cyrilzakka/clinical-trials huggingface dataset:
Impact of Beverage Powder With Micronutrients and Brahmi Extract on Cognitive Variables in Indian School Children

The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi (Bacopa monnieri) extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Bacopa monnieri (Brahmi) from Scrophulariaceae family has been traditionally used in India as 'memory tonic'. Brahmi's use as a cognitive enhancer has led to recent research to investigate a broad spectrum of cognitive domains. Additionally, micronutrient deficiency in children can impair cognitive functions, and micronutrient supplementation can help reduce/prevent deficiencies in those at risk. Several studies have been conducted so far which establish the cognition enahncing abilities of Brahmi, with no major side effects. The aim of the current study is to investigate the beneficial impact of 4 month consumption of a beverage powder fortified with Brahmi extract and multiple vitamins and minerals on short term memory as assessed using standardised cognitive test battery.

Eligibility Criteria:
Inclusion Criteria:

* Z-score of Body Mass Index (BMI) for age of \>-2 to \<-1
* Participant and participant's parents/legally authorized representatives (LAR) understand and are willing, able and likely to comply with all the study procedures
* Participant is in good general health; has no condition that could affect the safety of participant

Exclusion Criteria:

* Child in care: A child who is placed under the control/protection of an agency/organization/institution by the court/government
* Allergy/Intolerance/Hypersensitivity any study ingredient
* Severe anaemia (Hb\<8g/dL); Attention Deficit Hyperactivity Disorder; Reading dyslexia or behavioral disorders
* Health condition that could affect food metabolism; any physical or psychiatric illness that could lead to non-completion of study
* Concurrent use of other health food drinks/supplements, within 1 month prior to study start
* Sibling participation in study
A Study Evaluating the Efficacy and the Benefit of Integrated Personalized Diabetes Management (PDM) for Diabetic Patients.

This study is a German, prospective, multicenter, controlled, cluster-randomized, interventional comparative study evaluating the efficacy and benefits of integrated PDM care by measuring HbA1c levels in patients with Type 2 Diabetes. Patients will be randomized into two groups to use Accu-Chek Smartpix software and Accu-Chek Smartpix device.

Outcome of both studies (RD001732 and RD001231) will be integrated and additionally reported as PDM-ProValue study program (Integrated Personalized Diabetes Management) due to the high similarity in study characteristics, design and study results.

Eligibility Criteria:
Inclusion Criteria:

* existence of a signed Informed Consent form (before any study procedure)
* diagnosed Type 2 diabetes mellitus
* age ≥18 years
* insulin therapy for ≥6 months: BOT, SIT, CT or ICT
* HbA1c ≥7.5% (≥ 58,47 mmol/mol respectively), blood withdrawal for measurement in the last 90 days before study visit 1 (patient's inclusion)
* longer-term care (at least for the duration of the 12-month study participation) by the trial site
* insured by the statutory health insurance (GKV) as a compulsory member or voluntarily insured member or as a family co-insured member
* willing and able to participate in the study and to follow the study procedures, among other things sufficient command of the German language, spoken and written

Exclusion Criteria:

* Treatment of diabetes with insulin pump (CSII)
* Methodic and continuous with the use of particular software for processing of SMBG data - by the patient and at visits in the practice by the physician/diabetes educator - in the past 12 months before study participation.presence of terminal renal failure (eGFR \< 15ml/min) / dialysis and/or a loss of sight (visual acuity ≤ 0,05 of the better eye)
* Existing tumor illness (primary tumor/local recurrence/ metastases except Basal Cell Carcinoma) in the past 5 years before study participation newly diagnosed or treated acutely (hormone, chemo- or radiation therapy). Within a tumor free time of \< 5 years Medical Affairs will decide about individual cases
* permanent use of steroids in adrenal suppressant doses, of other immuno-modulatory drugs or chemotherapy
* known alcohol and drug abuse and medication abuse
* known metabolic disorders and/or disorders or therapies that could lead to or have led to wrong measured results (e.g. with the blood glucose measurement)
* existing pregnancy, breast-feeding or plan to become pregnant during study participation
* physical illness and/or psychological disorder with the result that the patient cannot implement the medical treatment recommendations independently
* dependency relationship to the sponsor or to the investigator, e.g. as a professional colleague or family member
Whole Body Electromyostimulation and Nutritional Therapy for Patients With Esophageal and Bronchial Carcinoma

The objective or the trial is to study the influence of a combined therapy involving protein-rich individualized nutritional therapy and highly effective muscle training via personalized whole-body electromyostimulation exercise on muscle mass, muscle functionality, physical capability, fatigue and quality of life in patients with esophageal and bronchial carcinoma in advanced or metastatic stage.

