cyrilzakka/clinical-trials huggingface dataset:
Digital Imaging Assessment of Ocular Prosthesis Motility

This study will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis. This will be measured using two software applications - Image J as well as the mediGrid smartphone app in measuring prosthesis motility by comparing it to the ruler as a "gold" standard.

The fit and function of an ocular prosthetic determines the effective motility (movement) within the patient's eye socket. A poor fitting ocular prosthesis will lead to poor motility, patient discomfort and increased mucus discharge, and can risk the integrity of the anterior surface of the implanted orbit. Currently the method to determine best fit of the ocular prosthesis is dependent upon the ocularist's skill in adding or subtracting material from the wax model that is replicated from an initial alginate impression of the patient's eye socket.

The proposal of this study is to utilise digital imaging to capture images to measure the motility of both the orbital implant and the ocular prosthesis. Two methods will be compared: excursion measurements on a photograph using digital software (Image J) versus use of a smart phone app (an iOS app known as mediGrid (IRISS Medical Technologies, UK; CE Marked, HIPAA compliant). This study will evaluate the degree of translational movement loss from orbital implant to ocular prosthesis and analysis will include comparisons between hydroxyapatite and acrylic implants and in patients without an orbital implant, also known as post-enucleation socket syndrome (PESS). A part of this study will also evaluate the accuracy of the two softwares Image J as well as the mediGrid smartphone app in measuring prosthesis motility by comparing it to the ruler as a "gold" standard.

Eligibility Criteria:
Inclusion Criteria:

* Adults with surgery to remove one eye
* Able to give consent and understand the study
* Able to cooperate by following instructions (keeping head still, perform gaze movements)
* Enucleation was performed with the integrated implant technique (recti muscles sutured directly to the scleral cap or the mesh around the implant in a location corresponding to muscle insertion.

Exclusion Criteria:

* Radiotherapy to socket
* Chemotherapy
* Implant exposure repair
* Secondary orbital implant
* Concurrent socket pathology:
* Socket infection
* Socket exposure
* Giant papillary conjunctivitis
* Presence of ocular motility disorders on either side of the face, such as nystagmus, known muscle restrictive disorders (thyroid eye disease, previous trauma, idiopathic orbital inflammatory disease) and neurological disorders (cranial neuropathies, multiple sclerosis).
Structured Treatment Interruptions With or Without Pegylated Interferon Alpha for HIV-Infected Patients After Prolonged Viral Suppression

The purpose of this study is to determine whether the adjunctional of interferon alfa to structured treatment interruptions correlated with a long time off treatment in HIV-1 infection.

The limitations of the drugs used against HIV include their toxicity, their tolerability, their propensity to induce resistance when not taken with absolute regularity and their cost. Treatment interruption in patients receiving antiretroviral treatment in the setting of chronic infection is associated with viral rebound and rapid CD4 T cell decrease conducting to antiretroviral therapy restart. In patients with high CD4+ cell counts (patients receiving treatment of chronic infection with controlled viremia and patients who are receiving highly active antiretroviral therapy (HAART) now in whom treatment would not have been started based on current guidelines), the investigators evaluated whether the adjunctional of interferon alfa 2b to 3 structured treatment interruptions correlated with a long time off treatment. HAART was interrupted for 4 weeks, restarted and continued for 12 weeks. After 3 such cycles treatment was indefinitely suspended 48 weeks after study entry. Another aim of this study was to assess the immunological and virological factors associated with the duration of treatment interruption (proviral HIV DNA at baseline and during follow-up, plasma HIV RNA at baseline and during follow-up, CD4 T cell and CD8 T cell HIV specific responses at baseline and after 6 months of interruption).

Eligibility Criteria:
Inclusion Criteria:

* Males and non pregnant females
* Confirmed laboratory diagnosis of HIV infection
* Have been on the same continuous HAART regimen for at least 6 months prior to inclusion
* Viral load below 50 cp/ml for at least 6 months
* CD4 over 350 cells/mm3
* Previous viral load over 10000 cp/ml in their history
* No CD4 cell count under 100/mm3 in their history
* For women of reproductive ages: negative serum pregnancy test
* Signed written consent to participate.

