cyrilzakka/clinical-trials huggingface dataset:
UMCC 9609 Tretinoin in Preventing Cancer of the Cervix in Patients With Cervical Neoplasia

RATIONALE: Tretinoin may help cervical neoplasia cells develop into normal cervical cells. It is not yet known whether tretinoin is more effective than a placebo in preventing cervical cancer in patients with cervical neoplasia.

PURPOSE: Randomized clinical trial to study the effectiveness of tretinoin in preventing cervical neoplasia from developing into cervical cancer.

OBJECTIVES: I. Determine whether topical tretinoin reduces the number of viral genome copies of human papilloma virus (HPV) per cell and inhibits HPV E6/E7 gene expression in patients with cervical dysplasia. II. Determine the dose of tretinoin for use in a definitive trial that produces the best overall modulation of these biomarkers.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cervical intraepithelial neoplasia classification (II vs III). Patients are randomized to 1 of 4 arms. Arm I: Patients receive low-dose tretinoin topically via cervical cap and polyurethane ether foam sponge changed daily for 4 days. Arm II: Patients receive intermediate-dose tretinoin as in arm I. Arm III: Patients receive high-dose tretinoin as in arm I. Arm IV: Patients receive placebo topically as in arm I therapy. Patients are followed for 6 months.

PROJECTED ACCRUAL: A total of 180 patients (45 per arm) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven cervical dysplasia (cervical intraepithelial neoplasia II or III) Lesions must be delineated after colposcopic biopsy No pap smears suspicious for invasive carcinoma No positive endocervical curettage

PATIENT CHARACTERISTICS: Age: Over 14 Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Immunologic: No proliferative skin disorder (e.g., psoriasis) No diagnosed autoimmune disorders No allergy to tretinoin or latex Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception (except intrauterine device) during and for 3 months after study Normal diet with adequate protein and carbohydrate intake No in-utero exposure to diethylstilbesterol No prior malignancy No prior toxic shock syndrome

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 1 week since prior tretinoin No prior retinoids (greater than 25,000 IU vitamin A or equivalent for at least 3 months) No other tretinoin during or for 3 months after study Endocrine therapy: No concurrent regular steroids Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No concurrent regular anticoagulant medication No concurrent nutritional supplements other than 2 multivitamins per day
Screening Using Portable Electronic Recorders for Sleep Apnea in Hypertensive At-Risk Populations (SUPER-SHARP Trial)

Uncontrolled hypertension is associated with an increased risk of heart disease, stroke, and mortality. Obstructive sleep apnea (OSA) is common in hypertension and treatment using continuous positive airway pressure (CPAP) has been shown to effectively lower blood pressure. Despite its clinical significance, OSA remains underdiagnosed in patients with hypertension, because the current standard of care to diagnose OSA is in-laboratory polysomnography, which is inconvenient and often inaccessible for high-risk populations. An alternative to in-laboratory polysomnography is home sleep apnea testing, which has been validated against in-laboratory polysomnography and may be more convenient, accessible, and potentially cost-effective. The objective of this study is to compare home sleep apnea testing to in-laboratory polysomnography in a randomized controlled trial. The investigators will assess whether the use of home sleep apnea testing, compared to use of in-laboratory polysomnography, leads to higher rates of OSA diagnosis and treatment using CPAP, a reduction in blood pressure, improved sleep-related outcomes, and greater patient satisfaction among patients with hypertension at 6 months. The investigators will also assess whether home testing is cost-effective.


Eligibility Criteria:
Inclusion Criteria:

* (1) Hypertension, defined as:
* uncontrolled blood pressure on or off medications, or
* controlled blood pressure on 2 or more blood-pressure lowering medications
* (2) At high risk for OSA:
* STOP-BANG sleep apnea screening tool ≥3, or
* Concomitant renal disease (estimated glomerular filtration rate \[eGFR\] 15-59), or
* Resistant hypertension, defined as a blood pressure above target despite 3 or more BP-lowering drugs at optimal doses (preferably including a diuretic)

Exclusion Criteria:

* prior diagnosis of OSA, current use of CPAP, life expectancy less than 6 months, eGFR\<15, gestational hypertension or preeclampsia, current use of dialysis, and physical/cognitive impairment/language barrier restricting the ability to complete the study assessments.
Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.

