cyrilzakka/clinical-trials huggingface dataset:
Abdominal Belt Use to Treat Low Back Pain

Objectives: To assess the effectiveness of an abdominal belt in the treatment of chronic mechanical-postural low back pain.

Methods: A randomized controlled trial was carried out, involving 60 consecutively selected patients with chronic low back pain randomly allocated to an intervention group (use of abdominal belt) and control group (non-use of abdominal belt). Patients were evaluated at the baseline of the study (T0) as well as 1 (T1), 3 (T3) and 6 months (T6) after the inclusion. The patients were assessed for: pain (VAS); functional capacity (Roland Morris), patient satisfaction (Likert scale); and number of anti-inflammatory pills ingested. Intention-to-treat analysis was also used.

Hypothesis - abdominal belt will improve pain in chronic low back pain patients


Eligibility Criteria:
Inclusion Criteria:

* patients from both genders,
* between 18 and 65 years of age,
* who sought medical care for a complaint of lumbar pain,
* diagnosed with Chronic low back pain, with VAS for pain between 4 and 8 cm (0-10),
* who agreed to participate in the study and signed terms of informed consent.

Exclusion Criteria:

* diagnosis or under diagnostic investigation of low back pain from secondary causes (spondyloarthopathy, infection, neoplasm, complete sciatica),
* fibromyalgia,
* previous spinal surgery,
* litigation (patients on leave from work or in work leave processes due to low back pain);
* having changed physical activity in previous three months;
* body mass index (BMI) higher than 30;
* acupuncture treatment or physiotherapy in the previous three months
Study Evaluating the Effects of Avanafil on Semen Parameters

The purpose of this study is to determine whether avanafil will affect different aspects of sperm production.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent
* Able to produce semen samples without requiring therapy (PDE5 inhibitors, over-the-counter (OTC) medication, and/or herbal supplements) for erectile dysfunction
* Be medically healthy (no clinically significant screening results for medical history, electrocardiogram (ECG), laboratory studies, physical examination, etc.) in the opinion of the investigator
* Be willing and able to comply with all study requirements

Exclusion Criteria:

* An International Index of Erectile Function (IIEF) erectile function domain score of less than 17;
* History of infertility, vasectomy, testicular mass, testicular trauma, testicular abnormality (including size), radiation to the testis, previous pelvic surgery, cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or cryptorchidism;
* Resting heart rate \<45 or \>90 beats per minute at screening (3 rechecks permitted);
* Screening systolic blood pressure \<90 or \>140 mmHg and/or diastolic blood pressure \<50 or \>90 mmHg (3 rechecks permitted);
* High serum FSH (\>18.0 mIU/mL), high serum LH (\>18 mIU/mL), or low serum testosterone (\< 270 ng/dL, early morning collection) on screening;
* AST or ALT \>2.0 x ULN or other evidence of significant hepatic impairment;
* Prostate specific antigen (PSA) level ≥4 ng/mL at screening;
* Individuals who perform rotating shift work during the course of the study.
Growth and Tolerance Trial on Infant Formula With HMO

The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age ≥ 37 weeks
* Birth weight ≥ 2500 grams
* No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
* Boys and girls
* Recruited \< 1 month/age
* Being available for follow up until the age of 4 months
* Exclusive formula feeding or exclusive breast feeding at time of recruitment

Exclusion Criteria:

* Gestational age \<37 weeks
* Birth weight \<2500 grams
* Severe acquired or congenital diseases, mental or physical disorders
* Illness at screening/ inclusion
* Incapability of parents/caregivers to comply with the study protocol
* Received antibiotics within the first month of life
* Not tolerating standard cow's milk based infant formula
* Participation in another clinical trial
* Maternal illicit drug use during pregnancy or post-partum period
* Parent/caregiver does not have a cell phone to use for filling out questionnaires
Simvastatin in Colorectal Surgery

Statins (HMG-CoA reductase inhibitors) are a widely used class of cholesterol-lowering drugs that have an established role in the medical management of cardiovascular disease. Their benefits have also been shown in the surgical setting with decreased cardiovascular complications and lower perioperative mortality following cardiac and vascular surgery. There is now considerable evidence showing statins have useful pleiotropic properties that extend beyond cholesterol lowering, including anti-inflammatory, anti-oxidant, immunomodulatory and fibrinolytic effects. Growing evidence suggests these effects may be useful in attenuating the proinflammatory and metabolic stress response to surgery and the benefit of statins may extend to other surgical settings such as abdominal surgery.