Tumor specific and inflammation promoting mediators lead to a loss of appetite, to systemic inflammation processes and to metabolic and hormonal changes including anabolic resistance. Consequences hereof are a decreased food uptake, a deteriorated nutrient utilization and a loss of muscles and/or fat leading to cancer cachexia. In addition, an accelerated muscle wasting can be a side effect of the oncologic therapy promoting cancer cachexia even further. The advancing muscle loss induces diminishing physical capability, a decreased tolerance of oncological therapy, functional losses even reaching loss of independence and a worsened prognosis.

The purpose of this study is to establish an innovative combined therapy involving protein-rich nutritional therapy and highly effective muscle training by personalized whole-body electromyostimulation (WB-EMS) exercise to improve muscle mass, functionality and strength of esophageal and bronchial carcinoma patients in advanced stage. An increase in muscle mass and strength leads to an increase in physical activity, physical capability as well as tolerance to and applicability of tumor therapy. In the course of a 3-months intervention study the efficacy of a combined protein-rich nutritional therapy with an innovative exercise therapy will be documented for patients with esophageal and bronchial carcinoma in advanced or metastatic stage. An effective stopping of the progress of muscle wasting or even increase of muscle mass, strength and function in the patients of the trial would benefit each patient and his family individually, since it could mean a considerable improvement in his quality of life and tolerability of oncological treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients with esophageal and/or bronchial carcinoma in curative or palliative treatment

Exclusion Criteria:

* Healthy persons or patients under age
* Pregnancy, Lactation
* Psychological disorders, epilepsia, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* Acute cardiovascular disease
* Rheuma
* Intake of anabolic drugs,
* Skin injuries in the area of electrode placements
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction
Complementary/Integrative Medicine for Brain Cancer Patients

Nearly a quarter of a million patients are diagnosed each year with tumors of the central nervous system, a third of them malignant. The most common malignant tumor of the brain is the high grade glioma( HGG), whose treatment begins with surgical resection of the tumor, followed by a combined chemo-radiation regimen, with the drug Temodal (temozolomide). This treatment is often accompanied by toxic effects (e.g., nausea, headache, constipation, weakness/fatigue, and others), with treatment of these effects limited in their effectiveness and safety. Complementary medicine treatments such as acupuncture and touch therapies (reflexology, Shiatsu, etc.) have been researched and found to be both safe and effective for some of the toxic effects of oncology treatment regimens.

The present pilot study is set to examine the impact of complementary medicine on the toxic effects of the conventional treatment for HGG. The study will include 40 patients and will last for two years, during which patients will be treated with acupuncture and/or touch therapies, this in parallel to their chemo-radiation regimen. The primary study outcome will be the scores on four Patient-Reported Outcome Measures (PROMs): the Measure Yourself Concerns and Wellbeing (MYCAW) study tool; the Functional Assessment of Cancer Therapy, Brain Cancer (FACT-Br) questionnaire; the Edmonton Symptom Assessment Scale (ESAS); and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30). Secondary study outcomes will include the safety of the complementary medicine treatments, and adherence to the planned oncology treatment regimen, as measured by the Relative Dose Intensity (RDI) calculation.


Eligibility Criteria:
Inclusion Criteria:

* patient aged 18 years and older
* diagnosed with high grade glioma (stage III-IV)
* following surgical intervention (tumor resection)
* prior to chemo-radiation treatment
* signing of informed consent form

Exclusion Criteria:

* inability/unwillingness to sign informed consent form
* unwillingness of treating oncologist to allow participation in the study
Adjustable Artificial Sphincter Victo in the Treatment of Male Incontinence Due to Prostate Surgery

The aim of this prospective academic research study is to evaluate the efficacy and safety of the Victo adjustable artificial sphincter in the treatment of male patients with urinary incontinence due to prostate surgery.

