cyrilzakka/clinical-trials huggingface dataset:
The Effects of Preoperative Immersive and Non-Immersive Virtual Reality Exposure on Dental Anxiety in Children:A Randomised Controlled Trial

The goal of this randomised controlled trial is to compare the effects of Immersive Virtual Reality(IVRE) and Non-Immersive Virtual Reality(NIVRE) andin children having dental anxiety.The main question\[s\] it aims to answer are:

1. Is there a significant difference in baseline dental anxiety scores, as measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
2. What is the mean change score in dental anxiety measured using the Malay-MCDASf and PR for IVRE, NIVRE, and control groups after the operative procedure?
3. Is there a significant difference in mean change score of dental anxiety measured using the Malay-MCDASf and PR across the IVRE, NIVRE, and control groups?
4. Is there a significant correlation between the Malay-MCDASf scores (subjective) and PR scores (objective) at preoperative, postoperative, and using the score changes for all groups?

Participants will be randomised into three groups, Immersive Virtual Reality, Non Immersive Virtual Reality and Control Group.Immersive Virtual Reality group will be asked to play with an immersive virtual reality dental game using Virtual reality device preoperatively after which they will undergo treatment. For the Non Immersive Virtual Reality participants will be asked to watch a dental cartoon using the virtual reality device passively before treatment and the control group of no intervention, to wait as usual before treatment. All groups will undergo dental treatment of resin based fissure sealant placement under cotton roll isolation in one permanent molar.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 9-12 years old.
* Children who can understand and complete the Malay-MCDASf questionnaire with a score of 19 and above.
* Children who requires fissure sealants on sound permanent tooth.

Exclusion Criteria:

* Children requiring emergency dental treatment for pain, trauma or facial cellulitis.
* Children that have undergone invasive dental treatment such as extraction and pulp therapy in the past 6 months.
* Children with hearing or visual impairment, developmental or intellectual disability, cognitive impairment, balance disorders such as vertigo and cybersickness, sensitivity to the motion or flash light, having accident in the eye, face, neck or arms, history of epileptic seizures, history of cardiac problems
* Parents who refuse to allow their children to participate in the trial.
Effects of Different Techniques of the Method Pilates in Chronic Low Back Pain

The purpose of this study is to compare different methods of application of the Pilates Method with exercises in controlling in low back pain in women aged between 45 and 60 years. Two groups will be formed. One will do Pilates exercises with stabilization segmental. The other group will do classic Pilates exercises. Will be measure pre and pos intervention of the responses already shown above.

The purpose of this study is to identify what type of Pilates exercise is more effective in controlling low back pain is exercise that uses the method of the classical manner or trunk mobilizations with exercises that target the neutral position of the lumbar spine and deep muscles and focus on stabilizing the trunk.

Eligibility Criteria:
Inclusion Criteria:

* Chronic low back pain classified by visual analogue scale being 3-6 points to more than 3 weeks
* Not be performing any other type of physical therapy

Exclusion Criteria:

* Pregnant women
* Back surgeries
* Cardiovascular and rheumatic diseases
OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia

Mutations in IDH genes are found in numerous cancers and more specifically in acute myeloid leukemia (AML). These mutations target specific amino acids, at positions 140 or 172 of IDH2, and 132 of IDH1. Mutant IDH proteins acquire an abnormal enzymatic activity allowing them to convert α-ketoglutarate (αKG) into D-2 hydroxyglutarate (D-2HG), an oncometabolite which massively accumulates in IDH-mutated cells. At high levels, D-2HG behaves as a competitive inhibitor of αKG and affects the activity of Fe(II)/αKG-dependent dioxygenases. This enzymatic family is involved in a broad spectrum of pathways such as demethylation of histone (JHDM histone demethylases) or DNA (methylcytosine hydroxylases of the TET family). As a result, IDH-mutated cells show altered survival, motility, invasiveness and cell differentiation. In AML, IDH1 mutations might be present in 10-15% at diagnosis

Ivosidenib (IVO) a first-in-class, oral, irreversible inhibitor of mutant IDH1 has shown clinical activity as a single agent in studies involving patients with IDH1 mutated relapsed or refractory (R/R) AML and in front line settings. In phase II clinical trials, IVO yielded 30-35% of complete response rates both in frontline and R/R settings, with long lasting responses. Based on these results, the FDA (Food and Drug Agency) gave its approval for newly-diagnosed AML IDH1mut patients who are ≥ 75 years old or who have comorbidities and in R/R. However, European Medicines Agency (EMA)'s did not approved IVO due to lack of evidences to support the application. Agios Netherlands B.V. (the company that previously own the drug before Servier Laboratories) withdrew its EMA application. Nevertheless, IVO has been available in France through a compassionate use program (CUP), since February 2020 for R/R patients and March 2022 for first line treatment.

