cyrilzakka/clinical-trials huggingface dataset:
Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial

This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.

The study will be based on a four-arm parallel group randomized control design. one hundred and twenty participants with SIJD will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into four groups A, B, C, and D. Experimental group A will be receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack, Stretching exercise, and MCE \& BT intervention, control group D will receive the hot pack, Stretching exercise intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age-30-60 Years
* sacroiliac joint pain (\>3 months)
* Presence of pain exacerbated as a result of bending laterally or backward
* Positive results on at least 2 of the pain-provocation tests \[FABER, Posterior shear and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests)

Exclusion Criteria:

* past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months
* lower extremity musculoskeletal disorders; known localized spinal pathology
* known congenital anomalies of hip, pelvis or spine that limits mobility
* known systematic arthropathy, neuropathy or metabolic disorder
* Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning
* pregnancy
Restylane Perlane to Shape the Nasal Dorsum and/or Nasal Root

The purpose of this study is to determine the safety and efficacy of using Restylane Perlane to shape the nasal dorsum and/or nasal root in comparison with a no-treatment control group


Eligibility Criteria:
Inclusion Criteria:

* Chinese origin
* Subject with desire to shape the nasal dorsum and/or nasal root
* Subjects who, in the opinion of the investigator, can achieve a clinically meaningful aesthetic correction of their nose with ≤ 1 ml Restylane Perlane

Exclusion Criteria:

* Subjects with previous nasal surgery, including grafts or implants to the nose area
* Subjects requiring filler treatment around the tip of the nose or between the eyebrows (glabella region) to achieve a good aesthetic outcome
* Subjects with a history of chronic sinusitis or rhinitis
* Subjects who have previously received aesthetic treatment in the forehead, glabellar and/or nose area with a dermal filler
Continuous EKG Monitoring Using S-Patch Ex : Prospective Observational Study (S-patch Registry)

Atrial fibrillation (AF) is associated with increased mortality and morbidity, and is a dominant, yet preventable, cause of cardioembolic stroke, which has more severe outcomes than other ischaemic stroke causes if left untreated. Approximately 10% of ischemic strokes are associated with AF (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation.

Early diagnosis of AF might enable oral anticoagulant therapy and prevent unwanted consequences of undetected disease, leading to the suggestion that screening for AF might be beneficial in populations at risk. However, there is still debate about whether screen-detected AF bears a similar stroke and mortality risk profile to clinically detected AF, particularly when AF screening is done at a higher intensity than single-time point.

The absence of studies reporting on hard clinical endpoints in AF screening has led to differences in recommendations globally. Most notably, systematic screening for AF is to be considered according to 2020 European guidelines, whereas the US Preventive Services Task Force concluded that current evidence is insufficient to assess the balance of benefits and harms of screening for AF.

The incidence of screen-detected AF strongly depends on the population screened and duration/intensity of screening. Single-time point screening of a general population ≥65 years of age detects undiagnosed AF in 1.4%, and the AF detected is largely persistent. In a large population-based study of individuals 75 to 76 years of age, a more intense 2-week screening program using twice-daily intermittent handheld ECG recordings identified AF in 3.0% (0.5% on the initial ECG4). The identical protocol restricted to those with ≥1 additional stroke risk factor identified 7.4% with AF.

This study was designed in to two arms. The purpose of Arm 1 is to upgrade the artificial intelligence by collecting the continued ECG monitoring data in patients with previous diagnosed AF. The purpose of Arm 2 is to investigate the detection rate of AF using systematic, intensive AF screening with continuous ECG monitoring and the rate of clinical outcome in individuals at high risk during one year follow-up.

Arm 1 Patients with AF are examined with 72 hour continued ECG monitoring Arm 2 Patients with high stroke risk (CHA2DS2-VASc score \>=2) are examined with 72 hour continued ECG monitoring

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are over the age of 19
2. Those with previous diagnosis of atrial fibrillation
3. Those without atrial fibrillation, but high stroke risk

Exclusion Criteria:

1. Those who refuse to participate in the trial.
2. Those without internet connection
Genetic Polymorphisms Predict Chemotherapeutic Outcomes in Patients With Metastatic Breast Cancer

The investigators want to research whether genetic polymorphisms of drug-metabolizing enzymes can be used to predict chemotherapeutic outcomes in patients with metastatic breast cancer.

