cyrilzakka/clinical-trials huggingface dataset:
Optimizing Postpartum Pelvic Health Through Self-Scar Tissue Massage of Episiotomy and Perineal Scar Tissue A Pilot RCT

The goal of this Pilot Randomized Control Trial (RCT) is to determine if a larger RCT evaluating the effect of self-scar tissue massage of episiotomy and/or vagina/perineal tear scar tissue on pelvic health outcomes is feasible.

The main questions it aims to answer are:

Can the investigators recruit 130 participants and aim for 80% retention of participants in this study?

Are the response rates to questionnaires and completeness of questionnaires acceptable?

Do the participants find the self-scar tissue massage intervention easy and acceptable to perform and do they adhere to the protocol?

Type of Study: Clinical Trial

Participant Population/Health Conditions: The participant population will be 18 years of age or older, primiparous, within 1 year postpartum after vaginal delivery with healed episiotomy and/or vaginal perineal tear(s) as confirmed to them by their maternity care provider or family doctor at their 6 week postpartum check or other appointment. The participants will also need to have sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.

Investigators will compare the scores on two reliable and validated pelvic health questionnaires in those in the intervention and control groups. The intervention group will be provided an instructional video on self-scar tissue massage and asked to perform self-scar massage and record their intervention and experience over a 6-week period. The control group will receive routine postnatal care (no self-scar massage training or performance). Patient medical records will be used to collect demographic data and labour and delivery characteristics. Two reliable and validated pelvic health questionnaires will be used for outcome measures. Baseline outcomes will be performed at the start of the study and then repeated 6 weeks later and again 18 weeks later.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Primiparous
* Within 1 year postpartum after vaginal delivery with episiotomy and/or vaginal/perineal tear
* Healed episiotomy and/or vagina/perineal tear as confirmed to them by their maternity care provider or family doctor at their postpartum check or other appointment
* Sufficient proficiency in English to understand intervention instructional video and complete written questionnaires.

Exclusion Criteria:

* Self-reported current vaginal infection or urinary tract infection
* Self-reported gynecological surgery after delivery
Promoting Health Through Play Program: Improving Parent and Child Outcomes

This project aims to assess the feasibility of an intervention program consisting of parent online group sessions in addition to guided individual play session between parent, child, and occupational therapy student (OTS) or an occupational therapist (OT).

The investigators speculate that the Promoting Health Through Play Opportunities program will be effective in improving:

1. Parent ability to support their child's playfulness as measured during 15-minute video-recorded joint play activity at home using the Parent/Caregiver Support of Childre Playfulness \[PC-SCP\].
2. Child's playfulness behavior as measured during 15-minute video-recorded joint play activity at home using the Test of Playfulness \[ToP\].
3. Child's psychological adjustment as measured by the Strength and Difficulties Questionnaire \[SDQ\].
4. Parent's perception and satisfaction from their involvement in the program as measured through open-ended questions.

The Promoting Health Through Play Opportunities program (Halperin et al., 2021; Waldman-Levi \& Halperin, 2022) is a strength-based intervention that provides tools to help parents become change agents in their child's life through the promotion of healthy play opportunities within the family context. This research project aims to enhance children's development through playful interactions with their parents. The investigators speculate that the program will be effective in improving parent and child joint play experience and child's social-emotional functioning.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Head Start pre-school program within New York greater area
* Parent-child dyads
* Child must be 3 to 5 years old, with/without delay or disability.
* If a parent has more than one child in this age range, the oldest of them will be recruited for the study
* Parent IS committed to attending pre-and-posttest as well as online group sessions
* Parent has access to a device other than a phone (tablet, iPad, laptop) and has stable internet connection to be able to participate in the online group and dyadic session
* For the English-speaking group, parent must be fluent in English
* For the Spanish speaking group, parent must be fluent in the Spanish language.

Exclusion Criteria:

* Parents with a sensory deficit (e.g., hearing or vision impairment) that will affect their ability to participate in an online group program
* Parents with psychiatric or behavioral disorders that affect their ability to participate in a group-based intervention
Body Composition Analysis in Cirrhotic Undergoing Paracentesis

Ascites is a frequent complication of liver cirrhosis, initial treatment consists on diuretics intake, however, as the disease progresses this complication becomes more severe, consequently other therapeutic options are used.

Paracentesis is indicated when severe ascites is present and it should be accompanied by albumin infusion.

Nutritional status is generally affected in patients with liver cirrhosis, even more patients with severe ascites show decreased energy intake due to gastric compression.


Eligibility Criteria:
Inclusion Criteria:

* Any genre.
* Age 18-70 years old.
* Diagnosis of liver cirrhosis of any etiology (documented by clinical, biochemical, radiological and / or biopsy.
* Presence of high volume ascites
* The signing of informed consent will be required for the inclusion of any patient.

