dysfunction.

Participants will be eligible to receive an FMT on or after Day +30 post-HCT. FMT will be performed using FMP material obtained from OpenBiome. 60 mL of FMP will be administered via NJ tube and 250 mL via colonoscopy. A second FMT may be performed at least 14 days after the initial FMT in GI clinical symptoms have partially improved or have not changed. The second FMT will be administered using the same procedure as in the initial FMT

Eligibility Criteria:
Inclusion Criteria:

* Age \< 22 years old.
* Received an allogeneic HCT greater than or equal to 30 days prior to enrollment
* Diagnosed with one of the following conditions:

  1. Steroid-resistant gut a GvHD (defined as GI symptoms that do not improve within 5 days after initial steroid therapy, \>/= 1mg/kg of prednisolone) OR
  2. Steroid-dependent gut a GvHD (defined as the presence of a response to methylprednisolone 2 mg/kg/day but relapsing when an attempt was made to taper steroid treatment).

     OR
  3. Current or prolonged GI dysfunction following HCT, defined as having diarrhea or loose stools \>/= 4 weeks with at least one of the following:

     1. Requiring NG or G-tube feeds
     2. Requiring TPN or IVF for more than 4 weeks
     3. Diagnosis of gastroparesis by GI specialist documented in the medical record
* Willing and able to provide informed assent/consent

Exclusion Criteria:

* Cytomegalovirus (CMV) or Epstein Barr Virus (EBV) IgG negative at the time of consent
* Female participant who is pregnant or nursing
* History of previous FMT
* Intra-abdominal surgery within 4 weeks of enrollment
* At increased risk for peritonitis: presence of intra-abdominal devices (G-or GJ-tubes are acceptable), receiving peritoneal dialysis, or ascites
* Concurrent abdominal radiation therapy
* Any acute or chronic illness/condition as well as medication that in the opinion of the investigator puts the subject at greater risk from FMT or may confound the study results.
RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections

Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections

Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be used for standard clinical analysis of bacterial species present or stored for later RNA sequencing. RNA sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the NSTI site. Medical charts will also be reviewed for basic patient information as well as wound care management practices. We hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to NSTI's.


Eligibility Criteria:
Inclusion Criteria:

* Patient or LAR agrees to the procedure and signs informed consent form
* Patient is at least 18 yrs of age
* Patient has been diagnosed with an NSTI

Exclusion Criteria:

* Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis
CSTOP Now! Child Sex Trafficking Stops with You

Focus: Intervention \& prevention of child commercial sexual exploitation or trafficking (CST) In Kentucky, familial SU/D increases risk of CST.

Primary goal: Implement and evaluate effectiveness of multi-level bystander-informed program (CSTOP Now!) aimed at Kentucky public middle schools for staff.

Randomization will occur at the Kentucky county level among 50 counties with at least 2 middle schools for a middle school-based cluster RCT set in 50 of Kentucky's 120 counties. Middle schools in half (n=25) of the 50 Kentucky counties will be randomized to the intervention condition, while middle schools in the remaining 25 Kentucky counties will be randomly assigned to the attention control. We have selected counties that are similar in population size, demographics (% white, % \<18 years of age, and % living in poverty, using 2019 Census estimates). Within each county, all middle schools (\>200 across 50 counties) will be invited to participate in this RCT.

Participating staff will be emailed a link that will take them to a description of the study. Participation will involve receipt of online training, as randomized at the county level, and completing surveys immediately before receipt of the first training and at the end of each of school terms annually.

Aim 1. Evaluate the effectiveness of child sex trafficking (CST) prevention training implemented among middle school staff randomized, at the Kentucky county level, to change middle school staff:

1. Knowledge of child sexual exploitation and trafficking (hypothesize greater knowledge in Intervention versus Control),
2. Attitudes towards child sexual exploitation and trafficking (hypothesize lower stigma in Intervention versus Control),
3. Willingness and efficacy to intervene (hypothesize greater efficacy in Intervention versus Control),
4. Use of 'bystander' actions to thwart child sexual exploitation and trafficking risk (hypothesize increase actions in Intervention versus Control),
5. Use child sex trafficking screening, referral and reporting (hypothesize increase actions in Intervention versus Control),

Aim 2. Evaluate effectiveness of child sex trafficking mass media intervention (Intervention versus Control), randomized and measured at the Kentucky county-level, based on middle school staff survey data:

1. To increase child sexual exploitation and trafficking screening \& reporting in short term (Years 1-2),
2. Begin to reduce child sexual exploitation and trafficking rates in longer term (Year 3-4) Analyses for both aims will be adjusted for school and county-level attributes

Eligibility Criteria:
Inclusion Criteria:

* Kentucky middle school staff in a public school
* Kentucky middle school staff in the intervention or attention control schools/counties.