1. Patients evaluation On all patients a complete clinical history and physical examination is performed, including routine hematology and biochemistry analyses. Hematology and biochemistry analyses are repeated at the end of each cycle. Toxicity is classified according to WHO criteria at each cycle for each patient. Response is assessed after two cycles of chemotherapy and every two cycles thereafter, using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
2. Sample collection and SNP genotyping Venous blood (4 ml) is collected from each subject and placed into tubes containing EDTA. Genomic DNA is isolated with a DNA Blood isolation kit.Genotypes are performed by PCR-RFLP, PCR-DHPLC and PCR-direct sequencing, etc.
3. Statistical Analysis x2 test is used to summarize the association of response and adverse events to chemotherapy with genetic polymorphisms.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed metastatic breast cancer
* Female
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* At least one measurable lesion
* Normal cardiac, hepatic, renal and bone marrow functions
* Life expectancy ≥3 months
* Discontinuity of previous chemotherapy for a minimum of 4 weeks

Exclusion Criteria:

* Central nervous system metastases
* Serious or uncontrolled concurrent medical illness
* History of other malignancies
PreDM Clinical Decision Support Intervention

Clinical practice guidelines recommend intensive lifestyle interventions and metformin to prevent or delay type 2 diabetes; yet these treatments are not routinely used among the 86 million U.S. adults with prediabetes who may benefit from them. While clinical decision support (CDS) represents an effective approach for delivering guideline-based care, the potential of this strategy to improve diabetes prevention efforts has not been definitively tested. This study developed the novel Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention and evaluated its impact on clinical outcomes.

Eighty six million U.S. adults have prediabetes, and up to 75% of them will eventually develop diabetes. Landmark clinical trials have established that intensive lifestyle interventions (ILI) and metformin are safe and effective treatments to prevent or delay diabetes in adults with prediabetes and overweight/obesity. Despite being included in expert clinical guidelines, these treatments are rarely used and few studies have explored how to promote their uptake in practice. One possible approach for increasing adoption of ILI and metformin in primary care includes clinical decision support (CDS), which uses electronic systems to create tailored recommendations for evidence-based clinical care. While a large body of evidence demonstrates that CDS can improve the delivery of other recommended preventive services, this approach has not been definitively studied for ILI and metformin. The investigators plan to address this critical knowledge gap by developing and evaluating the Prevent Diabetes Mellitus Clinical Decision Support (PreDM CDS) intervention for community health center patients with prediabetes and overweight/obesity. This novel CDS engages primary care providers and clinical staff to deliver intervention components.

This study tests the potential for CDS to promote diabetes prevention and weight loss efforts in primary care. The current study objectives were to: 1) interview providers about their preferences for CDS focused on prediabetes; 2) develop a novel CDS tool, the Prediabetes CDS (PreDM CDS), promoting evidence-based care for prediabetes; and 3) conduct a pilot evaluation of the novel CDS tool using electronic health record data. Study investigators hypothesize that the proposed PreDM CDS will increase patient's adoption of ILI and metformin, producing modest weight loss and improvements in other cardiometabolic markers.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years old
* prediabetes
* two weight measurements during the study period

Exclusion Criteria:

* The primary exclusion criterion is type 2 diabetes.
* The following additional criteria will exclude those in whom treatment is potentially harmful or outcomes assessment may be confounded: serum creatinine \>1.4mg/dL in women and \>1.5mg/dL in men, uncontrolled hypertension (≥180/100mmHg), prior antidiabetic medication orders, and gastric bypass surgery or pregnancy during the evaluation period.
Postoperative Pain Intensity Associated With the Use of Different Nickel Titanium Instrumentation Systems

In this study the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment was evaluated.

The aim of this clinical study was to evaluate the effect of different engine-driven nickel titanium (Ni-Ti) instrumentation systems (OneShape, Revo S and WaveOne) on postoperative dental pain in patients with asymptomatic teeth after a single-appointment root canal retreatment. A total of a hundred thirty nine patients with asymptomatic teeth and with no contradictory medical history who were indicated for non-surgical retreatment at the Endodontic Clinic, Faculty of Dentistry, Istanbul Medipol University, between September and December 2016 were included in this study. All of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. Out of a hundred thirty nine patients, a total of ninety-nine patients who met the inclusion criteria and agreed to participate was enrolled for the study and were divided into three groups (n=33). Consent was obtained from all study participants before the treatment. After removing previous root canal filling, instrumentation was performed using One Shape, Revo-S, and WaveOne in groups 1, 2, and 3, respectively. All retreatments were performed in a single appointment by one endodontist before permanent coronal restoration. Postoperative pain intensity was assessed at 6, 12, 18, 24, 48, and 72 h; 7 days; and 1 month after the retreatment. The teeth was examined according to for pain intensity, percussion \& palpation sensitivity, swelling, analgesic intake and clinical status.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic teeth
* Patients with no contradictory medical history
* Patients who were indicated for non-surgical retreatment and
* Patients who were above 18 years old

