cyrilzakka/clinical-trials huggingface dataset:
USG Nerve Blocks for ACL Reconstruction

Anterior cruciate ligament reconstruction is a routine surgical procedure. Traditional femoral/sciatic block combinations effectively reduce postoperative pain, but results in considerable motor blockade. The investigators aimed to evaluate postoperative pain relief and the degree of motor block with block combinations of femoral nerve (FEM) and obturator \[posterior branch\] nerve (ONP), versus saphenous nerve (SAPH) and ONP, versus placebo blocks with isotonic saline. All patients received standard patient controlled analgesia with morphine.Randomized, placebo-controlled and double-blinded clinical trial. Following IRB approval, 81 patients were planned to be randomized to one of three USG block combinations: Active FEM+ONP, active SAPH+ONP or no active blocks (sham blocks) Ropivacaine 0.75% was used for all active blocks following induction of general anaesthesia \[propofol-remifentanil, laryngeal mask airway\]. Primary outcome measure: Localized PACU pain scores (AUC) 0-6 hours postoperatively at rest.

Secondary outcome measures: Opioid consumption, opioid related side effects, PACU time, motor abilities of daily living scores \[modified Barthel/100 index\], perceived ill health \[Short form-8\] scores and degree of motor blockade \[Jensen- Børglum motor test\].


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Isolated primary ACL reconstruction in general anaesthesia with hamstring graft.
* ASA 1-3.
* Written and informed consent to study protocol.

Exclusion Criteria:

* ACL reconstruction with patellar tendon graft
* Uncooperative patients.
* Patients that do not understand or speak danish.
* Daily use of opioids equivalent to \> 40 mg morphine.
* Allergic to Ropivacaine.
* Alcohol abusers
* Contraindications to general anaesthesia.
* Pregnancy.
Tolerance of a Probiotic Formula

Evaluate the tolerance of a probiotic formula in infants


Eligibility Criteria:
Inclusion Criteria:

- Full term healthy infant aged 3-95 days

Exclusion Criteria:

* Prematurity
* Low birth weight
* Congenital anomalies
* Chronic disease
* Failure to thrive
* Allergy or atopic disease
* Recent exposure to antibiotics
Effectiveness of Neuroscience-based Pain Education in Patients With Chronic Neck Pain

The effectiveness of neuroscience-based pain education, myofascial induction technique, and home exercise programs will be compared in patients with chronic neck pain.

The study aims to present the immediate and long-term effects of Neuroscience-based Pain Education (NPE) and Myofascial Induction Therapy (MIT). It will evaluate parameters such as pain, quality of life, pain catastrophizing, and neck disability after treatment completion and at the 6-month follow-up.

The investigators aim to illuminate future studies concerning neuroscience-based pain education, which has gained prominence in recent years and continues to increase in importance annually.

The participants will be randomly assigned to one of three groups:

1 Group: Neuroscience-Based Pain Education Combined with Home Exercise Program Participants in this group will receive Neuroscience-Based Pain Education (NPE) treatment in addition to the home exercise program. Training sessions will be organized as one-on-one conversation sessions focusing on the neurophysiology of pain, and participants will be reinforced through PowerPoint presentations and visual aids such as pictures, templates, and metaphors.

Group: Myofascial Induction Techniques Combined with Home Exercise Program In addition to the home exercise program, Myofascial Induction Techniques (MIT) group participants will have MIT applied to the cervical and upper thoracic regions.

Group: Home Exercise Program After undergoing general training, participants in this group will be taught an exercise program. The program will include neck muscle stretching, strengthening, and posture exercises.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18-60 years old,
2. Patients with non-specific neck pain for at least 3 months,
3. Having pain severity of four or more according to the Visual analogue scale (VAS),
4. Patients with Pain Catastrophizing Scale score \> 30
5. Patients with a Central Sensitization Inventory score \> 30
6. Not having received physiotherapy and manual therapy within the last 3 months,
7. Those who have not received and will not receive medical treatment in the last 3 months.

