cyrilzakka/clinical-trials huggingface dataset:
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis

This is a pilot randomized, controlled trial of Vitamin D supplementation in patients on peritoneal dialysis to determine the feasibility of a future full-scale RCT exploring if oral administration of vitamin D3 could reduce the risk of subsequent Peritoneal dialysis-related (PD-related) peritonitis.

Aims of the study:

Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.

Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.

Patients will be screened for eligibility one month after the onset of PD-related peritonitis, those who meet the inclusion criteria will be enrolled in this study.

All consenting participants will be randomized into the vitamin D treatment group or the control group, general information and baseline biochemistry data would be collected. Patients in the treatment group will be treated with oral Cholecalciferol (2000IU/day) apart from routine treatment for PD. Those in the control group will receive routine treatment for PD. Both groups will be followed for 12 months. During the observational period, any onset of subsequent peritonitis will be recorded, serum 25(OH)D, biochemical indices will be measured every 3 months. Follow up would take place frequently, any outcome events would be recorded.

Aims and hypotheses:

Aim 1: To determine the feasibility of oral vitamin D supplementation among PD patients who have recovered from a recent episode of peritonitis.

Hypothesis1: A large、full-scale randomized controlled trail on the effects of oral vitamin D on the risk for peritonitis among PD patients is feasible.

Aim 2: To examine the effect of vitamin D supplementation on the risk for peritonitis among patients on peritoneal dialysis.

Hypothesis 2: Oral supplementation of vitamin D will reduce the risk of subsequent peritoneal dialysis.

Eligibility Criteria:
Inclusion Criteria:

1. Medically stable and receiving peritoneal dialysis (PD) for\>1 months
2. Age at least 18 years.
3. Serum 25(OH)D\<75nmol/l (30ng/ml)
4. Adequate dialysis on evaluation, weekly Kt/V ≥ 1.5 and no clinical uremic symptoms

Exclusion Criteria:

1. Receive Vitamin D2/D3 or drugs known to alter serum 25-hydroxyvitamin D (25(OH)D) levels during the previous 12 months;
2. History of allergic reaction to Cholecalciferol;
3. Current or past malignant disease, active hepatitis or hepatic failure, acute systemic infection, active autoimmune diseases, severe digestive malabsorption or eating disorder, HIV/AIDS;
4. A high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to hemodialysis (HD) or drop-out due to socioeconomic causes within 6 months;
5. Pregnant or breastfeeding;
Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.

Over 40% of patients with bowel cancer are over the age of 75. In older patients, rates of ill health and frailty are high, with frailty found in 6 in 10 patients over the age of 90. Surgery is the main treatment for bowel cancer, but the risks of surgery are higher in older people especially if they are frail. The main features of frailty are weight loss, lack of energy, weakness, slow walking speed and low activity levels. Frailty is a condition linked to an increased risk of death and major complications after surgery. As a result, older and frailer patients are often refused surgery for their cancer. If we could identify frailty more reliably before surgery, we could offer patients better counselling about the surgical risks and benefits. We could also offer treatments that might improve their fitness, making the surgery safer (pre-operative exercise, better post-operative support). Surgeons are not very good at measuring frailty because the clinical tests for it are complicated and take a long time to complete.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. Aged 70 years and over.
3. Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure.
4. About to undergo elective surgery for cancer.
5. Mental capacity to consent.

Exclusion Criteria:

1. Patients with unresectable cancer.
2. Patients presenting as an emergency.
3. Patients who are having chemotherapy or radiotherapy before their surgery.
Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)

Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS


Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient hospitalized in an intensive care unit
* Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission
* Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS

Exclusion Criteria:

* Opposition of patient, relative or legal representative for participation in the study
* Pregnant woman
* Pre-immunodepression
* Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (\> 0.5mg / kg / day).
Feasibility Pilot Study of Internet-based Cognitive Behavioral Therapy (CBT) for Body Dysmorphic Disorder With Global Recruitment

The aim of the study is to study an english-language version of BDD-NET (Enander, et al., 2014; Enander, et al., 2016), an internet-based treatment for Body Dysmorphic Disorder, on a globally recruited sample. This is an uncontrolled pilot study where a within-subjects repeated measures design was used to assess the feasibility of conducting all aspects of the study remotely, including recruitment, assessment, and treatment delivery.