Exclusion Criteria:

* Patients aged below 18 years;
* Symptomatic teeth,
* Teeth with vertical root fractures
* Teeth with excessive periodontal disease;
* Patients who received or required surgical endodontic treatment
* Patients diagnosed with systemic diseases
* Patients who used analgesics 12 h before or
* Patients who used antibiotics 1 month before the retreatment
Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).

A randomized controlled trial will conducts between January 2017 and January 2019, participants with acute fifth metatarsal fracture (Zone II) will recruit for this study at the orthopedic outpatient clinic of a police general hospital, Bangkok, Thailand. A total of 100 patients will randomly allocate to receive foot cast or short leg cast. acute closed fracture of proximal fifth metatarsal (zone II) patients.

Eligibility Criteria:
Inclusion Criteria:acute closed fracture of proximal fifth metatarsal (zone II) with following criteria

1. History of trauma and pain at lateral side of foot
2. Tenderness at base of 5th metatarsal
3. Radiographic finding shown fracture line at proximal 5th metatarsal bone

Exclusion Criteria:

1. more than 1 week
2. comminuted or multiple fracture
3. Open fracture
4. Ligament and tendon injury
5. Previous injury complication: nonunion, delayed union
6. Malignancy
7. refuse to inform consent
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

The primary purpose of this study is to develop a specialized behavioral activation treatment for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we utilize focus groups and pilot testing with 15 youths to develop the behavioral activation smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A subset of participants will also undergo an fMRI session to examine reward sensitivity.

1. 18-21 years of age,
2. a regular smoker for at least 6 months
3. currently smoking an average of at least 5 cigarettes per day
4. want to quit smoking
5. report current elevated depressive symptoms

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 21 years of age
* a regular smoker for at least 6 months
* currently smoking an average of at least 5 cigarettes per day
* want to quit smoking
* report current elevated depressive symptoms

Exclusion Criteria:

* current Axis I disorder
* psychoactive substance dependence (excluding nicotine dependence) within the past 6 months
* current use of psychotropic medication or participation in any form of psychotherapy
* a history of significant medical condition (e.g., cardiovascular , neurological, gastrointestinal), pregnancy and/or breast feeding, or other systemic illness
* limited mental competency \[Mini Mental State Examination score \< 23\] and/or the inability to give informed, voluntary, written consent to participate
* current use of any pharmacotherapy for smoking cessation not provided by the researchers during the quit attempt

Additional Exclusion criteria only for the fMRI portion:

* cerebrovascular disease
* high blood pressure
* diabetes
* use of psychotropic medications in 3 weeks prior to participation in fMRI protocol
* exposure to extreme trauma
* lifetime history of mania, psychosis, or pervasive developmental disorder,
* being ambidextrous or left handed
* any metal implants, heart pacemaker, permanent retainer
* tattoos containing metal dyes
* claustrophobia.
Nutritional Strategy for Glycemic Control in Patients With Type 2 Diabetes Mellitus (NUGLIC)

Adherence to a healthy dietary pattern is part of the self-care of patients with type 2 diabetes mellitus (T2DM), and may contribute substantially to therapeutic target goals and to a better quality of life as well. However, not all nutritional recommendations aimed at these patients are easily applicable in clinical practice. The primary objective of the study is to evaluate the effectiveness of a nutritional strategy for glycemic control in patients with T2DM users of a Public Health System after 6 months of follow-up. As secondary objectives, we will evaluate the impact of the proposed strategy on self-care and on the quality of life of the patients. In this randomized multicenter open-label randomized trial, 370 patients \>30 years old with T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who have not received or received nutritional counseling for at least 06 months will be enrolled. Patients allocated to the control group will receive individualized dietary prescription according to the guidelines of the Brazilian Society of Diabetes. Nutritional counseling in the intervention group will be performed based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance will be based on feasible goals built together (patient and nutritionist), and no diet will be prescribed for intervention group. In both groups, patients will receive glymeters for residential self-monitoring of glycemic levels. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and blood pressure will be also evaluated.


