cyrilzakka/clinical-trials huggingface dataset:
Calypso Knee System Clinical Study, OUS

A study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

Prospective, multicenter clinical study of the Calypso Knee System. A total of 81 subjects were enrolled in this study. Male or female subjects age 25 to 65 years, with a diagnosis of medial knee osteoarthritis and study knee pain with an overall WOMAC pain score ≥ 40 (scale 0-100).

The Calypso group was investigated under two clinical protocols, CP0001 in the USA, and CP0002 in Europe. Both clinical protocols followed the same supporting protocols and plans, such as radiographic, statistical, Clinical Events Committee (CEC), etc. The results from the combined analysis have been reported in both NCT03671213 (CP0001) and NCT03838978 (CP0002).

Eligibility Criteria:
Inclusion Criteria:

1. Participants age - 25 to 65 years
2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs (136 kg)
3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment

Exclusion Criteria:

1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
2. Knee ligament or meniscal instability
3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
Internet Treatment for Weight Loss in Primary Care

This study will test the effectiveness of two distinct treatments for weight loss:

1. Motivational Interviewing
2. Nutritional Counseling. These treatments will be compared to Treatment as Usual. Participants will be recruited through local primary care offices.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25-55
* Daily access to internet and phone

Exclusion Criteria:

* Co-existing physical and/or psychiatric conditions that require more significant treatment (e.g., bipolar disorder, psychotic illnesses), and/or require more intensive treatment or hospitalization (e.g., suicidality, severe mood disorders)
* Meets criteria for current substance abuse or dependence
* Currently receiving psychiatric, psychological, behavioral, or pharmacologic treatment that is known to affect weight or eating
* Pregnant, breastfeeding, or plans to become pregnant during the treatment period
* Cardiac disease, including ischemic heart disease, congestive heart failure, conduction abnormalities, or a history of heart attack
* Serious neurologic illnesses (e.g., seizure history) or medical illnesses (e.g., impaired hepatic or renal function)
* Uncontrolled diabetes, thyroid conditions, or hypertension
Early Vitrectomy for Endophthalmitis After Cataract Surgery

Post-operative infectious endophthalmitis is devastating condition that causes a diffuse intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by clinical examination and by the aid of B-scan ultrasonography.

There is no consensus regarding the timing of vitrectomy in cases with endophthalmitis after cataract surgery. The Endophthalmitis Vitrectomy Study concluded that vitrectomy should be preserved for cases with only light perception. The advances in posterior segment machines and small gauge cannulas decrease the incidence of intra-operative complications and encourage for early intervention in cases with endophthalmitis after primary cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Acute onset endophthalmitis within 6 weeks after primary cataract surgeries.
* Patients had undergone early pars-plana vitrectomy within 48 hours of their confirmed diagnosis.

Exclusion Criteria:

* Patients were diagnosed as endogenous or chronic endophthalmitis.
* Patients with a previous history of rupture globe surgery or trauma.
* Patients who didn't complete the follow up period.
The Effect of Counterstrain Technique on Muscle Stiffness and Pain on Trapezius Tender Points in Medical Students

Medical students are prone to developing neck pain due to prolonged studying and poor posture. This can manifest as tender points in the upper trapezius region. Counterstrain (CS) is an osteopathic manipulative technique that has shown efficacy in previous studies in treating tender points. The MyotonPRO is a myotonometric device that can be used to measure various muscle parameters such as muscle stiffness. There is limited research regarding the use of osteopathic manipulative medicine to produce measurable changes in muscle stiffness by the MyotonPRO. This educational study aims to establish the efficacy of CS technique in decreasing the pain level of upper trapezius tender points in medical students as well as determining if CS causes a significant decrease in muscle stiffness in treated tender points as measured by the MyotonPRO. The investigators hope this educational study will encourage further studies on how osteopathic manipulative techniques affects the physiologic parameters of muscles.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age

Exclusion Criteria:

* Traumatized (sprained or strained) tissues, which would be negatively affected by the positioning of the patient
* Illness or other conditions in which strict positional restrictions preclude treatment
* Instability of the area being positioned that has the potential to produce unwanted neurologic or vascular side effects
* Vascular or neurologic syndromes, such as basilar insufficiency or neural foraminal compromise whereby the position of treatment has the potential to exacerbate the condition
* Severe degenerative spondylosis with local fusion and no motion at the level where treatment positioning would normally take place
* Pregnancy
* Positive for COVID-19 as well as symptoms indicating a SARS-CoV-2 infection
Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.

Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications.

PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with hypersplenism and severe thrombocytopenia (platelet count \< 50,000/mm3).
2. the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR \< 1.7, no ascites, no encephalopathy).
3. Eligible for both femoral and radial puncture.

Exclusion Criteria:

1. Patients referred for embolization as treatment of traumatic splenic injury.
2. Patients lost during follow-up.
Traditional Medicine Syndromes in Internal Hemorrhoids: a Cross-Sectional Study

This study aims to investigate the characteristics of Traditional Medicine (TM) syndromes in patients diagnosed with internal hemorrhoids at Le Van Thinh Hospital. Internal hemorrhoids are a common anorectal disorder, and their classification in Traditional Medicine remains inconsistent. The study will examine the prevalence of TM syndromes in patients with internal hemorrhoids and assess the correlation between Goligher's classification and TM diagnoses.

The study will follow a cross-sectional observational design with an estimated 178 participants. Eligible patients are 18 years or older, diagnosed with internal hemorrhoids, and willing to participate. The primary outcomes include the prevalence of TM syndromes in internal hemorrhoids, severity classification according to Goligher's scale, and correlation analysis between TM syndromes and clinical severity.

The study has received approval from the Institutional Review Board (IRB) of the University of Medicine and Pharmacy at Ho Chi Minh City and will be conducted from December 2024 to April 2025 at Le Van Thinh Hospital, Vietnam.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older.
* Diagnosed with internal hemorrhoids at Le Van Thinh Hospital using Goligher's classification.
* Willing to participate and provide informed consent

Exclusion Criteria:

* Patients with colorectal cancer or other serious gastrointestinal diseases.
* Patients with acute inflammatory bowel disease that may interfere with the diagnosis.
* Patients with severe chronic illnesses affecting overall health.
* Patients unable to complete the study questionnaire due to cognitive or language barriers.
EEG in Children With Unilateral Cerebral Injury During Action and Action Observation(AOE)

To study the reactivity of the mu rhythm during action and action-observation by EEG in children with unilateral cerebral injury.


Eligibility Criteria:
Inclusion Criteria:

* unilateral cerebral injury
* hemiplegia

Exclusion Criteria:

* visual or mental or cognitive impairment
* no health insurance
Extended Use of Cannabidiol for the Prevention of Graft-versus-host-disease

Cannabidiol (CBD), a non-psychotropic ingredient of Cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. In a recent prospective phase II study (NCT01385124) 48 consecutive adult patients undergoing allogeneic hematopoietic cell transplantation were given CBD 300 mg/day starting 7 days before transplantation until day 30, on top of standard GVHD prophylaxis consisting of cyclosporine and a short course of methotrexate. There were no grade 3-4 toxicities attributed to CBD. None of the patients developed acute GVHD while consuming CBD. With a median follow-up of 16 months, the cumulative incidence rates of grade 2-4 and grade 3-4 acute GVHD by day 100 were 12.1% and 5%, respectively. Compared to 101 historical control subjects given standard GVHD prophylaxis, the hazard ratio of developing grade 2-4 acute GVHD among subjects treated with CBD plus standard GVHD prophylaxis was 0.3 (p=0.0002). Among patients surviving more than 100 days, the cumulative incidence of moderate-to-severe chronic GVHD at 12 and 18 months were 20% and 33%, respectively.

The aim of this study is to explore the safety and efficacy of extended use of CBD until day 100 in the prevention of acute and chronic GVHD.


Eligibility Criteria:
Inclusion Criteria:

1. Acute leukemia in complete remission
2. Myeloablative conditioning
3. Matched or one antigen or allele mismatched sibling or unrelated donor

Exclusion Criteria:

1. History of psychosis
2. Bronchial asthma
LigaSure Small Jaw® Versus Conventional Neck Dissection in Head and Neck Cancer Patients

The aim of this prospective randomized study was to investigate if the LigaSure vessel sealing system can reduce the operation duration and the postoperative drainage amount in patients undergoing neck dissection.

We compared the differences in perioperative and postoperative variables between LigaSure Small Jaw®-assisted and conventional neck dissection in head and neck cancer patients.

