cyrilzakka/clinical-trials huggingface dataset:
Effect of Abdominal Massage on Constipation After Cardiac Surgery

Background and Aim: Although the incidence of gastrointestinal complications after cardiovascular surgery is reported to be rare, it has been reported that patients experience problems with constipation within the week after discharge. The presence of abdominal distension due to constipation after cardiac surgery may lead to prolonged wound healing, paralytic ileus and gastric dilatation. This study aimed to evaluate the effect of abdominal massage on constipation after cardiac surgery.

Methods: A prospective, randomised controlled quasi-experimental study was conducted in the cardiovascular surgery clinic of a public hospital between September 2022 and July 2023. A power analysis was performed to determine the sample size. A total of 130 patients were randomly assigned to the experimental or control group using a simple randomisation method. Data were collected using a 21-item form from the first day after surgery. Burping and defecation times of the patients were evaluated and recorded.

Results: The mean age of the experimental group was 55.2±13.3 years, while the mean age of the control group was 60.4±10.6 years (p=0.015). There was no statistically significant difference between the groups in terms of sociodemographic characteristics, bowel preparation and preoperative fasting times. It was observed that bowel sounds started earlier in the experimental group (70.8% on the first postoperative day) compared to the control group (46.2% on the first postoperative day) (X2=16.629; p=0.005). The first burping time measurements in the control group (x̄=46.415 hours) were higher than those in the experimental group (x̄=31.262 hours). Postoperative defecation time was longer in the control group (x̄=99.51 hours) than in the experimental group (x̄=61.611 hours).


Eligibility Criteria:
Inclusion Criteria:

* - Being older than 18 years
* Agreeing to participate in the study
* Undergoing a cardiac surgery
* Not having a barrier for communication
* Not having a mental or cognitive disability
* Not using constipation treatment (like laxatives or enemas)
* Having no history of constipation disorders or gastrointestinal surgery.

Exclusion Criteria:

-
Family History Study on Cancer Risk

This study aims to identify the optimal method to recognize, risk stratify, and provide follow-up care for individuals at risk of hereditary cancer. The study team will conduct a Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.

The study team proposes a randomized, Hybrid Type II comparative effectiveness-implementation trial, with a mixed methods component and process/formative evaluations for stakeholder engagement. The study team will evaluate three methods for identifying and risk-stratifying individuals at risk of hereditary cancer and providing post-risk stratification longitudinal care.

Hypothesis: The study hypothesis is that Comparator 3 will identify more people at high risk of hereditary cancers and result in more screening behaviors, greater resource use, increased distress, higher perceived risk of cancer and higher satisfaction.

Long term objective: At study end, the study will show: 1) each comparator's strengths and weaknesses, 2) patient preferences, clinical outcomes, and compliance with each step from history collection to screening test completion, 3) the resources needed for each strategy, and 4) the contextual factors that impact their sustainability, dissemination and implementation. Study findings have high potential for generalizability because: 1) The multidisciplinary stakeholder team will help to minimize barriers to dissemination and implementation of the investigator's findings in other research settings; 2) Study results are independent of study setting; 3) The tested methods of family history assessment can occur remotely via paper or electronic interfaces; 4) The care coordination method has successful precedent in other disciplines and can be delivered remotely; 5) A process and formative evaluation with a diverse stakeholder team will inform sustainability, dissemination, and implementation, and result in an implementation guide; 6) The results will be relevant for both family history-based and direct-genetic testing strategies for population screening for hereditary cancer; 7) The results will inform population screening for any disease with hereditary risk.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ≥2 years of prior membership, ≥1 clinical visit in prior two years, and a listed email are eligible
* Patients must also have received healthcare services during the past 2 years at Kaiser Permanente Northern California (KPNC) sampling sites

Exclusion Criteria:

* Patients outside the targeted geographic area
* Patients who cannot speak or read English (given some survey instruments are validated only in English)
* Kaiser Permanente Northern California members in the no-contact database for research studies
A Safety and Efficacy Study of Duvelisib in Relapsed/Refractory Follicular Lymphoma

This is a phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in subjects diagnosed with follicular lymphoma (FL) that is relapsed or refractory to either chemotherapy or radioimmunotherapy (RIT).