Exclusion Criteria:

* Hepatic encephalopathy grade III or IV. 2) liver transplantation.
* Congestive heart failure.
* Hemodialysis.
* Acute or chronic renal failure.
* Nephrotic syndrome with protein loss.
* Alcoholism active in the last 6 months.
* Pregnancy.
* upper gastrointestinal bleeding.
Bedside Ultrasound Assisted Pediatric Lumbar Puncture

This is a prospective, randomized study evaluating the efficacy of bedside ultrasound assisted lumbar puncture in pediatric patients

Comparison of bedside ultrasound assisted lumbar puncture to traditional anatomical landmark approach in neonates and young infants requiring lumbar puncture

Eligibility Criteria:
Inclusion Criteria:

* Any patient 0-12 months old requiring a lumbar puncture in the pediatric emergency department or inpatient pediatric floor is eligible to participate in the study

Exclusion Criteria:

* previous back surgeries
* parent/ guardian inability to understand informed consent
* parent/guardian refusal of informed consent.
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis

The investigators conducted a pilot study including 17 patients with liver cirrhosis showing that a moderate exercise programme during three months increased thigh circumference,exercise tolerance and quality of life without adverse effects. The present study aim to more accurately evaluate the effect of exercise on muscle mass, effort tolerance and inflammatory response in patients with cirrhosis. This study will include 30 patients with compensated liver cirrhosis that will be randomized into two groups: exercise group and control group. Evaluation of muscle mass, effort tolerance, inflammatory response and quality of life will be made at the beginning and at the end of the study.

Exercise group: will do a physiotherapist supervised exercise programme 1 hour three times per week during three months and relaxation after exercise. Control group: only relaxation 1 hour three times per week during three months.

Assessment: clinical and laboratory examinations performed at baseline and at the end of the study. The investigators will analyze the changes in muscle mass by anthropometric measurements and advanced techniques (CT scan, densitometry), effort tolerance (stress test), quality of life (sF-36), glutamine synthetase activity in blood, oxidative damage and inflammatory response. The investigators will analyze the survival and complications of cirrhosis during the study and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Compensated liver cirrhosis

Exclusion Criteria:

* hepatocellular carcinoma
* active alcoholism (less than 1 year)
* decompensated cirrhosis
* variceal bleeding less than 3 months.
* contraindication for exercise
Pilot the Use of VA Make the Connection Campaign to Facilitate Help Seeking Among Vulnerable Veterans

This pilot study seeks to determine if exposure to the Make the Connection campaign messages developed by the U.S. Department of Veterans Affairs (VA) is associated with changes in mental-health related outcomes, specifically: (1) psychosocial determinants that drive help seeking behaviors (knowledge, attitudes and intentions); and (2) perceived barriers to seeking care. Participants are randomly assigned to message exposure or control (no exposure) conditions. Data from this project will inform mental health education and outreach efforts targeted towards Veterans experiencing mental health concerns.


Eligibility Criteria:
Inclusion Criteria:

Veterans of all gender/sex, race/ethnicities that in the past 6 months:

* utilized health services in the U.S. Department of Veterans Affairs (VA);
* screened positive on the PHQ-2, AUDIT-C or PC-PTSD and/or received a mental health diagnosis as documented in VA medical record
* Fluent in English language
* Capable of understanding goals of study
* Capable of providing verbal consent
* Willing and able to download/use study Android mobile application for duration of study

Exclusion Criteria:

* Not a U.S. Veteran who has utilized VA health care in the past 6 months
* Did not screen positive and/or was not diagnosed with mental health disorder
* Determined cognitively impaired and unable to provide verbal consent
* Determined to be in high distress during recruitment screening
* Currently institutionalized (i.e., hospitalized; incarcerated, etc.)
* Unwilling and/or unable to download and use use the study app
Using Triamcinolone Acetonide to Reduce Pain After Scleral Buckle Surgery

PURPOSE: Scleral buckle surgery is a widely used ophthalmic surgery for the correction of rhegmatogenous retinal detachment. Studies suggest that eye pain is a common and underestimated occurrence after scleral buckle surgery, but as of yet, there is no definitive management method for reducing pain following scleral buckle surgery. The investigators aim to control pain following scleral buckle surgery with sub-tenon's irrigation with triamcinolone acetonide at the time of surgery. Using a randomized prospective clinical study, the investigators test if this technique will reduce the pain, nausea/vomiting, and analgesic use caused by scleral buckle surgery.

