cyrilzakka/clinical-trials huggingface dataset:
Panretinal Photocoagulation During Vitrectomy for Diabetic Vitreous Hemorrhage

In this randomized clinical trial, the authors compare two cohorts receiving different endolaser spot amounts with similar laser settings in PDR subjects naïve to PRP undergoing PPV for the indication of VH.

Enrolled patients will be randomized into 1 of 2 possible treatment groups: Group A patients underwent endolaser PRP with a range of 200-300 shots during PPV, whereas Group B patients underwent endolaser PRP with a range of 500-600 shots during PPV. Simple randomization will allocate subjects into treatment groups during PPV. Once all applicable maneuvers (including satisfactory hemostasis) are completed by the surgeon apart from endolaser PRP, a coin toss simulation program will randomize subjects into treatment groups.

Eligibility Criteria:
Inclusion Criteria:

* The subject has type I or II diabetes mellitus
* The age of the subject is \> 18 years old
* Snellen best-corrected visual acuity ranges from 20/40 to hand motions at one foot in the research eye
* Proliferative diabetic retinopathy with a vitreous hemorrhage is present in the research eye, and the vitreous hemorrhage is considered to be the primary cause for the subject's reduced vision
* The subject is panretinal photocoagulation-naïve
* The vitreoretinal adhesion is Grade 0 or 1 according to the classification system published by Ahn et al in the research eye

Exclusion Criteria:

* The research eye had formerly undergone anterior or posterior vitrectomy.
* An opacity of the anterior segment (cornea or lens) is thought to be responsible for two or more lines of decreased visual acuity in the research eye (cataract, corneal scar, ectasia, etc.)
* Optic nerve or retina disease unconnected to diabetes mellitus is thought to be responsible for two or more lines of decreased visual acuity in the research eye (optic neuritis, macular degeneration, glaucoma, etc.)
* Amblyopia or a non-ocular source (i.e., cerebrovascular accident) is considered to be responsible for two or more lines of decreased visual acuity in the research eye
* Neovascular glaucoma with an elevated intraocular pressure (\> 30 mm Hg) is present in the research eye
* Uncontrolled systemic hypertension (systolic \> 200 mmHg or diastolic \> 120 mmHg) is present
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)


Eligibility Criteria:
Inclusion Criteria:

1. Planned cardiac surgery with CPB
2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
3. Patients between 18 and 85 years of age, inclusive
4. Freely given written or electronic informed consent
5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery

Exclusion Criteria:

1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:

   1. vitamin K antagonists (within 3 days)
   2. direct oral anticoagulants (within 2 days)
   3. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment
   4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment
   5. glycoprotein IIb/IIIa antagonist (within 24 hours)
2. Pre-existing coagulopathy, a history of bleeding problems, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
3. Renal insufficiency, defined as serum creatinine level \>2.0 mg/dL
4. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
5. History of anaphylactic reaction(s) to blood or blood components
6. Refusal to receive transfusion of blood or blood-derived products
7. Current participation in another interventional clinical trial or previous participation in the current trial
8. Treatment with any IMP within 30 days prior to screening visit
Handgrip Strengthening Exercise in Treatment of the Patients With Primary Sub-Acromial Impingement Syndrome

This study aims to investigate the relative effect of handgrip strengthening exercise in improving function, pain, strength, and active range of motion (AROM) of the shoulder among patients with primary sub-acromial impingement syndrome (SAIS).

The current study is a Single-Blind Randomized Clinical Trial to investigate the effectiveness of handgrip strengthening exercise in the treatment of patients with primary subacromial impingement syndrome. The randomization process will be based on concealed envelop picked up by participants.The patient will be conveniently recruited from the ministry of health hospitals in Jeddah.The patient who will meet the inclusion criteria; they will sign the consent form. The baseline data will be collected. The assessment will be carried out at the baseline, 4 weeks and 8 weeks; end of the treatment program; by the same blinded examiner for each patient and consist of the following instrument: Disabilities of Arm, Shoulder \& Hand (DASH questionnaire), Visual analog scale (VAS), Hand-held dynamometer (HHD), and smartphone clinometer.

Eligibility Criteria:
Inclusion Criteria:

* Willing to comply with all study procedures and be available for the duration of the study
* Aged 18 to 45
* Diagnosed by their referring physician with subacromial impingement syndrome and has a positive impingement \& rotator cuff test
* Pain intensity between 3 to 8 in VAS

Exclusion Criteria:

* History of shoulder fracture or dislocation, osteophytes, and labral tear.
* History of cardiac, neurological or musculoskeletal disease that precludes the ability to perform the exercise in the upper extremity.
* Treatment with another intervention.
* Hand or forearm dysfunction
* Rheumatoid disease
* Diabetic
* History of shoulder, cervical, and thoracic surgery
* Pregnancy
* Malignancy
* Symptoms for more than 1 year
* Bilateral SAIS
The Efficacy of Botulinum Toxin vs. Corticosteroid for the Treatment of Refractory Plantar Fasciitis

This single-blinded, randomized-controlled trial compares the efficacy of ultrasound-guided onabotulinumtoxinA (BTX-A) injections to the flexor digitorum brevis with current standard of care corticosteroid injections to the plantar fascia for the treatment of refractory plantar fasciitis in patients that have failed six weeks of non-operative treatment.

