cyrilzakka/clinical-trials huggingface dataset:
SANCC: Clinical Trial Early Intervention

Subarachnoid neurocysticercosis (SANCC) is a severe infection of the brain by the tapeworm Taenia solium. People who have this infection are usually diagnosed late in the disease process leading to very poor prognosis. This trial studies the safety of early medical intervention in people who have SANCC but do not have symptoms. The trial will enroll 18 participants in Peru.

PRIMARY OBJECTIVE:

I. To estimate the risk of serious adverse events (SAE) related to intervention in asymptomatic SANCC; these include drug-related side effects, moderate/severe intracranial hypertension, hydrocephalus requiring shunting or endoscopy, stroke, status epilepticus, or unexplained death.

OUTLINE:

Participants will be hospitalized for approximately 15-30 days while they receive treatment with the antiparasitic drug albendazole, as well as additional drugs (dexmathesaone and omeprazole) to address potential treatment complications. Participants will have continuous monitoring for adverse events while in the hospital. After participants are released to home, they will monitored for adverse events for an additional 12 months through home visits, telephone contact, and monthly clinical evaluations with serologic and radiologic assessment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female individuals older than two years with a diagnosis of asymptomatic SANCC confirmed by MRI.
* SANCC limited to the basal cisterns, the interhemispheric brain space, brain fissures or spine.
* Baseline laboratory results within acceptable ranges (specifically defined in the study protocol)
* Willingness to accomplish the two-week minimum hospitalization required.

Exclusion Criteria:

* Individuals who only have subarachnoid lesions in the convexity of the brain hemispheres will not be included because these lesions commonly respond well to therapy and behave as intraparenchymal lesions
* Co-occurrence of a) more than 20 intraparenchymal lesions in addition to their subarachnoid disease, or b) intraparenchymal lesions greater than 3.0 cm of diameter
* Individuals for whom a surgical intervention to treat their subarachnoid disease is considered clearly superior to a medical intervention
* Previously diagnosis or treatment for cysticercosis.
* Active pulmonary tuberculosis evidenced by chest X-ray and positive sputum smears, or symptoms compatible with tuberculosis (fever+sweats or fever+cough) not otherwise explained
* Individuals with positive markers for active hepatitis
* Other systemic disease that may affect therapy or short-term prognosis, including but not limited to chronic renal failure, hepatic insufficiency, cardiac failure, or steroid-dependent immune diseases
* Pregnancy. If a participant becomes pregnant during the study, she will continue in the study but will have radiological exams delayed until after delivery
* History of hypersensitivity to ABZ
* Chronic alcohol or drug abuse as defined in the study protocol
* Unwilling or unable to provide MRI exams (e.g. patients with ferromagnetic implants)
* Inability or unwillingness of subject or legal representative to give written informed consent.
Changes in Cardiovascular and Sleep Quality Parameters Under Eurythmy Therapy and Tai Chi in Comparison to Standard Care - A Substudy of the ENTAiER Trial

ENTAiER study is a multicentre randomized controlled trial to assess the efficacy and safety of eurythmy therapy and Tai Chi in comparison to standard care in chronically ill elderly patients with increased risk of falling. Subjects will be randomized to eurythmy therapy or Tai Chi or standard care alone. To investigate the changes in cardiovascular and sleep quality parameters under Eurythmy Therapy and Tai Chi in comparison to Standard Care in this trial, a substudy will be conducted only at the ARCIM Institute. The substudy will recruit enrolled participants from the ENTAiER trial to record various cardiovascular and sleep quality parameters. The aim is to compare changes in cardiovascular and sleep quality parameters under eurythmy therapy, Tai Chi and standard care alone in chronically ill elderly patients with increased risk of falling.

