cyrilzakka/clinical-trials huggingface dataset:
HEALTH4CLL2: A Randomized Waitlist Control Trial of Behavioral Interventions in Patients With Chronic Lymphocytic Leukemia

To learn if exercise and weight management can help to improve feelings of fatigue in CLL survivors.

Primary Objective:

--Evaluate the impact of an organized, longitudinal, diet and exercise training program on fatigue as assessed by the Functional Assessment of Cancer Therapy (FACT) score in patients with CLL.

Secondary Objectives:

--Assess changes in physical activity, dietary behavior, physical function using the PROMIS physical function questionnaire and performance tests of physical function, body mass index (BMI) and global quality of life. Additionally, we will assess changes in fecal microbiome composition, metabolic parameters including a comprehensive lipid panel, glucose, insulin, TNF alpha, IL6, leptin, resistin, adiponectin, IGF1 and IGFBP1 and immunologic function as assessed by T cell and monocyte phenotypic and functional assays in patients with CLL after participation in the behavioral intervention.

Exploratory Objectives:

-- Identify differences in the metabolic, immunologic and fecal microbiome composition in patients with CLL who have a high CLL comorbidity index score (CLL-CI) compared to patients with CLL and a low CLL-CI score. And, investigate the association of comorbidity score, disease features, CLL-specific prognostic factors and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18-85 years of age with a histologically confirmed diagnosis of CLL and the ability to provide signed informed consent.
* Self-reported physical activity will be assessed prior to enrollment and patients with a physical activity level below the level prescribed in our study will be eligible for inclusion.

Exclusion Criteria:

* Other active malignancy within 1 year of study enrollment (excluding non-melanoma skin cancer)
* Richter's transformation, another medical condition which would prevent safe participation in the behavioral intervention
* Major surgery within 1 month of enrollment
* Non-English speakers
* Cognitively impaired adults
* Pregnancy.
Urdu Translation, Validity and Reliability of Quick Disabilities of Arm, Shoulder & Hand (QuickDASH)

The purpose of this study is to translate Quick Disabilities of Arm, Shoulder \& Hand (QuickDASH) into Urdu and determine the validity and reliability of the Urdu version of QuickDASH.


Eligibility Criteria:
Inclusion Criteria:

Individuals with for shoulder, arm/wrist, or hand musculoskeletal injury/pain/symptoms. Capable of understanding and completing the self-reported questionnaires. The exclusion criteria were the -

Exclusion Criteria:

Presence of any systemic disease or any neurological disorder. The upper limb involvement is due to any recent surgery in less than 6 weeks.

-
Study of HuCNS-SC Cells in Patients With Infantile or Late Infantile Neuronal Ceroid Lipofuscinosis (NCL)

Patients with infantile or late infantile NCL have either a reduced amount of, or are missing, the palmitoyl protein thioesterase 1 (PPT1) enzyme or the tripeptidyl peptidase 1 (TPP-I) enzyme. Human central nervous system stem cells (HuCNS-SC) are an investigational product derived from human brain cells. HuCNS-SC have been shown to survive and migrate within the brains of mice. When grown in the laboratory, HuCNS-SC have been shown to produce the PPT1 and TPP-I enzymes. In mice missing the PPT1 enzyme, HuCNS-SC have been shown to increase the amount of this enzyme in the brain, to reduce the amount of abnormal storage material in the brain, and to prevent the death of some neurons (a type of cell) in the brain.

Participation in this study will involve screening assessments, surgery to implant HuCNS-SC, medication to suppress the immune system, and a series of follow-up assessments. The length of time from the start of screening through to the last follow-up visit will be approximately 13 months, with frequent visits to the study center during this time. After completion of this study, patients will be monitored for an additional 4 years under a separate long term follow-up protocol.