METHODS: Forty-eight patients undergoing scleral buckle surgery will be randomized into two groups. The experimental group receives a sub-tenon irrigation of 1 cc 40mg/mL triamcinolone acetonide around the base of the scleral buckle (0.25 cc in each quadrant) at time of operation. The control group does not receive any triamcinolone irrigation. Pain scores are measured 1 day post-operatively via 11-pt numerical rating scale as the primary outcome. The nausea/vomiting score is measured 1 day post-operatively via standard 6-pt scale. Patients track pain medication use via pill count. Values will be measured again at 1-2-week and 6 months post-op.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have rhegmatogenous retinal detachment and be scheduled to undergo scleral buckle surgery for correction

Exclusion Criteria:

* Advanced Glaucoma
* History of corticosteroid responsive elevation in IOP
* Allergy to Triamcinolone Acetonide or other corticosteroids
* Pre-existing chronic pain disorders
* Herpes zoster
* Prior corneal allograft
* Allergy to local anesthetic or penicillin
* Patients unable to consent on own behalf
* Patients unable to communicate pain and nausea levels
* Pregnancy
* Incarceration
Chronic Arterial Disease, Quality of Life and Mortality in Chronic Kidney Injury

CADKID-study is a prospective follow-up study assessing arterial disease, quality of life, mortality and their predictors in patients with severe chronic kidney disease.

Chronic kidney disease (CKD) is associated with increased risk of cardiovascular disease and mortality as well as impaired quality of life. Participants of this study all have severe CKD, defined as estimated glomerular filtration rate \< 30 ml/min per 1.73 m\^2. Stress ergometry, echocardiography, ultrasound assessment of arterial intima-media thickness, lateral lumbar radiograph, ECG, laboratory tests and quality of life assessment were performed at the baseline of the study and will be repeated during follow-up. Atrial fibrillation and other cardiac arrhythmias as well as pulse wave velocity measurements will be explored. Diet diaries are gathered and analysed. The aim of the study is to identify factors associated with cardiovascular disease, quality of life and mortality in this cohort.

Eligibility Criteria:
Inclusion Criteria:

* estimated glomerular filtration rate \< 30 ml/min per 1.73 m\^2

Exclusion Criteria:

* age under 18 years
* inability to give informed consent
Aging With Long Term Physical Disabilities

The purpose of this study is to determine the feasibility and efficacy of an adapted evidence-based program (REBIL) to reduce barriers to community participation and remove fall hazards at home for adults aging with physical disabilities.

Investigators will test the working hypothesis that the adapted program, focused on resolving environmental barriers, removing fall hazards, and building self-management skills in the home and community, will be feasible and superior to usual care for daily activity performance and participation outcomes in adults aging with physical disabilities.

Eligibility Criteria:
Inclusion Criteria:

* Age 45-65 years
* Self-report of difficulty with at least 2 daily activities using the Older Adult Retirement Survey Activities of Daily Living (OARS ADL) scale
* onset of a physical disability 5 years prior to participation (e.g., spinal cord injury (SCI), cerebral palsy, post-polio syndrome, stroke, amputation).
* live within 60 miles of the research lab

Exclusion Criteria:

* Currently institutionalized.
Comparison of Standard of Care or Treatment on Protocol

Patient will choose to either receive the standard of care according to National Comprehensive Cancer Network (NCCN) or approved guidelines for their condition or to be treated according to one arm of the protocol that they could not be enrolled on. The selection of the arm will be at physician discretion.

All patients failing to enroll in a specific therapeutic research protocol using FDA approved drugs or CTMS accepted therapies will be screened for this study. Patients will be randomized (Patient own choice) to either standard of care described in the NCCN guidelines and published as peer-reviewed phase II or III studies which show an efficacy or to one of the arms of the protocol they fail to enroll in, as determined by the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have a cancer requiring chemotherapy or radiotherapy

Exclusion Criteria:

* Inability to comply with study and/or follow-up procedures
* Any contraindication per the FDA notice to the selected drugs
* Pregnant (positive pregnancy test) or lactating. No effective means of contraception (men and women) in subjects of child-bearing potential
Population Pharmacokinetics of Amoxicillin in Neonates

The objective of NEOPOPI is to conduct a population pharmacokinetic study of amoxicillin in neonates, in order to evaluate and optimize neonatal dose regimen.

There will be no change to the medication treatment received by participants. An opportunistic pharmacokinetic sampling approach will be followed: samples will be scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this way, no additional invasive tests will be needed.

* Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the protocol
* Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
* Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
* Population pharmacokinetic analysis

Eligibility Criteria:
Inclusion Criteria:

* Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
* No parental opposition to the study participation

Exclusion Criteria:

• None
A Study to Evaluate Safety, Tolerability, PK and PD of HLX01 in Patients With CD20-positive B-cell Lymphomas

To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of HLX01 (a potential rituximab biosimilar) in patients with CD20-positive B-cell lymphomas.