This is an optional substudy of a multi-centre, parallel-group, three-arm randomized controlled trial - ENTAiER trial - to compare the changes in cardiovascular and sleep quality parameters under Eurythmy Therapy and Tai Chi in comparison to Standard Care in chronically ill elderly patients with increased risk of falling (see DRKS-ID: DRKS00016609). Subjects who consent to enroll in ENTAiER will be asked to participate in this substudy. The main focus of this substudy is on assessing the effects of Tai Chi and Eurythmy on the vegetative nervous system by measuring various parameters of heart rate variability and pulse wave analysis. In addition, the effects on sleep quality will be assessed. Participants of the substudy will undergo a measurement of heart rate variability with a long-term-ECG (Bittium Faros 360 TM), a pulse wave analysis, recorded with a vital function monitor (VitaGuard® 3100 monitor, getemed, Germany), and a blood pressure measurement and they fill in a sleep quality questionnaire (Pittsburgh Sleep Quality Index, PSQI) at baseline and after 3, 6 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for this substudy, subjects must be enrolled in ENTAiER main study and provide separate written informed consent for EYT_12 Substudy. See DRKS-ID: DRKS00016609 for inclusion criteria into ENTAiER main study

Exclusion Criteria for Substudy:

* Cardiac pacemaker
* Atrial fibrillation (documented in medical reports)
* To be eligible for this substudy, subjects must be enrolled in ENTAiER main study and provide separate written informed consent for EYT_12 Substudy. See DRKS-ID: DRKS00016609 for exclusion criteria into ENTAiER main study
Transversus Abdominis and Pelvic Floor Muscle Strengthening Exercise Program In Patients With Grade 1 Cystocele

Cystocele, a protrusion of the bladder, happens while the bladder descends into the vagina. There are more than one underlying causes for the development of cystocele ensuing in weak point of the muscles and the connective tissue surrounding the bladder and vagina.

This study will be a randomized clinical trial. After the department permission of physical therapy data will be collected from patient of Jinnah Hospital. Data will be collected before and after treatment. Randomization will be done by lottery method. Group A will be given pelvic floor strengthning exercises and goup B will be given transverse abdominas strengthning exercises. Each group will have 33 patients each. A 6-week physical therapy program will be planned. Group A will be given pelvic floor muscle strengthning exercise and the group B will given transverse abdominas exercises.Data will be entered and analysed by SPSS version 25.

Cystocele, in any other case called a protrusion of the bladder, happens while the bladder descends into the vagina.The bladder bulges via the anterior wall of the vagina, with which it's miles anatomically related. There are more than one underlying causes for the development of cystocele ensuing in weak point of the muscles and the connective tissue surrounding the bladder and vagina. This study will be a randomized clinical trial. After the department permission of physical therapy data will be collected from patient of Jinnah Hospital. Data will be collected before and after treatment. Total sample size is 60. Non probability convenient sampling technique will be used. Randomization will be done by lottery method. Group A will be given pelvic floor strengthning exercises and goup B will be given transverse abdominas strengthning exercises. Each group will have 33 patients each. A 6-week physical therapy program will be planned. Group A will be given pelvic floor muscle strengthning exercise and the group B will given transverse abdominas exercises. Individual sessions will be held twice a week for 60 minutes each. Each meeting will include a theoretical portion of up to 10 minutes and a practical portion of roughly 50 minutes. Home plan will also be shared with them. Post treatment analysis will be done in order to find the effects of both regims. Data will be entered and analysed by SPSS version 25. The aim is to compare the effects of transversus abdominis and pelvic floor muscle strengthening exercise program on disability and urinary incontinence in patients with grade 1 cystocele.

Eligibility Criteria:
Inclusion Criteria:

* Females age of 35 to 65 years will be included in our study.
* Females who will not able to contract the Pelvic floor muscles
* Female who hill have mixed urinary incontinence will be included in our study

Exclusion Criteria:

* Females with malignancies will be excluded
* Females with neurological issue will be excluded
* Females who hill have untreated urinary tract infection will be excluded from our study
Protocol-Specified Modification of Immunosuppression Directed to Protocol Biopsy in Kidney Transplantation

The risk-benefit of surveillance-protocol biopsy (SPBx) in kidney transplantation remains unclear. The study aims to compare outcomes of recipients with SPBx approach to recipients with standard approach which allograft biopsy was performed only when indicated.

The present randomized-controlled trial in kidney transplant patients aims to compare the outcomes and complications between who underwent immunosuppessive drug modification under surveillance-protocol biopsy and who underwent immunosuppressive drug modification following tough level only.