Eligibility Criteria:
Inclusion Criteria:

Patients MAY be eligible to participate in this research study if they:

* Are age 18 months to 12 years old
* Have a clinical diagnosis of infantile neuronal ceroid lipofuscinosis (INCL) or late infantile neuronal ceroid lipofuscinosis (LINCL)
* Have a mutation of the CLN1 or CLN2 gene
* Have severe cognitive, communication, behavior and language impairment

Exclusion Criteria:

Patients may not be eligible to participate in this research study if they:

* Have cognitive, communication, behavior and language function less than that of a 1 year old
* Have previously received an organ, tissue or bone marrow transplantation
* Have previously participated in any gene or cell therapy study
* Have infection with hepatitis virus, Cytomegalovirus, Epstein Barr Virus, or Human Immunodeficiency Virus (HIV)
* Have a current or prior cancer
* Have a bleeding disorder
* Are unable to have an MRI scan
Observational Study to Investigate the Effectiveness of Eprosartan on Pulse Pressure (Teveten_MS)

The study is to identify the effectiveness of Eprosartan on pulse pressure in hypertensive patients with metabolic syndrome

-Definition of pulse pressure (PP): Difference between systolic and diastolic blood pressure produced one heart beat.

Primary Objective

-To assess the changes of pulse pressure at 12 weeks

Secondary Objectives

* To assess the changes of pulse pressure at 4, 24 weeks
* To assess the changes of systolic blood pressure and diastolic blood pressure at each visit
* Percentage of responder rate\* at each visit and time to get normalized BP from enrollment
* Responder rate at last visit
* To assess IIEF-5 (5-item Version of the International Index of Erectile Function) score at enrollment and 24 weeks (percentage of patients with ED according to IIEF-5, Changes of IIEF-5 domains)
* Percentage of patients with erectile dysfunction (ED) according to IIEF-5 and changes of PP in subgroup (age 65, body mass index (BMI) 23, diabetes mellitus, dyslipidemia, benign prostate hypertrophy)
* Analysis of correlation between ED and concomitant disease and concomitant medications in patients who received Eprosartan
* Score changes of Framingham 10-year Coronary Heart Disease (CHD) risk at 1st visit, 4th visit
* Percentages of Eprosartan monotherapy and multiple antihypertensive therapies at enrollment and last visit
* Reason for treatment discontinuation (Inadequate BP control, adverse events, others)
* Adverse events

  * Responder rate: SBP \<140mmHg and DBP \<90mmHg (SBP \<140mmHg and DBP \<85mmHg for patients with diabetes mellitus)

Eligibility Criteria:
Inclusion Criteria:

1. 20-80 years old patient at the 1st visit
2. Patient who is determined to prescribe Eprosartan for hypertension (patient with at least one of the following conditions) (1) Newly diagnosed hypertension (2) Inability to tolerate hypertension (for example: adverse event) (3) Lack of response to current antihypertensive medications
3. Metabolic syndrome patient (fulfill 3 or more components before enrollment) (1) Waist circumference (\>90 for men, \>80 for women) (2) Triglycerides (≥150mg/dl) (3) HDL cholesterol (\<40mg/dl for men, \<50mg/dl for women) (4) SBP≥130mmHg or DBP≥85mmHg or on antihypertensive medications) (5) Fasting glucose level (≥100mg/dl) or on antidiabetic medications

   * MS diagnosis origin: Korean diabetes association

Exclusion Criteria:

1. Patients who is administered with 3 or more than 3 antihypertensive drugs
2. Patients who is contraindicated with Eprosartan by the product label
Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).


Eligibility Criteria:
Inclusion Criteria:

* Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

* Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)
Positron Emission Tomography (PET) Study Investigating Dopamine and Serotonin Receptor Occupancy After Multiple Oral Dosing of Lu AF35700

The purpose of this PET study is to verify the binding of Lu AF35700 after multiple oral dosing at the dopamine and the serotonin receptors in male patients with schizophrenia.

There were 3 to 4 cohorts of 2 patients per receptor group. Lu AF35700 was administered as multiple oral doses for up to 21 days before the PET scans were performed. The doses in all groups were selected with the aim of characterising the exposure response (occupancy) curve. The doses for all groups, with the exception of A1, B1, and C1, were subject to change within the dose range already investigated and found tolerable. The next dose for the groups was established at a dosing conference based on an evaluation of the occupancy obtained, and safety, tolerability, and pharmacokinetic data from all previous cohorts.