In this multicentric retrospective study, sponsor aim to evaluate the efficacy and safety of Ivo in two cohorts of IDH1mut AML patients treated within the CUP. The first cohort will concern patients treated in first line setting and the second cohort those treated in R/R disease. Results might provide new insights regarding IVO in real life settings and support signs of efficacy. This could provide new data for the haematologist community and for another appliance to grant EMA approval of IVO in the setting of R/R IDH1mut AML.


Eligibility Criteria:
Inclusion Criteria:

* Patient with IDH1 R132 mutated with newly diagnosed or Relapsed or Refractory (R/R) acute myeloid leukemia
* Patient treated within French compassionate access program that have started the treatment between 01/01/2017 to 01/08/2023
* patient treated by Ivosidenib received either as a monotherapy or in combination with other AML therapy (i.e. azacytidine, venetoclax)
* Patient not included within IDH inhibitor clinical trial.

Exclusion Criteria:

* Patients who expressed their opposition to entered in the study
* Patients who received IVO through a trial
Protective Behavioral Strategies and Brief Alcohol Interventions

Excessive college student drinking represents an important public health problem for both the students themselves and those with whom they interact. The objective of this research is to better understand how to reduce such high-risk drinking by improving prevention and treatment programs, which will provide an overall public health benefit. Subjects in the study will be randomized to one of two brief intervention conditions or an education-only control condition. It is hypothesized that those in the intervention conditions will report greater reductions in alcohol use and alcohol-related problems than those in the control condition.

The primary objective of this project is to examine factors that are associated with the effectiveness of intervention programs designed to reduce high-risk drinking among heavy drinking college students. Previous research has found similar effect sizes for different types of multi-component, brief interventions among college students, but little research has assessed the degree to which specific components of such interventions are associated with intervention outcomes. One common component of motivational enhancing interventions among college students involves providing cognitive-behavioral self-control strategies designed to reduce one's use of alcohol, which we term "protective behavioral strategies" (PBS). However, there are two important factors that limit our understanding of the effects of PBS on client outcomes. First, the use of these strategies in motivational enhancing programs has generally not been assessed in a systematic manner, due in part to the fact that until recently a standardized measure of such strategies did not exist. Second, researchers have yet to conduct studies that dismantle the specific effects associated with the PBS component on client outcomes. That is, studies have not tested interventions with and without assessment and feedback regarding a client's use of PBS. Participants in this project will be "at-risk" college student drinkers who will be assigned to one of three conditions: a brief intervention that includes a focus on PBS, a brief intervention that does not include this focus, and an education-only control condition. Participant will complete self-report measures of alcohol-related variables at baseline, 30-day, and 6-month follow-ups. Mixed-model analyses will be used to determine the effectiveness of the intervention programs, and structural equation modeling will be used to determine if increases in PBS result in reductions in alcohol use/alcohol-related problems.

Eligibility Criteria:
Inclusion Criteria:

* At least one binge drinking episode in the preceding month

Exclusion Criteria:

* At-risk for alcohol dependence or major depressive disorder
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects

This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.

The subjects will be administered a single dose of ASP1941 or placebo under fasting condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate pharmacokinetic and pharmacodynamic properties of ASP1941.

Eligibility Criteria:
Inclusion Criteria:

* Body weight between 50 and 85 kg, and Body Mass Index (BMI) between 17.6 and 26.4 kg/m2 inclusive

Exclusion Criteria:

* Medical history of metabolic disease, hepatic disease, heart disorder, respiratory disease, gastrointestinal disease, renal disease, cerebrovascular disorder, malignant tumor, drug allergy and drug/alcohol dependence
* Blood pressure, pulse rate, body temperature and 12-lead ECG are outside of the preset normal range
* Labo test results deviate from preset normal range
* Receiving treatment, including medication, within 14 days before the study
* Receiving medication in another clinical study or a post-marketing clinical trial within 3 months before the study
* Donates 500mL of whole blood within 3 months or 250mL within 2 months or blood components within 14 days before the study
* Drinking more than 45g of alcohol, or smoking more than 20 cigarettes per day
* Employed by the sponsor, delegated CRO or the study site
* Fasting plasma glucose level of \< 70 mg/dL or ≥110 mg/dL or with an HbA1c ≥5.8%
* Subjects with positive serology test for Hepatitis B antigen, Hepatitis A virus IgM, anti-Hepatitis C virus or anti-Human Immunodeficiency virus-1 or -2
Exercise Interventions in Parkinson's Disease

This study sets out to determine the effect of exercise performed over a longer period of time (6 months), delivered using community facilities, on motor and non motor symptoms, health and well being in people with Parkinson's Disease.