Exclusion Criteria:

1. Having a history of neck and spine surgery,
2. Patients with whiplash injury, fracture history,
3. Having unstable neurological findings,
4. Presence of a pathology such as hernia and root compression in the cervical region,
5. Those who regularly use analgesic and anti-inflammatory drugs,
6. A communication problem may prevent the implementation of the evaluations or treatment program.
BeEAC Conditioning Regimen in Malignant Lymphoma Subjects With Indications to Autologous Hematopoietic Stem-cell Transplantation

Nowadays there is no randomized trials for comparison the effectiveness and tolerability of different conditioning regimens.

Bendamustine is a unique chemotherapeutic agent that combines alkylating action of nitrogen mustard and the activity of purine antimetabolite. Bendamustine has shown its effectiveness for the treatment of patients with chronic lymphoproliferative diseases such as chronic lymphocytic leukemia and several indolent lymphomas. The literature also presents evidence of the effectiveness bendamustine in patients with Hodgkin's lymphoma who received multiple lines of prior chemotherapy, including high dose chemotherapy and transplantation of peripheral hematopoietic stem cells. There are also data of using bendamustine as a part of conditioning regimen.

In this context, it was planned a study for evaluation the safety and effectiveness of the BeEAC (bendamustine, etoposide, cytarabine, cyclophosphamide) conditioning regimen prior to autologous transplantation of peripheral hematopoietic stem cells for the treatment of relapsed/refractory malignant lymphomas.


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial
2. Be ≥ 18 years of age on day of signing informed consent
3. Eastern Cooperative Oncology Group (ECOG) \< 2.
4. Relapsed/refractory malignant lymphoma patients with indications to autologous hematopoietic stem-cell transplantation

Exclusion Criteria:

1. Participation in another clinical trials
2. Clinically relevant heart disease:

   * Myocardial infarction during previous 6 months
   * Unstable angina during previous 3 months
   * Congestive heart failure (III-IV NYHA)
   * Clinically relevant ventricular arrhythmias
   * corrected QT interval (QTc) \> 460 мс on ECG (calculated using Frederics formula)
   * Left ventricular ejection fraction ≤ 45% on Echocardiogram
   * Atrial Hypotension (systolic pressure \< 86 mmHg) or bradycardia (\< 50 per minute, exclusion - drug-induced bradycardia)
   * Uncontrolled arterial hypertension (systolic pressure \> 170 mmHg or diastolic pressure \> 105 mmHg)
3. Severe renal dysfunction (serum creatinine \> 250 µmol/l)
4. Severe hepatic dysfunction (total bilirubin \> 40 µmol/l)
5. Known history of Human Immunodeficiency Virus or active Hepatitis B and C
6. Psychiatric or substance abuse disorders that would interfere with the cooperation with the requirements of the trial
7. Hypersensitivity to investigational drugs
8. Pregnant or breastfeeding females or males and females with childbearing potential must be willing to use an adequate method of birth control (intrauterine device, vasectomy of female subjects' male partner, contraceptive rod implanted into the skin, combination method - (requires use of two of the following) diaphragm with spermicide, cervical cap spermicide, contraceptive sponge, condom, hormonal contraceptive)
AVE0005 (VEGF Trap) in Patients With Recurrent Symptomatic Malignant Ascites

The primary objective of this study was to compare the time between paracenteses before and after administration of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in ovarian cancer participants with symptomatic malignant ascites.

The secondary objectives were to further assess efficacy and safety of Aflibercept treatment, and the exploratory objectives were to assess pharmacokinetics, immunogenicity and health-related quality of life.

The study consisted of:

* A 30-day screening phase prior to Day 1
* Day 1 registration and pre-treatment paracentesis
* Aflibercept administration within 1-day of registration
* Two-week study treatment cycles (for efficacy data, the cut-off date was 6 months post-registration
* A 60-day post-treatment follow-up phase

During the study, participants were treated with Aflibercept study treatment through the duration of the study unless they met one the following criteria for discontinuation:

* Participant (or legal representative) chose to withdraw from treatment
* The investigator or sponsor thought that continuation of the study would be detrimental to the participants well-being
* Participant had intercurrent illness that prevented further administration of investigational product (IP)
* Participant had more than 2 IP dose reductions
* Participant had unacceptable adverse events (AEs)
* Participant had arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset angina, or worsening of preexisting angina
* Participant required surgical intervention for intestinal obstruction or gastrointestinal perforation

Eligibility Criteria:
Participants that met the following criteria were eligible.