Laboratory studies demonstrate the surgically-relevant benefits of statins and show they decrease peritoneal inflammation, reduce the severity of intestinal ischaemia-reperfusion injury, improve survival in models of abdominal sepsis, decrease the formation of postoperative intraperitoneal adhesions and improve the healing of colonic anastomoses. Retrospective clinical studies show statins improve outcomes in sepsis, reduce the postoperative systemic inflammatory response syndrome (SIRS) and are associated with decreased rates of surgical wound infections and postoperative respiratory complications following various non-cardiac general surgical procedures. However, no prospective studies have specifically evaluated the perioperative use of statins in abdominal surgery. Using colorectal surgery as a model for major abdominal surgery, the investigators will conduct a randomised controlled trial evaluating the effect of perioperative statin use on postoperative morbidity, local and systemic inflammatory response, and functional recovery after surgery.


Eligibility Criteria:
Inclusion criteria:

* Consecutive consenting patients undergoing elective colectomy, rectal resection, and reversal of Hartmann's procedure at Middlemore Hospital, Manukau Surgery Centre, Auckland City Hospital, and North Shore Hospital.

Exclusion criteria:

* Acute presentation
* Already taking statins or other lipid-lowering medication
* Known adverse reaction to statins
* Hepatic dysfunction
* Moderate to severe renal dysfunction
* Previous history of rhabdomyolysis
* On contraindicated medication
* Pregnancy
* Breastfeeding
* Patient choice.
TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers

TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production. This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and effectiveness of TQB2223 injection in combination with Penpulimab in subjects with advanced cancers.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
* Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥3 months;
* Histologically or cytologically confirmed malignancies;
* Subjects with advanced malignant tumors who failed standard treatment or lacked effective treatment;
* Patient has at least one evaluable lesion assessed by RECIST 1.1;
* The main organs function is well;
* Male or female patient had no plans to become pregnant and voluntarily take effective contraceptive measures during study period until at least 6 months after the last dose of study drug.

Exclusion Criteria:

* Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 5 years;
* History of uncontrolled intercurrent illness;
* Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
* Prior treatment targeting LAG-3;
* Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
The Efficacy of Erythropoietin Oral Gel Versus Erythropoietin Mouthwash in the Management of Recurrent Aphthous Stomatitis

Erythropoietin (EPO) exerts anti-inflammatory effects by inhibiting NF- kappa B-dependent formation of pro-inflammatory cytokines, thus it reduces local and circulating levels of these disease (recurrent aphthous stomatitis RAS) related cytokines. So, it is considered as a potent anti-inflammatory cytokine in inflammatory disorders and infectious disease. It also accelerates wound-healing and decreases the extent of apoptosis and the areas of the open wound. this drug seems to be a promising therapeutic option in oral lesions. the effectiveness of EPO oral gel and EPO mouth wash were compared on patients with recurrent aphthous stomatitis and investigated therapeutic mechanism by examining treatment effect on expression of IL-2 IN RAS.

Thirty patients with recurrent aphthous stomatitis were randomly assigned into three equal groups to receive topical Erythropoietin oral gel four times per day (after meals and at bedtime) (Group I).

Erythropoietin mouthwash 4 times per day (after meals and at bedtime) (Group II), and placebo isotonic (normal saline) with concentration 0.90% of sodium chloride (NaCl) (Group III).