Eligibility Criteria:
Inclusion Criteria:

* Current outpatient status (not currently admitted for inpatient care)
* Patient is fluent in English
* Patient has regular access to a computer with an Internet connection
* Patient has adequate skills to use the Internet effectively.
* Patient provides informed consent (both verbal, and click yes to consent on secure web page)
* Patient is 18 years of age or older (able to provide government issued photo ID)
* Patient has primary diagnosis of DSM-5 Body Dysmorphic Disorder, (determined using the SCID-5 module "G" which assesses diagnostic criteria on obsessive compulsive spectrum disorders)
* score ≥ 4 on the Body Dysmorphic Disorder Questionnaire (BDDQ),
* score ≥ 9 on the Dysmorphic Concern Questionnaire (DCQ)
* score ≥ 20 on the Body Dysmorphic Disorder Modification of the Yale Brown Obsessive Compulsive Scale (BDD-YBOCS).

Exclusion Criteria:

* Patient received Cognitive Behavior Therapy for Body Dysmporphic Disorder in the 12 months preceding treatment
* Patient changed psychotropic medications within the 12 weeks before treatment
* Patient receiving other ongoing psychotherapy at the time,
* Patient did not have access to a 24 hour psychiatric emergency center
* Patient could not provide an emergency contact person.
* Current substance dependence (assessed with M.I.N.I. 7.0, AUDIT, DUDIT)
* Lifetime bipolar disorder diagnosis (assessed with M.I.N.I. 7.0 and self-report)
* Psychosis present
* Severe depression (assessed with M.I.N.I., MADRS-S score ≥ 35)
* Personality disorder diagnosis (self-report and video-conference diagnostic interview),
* Lifetime history of suicide attempts (self-report) or clinically significant current suicidal ideation (≥ 5 on item 9 of MADRS-S; Columbia Suicide Severity Rating Scale (C-SSRS Lifetime Recent) - Clinical Version: Recent (past month) - Most Severe Ideation score ≥ 4).
* Additionally, eligibility continues to be assessed on an ongoing basis after initial inclusion. The MADRS-S, Appearance Anxiety Questionnaire (AAI), and Adverse Events Questionnaire (AEQ) are administered weekly in order to ensure that the treatment study continues to be a safe and appropriate level of care for participants.
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients With Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease

The main objective of the study is to evaluate the efficacy of satralizumab compared with placebo based on time from randomization to the first occurrence of an adjudicated MOGAD relapse in the double-blind (DB) treatment period


Eligibility Criteria:
Inclusion criteria

* Participants who are aged \>=12 years at the time of signing Informed Consent Form
* Confirmed diagnosis of MOGAD with a history of \>=1 MOGAD relapse in the 12 months prior to screening or \>=2 attacks in the 24 months prior to screening
* Expanded Disability Status Scale (EDSS) score of 0-6.5 at screening
* Best corrected visual acuity (HCVA) better than 20/800 in each eye at screening
* Participants receiving either no or ongoing chronic immunosuppressant treatment (IST) for MOGAD at the time of screening
* For women of childbearing potential: participants who agree to remain abstinent or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab

Exclusion criteria

* Presence of aquaporin-4-antibodies (AQP4-IgG) in the serum
* History of anti-N-methyl-d-aspartate receptor (NMDAR) encephalitis
* Any concomitant disease other than MOGAD that may require treatment with ISTs or OCS or intravenous (IV) corticosteroids at doses \>20 mg prednisone equivalent per day for \>21 days during the study
* Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of satralizumab
* Participants with active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection at baseline
* Participants with evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
* Participants with positive screening tests for hepatitis B and C
* Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
* History of severe allergic reaction to a biologic agent
Enhancing Knowledge and Attitudes Through the 'Healthy Nutrition' Education Program

This study aims to assess the impact of a "Healthy Nutrition" education program on the knowledge and attitudes towards healthy eating among elderly individuals residing in a Social Life Campus. The study utilizes a Solomon four-group experimental design, involving participants divided into an experimental group and a control group. Participants were selected based on their ability to effectively participate in the education program, with no psychological or neurological illnesses

The study was conducted using an experimental method to examine the effect of healthy nutrition education on the nutritional awareness and attitudes of older adults residing in a social living home for the elderly (SLHO) within the Izmir Buca Social Life Campus. The study was conducted between 01 February 2023 and 01 June 2024.