Eligibility Criteria:
Inclusion Criteria:

1. The patient is a man aged between ≤18 and ≥60 years
2. BMI of ≥19 kg/m2 to ≤ 37 kg/m2
3. The patient has a primary diagnosis of schizophrenia according to DSM-5™ (code 295.90)
4. The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤ 4 (moderately ill) at screening and safety baseline
5. The patient is currently under oral therapy with one or more of the antipsychotic medications listed in Appendix II.
6. The patient has a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80
7. The patient has a score of ≤ 4 (moderate) on the following PANSS items at screening and at safety baseline: P7 (hostility), G8 (uncooperativeness)

Exclusion Criteria:

1. The patient experienced an acute exacerbation requiring hospitalization within the last 3 months.
2. The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks.
3. The patient has a diagnosis or history of substance use disorder (except nicotine) according to DSM-5-TR® criteria ≤3 months prior to screening
4. The patient is at significant risk of harming himself or others according to the investigator's judgment or as indicated by an answer of "yes" to the question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the Screening Visit within the last six months on the lifetime version of C-SSRS.
5. Based on investigators judgment the patient has a medical or neurological disorder or treatment for such disorder that could interfere with the study treatment or impair treatment compliance.
6. The patient has had past episodes of extrapyramidal symptoms (EPS) under current medication within the last 3 month
7. The patient takes other medication than those listed as allowed concomitant medication in Appendix III
8. The patient is occupationally exposed to significant levels of ionizing radiation.

Other protocol-defined inclusion and exclusion criteria may apply
Soft Tissue Healing During Alveolar Ridge Preservation

Statement of the problem: Alveolar ridge preservation after tooth extractions is considered a challenge in oral surgery daily practice. Dental extraction is a traumatic procedure which leads to loss of alveolar bone. The alveolar bone remodeling, which occurs after tooth extraction, leads to vertical and horizontal bone volume loss. Although placentally derived allografts have been widely applied in medical procedures over the past 100 years, their use in the dental field is relatively new.

The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

The aim of this study is to compare the effect of covering versus uncovering the HAM on soft tissue healing after alveolar ridge preservation procedure using customized splints.

materials and methods: Careful extraction of the selected tooth will be performed. Then, the extraction sockets will be randomly allocated into two groups. The HAM particulate will be packed into the extraction socket as a standard method for both groups. Group A (n=24) socket will be covered with Human amnion membrane while group B (n=24) socket will be covered with the prefabricated acrylic splint. Soft tissue healing will be assessed (1ry outcome) every day for the first week, day after day second week, once in third and fourth week. Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post surgically. Postoperative medication will be prescribed to the patient and postoperative instructions will be explained in detail. Follow-up will be performed to assess the parameters and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

1.Patients who need simple teeth extractions.

Exclusion Criteria:

1. Patients with inability or anticipated failure to maintain adequate oral hygiene.
2. Pregnant or breast-feeding mothers.
3. Any medical condition or therapy that can affect healing.
The Effect of Listening to Music During CPAP on the Agitation Levels and Compliance.

Aim: This study was conducted to determine the effect of listening to music during CPAP on the agitation levels of intensive care patients who underwent CPAP due to COVID-19 and their compliance with the treatment.

Study Design: This study is a prospective, randomized, controlled clinical trial. Seventy-six intensive care patients with COVID-19 were included in this study and assigned to the music and control groups via the block randomization method. The study was completed with 70 patients. In this study, the patients and outcome assessors were not blinded. The Richmond Agitation and Sedation Scale (RASS) level, respiratory rate, oxygen saturation (SpO2), and mask air leakage amount were the result criteria.