All patients were followed up four 1 week, photographs were taken at the beginning and end of the treatment.

patients were assessed using pain visual analogue scale (PVAS), clinical assessments for the size of the ulcers and rate of their recurrence.

pretreatment and post treatment salivary samples were taken to detect the expression and levels of salivary IL-2.

Eligibility Criteria:
Inclusion Criteria:

* All patients should be free from any systemic disease or Behcet syndrome.
* Patients ≥18 years of age, male or female are eligible.
* Oral pain score of 4 or higher on a scale of 0-10 with 0 representing no pain in the presence of oral ulceration.
* Patient has only aphthous ulcer and It should had not been passed more than 4 days from beginning of their ulcer.

Exclusion Criteria:

* • Patients with poor oral hygiene or not willing to perform oral hygiene measures.

  * Smoking and alcohol use.
  * Pregnant and lactating females
  * Patients with history of any topical or systemic medication or steroid therapy 1 month prior to the investigation.
  * The vulnerable group; prisoners, mentally or physically disabled patients.
Reducing Bacteria That Cause Tooth Decay

The purpose of the study is to determine the effect of a two-step mouth rinsing procedure on reducing the germs (mutans Streptococci) that cause tooth decay. We hope that the two-step mouth rinse (0.3% NaOCl followed by 10% Povidone Iodine) decreases the tooth causing germs better than the one-step mouth rinse (10% Povidone Iodine). The mouth rinse for both treatment groups is done only once at the beginning of the study after the initial saliva samples are taken, and before a detailed examination of the teeth and gums. It is hypothesized that the treatment group receiving the NaOCl and Povidone iodine will have significantly lower microbial counts than the control group (Povidone iodine) because the NaOCl will disrupt the microbial biofilm and make the Povidone iodine more effective in decreasing the microbes in the biofilm. Microbial counts are made from Salivary samples taken from participants at baseline, one week, one month, two months and three months. The samples are tested by two commercial methods for determining microbial counts. The CariScreen Test is a rapid bioluminescence assay that quantitates the total number of all of the organisms present. The CRT test requires a culture media that is specific for the two germs (S. mutans and Lactobacillus) strongly associated with tooth decay. The results of the CRT Test are read after three days of incubation.


Eligibility Criteria:
Inclusion Criteria:

* being over 20 years of age;
* having at least one obviously cavitated tooth;
* refraining from smoking, brushing the teeth and using a mouthwash the day of the bacterial sampling;
* refraining from using a commercial mouth rinse during the three months of the study;
* having any two of the following risk factors in the Caries Management by Risk Assessment (CAMBRA) protocol which qualifies as a high caries risk.

The high caries risk factors included:

* receiving fillings within the past three years;
* snacking frequently between meals;
* presenting with hyposalivation due to medication, radiation or systemic conditions;
* visual presence of heavy plaque accumulation;
* and a minimum of 20 natural teeth.

Exclusion Criteria:

* using a systemic antibiotic within the past three months;
* currently receiving dental treatment or planning to receive treatment within the next three months (emergency treatment allowed);
* being pregnant or nursing;
* any thyroid disease or sensitivity to iodine;
* the use of a commercially available mouth rinse the day of the screening examination;
* smoking, brushing the teeth and using a mouth rinse the day of the bacterial sampling;
* not being able to make morning examinations.
Trial on Two Treatments for Adolescent Idiopathic Scoliosis

Adolescent Idiopathic scoliosis is a three-dimensional structural deformity of the spine and pelvic that occurs in children. More evidence has arisen to emphasize the important role played by pelvic asymmetry during the progression of scoliosis. The purpose of this study is to compare the effectiveness of pelvic adjustments accompanied with Schroth-based exercises, with the latter alone in adolescent idiopathic scoliosis, to assess the impact of pelvic asymmetry on the spinal three-dimensional parametric features in scoliosis.