Eligibility Criteria:
Inclusion Criteria:

* All kidney transplant recipients underwent transplantation at Chulalongkorn University

Exclusion Criteria:

* Pregnancy
* Recipients who cannot withhold aspirin, clopidogrel, warfarin, etc.
* Non-cooperated recipients
The Effect and Applicability of CBT-Based Weight Loss Treatment Model in Obese Patients With Comorbid Depression in Health Care

The aim of this study is find out how CBT-based weight loss program affects on eating behavior, weight loss, mood symptoms and risk for coronary heart diseases and type 2 diabetes and applicability of the program to obesity treatment among patients with comorbid depression. Our hypothesis is that the CBT-based intervention improves long-term weight management results and supports positively the change in eating behavior and the risk for CHD on type 2 DM.

The study is randomized controlled one-year intervention study with 1 year follow-up. Study subjects are adult obese (BMI\>35) subjects with comorbid depression. Number of randomized study subjects will be 80, 40 in intervention group, 40 in control group.

Intervention group will proceed through a 52-week CBT-based weight loss group intervention. The aim of the intervention is to modify eating behavior and lifestyle factors affecting weight and weight maintenance. There will be 22 group counselling of 90 minutes divided in five modules and also three individual person-centered counselling visit, during which participants had an opportunity to discuss their personal concerns about diet and weight loss plan. Control group will receive the usual care of obesity in Kuopio University hospital. (4-8 individual 45-minute visit conducted by dieticians)

Study visits are at baseline and one and 2 years after baseline. For example eating behavior, health behavior, motivation and depression are studied with questionnaires. Weight, waist circumference, height and blood pressure are measured. Laboratory tests (lipid, glucose etc) are taken.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* Diagnosed depression ( F32.0, F32.1, F32.2, F33.0, F33.1, F33.2)
* BMI \> 35

Exclusion Criteria:

* Psychotic disorder, schizoaffective disorder, psychotic depression or bipolar disorder
* Severe current substance abuse
* Serious psychiatric condition (i.e self-destructive or impulsive behavior)
* Clinically significant illness contraindicating weight loss (i.e cancer or severe heart disease)
* Simultaneous participation in another weight loss program
* Severe vision, hearing, motoric deficiency
Feasibility of Centralized Therapeutic Drug Monitoring of Fluoroquinolones in Multi-Drug Resistant Tuberculosis Patients

Observational, multi-centre, prospective study to investigate the feasibility of centralized TDM of moxifloxacin and levofloxacin in MDR-TB patients by determining turn-around time between sampling and receiving dosing advice.

In addition, the effect of TDM will be evaluated by comparing treatment results of prospective patients receiving TDM with historical controls without TDM.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary MDR-TB
* Sputum smear and sputum culture positive at baseline
* Oral administration of either moxifloxacin or levofloxacin
* Written informed consent (for use of the medical data)

Exclusion Criteria:

* Pregnancy or breast feeding
Scleral Fixation for Intraocular Lens-Bag Dislocation

Novel introflective sutures offer a minimally invasive approach for stable fixation of dislocated bag-IOL complexes, preserving visual acuity and reducing corneal complications in patients with pseudoexfoliation syndrome.

To assess the one-month outcomes of visual performance and positional stability of capsule-fixated intraocular lenses (IOLs) in patients with IOL-Bag complex dislocation. Patients with intraoperative complications or prior posterior capsule Nd-YAG laser were excluded. Surgical intervention involved creating a superior service keratotomy and using introflective sutures for IOL fixation. Best Corrected Visual acuity (BCVA), endothelial cell counts, and tonometry were assessed at multiple postoperative time points. We also evaluated the mean spherical equivalent (SE), and the residual cylinder and sphere at each follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patients affected by pseudoexfoliation syndrome, with inferior dislocation of the bag-IOL complex

Exclusion Criteria:

* patients who underwent intraoperative complications,
* dislocation in the vitreous chamber of the bag-IOL complex,
* patients who had already undergone posterior capsule Nd-YAG laser
Safety and Efficacy of CG53135-05 in the Prevention of Oral Mucositis in Patients Receiving Bone Marrow Transplant

