cyrilzakka/clinical-trials huggingface dataset:
Prophylactic Tamsulosin Use for Prevention of Post-Operative Urinary Retention

This randomized open-label study will be comprised of 2 cohorts: one control group and one treatment group. The trial will be conducted as an open label randomized trial to evaluate the efficacy of tamsulosin in the prevention of post-operative urinary retention. The study will include pre- and post-surgical evaluations of patients including symptoms of urinary retention and any adverse effects contributable to the study medication.


Eligibility Criteria:
Inclusion Criteria:

* Any male age 40 or older
* Scheduled to undergo one of the planned surgeries (thoracic, general, or urologic)
* Ability to give informed consent

Exclusion Criteria:

* Current use of alpha blocker
* Current use of a strong CYP 3A4 inhibitors
* Any allergy to tamsulosin, alpha-blocker medication class, or anaphylaxis allergy to sulfate containing medications
* Patients with any upcoming surgery for cataracts
* Currently enrolled in a clinical trial
* Inability to give informed consent
How Does Implementing a GetUp Assist Device in Addition to a Daily Low-intensity Functional or Traditional Training Program Affect Norwegian Female Office Workers' Physical Health After 12 Weeks?

This study aims to quantify the effect of daily transition routines between sitting and standing behaviour with an additional daily low-intensity traditional or functional training program on the physical health of sedentary Norwegian female workers after 12 weeks of implementation into their working environment.


Eligibility Criteria:
Inclusion Criteria:

* Females are included in this study due to the approximately twice-high prevalence of work-related musculoskeletal disorders.
* No experience with office fit training or participation in an ongoing similar training intervention is allowed.
* Working more than 6 hours a day at a computer workstation
* Physical inactivity (less than two sessions or bouts of exercise totalling 30 minutes/week).
* Musculoskeletal complaints are accepted as long as the pain is not a restricting factor. when performing the testing and training intervention exercises.

Exclusion Criteria:

* Participants not able to perform the testing battery.
Effect of Nutrition and Lifestyles on Obesity and Chronic Disease in China

This research is aimed at verifying the effects of diets with high protein and low glycemic index (GI) on weight management among overweight or obese Chinese adult. Additionally, the investigators intend to verify the effects of two new approaches, including food replacement and Internet-of-things (IOT) monitoring on weight control.


Eligibility Criteria:
Inclusion Criteria:

* Health adult, age:18-65，BMI（kg/m2）:27.0-40.0

Exclusion Criteria:

* Patients under regular medical treatment for chronic diseases like diabetes, hypertension, gout and hyperuricemia.
* The patients with chronic renal diseases or other diseases which impose restrictions on the intake of proteins.
* Mental patients.
* People who suffer from secondary obesity caused by endocrine, metabolic disorders or some central nervous system diseases.
* People who are under medical or surgical weight-loss treatments in the past three months.
* People whose weight fluctuations are not less than 5kg in the past two months；
* People with food allergies.
* Men or women who drink regularly over 25g or 15 g daily,respectively.
* Pregnant women and women who prepare to be pregnant.
* Lactating women
Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients

The purpose of this actual use human factors (HF) study is to validate the approved US TOBI Podhaler Instructions for Use (IFU), by establishing that the IFU effectively communicates the information necessary to achieve safe and effective use of the Podhaler device.

The objective of the HF study is to determine whether cystic fibrosis patients in the US, representative of potential TOBI Podhaler users, can understand and follow the approved IFU and the extent to which the approved IFU supports safe and effective use of the Podhaler device.

This study is an 'actual use' study, in that patients will inhale the contents of placebo capsules through the Podhaler device.

Due to the use of placebo capsules, the study is considered a clinical study and will be conducted accordingly. The study is therefore a human factors observational use study conducted within a clinical study. It is an open label, unblinded, non-randomized study and consists of two visits. At visit 2 patients who are eligible will participate in a human factor assessment to determine whether or not a patient understands the IFU content and can demonstrate safe and effective use of the Podhaler device.

Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 6 years and older at screening
* Confirmed diagnosis of CF
* Pulmonary function FEV1 value at least 25% of normal predicted values
* Must be physically and cognitively able to read, alone or with the assistance of their caregiver

Exclusion Criteria:

* Subjects currently enrolled in studies that are not considered observational noninvestigational studies.
* Subjects who have used the Podhaler device previously
* Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
* History of hypersensitivity to inhaled dry powder
* Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax
Comparison of 2 Mattresses for the Prevention of Bedsores by Measuring Skin Pressure in the Sacral Area

The main objective of this study is to compare the AIRSOFT DUO and the SENTRY 1200 constant pressure mattresses in terms of peak skin pressures measured at the sacral area.

The secondary objectives of the study are to compare the two devices in terms of:

A. body contact surface area. B. peak pressure at the heel area (combining right and left heels) C. occurrence of pressure ulcers anywhere on the body for 1 month D. patient comfort rated at 1 month (visual analog scale varying from 0-10) E. noise (Likert Scale). F. sleep quality (visual analog scale varying from 0-10).

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient spends more than 12 hours in bed and verticalisation is possible
* The patient has a stable medical condition (no complication in the last 10 days) and no visible pressure ulcers
* The patient is at risk for pressure ulcers as assessed by a score ≤ 15 on the Braden Scale
* The patient weighs less than 120 kg

Exclusion Criteria:

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The subject has a contra-indication for a strictly supine position
* The patient has a knee flexion deformity \> 10 °
* The patient is in a state of agitation or refuses to cooperate
* The patient's weight is greater than 120 Kg
* The length of stay is less than one month
Self Management Education Asthma

To evaluate the effects of a new statewide program to enhance identification, referral and provision of care to rural families of Hispanic children with moderately severe to severe asthma. Specifically, to determine if comprehensive medical care (CMC) plus an educational self-management program for rural Hispanic children and their families had an impact on asthma morbidity, as well as on cost and family adaptation.

BACKGROUND:

Because of New Mexico's large rural and heavily Hispanic population, it was an ideal setting to determine effective methods for case management, self-management educational programs and effective tertiary to primary care delivery collaboration.

The study was part of a demonstration and education initiative "Interventions for Control of Asthma Among Black and Hispanic Children" which was released by the NHLBI in June 1989.

DESIGN NARRATIVE:

A randomized block design was used with random assignment of subjects by county to treatment groups of 1. comprehensive medical care or standard tertiary care and education, or 2. CMC-Plus adding a structured self-management program--Open Airways/Respiro Abierto (developed and tested with support of NHLBI). CMC-Plus also received in home education and intervention from community based Hispanic family educators trained in an empowerment model of family intervention, in-home support, and education. Case management was provided by CMS; CMC and CMC-Plus were provided at the UNM-PPP in close collaboration with and transfer of care to the primary physician. Additional educational contact with primary care providers and emergency rooms were provided through the UNM Department of Family, Community \& Emergency Medicine which utilized the National Institutes of Health National Asthma Education Program's Guidelines for Step-Wise Care of Asthma. Asthma morbidity, cost of care, family adaptation and family satisfaction were evaluated using standardized instruments.

Eligibility Criteria:
No eligibility criteria
Washing Without Water: Cost-effectiveness of a Rapidly Spreading Nursing Intervention in Bedridden Patients'

The purpose of this study is to compare the traditional bed bath with 'washing without water' on

* 1) effects on skin integrity
* 2) patient and nurse satisfaction and 3) costs. In a cluster randomized trial we will randomize 50 nursing home wards (576 patients) to 'washing without water' or traditional bed baths. Bathing regimens are continued for six weeks.

Whereas effects on skin damage are not likely to be specific for setting, these results can be generalized to other patient groups.

RAPID IMPLEMENTATION of new interventions while cost-effectiveness and acceptability for patients and care providers are unclear, is never desirable. 'Washing without water' is such an intervention.

The traditional bed bath is executed by using tap water, towels, washcloths and soap. As an alternative, 'WASHING WITHOUT WATER' was recently introduced in the Netherlands. This concept consists of disposable washcloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion. 'WASHING WITHOUT WATER' can be used with all patients who need bathing assistance, especially when taking a shower or sitting in a hot tub is not possible.

