cyrilzakka/clinical-trials huggingface dataset:
Role of Preoperative D-dimer Levels in the Diagnosis of Adnexal Torsion

Adnexal torsion is the fifth most common gynecologic emergency. Thirty percent of all cases of adnexal torsion occur in females younger than 20 years. Approximately 5 of 100,000 females aged 1-20 years are affected, with girls older than 10 years at increased risk because of hormonal influences and gonadal growth that result in an increased frequency of physiologic and pathologic masses. The most common clinical symptom of torsion is sudden-onset abdominal pain that is intermittent, non-radiating, and associated with nausea and vomiting in 62% and 67% of cases respectively. Moreover, abdominal tenderness is a clinical sign which is reported in up to 88% of patients with adnexal torsion. None of the following tests are useful in the diagnosis of adnexal torsion: leukocytosis, pyuria, C-reactive protein, and erythrocyte sedimentation rate. Actually, transabdominal ultrasonography is the imaging modality of choice with a sensitivity of 92% and specificity of 96% in detecting adnexal torsion. A second-line imaging tool in the diagnosis of adnexal torsion is magnetic resonance, which may require a sedation in selected cases. Consequently, there are no clinical or imaging criteria sufficient to confirm the preoperative diagnosis of adnexal torsion to date. Therefore, patients with a clinical suspicion for adnexal torsion should undergo emergent diagnostic laparoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* Age \< 18 years
* presenting with lower quadrants abdominal pain
* Imaging suspicious for adnexal torsion

Exclusion Criteria:

* Female patients aged \> 18 years
* Previous surgery for adnexal pathologies
* Clinical symptoms and imaging suggesting a different surgical pathology (i.e., appendicitis, gastroenteritis)
BeCoMe-9: a Clinical Study of BE-101 for the Treatment of Adults with Moderately Severe or Severe Hemophilia B

The BeCoMe-9 Study (BE-101-01) is a Phase 1/2, first in human, multi-center, open-label, dose-escalation study to evaluate the safety and clinical activity of a single intravenous (IV) dose of BE-101 in adults with moderately severe or severe Hemophilia B. Once infused, BE-101 is designed to engraft and continuously secrete FIX into the circulation to restore clinically meaningful levels of active FIX. BE-101 is an autologous (person's own cells) B Cell Medicine (BCM) which uses CRISPR/Cas9 gene editing to precisely insert human FIX gene into those cells.

The study includes 2 distinct parts: Part 1 and Part 2. In Part 1, an ascending-dose design will be utilized to enable evaluation of increasing doses in a stepwise manner. The objective for this dose escalation is to identify the dose of BE-101 required to achieve desired FIX activity 28 days after infusion. Upon identification of a safe and efficacious dose in Part 1, an expansion phase (Part 2) will initiate. The initial cohort in the Part 2 expansion (Part 2a) phase will include up to 6 adult participants to further characterize the safety and activity of BE-101 at the selected dose. Additional cohorts for adolescents and redosing for participants in Part 1 of the study will occur following data availability of Part 1.

Up to 24 participants will be enrolled across Part 1 (up to 18) and Part 2a (up to 6). Consented participants will complete a screening period to assess eligibility and upon enrollment will undergo leukapheresis collection to support BE-101 manufacturing. Following administration, participants will be monitored for safety and clinical activity. The total duration of study participation is approximately 52 weeks post IV administration of BE-101.

Eligibility Criteria:
Inclusion Criteria:

* Adult Males (≥18) with moderately severe to severe Hemophilia B (FIX deficiency)
* Received ≥50 exposure days to Factor IX products preceding enrollment.
* Currently receiving prophylaxis treatment
* Adequate organ function and clinical labs
* Able to tolerate study procedures including leukapheresis.

Exclusion Criteria:

* Pre-existing or history of specific diseases

  * B-Cell malignancy, EBV lymphoproliferative disease
  * Primary immunodeficiency disease or disorder (PIDD) or systemic immuno-suppression
  * Arterial and/or venous thromboembolic events within 2 years prior to dosing
  * History of anaphylaxis or nephrotic syndrome
  * Active infection (HIV, Hep B or C)
* History of inhibitor to FIX or inhibitor
* History of an allergic reaction or anaphylaxis to FIX products
* Within 6 months from BE-101 administration:

  * Planned surgical procedure
  * Previously dosed with gene therapy or participated in an interventional clinical study
* Planned participation in clinical trial within one year after BE-101
* Administration of a vaccine within 28 days of dosing

Other protocol-defined inclusion/exclusion criteria may apply.
Prospective Randomized Evaluation Of Celecoxib Integrated Safety Vs Ibuprofen Or Naproxen

To answer the question of overall benefit: risk of celecoxib when compared to two most commonly prescribe traditional (non-selective) nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of arthritis pain. For this purpose, patients with osteoarthritis or rheumatoid arthritis with or at risk of developing cardiovascular disease will be recruited. The cardiovascular, gastrointestinal and renal safety and symptomatic benefit in each treatment group will be assessed accordingly.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with osteoarthritis or rheumatoid Arthritis with or at risk of developing cardiovascular disease and who require and eligible for chronic, daily therapy with an NSAID to control arthritis sign and symptoms.