Adolescent idiopathic scoliosis is the most common three-dimensional structural deformity of the spine among adolescence, the International Society on Scoliosis Orthopaedic and Rehabilitation Treatment recommend specific exercise therapy to delay the progression of scoliosis. Many specific exercise therapies are effective in reducing the angle of coronal scoliosis, but their efficiency in sagittal and axial deformities hasn't been convincing. Recent studies have found that the axial asymmetry of the pelvis may be involved in the pathogenesis of idiopathic scoliosis, but there is no clinical study on the treatment of scoliosis by correcting the axial torsion of the pelvis neither at home nor abroad. So in this study, "3 plus 1" multidimensional exercise therapy was applied to mild adolescent idiopathic scoliosis for the first time.

The present study is a single-center randomized controlled trial conducted at the department of rehabilitation medicine, Aerospace Center Hospital. The written Informed consent will be obtained from each patient and one of their parents before inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio either to the experimental group, in which the "3 plus 1" multidimensional exercise therapy will be performed and pelvic correction technique was adopted to correct pelvic axial rotation, or the control group, in which they will receive the Schroth-based exercise therapy. Blinded assessments will be conducted at baseline and 6-month after the intervention, including the differences in three-dimensional structural parameters of pelvis and spine, such as the ratio of the iliac widths, SRS-22 questionnaire, etc, to compare the efficacy of two different groups in improving the three-dimensional balance of the spine and the quality of daily life in adolescent idiopathic scoliosis.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of adolescent idiopathic scoliosis; Age from 10 to 18 years; A Cobb angle of 10 to 25 degrees; All maturity levels (Risser sign of 0-5).

Exclusion Criteria:

* Non-idiopathic scoliosis, which is caused by a neuromuscular, neurological, congenital malformation, or trauma-related comorbidity; Having mental problems or other contraindications to exercise; Previous fractures, rheumatic diseases, or operation history of lower extremities; Previous or current brace or surgical treatments for scoliosis.
Evaluation of the Postoperative Effect of Expanded Pedicled Deltopectoral Flap to Repair the Facial-Cervical Scars

This study evaluates the effect of Expanded Pedicled Deltopectoral Flap on facial-cervical scars repair, including flap sensation, L\*a\*b\* value,flap's elasticity,melanin content, hemoglobin content, and evaluation of scar and patient, doctor, and third-party satisfaction

The scars of face and neck caused by burning often show as large faciocervical scar.Important areas of current focus in face and neck scars management are functional outcomes and quality of patient life.The deltopectoral flap was first described by Bakamjian in 1965, and was recognized as one of the first choices for facial reconstruction, as the texture, color of the flap skin is similar to the facial skin. Since the tissue expansion technique was used to the flap, the flap became one of the best choices for the facial defect reconstruction,especially for Asian patients. It can be used with pedicled or free transferred.Complications at the donor or recipient site have been widely reported and often include dilator exposure,the flap blood circulation disorder and delayed healing, but the pattern of sensory recovery ,flap's elasticitycolor change have been studied less well.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent Expanded Pedicled Deltopectoral Flap to repair facial-cervical scars in 2006 -2018.
2. In compliance with ethical requirements, patients were voluntarily tested and signed informed consent.

Exclusion Criteria:

1. Peripheral neuropathy
2. Serious aphasia or cognitive impairment, and first-degree relatives can not get in touch.
3. Can not follow up
4. Allergic constitution
5. Connective tissue disease
6. Hormone or chemotherapy drugs are being used.
7. Diabetes
Tanezumab in Osteoarthritis Of The Hip

The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the hip according to ACR criteria with Kellgren-Lawrence x-ray grade of 2
* Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for Hip injections, arthroplasty or replacement surgery
* Pain level and function levels as required by the protocol at Screening and Baseline
* Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study
* Must agree to the contraceptive requirements of the protocol if applicable
* Must agree to the treatment plan, scheduled visits, and procedures of the protocol

Exclusion Criteria:

* Pregnancy
* BMI greater than 39
* Other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori

To evaluate the efficacy and safety of Traditional Chinese Medicine (TCM) decoction and powder combined with standard triple therapy on improving eradication rate of Helicobacter Pylori (H. pylori).A multi-center randomized control clinical trial design was adopted in the trial.