This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6 mmol/L at the start of the school week following weekend/holiday breaks in subjects who have been randomized to receive daily injections of I-deg or I-glar. Hypothesis: β-hydroxybutyrate levels will be lower in the morning of the first day of the school week in subjects receiving I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays. To remove variability due to potential non-compliance during the school week, this study will utilize our routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment
* HbA1c ≥8.5%9 and \<14% on enrollment
* Taking no medications known to affect blood glucose levels other than insulin.
* Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is \< age 18 before any trial-related activities
* Current regimen includes insulin detemir or I-glar, as long acting insulin
* Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration
* Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week
* Willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check

Exclusion Criteria:

* Female participants who are pregnant, breast-feeding or planning on becoming pregnant
* Participant (and parent if age \<18) unable to read, write, and speak English.
* Adolescents who are home schooled or no longer attending secondary school
* Participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels
* Known or suspected allergy to trial medication(s), excipients, or related products.
* Contraindications to study medications, including hypersensitivity to I-deg or one of its excipients, hypersensitivity to I-glar or one of its excipients, and administration of either during episodes of hypoglycaemia
Modified Bortezomib-based Combination Therapy for Multiple Myeloma

To investigate the efficacy of a modified bortezomib based combination therapy for patients with multiple myeloma.

Multiple myeloma (MM) is a common hematological malignancy in Chinese elderly population. The application of novel drugs improved the clinical outcome and survival of MM patients,even though MM remains an incurable hematological malignancy. Bortezomib is a typical one among these novel agents, its application resulted in great success, but its adverse events and high expense restricted its widely usage. Investigators modified the dose and frequency of bortezomib administration in combination therapy: Patients in the modified group received regimen with bortezomib (1.6mg/㎡) as an intravenous bolus once weekly on day 1, 8 in a 3 weeks cycle, in combination with dexamethasone,with or without doxorubicin/ cyclophosphamide/mitoxsnteone/thalidomide，while patients in the control group received similar combination therapy except with conventional bortezomib (1.3mg/㎡) administration twice weekly on day 1,4, 8,11.

The aim of this study is to investigate whether the modified bortezomib-based therapy may attain a similar efficacy as the conventional ones.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma based on standard diagnosis criteria:

  * plasmacytomas on tissue biopsy
  * bone marrow plasmacytosis
  * monoclonal immunoglobulin spike on serum electrophoresis
  * lytic bone lesions.
* Must have relapsed or relapsed/refractory disease
* 18 years of age or older
* All baseline studies must be performed within 21 days of enrollment.
* ECOG performance status of 0 to 2

Exclusion Criteria:

* Renal insufficiency (serum creatinine levels \> 2mg/dL)
* Concomitant therapy medications that include corticosteroids
* Peripheral neuropathy of Grade 3 or greater or painful Grade 2
* Evidence of mucosal or internal bleeding and/or platelet refractory
* ANC \< 1000 cells/mm3
* Hemoglobin \< 8.0 g/dL
* AST (SGOT and ALT) \> 2 x ULN
* Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol
* Known hypersensitivity to thalidomide or the development of erythema nodosum
* Active infection or serious co-morbid medical condition
* Pregnant or breast-feeding women
* Prior malignancy with the last three years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, on in-situ prostate cancer
Ramadan Fasting Effects in Patients With Cardiovascular Risk Factors

Ramadan Fasting has multiple effects on the variation of hematological and biochemical parameters.

This is a prospective observational study, including patients with cardiovascular risk factors and doing the fast of Ramadan with assessment before, during and after the month of Ramadan.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiovascular risk factors in stable conditions
* Ramadan fasting

Exclusion Criteria:

* Impossibility, contraindication or interruption of fasting
Early Alimentation Following Colorectal Surgery

This study wants to address the question of whether or not oral alimentation should be begun early in patients following colorectal surgery compared to the classical diet which depends on reappearance of functional intestinal transit. Early oral alimentation following colorectal surgery may decrease hospitalisation stay duration.

Following intestinal surgery, the classical protocol indicates the use of a naso-gastric tube and starvation more or less prolonged of the patient dependent of surgeon's view. Decision to feed the patient is based on gas and feces reappearance after surgery. However, prolonged starvation might be uncomfortable for the patient as well as increasing his hospitalization stay. Moreover, delayed feeding effect on anastomosis and wound healing is controversial and naso-gastric tube use is known to be uncomfortable and may generate secondary adverse events.

Some studies in opened surgery observed that early alimentation was beneficial against post-surgery mortality, infection risk and anastomosis dehiscence. In addition, early feeding seemed to decrease patient hospitalisation stay.