Exclusion Criteria:

* Already had interferon or interleukin-2 (IL-2)
* Positive hepatitis C virus (HCV) PCR
* Under treatment with abacavir during screening
* Serious psychiatric history, suicide attempt, or severe depression
* History of thyroid abnormality
* Opportunistic infection ongoing
* Lymphoma or Kaposi's sarcoma (KS) under chemotherapy
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)

This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.

The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)


Eligibility Criteria:
Key Inclusion Criteria:

1. PICC is anticipated to remain in place for at least 14 days
2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
3. Body weight ≥50 kg and ≤130 kg during the screening period
4. International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
5. Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol

Key Exclusion Criteria:

1. Unsuccessful PICC placement or any other complication associated with this procedure that in the opinion of the study investigator may present any safety concerns to the participant
2. History of prior venous thrombosis in the arm in which the PICC is to be placed
3. Peripheral catheter(s) in the same arm in which the PICC is to be placed or expected need for peripheral catheter(s) placement in the same arm the PICC is to be placed as described in the protocol
4. History of known thromboembolic disease or thrombophilia
5. Participants requiring therapeutic or prophylactic anticoagulation and/or antiplatelet therapy as described in the protocol
6. Expected to receive cancer therapy or other medication associated with a prior episode of Grade 4 thrombocytopenia as described in the protocol
7. Any history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, traumatic spinal or epidural anesthesia, or history of bleeding diathesis (such as but not limited to Hemophilia A or B, von Willebrand's disease, fibrinogen deficiency, and other inherited or acquired bleeding disorders)

Note: Other protocol defined inclusion/exclusion criteria apply
Healing Space Reiki Therapy: Effectiveness and Experiences

Reiki is an energetic healing method in which a therapist uses his hands on or near the clients body to channel life energy and send it to the client. This activates healing within the client and restores balance.

In this study clients at the Reiki training institute Healing Space are monitored for 4 weeks during 4 weekly Reiki healing sessions. Any client 18 years or older with any complaint can participate. A validated MYMOP questionnaire is used to monitor one main complaint, one secondary complaint and overall wellbeing after each of the 4 treatment sessions and before the start of treatment. A small number of clients will be interviewed for additional in depth data about their experiences. The aim of the study is to gain understanding about the effectiveness of Reiki.

Given the substantial international socio-economic burden of healthcare, the development of inexpensive, safe, and evidence-based treatments is highly desirable. Reiki, as a non-invasive and low-cost therapy, holds potential as a complementary approach to conventional medical treatments. However, the lack of consensus on its efficacy and mechanisms necessitates further investigation. This study aims to address these gaps by exploring the conditions clients report when visiting a Reiki healer and evaluating the subjective effectiveness and experiences of Reiki therapy. By doing so, the study seeks to contribute to the growing body of evidence on Reiki and inform its potential integration into healthcare systems.

This study is an observational prospective pre-post study with a convenience sample. The study is conducted at the Healing Space Reiki center in the Netherlands by Reiki practitioners trained at Healing Space. Each Reiki session lasts 1 hour and is conducted by 2 Reiki practitioners supervised by the founders of Healing Space. MYMOP questionnaires are provided before the first treatment (baseline) and then after each of the 4 treatments. A number of interviews is conducted after the complete treatment. All participants provided written informed consent. A waiver for full ethical assessment will be obtained from an ethical committee.

The MYMOP complaints are categorized into four primary groups: pain, psychological problems, fatigue, and other. Pre- and post comparisons of the four MYMOP measurements were performed usign paired t-tests and independent sample t-tests. Interviews are analysed thematically.

Eligibility Criteria:
Inclusion Criteria:

* Presence of any self reported complaint
* 18 years or older
* No other treatments for this complaint during the intervention period

Exclusion Criteria:

* Other treatments for the complaint during the intervention period
Efficacy of External CounterPulsation for Postoperative Coronary Artery Bypass Grafting Patients

The aim of this study is to evaluate the effect of External CounterPulsation on postoperative heart function and vein graft failure rates of coronary artery bypass grafting patients.