Exclusion Criteria:

* Kentucky middle school staff not in intervention or attention control schools/counties.
Single Dose Amikacin for Uncomplicated Cystitis in the ED: A Feasibility Study

The purpose of this study is to determine if a single dose of amikacin (a type of antibiotic) can be used to effectively treat emergency department patients with uncomplicated cystitis (inflammation of the bladder). Participating in this study will allow the patient to treat their urinary tract infection (UTI) with a single intramuscular (IM (into the arm)) or intravenous (IV (into the vein)) shot of amikacin, rather than having to go to the pharmacy to pick up a prescription for antibiotics, and then take antibiotics for 3-7 days. A single dose of amikacin has been demonstrated to be safe, effective and well tolerated in other studies, but some patients may decline to participate because they do not wish to have an IV or IM shot, or because they don't want to speak on the phone with a research assistant three times over the next 30 days.

he study is a prospective open-label cohort study that seeks to enroll 75 ED patients diagnosed with uncomplicated cystitis. Enrolled patients will be treated with a single dose of amikacin. The primary endpoint is clinical cure at 3 days. We chose a non-comparative design as our treatment strategy is literature- and guideline- supported; our goal is demonstrate that it is feasible to execute this approach out of the emergency department. Urine culture is not recommended in the in the initial management of patients with uncomplicated UTI treated in emergency or primary care settings.3

Data Collection Procedures: Patients will be enrolled as a convenience sample by the research team. The investigators will determine eligibility, approach the ED clinical team, then approach and consent the patient.

If consented, patient will be treated with amikacin 15 mg/kg IV or IM, based on actual body weight; for patients \>120% of IBW, we will use AdjBW (IBW + 0.4(ABW-IBW)) rounded to nearest 50 mg. Patients who already have an IV will receive the medication IV, otherwise the dose will be given IM.

The study measurements at enrollment are age, PMH, meds, allergies, symptoms, and symptom duration as well as urinalysis results, amikacin dose and route. Telephone follow-up at 3, 7, and 30 days will include the following data points: symptom resolution: (complete resolution / mostly better / a little better / same / worse); any new symptoms; any provider visits since index visit (if any visits, describe).

Eligibility Criteria:
Inclusion Criteria:

* female emergency medicine patients
* ≥14 years of age
* uncomplicated urinary tract infection
* a primary urinary complaint and nitrite-positive urine.

Exclusion Criteria:

* pregnancy
* abnormal genitourinary tract
* recent urinary tract instrumentation
* immunosuppression
* CrCl \< 25 mL/min
* evidence of pyelonephritis or sepsis
* any antibiotic treatment within 30 days
* not available for phone follow-up in 3, 7, and 30 days
* requires admission to the hospital
* abnormal mental status.
Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients

This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir in patients with Hepatitis C (HCV) genotype2,3,6. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).


Eligibility Criteria:
Inclusion Criteria:

Hepatitis C virus (HCV) genotype 2,3,6 infection (confirmed at screening). HCV RNA greater than 10,000 IU/mL at screening. Participant must be willing and able to comply with the protocol requirements. weight was more than 40 kg. age is between 18-75,either sex.

Exclusion Criteria:

Co-infection with hepatitis B virus or human immunodeficiency virus (HIV). Infection with HCV non-genotype 2,3,6,or Infection with mixed genotype,or Genotype cannot be confirmed.

Medical history of major functional organ transplantation. Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).

Participation in a clinical study within 3 months prior to first dose
Evaluation of Retreatment of Failed Revasculatized Teeth by Revascularization

Study will include 30 participants with failed revascularized young permenant teeth that will be retreated by revascularization and evaluated for success through 2 years


Eligibility Criteria:
Inclusion Criteria:

* central and lateral immature incisors
* child from 8- 10 years old
* healthy chidren
* failed revascularization

Exclusion Criteria:

* medically compromised children
* mentally compromised children