In order to conduct this study, patients having a colorectal surgery will be randomly attributed to the nil per os group, which is based on the reappearance of a functional intestinal transit, or to the experimental group, which will begin alimentation 12 hours after colorectal surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years old or more
* Class ASA (American Society of AnaesthesioIogy) I, II or III, +/- E
* Patient willing to participate in the study
* Patient who understands and accepts to sign the informed consent form
* Patient who will undergo elective or urgent colic resection using laparoscopy or opened surgery defined in section B

Section B: patient must meet one of the following inclusion criterion:

* segmental or total colorectal resection with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
* ileal resection in continuity with total or a segment of the colon with creation of a primary colo-colic or colo-rectal anastomosis not protected with a derivation ostomy
* Closing of a terminal or loop colostomy

Exclusion Criteria:

* Class ASA IV or V patient
* Documented problem of gastro-intestinal motility
* Pregnancy
* Any acute or recent (\<10 days) septic event
* Chemotherapy during the 4 weeks preceding surgery
* Previous irradiation surrounding the planned anastomosis location
* Small intestine iatrogenic transparietal laceration done during surgery
* Small intestine synchrone resection without continuity with the colon
* Intra-peritoneal chemotherapy administered during or following surgery
* Presence of residual peritoneal carcinosis at the end of surgery
* Colic surgery associated with another major intra-abdominal surgery
* Creation of a colo-anal or ileo-anal anastomosis
* Any per-surgery discovery which requires the use of a gastric drainage procedure following surgery
* Any post-surgery change in patient condition which requires naso-gastric tube holding after surgery
Measurement of Substance P in Saliva of Low Back Pain Patients

The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain
* A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)
* Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)

For healthy subjects:

* Volunteers with no pain (anywhere)
* That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.

Exclusion Criteria:

* Subjects with pain that is additional to or different from chronic low back pain
Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

The purpose of the study is to further evaluate the safety and efficacy of EUR-1008 as compared to Kreon® in the treatment of exocrine pancreatic insufficiency associated with Cystic Fibrosis in subjects 12 years of age and older.


Eligibility Criteria:
Inclusion Criteria:

1. Definitive diagnosis of CF based on the following:

   * One clinical feature consistent with CF and
   * Either a genotype with 2 identifiable mutations known to cause CF or a sweat chloride concentration \>60 mEq/L by pilocarpine iontophoresis
2. Pancreatic insufficiency documented by a monoclonal faecal elastase (FE) 100 μg/g stool at screening (test results within the previous 12 months are acceptable)
3. Currently receiving pancreatic enzyme replacement therapy
4. Adequate nutritional status based on the following: body mass index (BMI) \>19 kg/m2 in adult subjects or a BMI percentile 10th percentile for age in adolescent (12 to 17 years age group) subjects
5. Are clinically stable with no evidence of concomitant illness or acute upper or lower respiratory tract infection that requires antibiotics during the 7-day interval prior to screening and preceding entry into this clinical study

Exclusion Criteria:

1. Age \<12 years
2. Known contraindication, hypersensitivity, or intolerance to pork or other porcine PEPs
3. Current uncontrolled diabetes mellitus
4. History of solid organ transplantation
5. History of surgery affecting the bowel function and weight gain
A Study of the Intervention Effect of a Hybrid Exercise Program on Elderly With Sarcopenia

Sarcopenia is a geriatric condition characterized by a progressive decrease in skeletal muscle content and loss of muscle function. Resistance exercise, Taichi exercise and the hybrid exercise program consisting of the two aforementioned methods have been demonstrated could increase the skeletal muscle mass of the elderly with sarcopenia. However, note that the above contents may be performed in a different order in a treatment, equally important but less well understood is the sequence in which it should be performed. Surprisingly, the exercise sequence has not been comprehensively investigated. Therefore, investigators designed a self-ordered exercise program combining resistance exercise, tai chi and a hybrid exercise program to investigate whether the decline in skeletal muscle area could be better overcome and the reversal of sarcopenia in elderly with sarcopenia.


Eligibility Criteria:
Inclusion Criteria:

1. satisfied the Asian screening criteria for sarcopenia by the Asian Working Group for Sarcopenia;
2. age higher than 60 but less than 75 years of age.