The study was conducted among elderly residents aged 60 years and older, without psychiatric or neurological diseases. Participants were divided into experimental and control groups. The Solomon Four Group Design was utilized to compare the effects of the intervention, including pretest and posttest measurements to account for time-dependent changes.

Ethical approval for the study was obtained from the Izmir Democracy University Non-Interventional Clinical Research Ethics Committee, with the decision numbered 2023/02-13, dated 01/02/2023. All participants signed an informed consent form before the study commenced.

The "Healthy Nutrition" education program included two sessions lasting a total of 2 hours. The first session involved traditional presentation-based education, while the second session was an interactive question and answer session. Only the experimental group received this training.

Data collection involved:

Sociodemographic Data Form: Collected basic demographic information such as age, gender, and educational status.

Nutrition Knowledge Scale (NKS) and Healthy Nutrition Attitude Scale (HNAS): Used to measure participants' nutritional knowledge levels and attitudes. These scales were administered both before and after the educational intervention to assess the potential impact of the program.

Eligibility Criteria:
Inclusion Criteria:

* Must be a resident at İzmir Buca Social Life Campus.
* Must be willing to participate voluntarily.
* Must not have any psychological or neurological disorders (e.g., dementia, Alzheimer's disease) that would prevent participation in the training.

Exclusion Criteria:

* Non-voluntary participation: Individuals who are not willing to participate voluntarily.
* Presence of psychological or neurological disorders (e.g., dementia, Alzheimer's disease) that would prevent participation in the training.
Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Myeloid Leukemia

Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR T cells.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of myeloid leukemia was clear;Refractory treatment was defined as: (1) 2 patients who did not achieve partial remission after treatment with standard induced remission regimens.② The patients who relapsed within 6 months after the first remission were also called early recurrence.③ The failure relapsed 6 months after the initial response, but was retreated with the original induced response regimen.(4) multiple relapse.Relapse is defined as: patients who achieve complete remission after treatment, more than 5% of leukemia cells in the bone marrow, also known as intramedullary recurrence;Or the presence of leukaemia outside the bone marrow, also known as extramedullary relapse (usually in the central nervous system, testicular leukemia is the most common);
2. Diseased cells were confirmed to express CD123, CLL1 and other targets;
3. KPS \> 60 points;
4. Expected survival of more than 3 months;
5. No gender limitation, age 2-75;
6. Patients clinically diagnosed as high-risk type, refractory type of recurrence or not eligible for standard treatment;
7. No serious mental disorders;
8. Sufficient heart, liver and renal function (a. Liver function: ALT/AST \< 3 times upper limit of normal value (ULN) and bilirubin ≤34.2μmol/L;B. Renal function: creatinine \< 220μmol/L;C. Lung function: indoor oxygen saturation ≥95%;D. Cardiac function: left ventricular ejection fraction (LVEF) ≥40%;);
9. No other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program;
10. Can cooperate with trial management and follow-up;
11. Patients voluntarily participated in the study and signed the informed consent

Exclusion Criteria:

1. History of other malignant tumors;
2. Uncontrolled active infection;
3. Patients with underlying diseases requiring systemic use of glucocorticoids;
4. Acute or chronic GVHD;
5. T-cell inhibitor therapy;
6. Pregnant and lactating women;
7. Patients with active hepatitis B;
8. Other conditions considered by the investigator to be inappropriate for the study (HIV infection, intravenous drug addiction, etc.), or other conditions that may affect the analysis of the results of the clinical study.
Neuroplasticity With Daily Use of a Sensorimotor Priming Vibration System to Improve Hand Function After Stroke

More than 4 million stroke survivors in the U.S. suffer from post-stroke sensorimotor hand disability, which is typically permanent and difficult to treat. Hand disability has a profound negative impact on functional ability and independence. One way to improve hand function is to use peripheral sensory stimulation. Sensory stimulation in conjunction with therapy has been shown to improve motor outcomes more than therapy alone. While promising, most modalities of sensory stimulation interfere with natural hand tasks. To address these practical limitations, we have developed a new stimulation, imperceptible random-frequency vibration applied to wrist skin via a watch. In this study, we will determine if use of this vibration increases hand functional recovery.