CG53135-05, a recombinant human fibroblast growth factor-20 (rhFGF-20) protein, is under investigation for the prevention of oral mucositis. Oral mucositis is a commonly occurring side effect of high-dose chemotherapy in patients undergoing autologous hematopoietic stem cell transplant. The objective of this Phase II trial is to evaluate the safety and efficacy of CG53135-05 when administered as a single dose to patients at risk for developing oral mucositis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ages \> 18 yrs
* Patients undergoing high dose chemotherapy with or without radiation therapy treatment as conditioning for autologous hematopoietic stem cell transplantation. The conditioning regimens include at least one of the following: high dose melphalan (Mel 200), busulfan, or etoposide, with or without total body irradiation.
* Patients with Karnofsky performance scores \> or = 70%
* Informed consent for participation in study

Exclusion Criteria:

* Patients who weigh \< 33 kg
* Premenopausal female patients who are pregnant, lactating or are likely to become pregnant
* Patients with active medical conditions that preclude autologous hematopoietic stem cell transplantation
* Patients diagnosed with active acquired immunodeficiency syndrome (AIDS) or Hepatitis B/C
* Patients with known hypersensitivity to recombinant protein therapeutics
* Patients who have taken CG53135-05, palifermin or other investigational drugs in the past 30 days
* Patients who have untreated symptomatic dental infection
* Patients with a history of sensitivity or allergy to E. coli-derived products
* Patients with WHO Grade 3 or 4 oral mucositis (OM)
Preventing Intimate-partner Violence: Impact Evaluation of Engaging Men Through Accountable Practice in Eastern DRC

The objective of the study is to evaluate the impact of Engaging Men in Accountable Practice (EMAP) on the prevention of violence against women and girls in North and South Kivu (DRC). The study is conducted jointly by the World Bank's Africa Gender Innovation Lab and the International Rescue Committee (IRC). EMAP is a program developed and implemented by the IRC to engage men to reflect on how to reduce and prevent intimate partner violence through 16 weekly group discussion sessions. The study is a cluster randomized control trial in which two groups of 25 self-selected men in 15 communities receive the EMAP intervention while in 15 other communities, 50 self-selected men receive an alternative intervention. Key outcomes examined include: (i) Experience of past year physical, sexual and psychological violence reported by women whose partners are EMAP participants; (ii) Participant's gender attitudes and behaviors, conflict and hostility management skills; (iii) Power sharing and communication within the couple.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 or older but preferably at least 25;
* Resident of their village, having lived in the community for a minimum of six months with plans to continue living there for at least the coming six months;
* Ability to participate actively in group work and reflection activities;
* Commitment to attend meetings, sessions and other activities regularly without incentives;
* Commitment to non-violence toward women and girls for the duration of the EMAP intervention;

Exclusion Criteria:

* Involved in the IRC-led adolescent girl intervention (COMPASS).
The Effects of Trunk Impairment on Fatigue and Balance

Fatigue is a common symptom associated with cerebral palsy (CP); it has been estimated that up to 40% of adolescents with CP experience fatigue that impacts their quality of life and daily activities. Although fatigue was stated as the primary symptom, a limited number of studies were found on secondary motor and nonmotor symptoms related to trunk control in children when the literature was examined.


Eligibility Criteria:
Inclusion Criteria:

aged between 2-18 years old; (2) had a form of CP; (3) had the cognitive competence to participate to the all assessments.

Exclusion Criteria:

The sufferers who had an additional neurological or musculoskeletal disability, unstable medical conditions, any recent medical intervention (such as tendon lengthening surgery or botulinum toxin injection...) were excluded
The Effect of Lifestyle Intervention for Hypertriglyceridemia on the Pathogenesis of Adverse Pregnancy Outcome

During pregnancy, hypertriglyceridemia is associated with adverse pregnancy outcomes, including gestational hypertension, preeclampsia, gestational diabetes mellitus, large for gestational age (LGA), and preterm delivery. However, whether lifestyle intervention for hypertriglyceridemia during pregnancy improves pregnancy outcomes remains unknown. Therefore, we will conduct a randomized controlled trial to investigate this issue.

At a tertiary medical center, we will enroll 70 pregnant women in this prospective, open-label, randomized controlled, pilot study comparing the effect of lifestyle intervention for hypertriglyceridemia versus control between Mar 2020 and Mar 2022. Pregnant women recruited will be randomized into two groups. The intervention group will receive lifestyle intervention; whereas the control group will receive regular surveillance only. Only intervention group will have diet education and exercise goal. They will go to dietitian OPD twice at GA 30-31+6 and 33-34+6 for Mediterranean diet education. As for exercise, participants in intervention group are asked to at least take 10000 steps 3 days a week. Diet modification and exercise intervention will persistent until delivery.