This is an open-label, single arm, multi-center clinical trial to evaluate the efficacy and safety of duvelisib administered to subjects who have been diagnosed with follicular lymphoma that is relapsed or refractory to either chemotherapy or RIT.

Subjects (n=57) will receive 25 mg duvelisib twice daily (BID) over the course of 28-day treatment cycles for up to 12 cycles.

After completing 12 treatment cycles of duvelisib, subjects may continue to receive additional cycles of duvelisib until disease progression or unacceptable toxicity. However, to receive additional cycles of duvelisib beyond 12 cycles, subjects must have evidence of response (CR, PR or SD) by the end of Cycle 12.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must have been fully informed and signed informed consent form.
2. Subjects must be adults (\>/=18 years), male or female.
3. Subjects who have been defined as FL by histologic or cytologic diagnosis, and must have relapsed or been refractory (at least two prior regimens for FL).
4. Measurable disease with a lymph node or tumor mass ≥1.5 cm in at least one dimension by CT, PET/CT or MRI according to Lugano 2014 criteria.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
6. Adequate renal and hepatic function.
7. Women of childbearing potential must have a negative serum or urine β human chorionic gonadotropin (βhCG) pregnancy test.
8. Willingness of male and female subjects who are not surgically sterile or postmenopausal to use medically acceptable methods of birth control for the duration of the study, including 30 days after the last dose of duvelisib.

Exclusion Criteria:

1. Grade 3B FL and/or clinical evidence of transformation to a more aggressive subtype of lymphoma.
2. Known hypersensitivity to the study drug duvelisib or excipients.
3. Previous treatment with a PI3K inhibitor or BTK inhibitor.
4. Prior history of allogeneic hematopoietic stem cell transplant (HSCT).
5. Prior chemotherapy, cancer immunosuppressive therapy, radiotherapy or other investigational agents within 4 weeks before the first dose of study drug.
6. Symptomatic central nervous system (CNS) Lymphoma.
7. Ongoing systemic bacterial, fungal, or viral infections at the time of initiation of study treatment.
8. Human immunodeficiency virus (HIV) infection.
9. Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection.
10. Hepatitis B or hepatitis C Infection.
11. History of stroke, unstable angina, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to first dose of study drug.
12. Female subjects who are pregnant or breastfeeding.
Passive Leg Raise During Cardiopulmonary Resuscitation

during cardiopulmonary resuscitation, an important element of the procedure is to achieve optimal organ perfusion. For this purpose, high quality chest compressions is one of the basic elements of the procedure. however, similarly as in the case of hypovolemic shock, elevation of the lower limbs may be helpful. The study is a randomized cross-over study and includes the effect of lower limb elevation on hemodynamic parameters in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* healthy participants
* voluntary informed consent

Exclusion Criteria:

* hip injury during the six months preceding the examination
* back pain
* kidney damage
An Intervention to Decrease Infant Crying

This is a study looking at the Happiest Baby on the Block technique. The investigators hypothesized that infants of mothers given a 30 minute videotape demonstrating the Happiest Baby on the Block technique would fuss/cry less and sleep longer than infants of mothers given a 30 minute videotape on general newborn care. The investigators also hypothesized that mothers given the Happiest Baby on the Block videotape would have lower levels of stress.

Mothers recorded their babies fussing, crying and sleeping on paper diaries when their infants were 1, 4, 6, 8 and 12 weeks old.

Eligibility Criteria:
Inclusion Criteria:

Mothers of singleton newborns

* 37 to 41 week gestation
* healthy (no ICU admission)

Exclusion Criteria:

* not able to view videotape at home
* not able to speak English
Faecal Microbiota Transplantation in Ulcerative Colitis

The purpose of this study is to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis (UC) by conducting a randomised controlled trial

This study involves the assessment of the safety and efficacy of FMT in the treatment and induction of remission for patients with mild to moderate ulcerative colitis. It is a double blind study with patients randomised in a 1:1 manner to either active or placebo therapy

Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis \>3 months duration
* Active mild-moderate ulcerative colitis (Mayo 4-10)
* Ulcerative colitis of any extent except isolated proctitis \< 5cm
* Live within driving distance of clinical site (to attend multiple study visits)

Exclusion Criteria:

* Pregnancy
* Active gastrointestinal infection
* Other gastrointestinal disease / comorbidities
* Prior colonic surgery
* Recent antibiotic or probiotic use
* Prednisone \> 20mg
* Monoclonal antibody immunosuppressive therapy
Study of Topical Ocular PAN-90806 in PDR

The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with proliferative diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older with type 1 or type 2 diabetes
* Proliferative diabetic retinopathy (PDR) in study eye retina with or without diabetic macular edema (DME) involving the center of the macula
* Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria:

* Current or recent use (within the last 3 months) of anti-vascular endothelial growth factors (anti-VEGF) in either eye;
* Uncontrolled hypertension despite use of antihypertensive medications
* Unwillingness to refrain from wearing contact lenses for the duration of the study.
* Participation in any investigational drug or device study, systemic or ocular, within past 3 months
* Women who are pregnant or nursing
* Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation
Efficacy of Massage in Stroke Spasticity

Stroke is one of the common diseases in the elderly. It is the third ranking cause of death and affects health care system in our country. One of the most important consequences of stroke is spasticity. Some stroke patients suffered from severe spasticity or hypersensitive reflex to stimuli. It can cause contracture, limit self care function, transfer or ambulation. Most of stroke patients have to depend on their relatives or families.

Thai traditional massage is one of the popular alternative medicine in Thailand. Lots of stroke patients who suffered from spasticity sought treatment. To the investigators knowledge, there is no study concerning efficacy of massage in decreasing spasticity for stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Stroke with onset of \>=6 months
* Age \>=50 years
* Spasticity grade of knee flexor or elbow flexor was 2-3 classified by Modified Ashworth scale (MAS)
* Ability to follow command and communicable

Exclusion Criteria:

* Having contraindications for massage including fever \> 38 degree, uncontrolled blood pressure, bleeding tendency, on anticoagulant drug, having ulcer or healing fracture of limbs, contamination skin disease, severe osteoporosis
* Serious contact diseases, for example AIDS, TB
* History of malignancy
* Fixed joint contracture at elbow or knee of paralyzed limb
* History of botulinum toxin injection or Phenol/Alcohol nerve block within 3 months
* Previous history of TTM
* Severe dementia or uncontrolled psychiatric problems
Gefitinib Versus Pemetrexed for Previously Treated NSCLC Patients

To compare the efficacy of gefitinib versus pemetrexed as second-line chemotherapy for patients with previous treated non-small cell lung cancer


Eligibility Criteria:
Inclusion Criteria:

* Cells pathologically diagnosed as histological or radical surgery or radiation therapy is not possible stage IIIB and stage IV non-small-cell lung cancer patients
* second line
* ECOG 0～2
* Patients with normal liver function and renal function

Exclusion Criteria:

* Patients with severe acute infection requiring antibiotic therapy
* Patients who have received treatment in other areas of cancer within 5 years
* During pregnancy and lactation patients
The TOGETHER Project - Heart

The researchers are trying to develop a way to measure the risk of transplant rejection with a blood test.

The study will utilize peripheral blood assays collected at time points that are considered standard of care at most institutions. Subjects will have peripheral blood collected at 1 month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for cause time points. These samples will then be used for purposes of developing an RNA-seq based peripheral blood assay in adult heart transplant recipients.

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria are eligible for enrollment as study participants:

* Adult (≥18 years) solitary heart transplant recipient
* Patient is willing and able to provide informed written consent

Exclusion Criteria:

Patients who meet any of these criteria are not eligible for enrollment as study participants:

* Adult (\<18 years) heart transplant recipient
* Patient refusal to enroll in the studyc3. Any simultaneous heart and extra organ transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had previous transplants may be included.
Comparison of the Effectiveness of Preemptive Paracetamol and Ibuprofen in Acute Postoperative Pain

This study will evaluate two different analgesic regimen used for acute postoperative pain.

Laparoscopic cholecystectomy is a type of surgery that causes moderate postoperative pain. Paracetamol and non-steroid anti-inflammatory analgesics plus opioids are the mainstay treatment options of the moderate postoperative pain. These drugs are the most common used analgesics to ameliorate this type of pain and to reduce the consumption of opioids and their side effects.