Treatment of plantar fasciitis is not well described in the current literature, often making management difficult for both providers and patients. Recent literature has suggested potential use of Onabotulinumtoxin A (BTX-A) as an effective treatment to reduce pain and allow patients to return to their previous level of functional activity. The study will consist of veteran patients at the George E Wahlen Department of Veteran's Affairs (SLC VA) in Salt Lake City, UT. This pilot study aims to randomize patients with plantar fasciitis into current standard of care treatment with corticosteroid injection into the plantar fascia and experimental treatment with BTX-A injection into the flexor digitorum brevis cohorts. We predict that those who receive BTX-A injections will report better outcomes on the Numeric Pain Rating Scale (NPRS) as well as the Foot and Ankle Ability Measure (FAAM) when compared to those receiving corticosteroid. The results of this study could aid in providing evidence towards more reliable and beneficial treatment of plantar fasciitis.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed increased pain when pressure applied at the medial calcaneal tubercle
2. X-ray negative for calcaneal fractures or tumors
3. Patient with plantar fasciitis who have failed 6 weeks of non-operative treatment

Exclusion Criteria:

1. Prior botulinum toxin injections in the plantar fascia
2. Any botulinum toxin injections in the past 3 months
3. Cortisone injection in the plantar fascia in the previous 3 months
4. Previous surgery on the plantar fascia
5. Active workers compensation claim for plantar fasciitis
6. Active infection or fever
7. Botox or steroid allergy
8. Pregnancy
9. Current other treatment specific to the plantar fascia or intent to undergo during the trial
Phase III Study of Camrelizumab in Combination With Chemotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma

This study is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study. Target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. Study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in China. camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Treatment cycles of chemotherapy will be at most 6 weeks which will be decided by investigators. Progression-free survival (PFS) determined by the Independent Review Committee (IRC) will be the primary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years and ≤75 years;
2. Subjects with histopathological diagnosis of nasopharyngeal carcinoma;
3. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment;
4. Has not received prior systemic treatment;
5. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status
6. Subject must have a measurable target lesion based on RECIST v1.1;

Exclusion Criteria:

1. Allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatin and other platinum drugs;
2. Prior therapy as follow:

   * Anti-PD-1 or anti-PD-L1;
   * Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication;
   * Concurrent medical condition requiring the use of cortisol (\>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent for replacement therapy;
   * Received major operations or serious injuries within 4 weeks of the first dose of study medication;
3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment;
4. Pregnancy or breast feeding;
Safety of Cardioversion of Acute Atrial Fibrillation

The purpose of this study is to investigate the complications of cardioversion of acute (\<48 hours duration) atrial fibrillation (AF).

Primary Outcome Measures:

- Incidence and predictors of thromboembolic complications, especially stroke, and death \<31 days after cardioversion of acute AF

Secondary Outcome Measures:

* Number of therapy non-responder and early recurrence of AF
* Bleeding complications during the 31 days follow-up
* Hemodynamic complications of cardioversion

Estimated Enrollment: 3000 cases

Study Start Date: Jun 2011

Estimated Study Completion Date: December 2011

It has been a common practice to perform cardioversion of acute (\<48 hour) AF without any anticoagulation. The new European guidelines recommend that anticoagulation should be started already before cardioversion in all patients with CHADS2VASC score indicating need for long-term oral anticoagulation. The evidence behind these guidelines is, however, scarce. In this retrospective study we collect data on the safety of acute AF cardioversion from emergency rooms of two university hospitals and one secondary referral center from the years 2003-2010.

Inclusion criteria:

All patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted \<48 from the beginning of the symptoms.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to emergency room because of acute AF in whom electrical or pharmacological cardioversion was attempted \<48 from the beginning of the symptoms

Exclusion Criteria:

* duration of the AF is unknown or \>48 hours
ArterX Safety and Efficacy Study for Cardiac Indications

The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.


Eligibility Criteria:
Inclusion Criteria:

\>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.

The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.

The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.

The subject is determined by the surgeon to be at risk for poor hemostasis.

Exclusion Criteria:

Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.

Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.

Subject is pregnant, may become pregnant or is currently breast feeding

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Exercise During and After Neoadjuvant Rectal Cancer Treatment

This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.