Eligibility Criteria:
Inclusion Criteria: \>30 years old with medical diagnosis of T2DM, glycated hemoglobin (HbA1C) ≥7% at the moment of the screening and who have not received or received nutritional counseling for at least 06 months.

Exclusion Criteria:

* Patients with type 1 DM (T1DM), latent autoimmune diabetes in adults (LADA) or HbA1C ≥ 12%;
* Severe neuropathy;
* Chronic kidney disease;
* Active cancer or life expectancy \<6 months;
* Chemical dependence or use of antipsychotic drugs;
* Autoimmune disease or chronic use of steroids;
* Gastroparesis;
* Pregnancy, lactation, gestational DM;
* Acute coronary syndrome (ACS) in the last 60 days;
* Wheelchair users;
* Extreme obesity (body mass index \[BMI\] ≥40kg/m²);
* Cognitive, neurological or psychiatric condition that prevents participation in the study;
* Participation in other clinical trials.
Focal Brachytherapy in Patients With Selected "Low-risk" Prostate Cancer - a Phase-II-trial

This trial examines the feasibility and toxicity of focal brachytherapy in patients with low-risk prostate cancer.

Patients with low-risk prostate cancer will receive HDR-Brachytherapy: 2 x 13,5 Gy.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Histologically confirmed prostate cancer
* Gleason Score of index lesion ≤ 6 (3+3)
* Tumor stage: cT1-2a cN0 cM0
* Unilateral affection; index lesion ≤ 0.5ml with or without clinically non-significant lesion contralateral. No more than 25% of the punch should be affected. Therefore a 3D-TPM-biopsy is mandatory before treatment.
* PSA ≤ 10/ng/ml
* Prostate volume \< 60 m\^3
* No distant metastasis
* Life expectancy \> 10 years
* Informed consent

Exclusion Criteria:

* Tumor stage ≥ T2b
* Known metastasis: N+ and/or M1
* General anesthesia or peridural anesthesia is not possible
* Coagulation disorder
Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection

The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy)
* Patients classified in class D according estimated risk of PAL
* Age between 18 and 80 years

Exclusion Criteria:

* Those patients that according to Investigator assessment are not going to tolerate the procedure
* Clinical and anesthetic criteria that contraindicate surgery
* Severe uncontrolled illness
* Pregnancy
* Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization.
* Lack of Informed Consent or patient refusal
* Postsurgery mechanical ventilation or repeated surgery in follow-up month.
Randomized, Masked Comparison of Bromfenac and Besifloxacin BID With Either Prednisolone BID or Loteprednol 0.5% BID for Prevention of Retinal Thickening and CME Following Phacoemulsification

The purpose of this study is to determine if Lotemax eye drops are at least as effective as Pred Forte eye drops, which are the standard of care after cataract surgery.

Prednisolone 1%, a topical steroid, is considered standard of care following cataract surgery to reduce inflammation. We aim to determine if Lotemax is at least as effective as Prednisolone. If so, these findings would demonstrate that physicians have other treatment options to consider.

Eligibility Criteria:
Inclusion Criteria:

* Male or female \>18 years of age scheduled to undergo cataract surgery
* Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
* Expected visual outcome of BCVA (best corrected visual acuity)\> 20/25 postoperatively, as determined by potential visual acuity testing and review of preoperative corneal topography and OCT (optical coherence tomography).
* Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

Exclusion Criteria:

* Known contraindication to any study medication or any of their components
* Required use of ocular medications other than the study medications during the study
* Evidence of macular disease (Epiretinal membrane, Vitreomacular traction syndrome, macular hole) on preoperative OCT (optical coherence tomography)
* Presence of significant dry macular degeneration that may impact postoperative visual results.
* History of retinal vein occlusion or diabetic macular edema, uveitis or any macular disease predisposing them to cystoid macular edema or prolonged intraocular inflammation.
* Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
* Anticipated need for mechanical iris dilating devices
* Presence of Epithelial Basement Membrane Dystrophy, significant dry eye, significant blepharitis, or any other corneal condition that may impact BCVA (best corrected visual acuity) postoperatively