The primary end point is the change of biomarkers of preeclampsia and macrosomia, including maternal blood PlGF and sFLT1, and cord blood c-peptide, leptin, IGF-1, IGF-2, IGF-BP1 and IGF-BP3. The secondary end points include the change of frequency of adverse pregnancy outcomes, including individual outcome and the composite outcome, such as gestational hypertension, preeclampsia, preterm delivery, and large for gestational age (defined as birth weight ≥ 90th percentile), change of maternal body weight, change of maternal blood pressure, which is defined as 3 mm-Hg, change of maternal HOMA2-IR, change of maternal plasma triglyceride level and other lipid profile (total cholesterol, HDL, and LDL), echography finding of fetus, neonatal birth weight, change of glucose, and lipid profile (total cholesterol, HDL, LDL, and TG) of fetus cord blood, placental expression of preeclampsia (PlGF, sFLT1) and growth factors (IGF-1, 2, BP1 and BP3).


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women older than 20-year-old
* During GA 24-28+6 weeks
* Carrying a singleton
* Having hypertriglyceridemia (plasma triglyceride at GA 24-28+6 excess 246 mg/dL but not higher than 1000 mg/dL).

Exclusion Criteria:

* Using steroid
* Using anti-platelet or anti-coagulant
* Using lipid-lowering agents
* Hypertriglyceridemia is caused by secondary cause, such as hypothyroidism, cushing syndrome, nephrotic syndrome, alcohol use or medication use.
* Have been diagnosed with chronic hypertension, overt diabetes mellitus, gestational diabetes mellitus, secondary hypertriglyceridemia, autoimmune disease, or malignancy.
* Have received the artificial fertilization.
* Not having fetus echography examination at GA 22-23+6
* Not going to deliver the baby at National Taiwan University Hospital
* Have underwent other clinical trials
Additional Effects of Ujjayi Pranayama

Studying the impact of Ujjayi pranayama on post-Coronary Artery Bypass Grafting (CABG) patients has the potential to positively influence healthcare. This research fosters a patient-centered approach, enhancing cardio respiratory function. Patient education on these practices can empower individuals, actively contributing to their recovery and overall well-being.

. Exercises such as Ujjayi pranayama lower heart rate and benefit high blood pressure sufferers. To determine additional effects of Ujjayi pranayama on pulmonary function in post coronary artery bypass Graft (CABG).

Eligibility Criteria:
Inclusion Criteria:

* Participants who have 1st post op Day
* Hemodynamically stable \& well oriented patient
* Extubated Patient
* Voluntary based patients
* After approval of surgeon CABG patient were recruited
* Tachypnea

Exclusion Criteria:

* Hemodynamically unstable,
* Uncontrolled Hypertension,
* MSK disease,
* Any previous history of tuberculosis,
* Neurological disease ,
* Acute exacerbation of COAD \& Asthma Attack,
* Any trauma, anxiety or Rib fracture case ,
* During surgery complaint of graft failure ,
* Unwilling to participate ,
* Postural Hypotension.
Effects of Neurofeedback and Transcranial Pulse Stimulation on Attention

The present study aims to examine and compare the effectiveness of transcranial pulse stimulation and neurofeedback among adults who are weak in attention.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years and above
* Right-handed
* Normal/corrected hearing and vision
* Having basic literacy skills
* Having sustained attention scores below the threshold

Exclusion Criteria:

* Having medical history related to brain
* Having mild cognitive impairment
* Showing symptoms of depression and anxiety
* Having intellectual disability based on IQ scores
* Having diagnoses of any psychiatric or cognitive disorders besides attention deficit hyperactivity disorder (ADHD) inattentive and combined types
* Having long-term history of smoking cigarettes
* Engaged in alcohol and/or substance abuse
* Having history of hemophilia or other blood clotting disorders or thrombosis
* Having corticosteroid treatment within the last six weeks before first intervention
* Having contraindications for MRI scanning