The study design is a double-blinded randomized controlled study. Subjects will wear the device for at least 8 hours/day every day for a month, during which they will come to the laboratory for weekly evaluation. Follow-up evaluation will occur 3 months after. The device will deliver vibration (treatment) or no vibration (control).

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke survivor (\>= 6 months post stroke)
* Ability to move an object with the paretic hand
* Fingertip sensory deficits
* Ability to put on a watch daily (by oneself or with help)

Exclusion Criteria:

* Currently undergoing other upper extremity rehabilitation therapy
* Upper limb botulinum toxin within 3 months prior to or during enrollment
* Change in neurological disorder medications during the enrollment
* Complete upper limb deafferentation
* Rigidity (Modified Ashworth Scale=5)
* Brainstem stroke
* Comorbidity (peripheral neuropathy, orthopaedic conditions in the hand that limit ranges of motion, premorbid neurologic conditions, compromised skin integrity of the hand/wrist due to long-term use of blood thinners)
* Language barrier or cognitive impairment that precludes following instructions and/or providing consent

If a participant has contraindications for Transcranial Magnetic Stimulation (TMS), the participant will not do TMS.
PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting

The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining.

We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

Our first aim is to investigate the prevalence of altered vaginal microbiotas among women seeking fertility treatment in Denmark. Secondly we want to establish whether there are correlations between altered vaginal microbiotas and self-measurements of both the vaginal pH performed with the Saling pH glove™ and a self-collected swab with Copan Eswab™ because these would be useful for an easy-access longitudinal screening option. Finally, the third aim was to explore how the species composition of vaginal microbiotas measured by a multiplex qPCR assay was reflected in Nugent scores.

A possible 4th aim is to identify patterns in the relative abundances of different species with 16sRNA primers among fertile women compared with infertile women because these differences could be indicative of a vaginal microbiota associated with bad fertility outcome.

Eligibility Criteria:
Inclusion Criteria:

* Seeking IVF treatment

Exclusion Criteria:

* Bleeding and sexual intercourse within 24h
Botulinum Toxin A to Treat Arm Tremor

The objective of this study is to assess the efficacy and safety of a single, kinematic-analysis-based intramuscular injection of NT 201, compared with placebo, in moderate to marked essential tremor of the upper limb.


Eligibility Criteria:
Main Inclusion Criteria:

* Diagnosis of 'definite essential tremor' in accordance with modified TRIG criteria, as follows:

  * Bilateral postural tremor with or without kinetic tremor, involving hands and forearms, that is visible and persistent.
  * It is to be noted that:
  * Tremor of other body parts may be present in addition to upper limb tremor.
  * Bilateral tremor may be asymmetric.
  * Tremor is reported by patient to be persistent, although the amplitude may fluctuate.
* First onset of essential tremor at least 6 months before screening with stability of the tremor symptoms over 4 weeks and in the opinion of the investigator definite diagnosis of essential tremor.
* Moderate-to-marked upper-limb postural and/or kinetic tremor at wrist level, corresponding to Fahn-Tolosa-Marin upper-limb tremor rating of at least 2 categories (scale part C, items 16-23) in the limb to be treated between of 2 or higher.
* Visible tremor at wrist level in at least one of the four positions/tasks used in kinematic assessments
* Tremor deemed by the investigator to require a treatment with 30 - 200 U NT 201 for a treatment of up to three joints of the selected upper limb (wrist treatment mandatory).
* Stable concomitant anti-tremor medication and no clinically relevant findings in routine laboratory examinations.

Main Exclusion Criteria:

* Any neurological signs abnormal for the subject's age, other than the tremor itself and Froment's maneuver.
* Exposure to the following tremorogenic drugs: Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or potentially tremorogenic drugs is allowed only if, in the opinion of the investigator, this will not interfere with the study drug evaluation. In these cases, a stable medication should be reached 4 weeks before screening and intended for the time during the study drug evaluation.
* Trauma to the central nervous system or the nerves of the target limb within the three months preceding the onset of tremor.
* Evidence of psychogenic origins of tremor.
* Life habits (e.g. smoking, alcohol or substance abuse) prejudicial to study participation.
* Prior surgery to treat tremor
* Recent (16 weeks) treatment with any Botulinum toxin product for any reason.
* Relevant recent or planned surgery or other specified relevant treatments and/or concomitant disorders.