Exclusion Criteria:

* Subjects have had a recent cardiovascular event, unstable cardiovascular conditions, or any major surgery (cardiac or non-cardiac) within 3 months prior to randomization;
* Subjects with medical or laboratory abnormality that would make the subject inappropriate for entry into this trial
* Subjects require treatment with aspirin \> 325 mg /day
* Subjects with known hypersensitivity to celecoxib, ibuprofen, naproxen, aspirin or esomeprazole, etc.
Metformin in Obese Children and Adolescents

The purpose of this study is to determine whether metformin is effective in reducing BMI and insulin resistance in obese children and adolescents.

The prevalence of obesity in children and adolescents is increasing rapidly and is associated with significant medical and psychosocial consequences persisting into adulthood.

Obesity may lead to metabolic complications, such as insulin resistance, which can progress via impaired fasted glucose and impaired glucose tolerance to type 2 diabetes mellitus (T2DM) and to the development of micro- and macro-vascular complications.

Metformin, an oral anti-diabetic licensed for T2DM for adults and children from 10 years onwards, is already used off label in obese children and adolescents with insulin resistance, even though the specific effects of metformin in these obese children and adolescents have not been elucidated, particularly upon long-term use.

The rationale for this study is based on the hypothesis that metformin may reduce body mass index (BMI), insulin resistance and percentage of body-fat in obese children and adolescents with insulin resistance. Further more it is anticipated that metformin may delay the progression to T2DM and thereby micro- and macro-vascular complications in obese children and adolescents with insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 10 and ≤ 16 years at study entry
* Caucasian descent
* Obesity defined as BMI-SDS \> 2.3
* Insulin resistance defined as HOMA-IR ≥ 3.4.
* An obtained informed consent from subjects and parents/caregivers.

Exclusion Criteria:

* Presence of T2DM (American Diabetes Association criteria)
* Presence of endocrine disorders with steroid therapy
* Suspicion of polycystic ovarium syndrome;
* Height \< -1.3 SD of target height;
* Syndrome disorders with or without mental retardation;
* Use of anti-hyperglycaemic drugs;
* Pregnancy (pregnancy test will be performed, if applicable);
* (History of) alcohol abuse;
* Impaired renal and/or hepatic function (defined as GFR \< 80 ml/min. GFR=40 x length (cm) / serumcreatinin (μmol/l and ALAT \>150% of normal value for age);
* Use of ritonavir; use of ACE inhibitors;
* Insufficient knowledge of the Dutch language.
A Study of RD14-01 in Patients With Advanced Solid Tumors

This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.

This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors. The dose-escalation phase will investigate 3 dose levels to the. The dose-expansion phase will enroll .

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years.
2. Patients with histologically or cytologically confirmed advanced solid tumor, who have progressive disease, have undergone systemic therapy for advanced disease, and for whom no standard therapy is available.
3. ROR1+ by central laboratory immunohistochemistry (IHC).
4. Adequate organ and marrow function.
5. At least one measurable lesion as per RECIST v1.1.
6. . Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Ability to understand and provide informed consent.

Exclusion Criteria:

1. Prior treatment with any agent targeting ROR1
2. Presence of active central nervous system (CNS) metastasis
3. Impaired cardiac function or clinically significant cardiac disease
4. Untreated or active infection at the time of screening or leukapheresis
5. HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis
6. Untreated or active infection at the time of screening or leukapheresis
7. Pregnant or breast-feeding females
Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)

The overall aim of the study is:

To provide accurate and reliable information regarding NSCLC clinical management across Central Eastern European countries and Russia in order to detect unmet medical needs of this disease in terms of:

* Patient and hospital characteristics.
* Diagnostic and treatment approaches: initial and subsequent.
* Follow-up patterns in clinical management.
* Outcomes: symptoms, death, functionality, quality of life.
* Use of resources and burden on patients and health care systems. Addendum objective is to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian population


Eligibility Criteria:
Inclusion Criteria:

* Confirmed NSCLC diagnosis (e.g.bronchoscopic biopsy or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2010 and March 31st, 2010
* For Patient Reported Outcome (PRO) sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.
* Tumour tissue samples (in paraffin-embedded blocks) suitable for EGFR mutation testing available.