Coronary artery disease (CAD) is prevalent worldwide and the leading cause of mortality of citizens. Coronary Artery Bypass Grafting (CABG)is one of the major revascularization procedures for multi-vessel disease nowadays. However vein graft failures (VGF) are known to occur frequently following CABG surgery . It is estimated that VGF developed in 25% patients in half a year postoperatively, and up to 50% vein grafts would result in occlusion in ten years postoperatively. Surgical success depends on the continued patency of grafts, and VGF has been associated with worse outcomes in CABG patients. Thus prevention of VGF following CABG is an active area of scientific inquiry. External counter pulsation (ECP) is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole.ECP has been elucidated that it may release angina symptoms and improve the prognosis of CAD, however, it remained unknown that weather EECP can reduce VGF rates following CABG surgery. The aim of this study is to evaluate the effect of ECP on heart function of CABG patients and VGF rates.

To address this investigation, patients underwent CABG with at least one vein graft are enrolled and randomize them into control or ECP group, the ECP intervention will be carried out with a standard protocol which involves 35 one-hour sessions (5 days a week) for continuous 7 weeks, and the follow-up will last for 2 years. The primary endpoints are the 2-year major composite cardiovascular events (MACEs,) and 2-year vein graft patency rate determined by coronary CT angiography, secondary endpoints include scoring of angina pectoris, heart function by echocardiography, biomarkers of arteriosclerosis and endothelial function.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent coronary artery bypass grafting surgery

Exclusion Criteria:

* Cerebral hemorrhage within six months;
* Obvious aortic insufficiency;
* Aortic aneurysm;
* Aortic dissection;
* Coronary fistula or severe coronary aneurysm;
* Symptomatic Congestive heart failure
* New York Heart Association（NYHA）heart function class IV
* Valvular heart disease;
* Congenital heart diseases;
* Cardiomyopathies
* Uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg;
* Lower limb infection;
* Deep venous thrombosis;
* Progressive malignancies
Zinc-MNP Trial for Prevention of Diarrhea and Promotion of Linear Growth

This is a randomized, double-blind, community-based efficacy trial of different doses, forms, and frequencies of zinc supplementation for the prevention of diarrhea and promotion of linear growth among children 9-11 months of age in Dhaka, Bangladesh.

Zinc is essential to support growth in young children especially for tissues undergoing rapid cellular differentiation and turnover, such as those in the immune system and gastrointestinal tract. Therapeutic zinc supplementation has been initiated in low-income countries as part of diarrhea treatment programs to support these needs for young children but, the effects of preventive supplemental zinc as a tablet or as a multiple micronutrient powder (MNP) on child growth and diarrheal disease are mixed and pose programmatic uncertainties. Thus, a randomized, double-blind community-based efficacy trial of five different doses, forms, and frequencies of preventive zinc supplementation vs. a placebo was designed for a study in children aged 9-11 months in an urban community in Dhaka, Bangladesh. The primary outcomes of this 24-week study are incidence of diarrheal disease and linear growth. Study workers will conduct in-home morbidity checks twice weekly; anthropometry will be measured at baseline, 12 weeks and 24 weeks. Serum zinc and other related biomarkers will be measured in a subsample along with an estimate of the exchangeable zinc pool size using stable isotope techniques in a subgroup. Therapeutic zinc will be provided as part of diarrhea treatment, in accordance with Bangladesh's national policy. Therefore, the proposed study will determine the additional benefit of a preventive zinc supplementation intervention.

Eligibility Criteria:
Inclusion Criteria:

* 9-11 months of age
* Weight-for-length Z score \>= -3 according to the 2006 World Health Organization Growth Standards
* Hemoglobin concentration \> = 7.0 g/dL

Exclusion Criteria:

* Presence of severe acute malnutrition, defined as a WLZ \<-3 and/or the presence of bipedal edema and/or mid-upper arm circumference \<115 mm;
* Presence of severe anemia, defined as a hemoglobin concentration \< 7.0 g/dL
* Congenital anomalies (e.g. cardiac defects, cleft lip or palate) or any other conditions that interfere with feeding;
* Chromosomal anomalies and other organic problems (e.g. jaundice, tuberculosis)
* Currently consuming MNPs with no intention of stopping
Exercise Induced Muscle Damage Post Dance and Sprint Specific Exercise in Females

There is a paucity of studies investigating exercise-induced muscle damage (EIMD) in females and only one in response to dance-type exercise. This study aimed to firstly elucidate the physiological profile of EIMD following a dance-specific protocol, and second to compare the magnitude of damage to that experienced following a sport-specific protocol in physically active females.