Inclusion Criteria:

* Symptomatic malignant ascites resulting from advanced ovarian epithelial cancer (including fallopian tube and primary peritoneal adenocarcinoma) that required at least 3 previous therapeutic paracenteses at a frequency of 1 to 4 paracenteses per month for management.
* Platinum resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.
* Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance.

Exclusion Criteria:

* Peritoneovenous or other type of shunt that was placed for the management of ascites
* Prior treatment with a VEGF or VEGF receptor inhibitor
* Uncontrolled hypertension

The above information is not intended to contain all considerations relevant to participation in a clinical trial.
The Effectiveness of MInding the Baby in a Danish Community Sample

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. MTB is delivered by an interdisciplinary team. Ten Danish sites will be randomized to training at time 1 or 2 and recruit usual care control families before they receive the training. Families are assessed before they give birth and when their child is three months, one and two years old with a range of assessments including maternal sensitivity, parent mental Health, child development, and health related register data. The aim of the trial is to assess the effectiveness of Minding the Baby to improve mother-child relations and the mental health of parents and children.

Minding the Baby is an intensive and preventive home-visiting programme that helps vulnerable or high risk mothers. The focus of the intervention is to reduce negative infant and maternal outcomes and strengthen the attachment relationship. MTB is delivered by an interdisciplinary team of highly skilled practitioners, who have health and social work experience, integrating advanced practice nursing and mental health care for mothers and infants. In the proposed Randomised Control Trial (RCT) the investigators will study the efficacy of this innovative intervention across ten Danish sites. Site staff will be trained at two sessions one year apart. Sites are randomized to training at time 1 or 2. All sites will recruit treatment as usual control families before they receive the training and start offering the intervention to all families. Potential participants will be approached by a local front staff member (e.g. midwife, helath visitor or social worker) who will inform mothers of the project in the early pregnancy. Consenting eligible participants will be assessed before they give birth and when their child is three months, one and two years old.

The effectiveness of the MTB programme will be evaluated by assessing a range of maternal and infant outcomes, including maternal sensitivity, parent mental Health, child development, and register data on e.g. infant maltreatment and neglect, hospitalization, income, immunization. By combining parent report, observational and register data researchers will get a unique opportunity to advance knowledge regarding effective ways to support some of the youngest and most vulnerable children in Denmark.

Eligibility Criteria:
Inclusion Criteria:

- Pregnant vulnerable women

Exclusion Criteria:

* Current severe substance abuse
* Severe psychotic illness
* Profound or severe learning disabilities
* Life-threatening illness in parent or child
* Non-Danish speaking
Is Patients With Pulmonary Disease Benefit a Program With Yogic Exercises?

Is Yogic Exercises (12 weeks) increasing respiratory function, functional capacity and quality of life in patients with obstructive lung diseases. With follow up after 6 months.

Is Yogic Exercises increasing respiratory function in patients with obstructive lung diseases. Will YE improve respiratory muscle strength, functional capacity, inspiratory and expiratory pressure, lung function, perceived dyspnea, dyspnea-related distress (DD), less frequency of dyspnea and heart rate variability in patients with pulmonary disease. Qualitative content analysis will be performed on approximately 15 interviews with patients participated in the yoga group about their experiences and their benefits perceived/experienced of the yogic exercises

We want to try YE as an alternative treatment in patients with mild to severe pulmonary disease.