Ibuprofen is a well-known anti-inflammatory drug and has been used as an oral formula for a long time. Few studies using its new intravenous formula had been conducted to evaluate its effectiveness for mixed type of surgeries . However, its intravenous formula has not been studied for laparoscopic cholecystectomy. Therefore, this study will compare the effects of postoperative analgesic potencies of preemptive intravenous paracetamol and ibuprofen in patients undergoing laparoscopic cholecystectomy.

Eligibility Criteria:
Inclusion Criteria:

1. American Society of Anesthesiologist Functional Status 1-2
2. Body mass index smaller than 30
3. Undergoing laparoscopic cholecystectomy
4. Age between 18-60 years

Exclusion Criteria:

1. Age under 18, above 60
2. Weight under 40 kg
3. Body mass index above 30
4. Contraindication for opioid and non-steroid anti-inflammatory drug usage
5. Allergy against paracetamol, opioids and anti-inflammatory drugs
6. Peptic ulcer
7. Tendency to bleeding
8. Pregnancy or breast feeding
9. Moderate or severe renal, hepatic or cardiac insufficiency
10. Coronary artery disease
11. Asthma
Optimizing the Previs Device for Prediction of Postoperative Ileus

The research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.

Following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. When ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. Because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. Clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus

Participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. They will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.

Age 18 to 100.

Exclusion Criteria:

Allergies to any of the device components. Inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).
Effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars With Necrotic Pulps. .

This study aims to assess the effect of Calcium Hypochlorite Versus Sodium Hypochlorite as Root Canal Irrigants on Postoperative Pain and Bacterial Reduction in Mandibular Premolars with Necrotic Pulps.


Eligibility Criteria:
Inclusion Criteria:

1. Systematically healthy patient (ASA I, II).
2. Age between 20 and 55 years
3. Male or female.
4. Mandibular premolar teeth having single canals diagnosed with pulp necrosis with asymptomatic apical periodontitis.
5. Radiographic examination using Digora intraoral periapical sensor plate and software showing mandibular premolars with (0-2 mm) periapical radiolucency.

Exclusion Criteria:

1. Medically compromised patients having significant systemic disorders. (ASA III or IV).
2. History of intolerance to NSAIDS.
3. Teeth with:

   * Immature roots
   * Vital pulp tissues.
   * Association with swelling.
   * Acute peri-apical abscess or acute exacerbation of a chronic abscess.
   * Mobility Grade II or III.
   * Previously accessed or endodontically treated
   * Deep periodontal pockets more than 4 mm
   * Vertical root fractures, coronal perforation, calcification, and external or internal root resorptions.
4. Patients who could not interpret the NRS.
5. Patients with diabetes, immune-compromising, and immunosuppression disease and pregnant women were, also, excluded.
A Multi-centric Clinical Trial in China for Skin Diseases Intelligent Diagnosis and Treatment System

In response to clinical needs, infrared multi-spectral images are combined with traditional clinical images and other multi-modal data to build a more efficient intelligent auxiliary diagnosis system and intelligent equipment for skin health and diseases, including skin lesions automatically segmentation on skin diseases images, automatically design surgical margin and planning for skin tumor surgery.

Database: Relying on the preliminary foundation, build the first standardized infrared multispectral image database of skin diseases, and further integrate other medical images and medical history texts to iterate into a large multimodal skin disease database.

Model: Design a deep learning network based on multi-scale and multi-level. The collaborative attention learning network realizes the collaborative representation of multi-modal data at the feature level, builds a multi-modal skin disease auxiliary diagnosis model, and realizes breakthroughs in algorithms. Develop the segmentation network of skin lesions and model for surgery planning, including surgical margin design and navigation of intraoperative sampling.

System: Propose an artificial intelligence system combined with the real-time augmented reality to assist dignosis and surgery for skin diseases.

Equipment: Based on the self-developed high-performance system, construct and assemble infrared multi-spectral skin disease auxiliary diagnosis equipment and multifunctional device for skin tumors surgery.

Eligibility Criteria:
Inclusion Criteria:

* Informed consented.
* With a diagnosis of skin disease made by at least 3 dermatologists.
* Without life-threatening risk to intervention.
* Requires surgical treatment (For devices).

Exclusion Criteria:

* Having difficulties to follow-up.
* Poor general condition.