Patients who were scheduled to undergo neck dissection due to head and neck cancer were eligible for this study. After receiving a detailed explanation, all patients signed an informed consent form before randomization. The study group were treated using the LigaSure vessel sealing system (Small Jaw®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection. Relevant data included tumor-related variables, perioperative parameters, postoperative drainage status, postoperative subjective pain, and analgesic consumption amount were recorded and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 to 80 years scheduled to receive neck dissection due to head and neck cancer

Exclusion Criteria:

* history of coagulation disorders
* prior radiation to the neck
* prior neck dissection
* declined to participate
Effects of Different Flow Anesthesia on Atelectasis

Evaluation of atelectasis that may be caused by different flow rate anesthesia applications during the operation with lung ultrasound score.


Eligibility Criteria:
Inclusion Criteria:

* operation time 2-5 hours
* elective septoplasty and rhinoplasty
* ASA I-II

Exclusion Criteria:

* morbid obesity
* malignant hyperthermia
* opioid sensitivity
* alcohol or drug addiction
* congestive heart failure
* chronic obstructive pulmonary disease
* coronary artery disease
* anemia
* liver and kidney diseases
* pregnancy
* breast-feeding
* history of allergy to drugs used
Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa

Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness. The treatment is very difficult and not always effective. That´s the reason why we are looking for new ways of the therapeutic approach.

Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which modulates the neuronal excitability. According to previous research it has a potential to help people with Anorexia Nervosa.

The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the inhibitory one). We put them on the skull into the different positions, in dependence on the fact, if we want to excite or on to inhibit the parts of the brain under the electrodes.

There are several hypothesis how could the tDCS help in patients with AN. One of them speaks about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in resetting the inter-hemispheric balance.

Stimulation of 2 milliampere is applied for 30 minutes in every real session. Together there are 10 sessions, the application is every workday within 2 weeks.

All measurements and questionnaires are made 4 times:

1. Before the stimulation
2. On the day of the last stimulation
3. 14 days after the last stimulation
4. 28 days after the last stimulation

Eligibility Criteria:
Inclusion Criteria:

* patients with the diagnosis of anorexia nervosa

Exclusion Criteria:

* patients: with the diagnosis of epilepsy, after a serious injury of head, with chronic headache, with some metal or electronic implants in their heads and patients who are pregnant.
Molecular Prognosis of Lymphomas of the Central Nervous System (ALYCE-molecular)

Central nervous system lymphoma (PCNSL) is a diffuse large B cell lymphoma (DLBCL) entity with a particularly poor prognosis (median survival less than 3 years). They are still poorly characterized biologically, largely because of their rarity (300 cases / year in France) and the difficulty for obtaining a material of sufficient quality and quantity. It is nevertheless assumed that their pathophysiology is particular, since they develop exclusively in an immunological sanctuary, and that they present some characteristic molecular abnormalities (mutation of MYD88 or TBL1XR1 for example).

A collection of 74 PCNSLs has created, clinically annotated, from which frozen material is available in addition to the material fixed and included in paraffin (cohort ALYCE). Informed consent was gathered for all patients. Comparative Genomic Hybridization-array analysis of this cohort has already revealed abnormalities associated with a poor prognosis (unpublished data). The objective of this study is to complete this analysis by sequencing a panel of 96 mutant genes recurrently in DLBCLs and PCNSLs, and the molecular determination of the original cell by the (RT-MLPA) Reverse Transcriptase-Multiplex Ligation-dependent Probe Amplification technique.

The integration of genetic, molecular and transcriptomic data may define prognostic markers and open perspectives for translational research in PCNSL.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* With a lymphoma of the central nervous system
* Patients having signed the consent for the conservation of their samples within the cohort

Exclusion Criteria:

* \<18 old years
* Other diagnosis than lymphoma of the central nervous system
* No consent form signed
Safety and Efficacy of Topical NVC-422 Gel in Impetigo

This is a randomized, double-blind study comparing 0.1% NVC-422, 0.5% NVC-422 and 1.5% NVC-422 topical gel in children with impetigo.

This study is a randomized, sequential group, double-blind study. The first 60 subjects enrolled will be randomized to either 0.1% NVC-422 or 0.5% NVC-422. Randomization is 1:2 where 20 subjects will receive 0.1% NVC-422 and 40 subjects will receive 0.5% NVC-422. If there are no safety issues regarding the first 2 doses tested, the next 60 subjects will be randomized to either 0.1% or 1.5% NVC-422 with 20 subjects receiving 0.1% and 40 subjects receiving 1.5% NVC-422.