Results: The mean RASS score of the patients in the intervention group was 2.14±0.69 before CPAP, 1.63±064 at the 1st minute, 0.89±0.58 at the 15th minute, and 0.74±0.61 at the 30th minute. The mean RASS score of the patients in the control group was 2.06±0.53 before CPAP, 1.80±0.58 at the 1st minute, 1.43±0.60 at the 15th minute, and 1.46±0.61 at the 30th minute of CPAP. There was a statistically significant difference between the groups at the 15th and 30th minutes (t=-3.81, p \< .001; t=-4.89, p \< .001, respectively).


Eligibility Criteria:
Inclusion Criteria:

1. over 18 years old
2. Received CPAP treatment for 1 day in the intensive care unit,
3. Not hearing impaired,
4. No sedation treatment
5. Not diagnosed with a psychiatric illness,
6. Hemodynamically stable,
7. Not taking drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate
8. Patients with a Glasgow Coma Scale score of 14 and above will be accepted.

Exclusion Criteria:

1. The patient's desire to leave the study
2. be under the age of 18
3. putting the patient on mechanical ventilation
4. have a hearing impairment
5. Receiving sedation therapy
6. diagnosed with psychiatric illness
7. Using drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and pulse rate
8. Patients with a Glasgow Coma Scale score below 14 will not be included in the study.
Biomechanical Relationship Between Trunk Flexion and Mouth Opening: Pilot Study

The aim of the present study is to analyze if there is a biomechanical relationship between trunk flexion and buccal opening and to observe if there is an improvement of trunk flexion by performing the "sit and reach" test when stretching the masticatory muscles.

The study design is made up of a double-blind clinical trial with 60 participants randomly divided into two groups of 30 people each (Treatment group and Control group). Basal measurements of the mouth opening were taken with a vernier caliper and the trunk flexion measurements were taken by means of the "sit and reach" test. These measurements were carried out again after the intervention, which consisted of self-stretching of the masticatory muscles for the Treatment group and an occlusion of the mouth for the Control group. In the results there was an increase in the trunk flexion compared to the initial values in both groups (Treatment group 2.8 (1.51), Control group 1.97 (2.31) and this increase was greater in the Treatment group even though the difference with the Control group was not statistically significant. Therefore, the stretching of the masticatory muscles does not cause an immediate increase in the degree of trunk flexion measured by the "sit and reach" test. As a consequence, we cannot confirm the existence of a biomechanical relationship between trunk flexion and mouth opening.

Eligibility Criteria:
Inclusion Criteria:

1. Being between 18 and 26 years old (both included).
2. Having signed the consent form.
3. Being able to introduce three knuckles of the non-dominant hand between the incisors.

Exclusion Criteria:

1. Having a musculoskeletal injury in the lower extremity and / or in the jaw.
2. Being in the process of receiving physiotherapy treatment and / or having undergone any odontologic or maxillofacial surgery in the last month.
3. Having suffered dislocations, painful clicks or being diagnosed with some type of temporomandibular joint (TMJ) dysfunction.
4. Having hypermobility in the temporomandibular joint (TMJ) that is, the measurement of the buccal opening being greater than 60 mm.
Antimullerian Hormone in Endometriomas

The purpose of this multicenter study is to evaluate the ovarian reserve after alcohol sclerotherapy of endometriomas versus conventional surgery.

Between 5-10% fertile women are affected by endometriosis, and ovarian endometrioma is present in 17-44% of cases, with 40% of patients with endometriomas being sterile. However, the "gold standard" treatment is laparoscopic ovarian cystectomy and this therapy is associated with a diminished ovarian reserve, with a significant antimullerian hormone (AMH) decrease.

Alcohol sclerotherapy is a new minimal invasive procedure in endometrioma treatment whose potential beneficial effect in fertility preservation is not still demonstrated.