This was a phase Ia, multicenter, open-label, dose-escalation clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics characteristics of HLX01 injection in patients with CD20-positive B-cell lymphomas.

Eligibility Criteria:
Inclusion Criteria:

* 18 years ≤ aged ≤ 65 years, male or female;
* having histologically confirmed diagnosis of relapsed/refractory CD20-positive B-cell lymphomas which needed consolidation therapy;
* Eastern Cooperative Oncology Group (ECOG) performance status≤1 and life expectancy ≥3 months;
* providing signed and dated informed consents.

Exclusion Criteria:

* Usage of rituximab or other anti-CD20 monoclonal antibody within 2 years before enrollment;
* usage of hematopoietic cytokines within 1 week before enrollment, e.g. granulocyte colony stimulating factor (G-CSF);
* recent major surgery (excluding diagnostic surgery) within the past 8 weeks;
* peripheral nervous system diseases or central nervous system diseases;
* inadequate hematologic function met any of the following at screening: white blood cell count \<3.0×109/L, absolute neutrophil count (lobocyte and rhabdocyte) \<1.5×109/L, platelet count \<100×109/L, hemoglobin \<90 g/L, for patients with bone marrow involvement, absolute neutrophil count (lobocyte and rhabdocyte) \<1.0×109/L, platelet count \<75×109/L, hemoglobin \<80 g/L;
* inadequate liver function met any of the following at screening: total bilirubin\>1.5×the upper limit of normal range (ULN), ALT or AST\>2.0×ULN, alkaline phosphatase (ALP)\>3.0×ULN;
* abnormal renal function (serum creatinine\>1.5×ULN);
* abnormal thyroid function (TSH\< lower limit of normal or \> upper limit of normal with clinical significance judged by investigators);
* positive test result(s) for serum HIV antigen or antibody;
* seropositivity of HBsAg, or seropositivity of HBcAb and HBV DNA\>ULN; seropositivity of Anti HCV antibody;
* history of herpes zoster and left with sequelae or latent infection;
* other serious disease which may restrict subjects to participate in the trial (such as ongoing active infection, uncontrolled diabetes mellitus, severe cardiac insufficiency or angina pectoris, gastric ulcer, active autoimmune disease, etc.);
* pregnancy or breast feeding female, or not willing to use effective contraceptive measures during the study;
* allergic constitution, or known allergic to components of rituximab or other anti-CD20 monoclonal antibody;
* history of alcoholism or drug abuse; participation in other clinical trials within 3 months before enrollment;
* not suitable for enrollment at investigator's discretion.
Comparison Between the Supreme Laryngeal Mask Airway and the Laryngeal Tube Suction During Spontaneous Ventilation

The study compared the Laryngeal Tube Suction (LTS-D) Disposable with the Supreme Laryngeal Mask Airway (SLMA) during spontaneous ventilation. The investigators hypothesized that the LTS-D and the SLMA perform similarly during spontaneous ventilation despite differences in their structural design.

The Supreme Laryngeal Mask Airway (SLMA), (Intavent Orthofix, Maidenhead, UK), and Laryngeal Tube Suction -Disposable (LTS-D, (VBM Medizintechnik GmbH, Sulz, Germany), are second generation single-use supraglottic airway devices (SADs) with gastric access, for airway management in spontaneously and mechanically ventilated patients undergoing general anesthesia.

The SLMA has been compared to the Proseal Laryngeal Mask Airway (PLMA) during mechanical and spontaneous ventilation the LTS II (multiple use version of the LTS-D) with the PLMA.

Recently, the LTS-D and SLMA have been compared when used during pressure controlled mechanical ventilation.

To date, there is no published data comparing the SLMA to the LTS-D during spontaneous ventilation. The investigators hypothesized that the SLMA and LTS-D perform similarly during spontaneous ventilation despite differences in their structural design.

The chief aim of this prospective randomized study was to compare the SLMA and the LTS-D with respect to 1) Oxygen saturation and End Tidal carbone dioxide during spontaneous ventilation, 2) time to achieve an effective airway, 3) ease of insertion, 4) need for interventions to achieve an effective airway, 5) cuff seal (leak) pressure at an intracuff pressure of 60 cm H2O, 6) ventilatory variables during spontaneous ventilation, 7) fiberoptic score, 8) adverse perioperative events.

Eligibility Criteria:
Inclusion criteria:

* Patients, American Society of Anesthesiologists ( ASA) physical status I and II, with normal airways for minor elective surgery.

Exclusion Criteria:

* Age \<18 years,
* Weight \<50 kg,
* Cervical spine disease limiting neck a known difficult airway, and
* Patients with active gastroesophageal reflux.