Eligibility Criteria:
Inclusion Criteria:

* those who met chronic gastritis (chronic superficial gastritis and chronic atrophic gastritis) diagnostic criteria;
* aged between 18-65 years old;
* positive H. pylori infection confirmed by two or more methods of different
* principles (stop using PPI, H2RA, bismuth, and antibiotics since two weeks before examination);
* patients were informed consent and willing to accept corresponding treatments.

Exclusion criteria:

* Patients having chronic atrophic gastritis with severe dysplasia, upper gastrointestinal bleeding, peptic ulcers, and gastrointestinal tumors;
* digestive organic disease (such as chronic pancreatitis, cirrhosis, etc.), or systemic diseases affecting intestinal motility (such as hyperthyroidism, diabetes mellitus, chronic renal insufficiency, mental, and neurological diseases, etc.);
* those who were accompanied by serious heart, liver and other major organs lesions, blood diseases, and cancer (ALT, AST two times higher than normal value);
* those who had taken medicines that might affect H. pylori detection results within two weeks (antacids, H2RA, PPIs, bismuth and antibiotics, etc.);
* pregnant and lactating women; patients with history of systematic and neuropsychiatric disorders; those who had history of any drug allergy; and those who were participating in other clinical trials.
Inflammatory Bowel Disease in South Eastern Norway

The IBSEN III study will investigate the incidence of inflammatory bowel disease in South Eastern Norway and describe the clinical course of the disease. The investigators will map newly diagnosed and treatment naive IBD patients at various levels (epidemiological, clinical, psychosocial and nutritional as well as immunological, genetic, epigenetic and microbial) as a basis to improve targeted and individualized treatment and care. The investigators will include incident IBD patients at all local- and university hospitals in the South Eastern Health Region in 2016-2018 and follow-up prospectively for five years. The investigators will use standardized and validated registration methods allowing comparability with previous national and international IBD cohorts, link data to national health registries and collect blood, feces and biopsies for bio banking.


Eligibility Criteria:
Inclusion Criteria:

Ulcerative colitis:

Diagnostic criteria (at least three out of four criteria present):

1. A history of diarrhea and/or pus in stools for more than 4weeks or repeated episodes.
2. Macroscopic appearance at endoscopy of continuous mucosal inflammation affecting the rectum in continuity with some or the entire colon.
3. Microscopic features on biopsy compatible with UC,
4. No suspicion of CD on small bowel X-ray, ileocolonoscopy or biopsy.

Crohn's disease:

Diagnostic criteria (at least two of four criteria present):

1. History of abdominal pain, weight loss and/or diarrhea for more than three months.
2. Characteristic endoscopic findings of ulceration (aphthous lesions, snail track ulceration) or cobble stoning or radiological features of stricture or cobble stoning.
3. Histopathology consistent with Crohn's disease (epitheloid granuloma of Langerhans type or transmural discontinuous focal or patchy inflammation).
4. Fistula and/or abscess in relation to affected bowel segments.

Inflammatory bowel disease, type unclassified (IBDU) :

Patients with evidence on clinical and endoscopic grounds for chronic inflammatory bowel disease affecting the colon, without small bowel involvement, and no definitive histological or other evidence to favor either CD or UC.

Pediatric patients:

Will be diagnosed according to the Porto-criteria and defined as:

Pediatric onset IBD ≤ 16 years Early Onset IBD (EOIBD) \< 10 years Very Early Onset IBD (VEOIBD) \< 6 years Infantile (and toddler) IBD \< 2 years Neonatal IBD \< 28 days

Exclusion criteria:

* Other causes of acute or chronic bowel inflammation must be excluded, i.e. infectious colitis, radiation colitis, diversion colitis, solitary rectal ulcer syndrome, graft versus host disease, diverticular colitis, medication associated colitis, ischemic colitis, microscopic colitis, enema associated colitis.
* Refusal or not able to give informed consent