Exclusion Criteria:

1. with serious illness or breathing failure;
2. with neuro-muscular diseases;
3. taking medication that has an effect on the function of skeletal muscles;
4. with conditions relating to the neurological system or the mental health;
5. in another scheduled training plan.
Complex Decongestive Therapy on Distal Radius Fracture

Trauma results in inflammatory reactions accompanied by high protein edema. Trauma can also reduce the carrying capacity of the lymphatic system below normal lymphatic load, leading to exposure of lymphedema. Cellular wastes accumulated in interstitial fields and prolonged exudation period create a physiological problem. It causes the recovery time of tissues to be completed late and the functional gains to be delayed.

The aim of the study is to investigate the effect of Complex decongestive therapy on traumatic edema, pain and functionality.

Patients are composed of patients who are referred to the physical medicine and rehabilitation clinic. All patients eligible for the study were informed about treatment and possible risks, and a consent form was signed. Determined evaluations were made to the patients. After 3 weeks of treatment, patients will be invited to the controls and the long-term effects of the treatments will be investigated.

Patients with a diameter difference of more than 50 ml between two extremities and patients without Sudeck Atrophy will be included in the treatment.

The study was planned as a single blind with randomized control. The physiotherapist who performed the treatment received manual lymph drainage therapy training.

The patients were distributed to groups with a computer-based data distribution system. While the patients are sent for treatment, they are directed according to the first assessment. The person who performed the assessment and those who received treatment were planned differently.

The primary purpose of the study was to investigate the long-term effectiveness of complex decongestive therapy on traumatic edema, as well as to evaluate long-term hand functions. Other objectives are to investigate the long-term effects on range of motion, muscle strength, grip strength, pain, and daily living activities.

Eligibility Criteria:
Inclusion Criteria:

* Over 45 years
* Unilateral distal radius fracture treated with plaster cast
* Begin treatment after (7-10) days after removing the plaster
* At least 50 mL of the volume difference between the upper extremities
* Having signed the consent form

Exclusion Criteria:

* Associated ulna fracture
* Pathological fracture
* polytrauma
* Bilateral fractures
* With chronic kidney disease
* The presence of infection
Clinical Performance of Short Fiber Reinforced Flowable Resin Composite Restorations 2y RCT

Clinical performance of short fiber reinforced flowable resin composite restorations versus conventional resin composite restorations will be tested in posterior teeth (2y randomized clinical trial).


Eligibility Criteria:
Inclusion Criteria:

* Patients with large proximal carious cavities in molars.
* Pulp asymptomatic vital carious upper or lower molars.
* Good oral hygiene.

Exclusion Criteria:

* Presence of signs and symptoms of irreversible pulpitis or pulp necrosis
* Severe medical complications.
* Allergic history concerning methacrylates
* Evidence of parafunctional habits.
Study of Immunosuppressive Therapy Toxicities in Kidney Transplant Recipients at Regional or Satellite Community Clinics

This is a multicentre, observational, non-interventional, retrospective analysis by chart review.

This study will compare differences in patient and graft related outcomes in renal transplant recipients followed in regional transplant centers versus satellite clinics.

Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 months post transplant
* Patient had the current transplant during the period 1 July 1997 to no less than 18 months prior to chart review
* Patient is currently on tacrolimus/MMF or AZA - or cyclosporine/MMF or AZA based immunosuppressive therapy
* Patient is not a recipient of dual kidney or multi -organ transplant
* Patient has a functioning graft (i.e. patient does not require dialysis)
* Patient is recipient of a renal transplant including living or cadaveric, related or non-related, or pediatric en bloc kidneys, but excluding kidney-pancreas transplant recipients
* Patient received the current transplant at one of six identified regional transplant centers
* Patient is currently followed in a regional or satellite community based nephrology clinic
5-minute Mindful Pain Management Strategy

This project is a single-site, two-arm, pilot study assessing the feasibility and preliminary efficacy of a 5-minute Mindful Mapping intervention for adults with chronic musculoskeletal pain (n=60) relative to a time- and attention-matched control condition.

This was a two-arm (Mindful Mapping vs. Serial Sevens), remotely delivered, parallel-group, pilot RCT. All procedures were approval by the local IRB and preregistered (NCT06394765). Written informed consent was obtained from all participants prior to their inclusion in the study. Participants were randomly assigned (1:1) to either the Mindful Mapping intervention (n=30) or a control condition, Serial Sevens (n=30). Randomization was performed using a computer-generated sequence.

Eligibility Criteria:
Inclusion Criteria:

* having a chronic pain diagnosis
* being able not to commit to another (new) treatment during the course of the study
* understanding English instructions fluently
* Being 18 and above

Exclusion Criteria:

* having learned to practice mindfulness meditation any time in the past
* being unable to perform most basic tasks due to pain or pain treatment