Twenty nine female recreational dancers from a University dance team volunteered to take part in the study. A 3-day food diary and activity log completed prior to testing determined that there were no differences in physical activity levels or energy and macronutrient intakes between participants. Subjects were asked to replicate their reported diets as closely as possible throughout the testing period. A menstrual cycle questionnaire was also completed in order to determine menstrual cycle phase; all testing took place during the early/mid luteal phase.

Participants were randomly assigned to two exercise groups designed to induce EIMD; either a dance-specific protocol (DPFT) or a sport-specific repeated sprint protocol (SSRS). Participants completed the DPFT (n=15) or SSRS (n=14) and a battery of commonly used muscle damage indices were measured pre, immediately post and 24-, 48-, and 72 h post muscle damage. These were; delayed onset muscle soreness (DOMS), limb girth, countermovement jump height (CMJ), reactive strength index (RSI), maximal voluntary isometric contraction (MVC) sprint performance, and total creatine kinase (CK) activity. Participants were tested at the same time on subsequent days (± 1 h) to account for diurnal variation. Participants were asked to avoid strenuous exercise, alcohol, caffeine, nutritional supplements and any anti-inflammatory drugs or alternative treatments for the duration of the study.

Statistical software (IBM SPSS v21, IBM, USA) was used for inferential analysis and significance was accepted at the P \< .05 a priori. Mauchley's test assessed the sphericity of the data and where appropriate, violations were corrected using the Greenhouse-Geisser. To explore our first objective, a one-way analysis of variance (ANOVA) with repeated measures (group, 1; time, 5) was performed on all variables in order to analyse the muscle damage response to the DPFT. For the second aim a two-way ANOVA with repeated measures (group, 2; time, 5) was used for all variables to allow for comparison of the muscle damage response between the DPFT and the SSRS. Where appropriate LSD post-hoc analysis was performed.

Eligibility Criteria:
Inclusion Criteria:

* physically active
* at least 3 years experience in dance training

Exclusion Criteria:

* presence of any medical or physical conditions, either chronic or sustained in the last 3 months which would make participation difficult or harmful to the participant
* eg. history of cardiovascular disease and musculoskeletal disorders
Hypnosis in Virtual Reality in Patients in Protector Isolation Room for Aplasia in Clinical Hematology.

Hematology patients are frequently treated in hospital for aplasia. Patients are then placed in protective isolation room. This situation of protective isolation can represent a significant source of stress and anxiety for the patient. Hypnosis is already used to treat anxiety in patients with cancer.

The purpose of this study is to evaluate the impact of virtual reality medical hypnosis sessions on anxiety and chronic pain of patients hospitalized for aplasia in order to broaden the supportive care proposals in the clinical hematology service of Sévigné Private Hospital.

After verifying the patient's eligibility criteria and obtaining the signed informed consent form, the patient is randomized to the arm receiving hypnosis in virtual reality or to the control arm. The study ends after three consecutive days in protector isolation with one session hypnosis in virtual reality per day.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥ 18 years.
* Haematological pathology
* Patient hospitalized in protective isolation for aplasia defined by a rate of polymorphonuclear neutrophils \<0.5 G / L.
* Patient having signed his informed consent.
* Patient with social security coverage.
* Patient treated and monitored in the center for the duration of the study (maximum 1 month)

Exclusion Criteria:

* Patient unable to undergo protocol monitoring for psychological, social, family or geographic reasons.
* Patient deprived of his liberty or under guardianship.
* Patient with an underlying or concomitant pathology incompatible with inclusion in the trial, whether psychiatric or somatic
* Patient with a contraindication to the use of virtual reality (psychiatric disorders, unbalanced epilepsy, visual or hearing disorders).
Hypersensitivity to PACAP-38 in Post-Traumatic Headache

The aim is to investigate whether signaling molecule PACAP-38 induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age upon entry into screening
* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
* ≥ 4 monthly headache days on average across the 3 months prior to screening
* Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

* \> 1 mild traumatic injury to the head
* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
* History of moderate or severe injury to the head
* History of whiplash injury
* History of craniotomy
* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
* Baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features