However, while several claims are made about the positive effects of 'washing without water' as compared to traditional bathing, EVIDENCE IS LACKING. Also, 'washing without water' is CONTROVERSIAL. While some are eager to adopt the new concept, others see it as 'efficiency gone loose' and denying patients one of the most basic elements of care: a proper bath. This study therefore addresses the cost effectiveness of 'washing without water' in bedridden patients.

Eligibility Criteria:
Inclusion Criteria:

* long stay psychogeriatric nursing home residents
* long stay somatic nursing home residents
* 100 randomly selected nurses from the participating nursing home wards

Exclusion Criteria:

-
SBRT Combined with Camrelizumab and Apatinib for Conversion Therapy in Patients with Unresectable Hepatocellular Carcinoma.

•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form (ICF).
* Aged 18 years or older.
* Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
* Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
* ECOG Performance Status of 0 or 1.
* Child-Pugh class of A.

Exclusion Criteria:

* Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
* Existence of active autoimmune disease or history of autoimmune disease and may relapse.
* Patients with innate or acquired immune deficiency (e.g., HIV infection).
* Known allergies to study drugs or excipients.
Combination Chemotherapy in Treating Patients With Stage III Ovarian Epithelial Cancer or Gastrointestinal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them by intraperitoneal infusion may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of intraperitoneal combination chemotherapy in treating patients who have stage III ovarian epithelial cancer or gastrointestinal cancer.

OBJECTIVES:

* Assess tolerance and complications from consolidation therapy with intraperitoneal floxuridine and cisplatin and/or carboplatin in patients with stage III ovarian epithelial cancer or gastrointestinal cancer with peritoneal involvement.
* Determine the sites of failure and estimate the time to failure following treatment with this regimen in these patients.

OUTLINE: Patients are stratified according to type of residual disease at second look laparotomy or laparoscopy (micro only vs no greater than 0.5 cm vs greater than 0.5 cm and no greater than 1 cm), and by CA-125 level (elevated vs normal on day -7).

Patients receive intraperitoneal floxuridine on days 1-3 followed by intraperitoneal cisplatin and/or carboplatin on day 3. Treatment continues every 3 weeks for 4-6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 4 and 6 weeks, then at 6, 12, 18, and 24 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study over 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage III ovarian epithelial cancer or gastrointestinal cancer with peritoneal involvement
* Patients with ovarian cancer must have completed first induction treatment with a platinum based regimen (carboplatin and/or cisplatin) and be in clinical complete response at time of assessment for study
* No ovarian cancer of low malignant potential

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-2

Life expectancy:

* Greater than 2 months

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin less than 1.5 mg/dL
* SGOT less than 3 times upper limit of normal

Renal:

* Creatinine clearance at least 40 mL/min

Other:

* No underlying medical or psychiatric condition that precludes informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Laparoscopy or laparotomy required within 8 weeks of study to assess residual disease
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection of hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
* Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

* Subject is scheduled for a total colectomy, colostomy, ileostomy
* Subject has complete bowel obstruction
* Subject is currently taking opioid analgesics or has taken opioid analgesics within the prior 2 weeks
A Phase 3 Trial in Bowel Preparation for Colonoscopy

This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients and inpatients aged: ≥19
* A prospective colonoscopy person
* Written informed consent to participate in the trial

Exclusion Criteria:

* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
* Patients with ongoing severe acute Inflammatory Bowel Disease.
* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
* Pregnant women or pregnant women or pregnant women
* Severe heart disease (cardiac failure (NYHA class 3 and 4))
* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
* People who have hypersensitivity or allergies to clinical trial drug components.
Study Comparing Postoperative Treatment After Surgical Decompression for Lumbar Spinal Stenosis.

The aim of the study is to assess the benefit of wearing a lumbar orthosis after surgery for spinal stenosis. It will be evaluated if a post-surgery immobilization for 6 weeks with a lumbar orthosis reduces early recurrence, increases walking distance, decreases significantly faster pain and pain medication after surgery

Spinal stenosis and orthoses The study situation in this regard is very poor, high-quality level 1 studies are not available.