The EXERT trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety. Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision. Participants will be randomly assigned to exercise training or usual care. Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery. Participants in the usual care group will be asked not to increase their exercise from baseline. Assessments will be completed pre NACRT, post NACRT, and pre surgery. The primary endpoint will be cardiorespiratory fitness (VO2 peak) at the post-NACRT time point assessed by a graded exercise test. Secondary endpoints will include functional fitness, quality of life, and symptom management. Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision

Exclusion Criteria:

* Unable to consent
* Unable to perform aerobic exercise
* Intention to engage in a structured exercise program during NACRT and/or after NACRT and prior to surgery
Sterile Water Injections for Relieving Ureterolithiasis Pain

Ureterolithiasis pain is a severe condition for which it takes some 30 minutes for standard treatment to yield maximal pain relief, a period during which the patient suffers severe to intolerable pain. It would thus be valuable to further evaluate sterile water injection as a method for achieving rapid relief for this type of pain.


Eligibility Criteria:
Inclusion Criteria:

* Ureterolithiasis pain, acute onset,
* Requires pain relief,
* Standard treatment prescribed,
* Age 18-60,
* Ability to understand and follow instructions

Exclusion Criteria:

* Other administration of NSAID for analgesia 12 hours prior to intervention,
* Pregnancy with obstructed flow of urine
European Study on Three Different Approaches to Managing Class 2 Cavities in Primary Teeth

The purpose of this randomized clinical trial is to compare the clinical effectiveness of three treatments involving different caries management strategies (conventional restorations, Hall technique, and Non-Restorative Caries Treatment) to the management of class II carious primary molars in children (3-8 year-old).

At present, many materials and techniques are used to treat carious primary teeth. All of these have their proponents who claim they provide the best performance in terms of longevity, aesthetics, bio-compatibility, etc (Qvist, 2010; Yengopal et al., 2009). However, despite the great variety of techniques and materials, there is no definite evidence for the most effective approach when dental caries in primary molars is concerned, as yet. On the other hand, there is conclusive evidence that shows that glass-ionomer cement is an inappropriate material for class II restorations in primary teeth, due to its significant shorter longevity compared with other restorative materials like compomer and amalgam.

Recently, there is re-surging interest in more biological (less-invasive) techniques: such as the Non-Restorative Caries Treatment (Peretz \& Gluck, 2006; Gruythuysen et al., 2010) or stainless steel crowns with the advent of the Hall technique in Scotland (Innes et al., 2007). However, there is lack of comparative evidence from high quality clinical trials leading to uncertainty in the effectiveness of these techniques. In addition, these techniques are rarely compared with standard fillings.

Eligibility Criteria:
Inclusion Criteria:

- Children aged 3-8 years who attend the Preventive and Paediatric Department of Greifswald University, Germany.

(Lithuania: children who attend the paediatric dentistry department, Dental Faculty, Lithuanian University of Health Sciences)

* At least one primary molar tooth with caries into dentine involving two dental surfaces (diagnosed according to the International Caries Detection and Assessment System \[ICDAS\], codes 3 to 5)
* Willing to be examined

Exclusion Criteria:

* Clinical or radiographic signs of pulpal or peri-radicular pathology
* Patients with a systemic disease requiring special considerations during their dental treatment.
* Parents/children who refuse to participate in the study
How Well do Primary Care Doctors in Region Örebro County, Sweden Follow Diagnostic Guidelines of IBS?

The aim of this project is to investigate the implementation of the Rome criteria in daily primary care clinical practice and adherence of general practitioners (GPs) to recommended diagnostic approaches for IBS.

Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder. To diagnose IBS, the so-called Rome Criteria combined with limited laboratory tests should be used. However, within the primary care, too much unnecessary diagnostics, for example radiology and endoscopy, are used. This is meaningless, stressful for the patient and they also cost a lot of money.

In Örebro Region there are 29 public general health centers. Approximately 300.000 inhabitants are listed within these health centers. Approximately 150 doctors are currently working within the primary health care of Örebro Region. The software program Medrave and the electronic patient register in Örebro Region allows to search for the International Statistical Classification of Diseases (ICD-10) for IBS (K58.9 and K58.0) This allows retrospective research regarding diagnosing IBS, the used diagnostic tools, comorbidities, as well as the different treatments that were used.

Patients diagnosed with IBS will be identified by ICD-code K.58. By evaluating their patient register it will be determined how the GP has made the IBS diagnosis. Patients will fall into three categories: those who received a positive IBS diagnosis using the Rome criteria, those who received a negative IBS diagnosis and those whose patient record is lacking sufficient information.

Data will also include demographics, number of GP contacts and referrals to specialists, diagnostic procedures, treatments, and relevant somatic, psychological and psychiatric comorbidities. Data regarding substance abuse will be collected as well.

Eligibility Criteria:
Inclusion Criteria:

• All adult patients (both sexes) who were diagnosed with IBS according to ICD-10 in Region Örebro County 2015-2019.

Exclusion Criteria:

• Patients \< 18 years or \> 65 years