Eligibility Criteria:
Inclusion Criteria:

* Mild to severe pulmonary obstructions according to GOLD 1-3 (Global Initiative for Chronic Obstructive Lung Disease),
* FEV (forced expiratory volume) in one second (FEV1) % of predicted respiratory function (30% ≤ FEV1 ≤ 90%)
* FEV1/FVC \< 0.70 (\<65 over 65 yrs). \*FVC=forced vital capacity

Exclusion Criteria:

* Severe neurological, orthopedic or rheumatologic injuries
* Severely decreased thorax mobility and lung function.
* Severe lung diseases
* Other chronic diseases that will interfere with performance.
* Under 200 meters on the 6MWT
* Acute dyspnea
* Surgery within 6 months
* Medication affecting attention, sudden change of medication.
DaxibotulinumtoxinA for Injection for the Management of Plantar Fasciitis

The specific aim of the study is to compare the safety and efficacy of a single administration of DaxibotulinumtoxinA for Injection versus placebo for managing plantar fasciitis.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent, including authorization to release health information
* Skeletally mature, male or female patients 18 to 65 years of age with diagnosis of plantar fasciitis
* Persistent heel pain for more than three months
* Women of child bearing potential must have a negative urine pregnancy test (UPT) at Screening Visit and must use an effective method of birth control during the course of the study

Exclusion Criteria:

* Previous surgery on the midfoot or hindfoot
* Neuromuscular disease
* Systemic muscle weakness
* Planning a pregnancy during the study
* Current enrollment in an investigational drug or device study or participation in such a study within the last 30 days prior to first visit
Organoids Derived From Induced-Pluripotent Stem Cells (iPS) From Patients With High Grade Astrocytoma

The objective of this study research proposal is to model human gliomagenesis using 3-Dimensional (3D) brain organoids derived from human induced pluripotent stem cells (hiPSCs).

The working hypothesis is that 3D brain organoids can develop glioma-like structures and recapitulate phenotypic traits of gliomas when generated from hiPSCs expressing genetic mutants associated with glioma predisposition.

Methodology : To develop this pioneer study on the use of hiPSC-based brain organoids as a strategy to model gliomagenesis and study the impact of genetic mutants, it will be collect the peripheral blood mononuclear cell from 20 patients with high grade astrocytoma with or without IDH mutation. iPS will be generated from these PBMC and will be genetically modified according to different mutations. Then, it will be generate brain organoids according to standard protocols. Brain organoids generated from all different cells will be collected at different time points and analyzed for the presence of glioma-like structures and phenotypic hallmarks of gliomas.

From the proposed experiments, it will be expect that brain organoids will develop glioma-like features upon the presence of genetic mutations. Thus, it will be expect to demonstrate that brain organoids can be used as a reliable strategy to test the impact of genetic mutants, including the possible synergistic cooperation between different mutations on early gliomagenic events.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 years or older
* Astrocytoma grades 3 or 4, confirmed by anatomopathological diagnosis
* Patient having signed an informed consent

Exclusion Criteria:

* Person in emergency situation, a legal person of legal age (guardianship, guardianship or legal guardianship), or unable to express his / her consent
* No affiliation to a social security scheme (beneficiary or beneficiary)
* Pregnant or lactating woman
Catheter Ablation of Haemodynamically Not-tolerated Electrical Storm in Structural Heart Disease

This is a multi-center, parallel-group, randomized, open-label trial evaluating the clinical outcome and efficacy of emergency catheter ablation versus conventional stepped-care strategies in patients with haemodynamically not-tolerated ventricular tachycardia (VT).

The prognosis of haemodynamically not-tolerated VT in structural heart disease is very poor, with a high 30-day mortality rate \>30%, resulting in extremely heavy medical burden. Current guidelines lack specific recommendations for managing this condition. The prevailing treatment strategy involves a sequential approach-beginning with anti-arrhythmic drugs, sedation, and anesthesia, followed by haemodynamic mechanical support devices. Catheter ablation is only used as the final rescue treatment. Typically, patients undergo repeated electrical cardioversion and receive multiple vasopressors and antiarrhythmic drugs, facing increased risks of complications from enhanced haemodynamic support. Studies have shown that these patients often eventually progress to irreversible pump failure, miss the window for effective catheter ablation, and ultimately die. Early cardioversion and maintenance of sinus rhythm, may significantly reduce mortality rates in patients with haemodynamically not-tolerated VT. Therefore, emergency catheter ablation is expected to reduce the mortality of haemodynamically not-tolerated ventricular tachycardia.