A study by Prateepavanich et al. from 2001 shows advantages in the therapy with lumbar orthoses in neurogenic spinal claudication in the context of conservative therapy (9). Regarding postoperative prescription, expert opinions have long diverged (10). Nevertheless, in a survey of North American spine surgeons, over 60% reported prescribing an orthosis postoperatively (11).

2 Aim of the study

The aim of this study is to show that patients after surgical decompression for lumbar spinal stenosis and patients after surgical sequestrectomy benefit from temporary postoperative immobilization using a lumbar orthosis.

To show that postoperative therapy with a lumbar orthosis prolongs walking distance and reduces early recurrence.

It will be shown that postoperative pain decreases significantly faster and thus pain medication can be reduced faster early postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Decompression with hemi-/ partial laminectomy, one. Laminectomy, and foraminotomy. Flavectomy with undercutting due to uni-and multi-segmental spinal stenosis.
* Age 20-80 years
* Pre-operative walking distance at least 100m
* Consent form signed by the patient

Exclusion Criteria:

* Fusion surgery or recurrent surgery
* Tumors of the spine
* Cervical spinal stenosis or myelopathy
* Rheumatoid arthritis or similar autoimmune disease
* Infection - request for a pension
* Dyspnea due to heart failure with limited walking distance
* Peripheral Arterial Occlusive Disease (PAOD)-
Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)

The objective of this trial is to investigate the efficacy (American College of Rheumatology 20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of foreign data to the Japanese population.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a diagnosis of adult-onset RA of at least 6 months but not longer than 15 years in duration as defined by the 1987 American College of Rheumatology classification criteria.
* Subjects must have active RA disease as defined by:

  * At least 9 tender joints and 9 swollen joints
  * ESR of 30 mm/hour or CRP of 1.5 mg/dL
* Subjects must have received treatment with MTX for at least 6 months prior to the start of study drug administration. The dose of MTX must have remain fixed for at least 2 months prior to the study and the dose of MTX should be within 6 to 8 mg/week.

Exclusion Criteria:

* Patients who have a diagnosis of any other inflammatory arthritis
* Patients who have a secondary, non-inflammatory type of arthritis (eg, osteoarthritis, fibromyalgia)
* Patients who currently have, or who have a history of, a demyelinating or convulsive disease of the central nervous system (eg, multiple sclerosis, epilepsy)
* Patients who have NYHA (New York Heart Association) Class III or IV congestive heart failure
* Patients who currently have, or who have a history of, tuberculosis
* Patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease)
* Patients who currently have, or who have a history of, malignancy
* Female patients who are breastfeeding or pregnant, who are of childbearing potential
* Patients who previously received treatment with 2 or more anti-TNFα drugs or who previously failed to respond to treatment with 1 or more aint-TNFα drugs.
Comparison of Insulin Glargine and NPH Human Insulin in Progression of Diabetic Retinopathy in Type 2 Diabetic Patients

To compare the progression of diabetic retinopathy in type 2 diabetic patients with mild-to-moderate diabetic retinopathy treated with insulin glargine vs NPH human insulin.

Randomized, open-label assignment of type 2 patients who are on a stable antidiabetic regimen to treatment with either insulin glargine or BID NPH human insulin, with baseline diabetic retinopathy of severity 53/\<53 on the ETDRS scale, for 5 years of followup. Outcomes measured by seven-field fundus photography at baseline, 1.5, 3,6,and 9 months, and annually.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus for at least 1 year
* treated with oral antidiabetic agents or insulin at stable doses for at least 3 months
* HbA1c between 6 and 12% inclusive
* baseline retinopathy severity not to exceed 53/\<53 on the ETDRS scale
* unlikely to require laser surgery or vitrectomy within upcoming year

Exclusion Criteria:

* prior treatment with insulin glargine
* treatment with insulin analogs (eg insulin lispro or aspart) in the year prior to enrollment