The lesion most representative of the subject's infection will be identified as the target lesion. This target lesion will be photographed, graded clinically, and its location recorded. At Visit 1, Screening and/or Baseline, a Gram stain will be performed to assess presence of Gram-positive cocci. If Gram-positive cocci are present, a swab for culture and sensitivity will be obtained. Treatment will began immediately after randomization.

Treatment will be 3 times per day (TID) for 7 consecutive days, following a morning, afternoon, and evening schedule.

After the start of treatment (Day 1), subjects will be assessed for safety on Day 4 (± 1). Clinical and bacteriological assessments of the target lesion will also occur on Day 8 (+1) and Follow-up on Day 15 (± 2).

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 2 - 12 years of age
* Parents or Legal Guardians must sign a written informed consent document
* Positive Gram stain of target lesion showing Gram-positive cocci;
* Clinical diagnosis of primary non-bullous impetigo as per the protocol
* Skin Infection Rating Scale total score of at least 4, with at least three of the five primary signs and symptoms present at baseline including a score of 1 or greater for exudate/pus;
* Screening within one day of enrollment into the study.

Exclusion Criteria:

* Presence of other skin diseases at or near the investigational target area to be treated;
* Disease is so widespread or severe that, in the opinion of the investigator, oral antibiotic treatment is needed
* Active impetigo lesions greater than 5 cm2
* Signs and symptoms of a current infection requiring antibiotic treatment
* Use of systemic or topical antibiotics or steroids within 72 hours prior to study entry
* Females of childbearing potential
The Effects of Core Stabilization Exercises on Balance, Proprioception, and Knee Muscle Strength in Children with Adolescent Idiopathic Scoliosis

Scoliosis can be defined as a 3-dimensional deformity in which the lateral deviation and rotation of the vertebrae occur, as well as changes in the physiological curves of the spine. The gold standard criterion is that the Cobb angle, which determines the lateral deviation of the spine in the frontal plane, is greater than 10°.

Postural control and balance occur as a result of the integration of many sensory information. It is thought that postural control and balance in Adolescent Idiopathic Scoliosis (AIS) patients are adversely affected by biomechanical changes in sensory input, central integration, weight transfer mechanism and the structure of the medulla spinalis. In addition to these, vestibular disorders and proprioceptive losses may have an effect on balance.

Decline in balance reduces the quality of life of individuals with AIS. In addition, exercise has an important place in the treatment of individuals with AIS. In order to get more efficiency from the exercises, it is necessary to improve the balance.

The aim of this study is to evaluate the changes in balance, proprioception, and knee muscle strength of patients, to determine the place of balance exercises in the treatment of individuals with AIS, and to investigate the effect of core stabilization exercises on balance and proprioception in patients with AIS.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with AIS between the ages of 10-18
* Cobb angle is between 10-40 degrees
* The child's and family's consent to participate in the study
* The child does not receive any other treatment that will affect his scoliosis

Exclusion Criteria:

* Surgical operation in the last 3 months
* Presence of an orthopedic, neurological, systemic disease that will prevent him from exercising
* Having mental, communicative and behavioral disorders that may cause problems understanding commands and questions or performing exercises
* Exercising 3 or more days a week.
Adapted Physical Activity for Breast Cancer HER2 Positive Patient

The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.

After the assessment of their physical fitness, a home-based adapted physical activity program composed by aerobic and muscle strengthening exercises will be delivered to each patient. The aim of the intervention is to reach international recommendation in a progressive way during neoadjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Women \> 18 years old
* Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2
* Affiliation to the French social security scheme
* Patient who signed the participation consent before entering the trial
* Medical fitness certificate for sport

Exclusion Criteria:

* Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer
* Metastatic cancer
* Karnofsky index ≤ 90%
* Men
* Pregnant women
* Significant psychiatric or neurological abnormality
* Patient deprived of liberty by a court or administrative
* Contraindication for physical activity
* Patient unable to complete questionnaires (language barrier)
* Participation in a clinical trial with the same objective
Study to Compare the Efficacy and Safety of CC-5013 vs. Placebo in Subjects With Metastatic Malignant Melanoma.

Subjects are randomized to one of two treatment arms. All subjects are screened for eligibility within 28 days prior to randomization. The study consists of a treatment phase and a follow-up phase. Subjects are treated in repeating 4 week cycles.


Eligibility Criteria:
* Understand and voluntarily sign an informed consent form
* Able to adhere to the study visit schedule and other protocol requirements
* Metastatic malignant melanoma now stage IV, relapsed or refractory to standard metastatic therapy
* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug
* Patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.