Participation in exercise is beneficial for health and well being, but the effect over a longer period of time in people with Parkinson's disease (PD) has not been established. People with PD currently only receive short-term support for exercise therapy interventions funded from the National Health Service; it is therefore unsurprising that people with PD are observed to have low levels of physical activity that decrease over time.

Using mixed methodology the investigators will explore the effect of exercise delivered over a longer period of time (six months) in people with PD. The investigators will examine the views of people participating in the program.

Aims

Using a randomized controlled trial with one intervention arm and an active comparator control group with blinded assessments and semi-structured interview techniques the investigators will determine in people with PD:

1. The effect of longer-term exercise participation on motor symptoms
2. The effect of longer-term exercise participation on non motor symptoms, fitness, health and well being.
3. Participants views of the process and sustainability of community provision of exercise over a longer period of time.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease diagnosed by neurological examination; idiopathic PD defined by the UK Parkinson's Disease Society Brain Bank Criteria
* Able to walk ≥ 100m
* maintained a stable medical regime for 12 weeks prior to initiation of the study, and anticipated to maintain a stable regime for the course of study (as determined by the referring clinician).

Exclusion Criteria:

* Dementia
* History of additional prior neurological condition
* Severe depression or psychosis or a mental state that would preclude consistent active involvement with the study over its duration
* Cardiac precautions that would prevent the subject from completing the exercise program or the full battery of outcome measures
* Any known contraindication to exercise
* Reduced cognition of any cause \[Minimental state examination \[(MMSE) \< 23\]
* An orthopaedic condition that independently limits walking;
Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.


Eligibility Criteria:
Key Inclusion Criteria:

Incidence Phase

* CGM, TGW, TGM, and GNB who have condomless receptive anal sex with partners assigned male at birth and are at risk for HIV infection.
* HIV-1 status unknown at screening and no prior HIV-1 testing within the last 3 months.
* Sexually active with ≥ 1 partner assigned male at birth (condomless receptive anal sex) in the last 12 months and 1 of the following:

  * Condomless receptive anal sex with ≥ 2 partners in the last 12 weeks.
  * History of syphilis, rectal gonorrhea, or rectal chlamydia in the last 24 weeks.
  * Self-reported use of stimulants with sex in the last 12 weeks.

Randomized Phase

* Negative local rapid fourth generation HIV-1/2 Ab/Ag, central fourth generation HIV-1/2 Ab/Ag, and HIV-1 RNA quantitative nucleic acid amplification testing (NAAT).
* Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min at screening according to the Cockcroft-Gault formula for creatinine clearance (CLcr).

Key Exclusion Criteria:

Incidence Phase

* Prior use of HIV PrEP (including F/TDF or F/TAF) or HIV postexposure prophylaxis (PEP) in the past 12 weeks or any prior use of long-acting systemic PrEP (including cabotegravir or islatravir).
* Prior recipient of an HIV vaccine or HIV broadly neutralizing antibody formulation.

Randomized Phase

* Acute viral hepatitis A, B or C or evidence of chronic hepatitis B or C infection.
* Severe hepatic impairment or a history of or current clinical decompensated liver cirrhosis.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
QL1706 Monotherapy or in Combination With Bevacizumab and XELOX as First-line Treatment of Unresectable Advanced or Metastatic CRC

This is an open-label, muticenter phase II study to evaluate the efficacy and safety of QL1706 monotherapy or in combination with bevacizumab and XELOX as first-line treatment of unresectable advanced or metastatic CRC.


Eligibility Criteria:
Inclusion Criteria:

* 1. Subjects participate voluntarily and sign informed consent.
* 2. Age ≥ 18 and ≤ 80 years old, male or female.
* 3. Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the colon or rectum.
* 4. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1).

Exclusion Criteria:

* 1. Diagnosed additional maliganancy within 5 years with the expection of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin,curatively resected in situ cervival or non-muscle invasive bladder cancers.
* 2. Presence of brain metastases (asymptomatic brain metastases or symptomatic brain metastases who are stable at least 4 weeks, were allowed to be enrolled).
* 3. Has active autoimmune disease that has required systemic treatment in past 2 years.
* 4. Significant cardiovascular disease.
Use of Spectral OCT in Combination Therapy

This study will investigate the safety and efficacy of treatment of choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) with a combination of ranibizumab (Lucentis) and verteporfin PDT (Visudyne), as compared with ranibizumab monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Patients with visual acuity of 20/40-20/320 in the study eye
* Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size.
* Total area of lesion components other that CNV must be less than 50% of the total lesion size.
* The lesion must be \< 5400microns in greatest linear dimension (GLD).
* Lesion size \< 10 DA
* Occult with no classic CNV lesions must have presumed recent disease progression:

  1. Blood associated with the lesion at baseline
  2. Loss of visual acuity in the previous 3 months: a: \> 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
  3. \> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months

Exclusion Criteria:

* Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (-8 or more with evidence of posterior segment abnormalities consistent with pathologic myopia), or CNV secondary to causes other than AMD
* Geographic atrophy in the study eye
* Tear (rip) of the retinal pigment epithelium
* Presence of fibrosis, hemorrhage, pigment epithelial detachments, or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
* Intraocular surgery within 6 weeks of enrollment
* Active or history of ocular inflammation or infection in the study eye within the last 30 days
* Subretinal hemorrhage \> 50% of the total lesion
* History of submacular surgery, or transpupillary thermotherapy in the study eye
* Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications
* Patients with severe disciform scarring
* History of intraocular surgery in the study eye including pars plana vitrectomy, except for uncomplicated cataract surgery within 60 days prior to screening
* History of YAG laser posterior capsulotomy in the study eye within 30 days prior to screening
* Inability to make study visits
* Advanced glaucoma, uncontrolled glaucoma in the study eye (defined as intraocular pressure, IOP ≥ 25 mmHg) despite treatment with two or more topical pharmacological anti-glaucomatous medication)
* Allergies to porphyrins or a known hypersensitivity to any component of Visudyne®
* Patients with porphyria
* Pregnancy or lactation
Real World Registry for Use of the Ion Endoluminal System

The primary objective of this study is to evaluate the performance of the Ion Endoluminal System with real-world use for pulmonary lesion localization or biopsy.

This study is a single-arm, post-market, prospective, multi-center, observational study of subjects undergoing a shape-sensing robotic-assisted bronchoscopy lung lesion localization or biopsy procedure with the Ion Endoluminal System. The primary outcome of this study is focused on evaluating the performance characteristics of the pulmonary lesion biopsy procedure as evaluated by diagnostic yield.

Clinical trial registration is submitted voluntarily under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older at the time of the index procedure.
* Subject is a candidate for an elective, planned lung lesion localization or biopsy procedure utilizing the Ion Endoluminal System.
* Subject able to understand and adhere to study requirements and provide informed consent.

Exclusion Criteria:

* Subject is under the care of a Legally Authorized Representative (LAR) and is unable to provide informed consent on their own accord.
* Subject is participating in an interventional research study or research study investigational agents with an unknown safety profile that would interfere with participation in this study.
* Female subjects who are pregnant or nursing at the time of the index bronchoscopy procedure, as determined by standard site practices.
* Subjects that are incarcerated or institutionalized under court order, or other vulnerable populations.
Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan

Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine


Eligibility Criteria:
Inclusion Criteria:

* Uncomplicated malaria

Exclusion Criteria:

* Severe cases
* Pregnancy
A Safety and Pharmacokinetic Study of CVX-096 in Type 2 Diabetics

The purpose of this study is to determine safety and tolerability of CVX-096 in adult, type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and/or female patients (females will be women of non-childbearing potential) with an historical diagnosis of type 2 diabetes mellitus, who are currently being treated with metformin at a dose at or near maximum.
* Hb A1c between 7-10%.
* Fasting C-peptide \>0.4 nmol/L.

Exclusion Criteria:

* History of clinically significant chronic conditions other than T2DM not well controlled by either diet or medications.
* Patients with pancreatitis or considered a high risk for pancreatitis.
* History of contraindications to metformin therapy.
* Previous treatment with an approved or investigational GLP 1 mimetic.
Effectiveness of Physiotherapy on Postcesarean Pain and Functional Activities

This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems.

This study aims to investigate the effectiveness of physiotherapy applications in early postcesarean problems which make difficulties in functional activities, and includes a physiotherapy intervention group and a control group. Physical characteristics, obstetrical and surgical histories, and systemic problems, back pain, low back pain, headache, urinary/fecal incontinence problems and bowel habit of the subjects both in pregnancy and postpartum periods are recorded. First ambulation time after cesarean, presence of syncope, related vital signs, onset time of bowel peristalsis and defecation are also recorded. Intensities of incisional pain and difficulty in performing functional activities are evaluated by daily 0-10 cm visual analogue scales (VASs). Also, intensities of back pain, low back pain, headache, bloated feeling of the abdomen, and fatigue are also evaluated by daily VASs. Physiotherapy program included breathing exercises, active joint movements of the lower limbs, posture exercises, connective tissue manipulation and transcutaneous electrical nerve stimulation.

Eligibility Criteria:
Inclusion Criteria:

cesarean section giving birth to single baby having cesarean under general anesthesia

Exclusion Criteria:

giving birth to multiple babies being followed in intensive care unit after cesarean because of complications