The investigators would like to demonstrate that this procedure improves fertility preservation and reduces morbidity and costs in contrast with conventional surgery. Moreover,the investigators would like to demonstrate that this procedure could be performed in different centers with similar results.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Age ≥18 and \<40 years
* Unilocular endometrioma according ultrasounds
* Endometrioma size: 35-100 mm during \> 3 months from diagnosis
* CA125 \<200 IU/mL and HE4 \< 70,
* AMH previous surgery between 1.2-4 ng/mL

Exclusion Criteria:

* Previous ovarian surgery or gynecological cancer
* Severe extraovarian endometriosis
* Dermoid or high risk of malignancy cysts
* Hormonal treatment 3 months before
* Pregnancy
* Mental disability
Protein-bound Toxin Removal Between Limited Blood Flow Super High-flux Online HDF and High-Efficiency Online HDF

High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance protein-bound toxin and middle molecular toxin removal and improve patient survival. Unfortunately, the majority of patients could not reach that high BF because of vascular access issue. This randomized crossover study was conducted to compare these uremic toxin removals between the new modality (limited BF OL-HDF with super high-flux dialyzer) and the control (high-efficiency OL-HDF). The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks.

Elevated protein-bound toxins including p-cresol (pCS) and indoxyl sulfate (IDS) as well as middle-molecular toxins such as beta2-microglobulin (B2M) which could not be removed by hemodialysis (HD) are obviously correlated with high mortality. High-efficiency post-dilution online hemodiafiltration (OL-HDF) using high-flux dialyzer and requiring high blood flow rate (BF ≥400 mL/min) has been reported to enhance pCS, IDS, and B2M removal and improve patient survival. Unfortunately, the majority of patients could not reach that high BF because of vascular access issue. We innovated the OL-HDF modality for this limited BF situation by integrating the novel super high-flux membrane dialyzer (SHF; PES-17Dα, Nipro Corporation, Japan) into pre-dilution OL-HDF. This randomized crossover study was conducted to compare the uremic toxin removals between the new modality (limited BF OL-HDF with SHF) and the control (high-efficiency OL-HDF). The OL-HDF patients were randomized to undergo either new modality or control for 2 weeks before crossover to the other modality for another 2 weeks. Removals of pCS and IDS as well as small and middle molecule toxins were compared. The pCS and IDS were measured by high performance liquid chromatography. The dialysate albumin loss and patient safety were also monitored.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease patients treated with thrice-a-week OL-HDF for at least 6 months
* Residual urine \< 100 mL/day

Exclusion Criteria:

* Active cardiovascular disease
* Active malignancy
* Pregnancy
* Breast-feeding
REThink Chronic-A Mobile Therapeutic Game

The general objective of the study is to test the efficacy of an online therapeutic game (REThink Game) for the prevention of emotional disorders in children and adolescents aged between 8-16 years with a chronic physical disease.

The objective of the study is to test an online therapeutic game which, being an evidence-based prevention tool for children and adolescents, might contribute to preventing emotional disorders in children and adolescents aged between 8-16 years old diagnosed with a chronic physical disease. REThink is a scientifically validated therapeutic game for children and adolescents to improve their emotional skills. The enrollment will take place both online and in pediatric medical institutions. The research study will include one parent of the eligible child/adolescent. The children and adolescents will be randomized into two equal groups: the intervention group which benefits of the entire REThink game and the treatment-as-usual group which benefits of a free trial version of the app. Three assessments will be performed to evaluate the variables of interest: before intervention (baseline), after intervention (post-intervention), and a follow-up six months after the post-intervention assessment was performed.

Eligibility Criteria:
Inclusion Criteria:

* are aged 8 to 16 years old
* are diagnosed with a chronic physical disease
* have consent from the parent or legal tutor to participate in the study
* are fluent in Romanian
* have access to a mobile phone, tablet or laptop

Exclusion Criteria:

* have intellectual disabilities or physical limitations which make it impossible for the them to play the game
* have traumatic brain injuries
* have a diagnosed mental disorder
* demised during the study period
FMT in Gut aGVHD Treated

With the stem cell transplanting increasing, patients which effected with gut GVHD were also increased. To evaluation the safety and efficacy of FMT for gut GVHD,patients with gut GVHD were recruited.


Eligibility Criteria:
Inclusion Criteria:

* gut GVHD

Exclusion Criteria:

* Age\>60; or Age\<10