In this study, we aim to evaluate the effect of emergency catheter ablation in haemodynamically not-tolerated ventricular tachycardia. Current study will include 96 patients, and all patients will be randomized to either the emergency catheter ablation arm or stepped-care strategies arm in a 1:1 fashion. The follow-up duration is 1 year. The primary outcome is a composite outcome of VT recurrence, cardiovascular re-hospitalization, and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 80 years;
2. Having structural heart disease, including ischemic cardiomyopathy and nonischemic cardiomyopathy;
3. Haemodynamically not-tolerated, defined as persistent hypotension (systolic blood pressure \<90 mmHg and mean arterial pressure 30 mmHg lower than baseline or \<70 mmHg, with associated signs of end-organ hypoperfusion);
4. Electrical storm, defined as \>3 VT episodes within 24 hours.

Exclusion Criteria:

1. Reversible causes of ventricular tachycardia or cardiomyopathy;
2. Ventricular thrombosis diagnosed by echocardiography and/or cardiac magnetic resonance;
3. Acute ST-segment-elevation myocardial infarction within 60 days;
4. Cardiac surgery within 60 days;
5. Unstable angina;
6. Pregnancy.
Curve of Spee: Speed of Leveling Using Different Orthodontic Archwires

The objectives if this study was to evaluate the efficacy of 3 different rectangular archwires in the correction of the curve of Spee (COS), to record the time needed to level excessive COS in the mandibular arch using the 3 archwire sizes, to investigate the changes in intercanine and intermolar widths and arch length during leveling, to measure the arterio-posterior and vertical movement for the lower incisors and lower molars, to record pulpal blood flow and to detect the root resorption in the lower anterior teeth associated with leveling excessive COS using the 3 different archwires.

Fifty one subjects with an excessive COS were included in this study. The subjects will be randomly divided into three groups; Group one (17 patients): leveling of COS using 0.017X0.025-inch stainless steel archwire. Group two (17 patients): leveling of COS using 0.019X0.025-inch stainless steel archwire. Group three (17 patients): leveling of COS using 0.021X0.025-inch Titanium molybdenum archwire.

In the three groups, a 5mm depth reverse COS will be inserted. Records consisted of lateral cephalograms (pre-treatment, at T0 and post-treatment), peri-apical radiographs (at T0 and at T5), study casts (pre-treatment and at each time point during the tudy). Patients will be followed up on monthly visits without removing leveling archwires where alginate impressions were taken for the lower arch. Pain scores during the first week of leveling will be recorded using visual analogue scale (VAS).The amount of COS correction in mm, changes in intercanine in mm, intermolar and arch length in mm, pain scores and lower incisors root resorptions in mm will be measured.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16 years and ≤ 30 years
* Overbite covering more than half of the lower incisor height
* Curve of Spee ≥ 4 millimeters
* Mild crowding in lower arch where non-extraction treatment is indicated.
* Normally inclined or retroclined lower incisors
* Averaged or reduced lower vertical height
* Good oral hygiene and healthy periodontium
* All permanent teeth are present except for the third molars

Exclusion Criteria:

* Severe crowding in lower arch where extraction treatment is indicated.
* Missing permanent molars or Premolars
* Poor oral hygiene and Periodontal disease
* Systemic health problems and medications were taken
* History of previous orthodontic treatment
* Smoking
Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography

The investigators aim to evaluate the effect of Ketamine/Propofol Admixture on hemodynamic stability, recovery time ,patient \& doctor satisfaction scores during Endoscopic Retrograde Cholangiopancreatography.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists ( I ,II )

Exclusion Criteria:

1. Presence of liver and/or kidney failure, neuropsychiatric disorders, morbid obesity.
2. History of substance abuse or dependence.
3. History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs.
4. Pregnancy.