Exclusion Criteria:

* Mixed histology of small cell and non-small cell lung cancer.
Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers

The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start


Eligibility Criteria:
Inclusion Criteria:

* Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
* Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
* Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
* Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent
* Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
* History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
* Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
* Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
* Two or more previous attempts to eradicate H. Pylori
Anesthesia Tumescent for Surgical Management of Tenosynovitis.

The aim of this study is to evaluate the effectiveness of the tumescent anesthesia technique in the surgical management of hand tenosynovitis. For this, an open clinical trial was conducted, which included patients with hand tenosynovitis (carpal tunnel syndrome, trigger finger and Quervain syndrome), which were randomly assigned to a group. The control group was released pulleys and ligaments with local anesthetic technique and hemostasis with pneumatic tourniquet; While the study group was released from the pulleys and ligaments with tumescent anesthesia. The study variables were: anesthesia time, trans-surgical bleeding, pain, total procedure time and tissue reperfusion time.

Introduction: The WALANT technique (Wide Awake Local Anesthesia No-Torniquet) proposes the use of local anesthesia, epinephrine and tourniquet in the areas of the hand to be repaired, making costs and time and comfort more efficient.

Objective: Evaluation of the effectiveness of the WALANT technique versus regional anesthesia with tourniquet in pain control, surgical management of stenosing tenosynovitis.

Material and methods: Open clinical trial including patients with the trigger finger, tunnel syndrome in the operating room, candidates for surgery, and excluding previous surgeries at the site of the injury, hemodynamic instability, peripheral vascular diseases, smoking, anxiety, or psychiatric diseases. The anesthetic method was applied to the incision sites according to the diagnosis and the proposed procedure. At the end of the test, tumescent solution and control, 1% lidocaine plus pneumatic tourniquet on the forearm at 250mmHg. The main variables were: type of anesthesia and pain during the procedure. Descriptive and inferential statistics were applied (xi2, t-student or Mann-Whitney U).

Eligibility Criteria:
Inclusion Criteria:

* Right holders of the Mexican Social Security Institute
* Over 18 years
* Trigger Finger Diagnosis
* Diagnosis of Carpal Tunnel Syndrome
* Diagnosis of Quervain Syndrome
* Acceptance and signature of informed consent

Exclusion Criteria:

* Necessity for concomitant surgery
* Previous surgeries on the injured site
* Hemodynamic instability
* History of peripheral vascular diseases
* Do not wish to participate in the study
* Hypersensitivity to medication
* Smoking
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription

Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Xyrem ® on prescription

Exclusion Criteria:

* No limitations
Injury Epidemiology Within Scottish Professional Football

The aim of the present study is to establish the injury incidence, severity and burden typically observed within Scottish professional football clubs. In line with the well-established model of sports injury prevention research proffered by van Mechelen, the first stage in this process is establishing the extent of the problem i.e. injury incidence, severity and burden. Such a multi-club study has never been conducted within Scotland despite a thriving professional game.


Eligibility Criteria:
Inclusion Criteria:

* Professional football player contracted to an SPFL club

Exclusion Criteria:

* Loss of professional status as a footballer
Prolonged Enoxaparin in Primary Percutaneous Coronary Intervention

This is a feasibility study aiming to generate pilot data on safety and efficacy of a novel anticoagulant regimen (enoxaparin bolus and prolonged infusion) compared to the local standard-of-care in opiate-treated patients undergoing primary percutaneous coronary intervention.

Delayed absorption of oral P2Y12 inhibitors in patients undergoing primary percutaneous coronary intervention (PPCI) may increase the risk of stent thrombosis. Parenteral treatment is needed mitigate this risk.

We have recently shown a novel regimen of enoxaparin (bolus 0.75 mg/kg followed by an infusion of 0.75 mg/kg/6h) to provide consistent antithrombotic effects until the end of the infusion (1). We have also demonstrated the high prevalence of delayed platelet inhibition in opiate-treated patients (1).

This is a feasibility study for a larger randomised controlled trial (RCT). We aim to assess recruitment rate and collect pilot data on safety and efficacy. This will be a single-centre, open-label RCT comparing this novel regimen of enoxaparin to the local standard-of-care which usually consists of unfractionated heparin and a glycoprotein IIb/IIIa inhibitor. The study population will be opiate-treated patients undergoing PPCI. Pre PPCI, patients will be allocated in 1:1 ratio using a simple randomisation method using sealed envelopes, to either enoxaparin 0.75 mg/kg bolus followed by 0.75 mg/kg infusion over 6 hours (n=50) or the standard-of-care of UFH and tirofiban (n=50).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Confirmation of the diagnosis of STEMI by the clinical team on the basis of history and ECG changes
* Intention to proceed with PPCI
* Treated with opiates for analgesia
* Feasibility to obtain informed verbal consent pre PPCI

Exclusion Criteria:

* Active bleeding that cannot be controlled by local measures
* Pregnant patients
* Patients with end-stage renal failure requiring renal replacement therapy
* Patients with cardiogenetic shock
* Known thrombocytopenia (Platelet count \<100,000)
* Known history of intracranial haemorrhage
* Known current treatment with oral anticoagulants
* Known history of major surgery or trauma or history of GI/GU haemorrhage within the last month
* Known intracranial malignancy or aneurysm
* Known allergy to enoxaparin
* known hypersensitivity to benzylalcohol
* Patients with known acute bacterial endocarditis
* Known active gastric or duodenal ulceration
* Inability to easily understand verbal information given in English for any reason
* Inability to give informed consent due to either temporary or permanent mental incapacity
* Current participation, or participation within the last month, in an interventional clinical trial.
The Efficacy of Omega-3 Fatty Acids in Maintaining Optimal Mental Health in Elderly People

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures.

The efficacy of EPA-DHA supplementation will be assessed in a randomized placebo-controlled trial with cognitive decline and early signs of depression as primary outcome measures. In this study 300 elderly people will be randomly allocated to one of three treatments. Two groups will receive fish oil capsules with different doses EPA/DHA (a normal dose or a high dose) and the third group will receive placebo capsules. At the start and at the end of the intervention period cognitive function, the occurrence of depression, quality of life, anthropometric values and biochemical indicators will be measured.

After completion of the trial a workshop will be organized in which the outcomes of the proposed study will be presented to representatives of several key areas concerning mental health of elderly people.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 65 years and over
* Informed consent signed

Exclusion Criteria:

* A score of \> 16 on the CES-D (Centre for Epidemiological Studies-Depression Scale
* A score of \< 21 points on MMSE (Mini-Mental State Examination)
* Current or recent (\<4 weeks) use of fish oil supplements or intake of more than 4 times fish as judged by a fish consumption questionnaire
* Current use of pharmacological antidepressants
* Current use of dementia (Alzheimer) medication
* Serious liver disease
* Use of more than 4 glasses of alcohol per day
* Unable to participate as judged by the responsible medical physician
* Allergy to fish(oil)
* Swallowing problems
* Participation in another clinical trial less than 2 months before the start of the trial or at the same time
High-intensity Versus Low-intensity Laser Acupuncture in Chronic, Non-specific Low Back Pain

The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture versus low intensity laser acupuncture on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and function in patients with chronic nonspecific low back pain (CNLBP).

Chronic nonspecific low back pain is a type of persistent back pain that affects people of all ages and contributes to the global disease burden (CNLBP). The major objective of treatment is to lessen pain and its aftereffects. One noninvasive, targeted light therapy for treating musculoskeletal disorders is low-intensity laser therapy (LLLT). It has analgesic, anti-inflammatory, muscle-relaxant, and tissue-repair properties. Additionally, LILT has been demonstrated to relieve generalized lower back pain. Another light therapy that is painless and noninvasive, high-intensity laser therapy (HILT), stimulates tissue while delivering analgesic, anti-inflammatory, and anti-edematous benefits. It has been demonstrated that acupuncture, a popular complementary therapy, can relieve musculoskeletal pain and increase muscle strength.To date, however, there has been limited investigation into the effects of high- versus low-intensity laser acupuncture on CNLBP. Thus, the current study will be conducted to explore the efficacy of HILT versus LILL on peak torque of trunk extensors, fatigue of trunk extensors, back pain, ROM and functional disability in patients with chronic, nonspecific low back pain.

Eligibility Criteria:
Inclusion Criteria:

1. The patients had CNSLBP with age from 20 to 40 years from both genders.
2. Patients will be referred from an orthopedist with diagnosis of chronic low back pain without underlying pathological causes.
3. The patients with chronic nonspecific low back pain more than 3months. Minimum pain intensity of 30 mm on the visual analogue scale (VAS) for pain, which ranges from 0 to 100 mm.
4. Patients with normal BMI ranges between 18.5:24.9 kg/m2.
5. The study populations must be willing to participate in the study

Exclusion Criteria:

1. Neurological, infectious diseases and systemic illness such as rheumatologic diseases,systemic lupus erythematosus, diabetes mellitus type I or II.
2. Psychiatric/mental deficit.
3. Patients who had a previous surgical history (within 6 months) will also excluded.
4. participation in other treatment within the previous 3 month.
5. Pregnancy.
6. History of spinal fracture, tumor, osteoporosis
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients

The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.


Eligibility Criteria:
Inclusion Criteria:

* Men and women age ≥18 to ≤65 years with acute schizophrenia
* Provision of written informed consent prior to enrolment

Exclusion Criteria:

* Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
* Patients with substance dependence
* Female patients who are pregnant, lactating or at risk of pregnancy