This is a non-interventional prospective study. The study will include male patients who underwent the Victo artificial sphincter placement due to severe incontinence.

Before the procedure, all patients will undergo a standard diagnostic work-up. After the procedure, the patients will be invited for regular visits 3 months after device activation and subsequently every 12 months. In addition to the regular visits, patients will be allowed to contact the study center at any time if their continence worsens enough to require adjustment or if they experience any complications.

The surgical technique of the Victo artificial sphincter implantation has been described in detail elsewhere.

A non-parametric one-way ANOVA Friedman test will be used to compare the changes of categorical variables from baseline to the end of follow-up. Wilcoxon rank-sum test will be used to assess the change of the non-categorical variables. P-value \< 0.05 is considered statistically significant and no correction for multiple testing will be applied.

Eligibility Criteria:
Inclusion Criteria:

* urinary incontinence due to previous prostate surgery
* primo-implantation of the artificial urinary sphincter
* subject willing and able to give informed consent

Exclusion Criteria:

- none
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers

This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).

In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label manner; once in the fasted state and once in the fed state.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be medically documented as healthy and acceptable at physical examination.
* Subjects serum uric acid level at screening ≥ 4.5 mg/dL.
* Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher
* Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
* Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
* Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

Exclusion Criteria:

* Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
* Any history or suspicion of kidney stones.
* Positive for HIV, Hepatitis B, and/or Hepatitis C.
* Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
* Undergone major surgery within 3 months prior to Day 1.
* Women who are pregnant or breastfeeding.
* Subjects who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
* Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration.
* Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Latent Toxoplasmosis in Females With Borderline Personality Disorder

Borderline personality disorder is a common mental disorder with core features of affective dysregulation, impulsivity, and identity disturbance. Although this disorder is mostly understood as a result of a combination of biological factors (genes, temperament) and early aversive experiences (often of traumatic nature), recent data suggest that other factors may be important in its development and course. Preliminary findings show that patients with borderline personality disorder have higher prevalence of Toxoplasma seropositivity. This infection may manifest in symptoms such as affective dysregulation, aggression, suicidality, or anxiousness. As such, it may play a role in the psychopathology of the borderline personality disorder. The aim of this study is to explore the prevalence of Toxoplasma seropositivity in a sample of females with borderline personality disorder, its clinical correlates, and a potential impact on outcomes of an intensive six-week inpatient schema-therapeutic treatment. Results may enrich our understanding of this disorder and lead to improvements of the therapeutic approaches.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* Female
* Borderline personality disorder diagnosis according to the Diagnostic and Statistical Manual of Mental Disorders-5 criteria
* Signed informed consent

Exclusion Criteria:

* Current substance abuse disorder
* Psychotic disorder, bipolar disorder, organic mental disorder current or past
* Severe suicidal risk
* Severe somatic illness (e.g., endocrinopathy, oncologic, hematologic, cardiologic, or neurologic illness)
Improving Communication and Building a Stronger Medical Home Among Spanish-speaking Families

This study will seek to improve communication with Spanish speaking families and patients with Cancer and Blood Disorders.

The Principal Investigator seeks to improve communication with Spanish speaking families with the following goals: 1) to increase patient and family sense of inclusion in the medical community, 2) to increase patient and family medical knowledge and understanding, 3) to improve patient adherence with critical medical regimens, and ultimately, 4) to increase equality of comprehensive medical care delivery across the continuum of care including physical and psychosocial domains.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 22 years of age
* Diagnosis of leukemia or non-Hodgkin lymphoma
* Spanish as preferred language for patient, parent or guardian
* Received or receiving care at the Center for Cancer and Blood Disorders (CCBD)

Exclusion Criteria:

* Patients without oncologic diagnosis
* Patients with parents whose language preference is English
* Patients who received care solely outside of the CCBD
Study to Identify Factors Influencing Access of Pregnant Women and Their Infants to Local Healthcare Systems

This study collected information regarding the factors that might influence access of pregnant women to the local healthcare system. The main visits of the study screened \& enrollment, delivery and 90 day infant follow-up. Data were collected mainly from questionnaires administered to pregnant women at these visits. The questionnaires contained the following standard questions which were asked at each visit, in addition to some visit-specific questions related to delivery and health status of infants up to 90 days of age. The standard questions related to the following aspects:

* Logistics of transportation to the study site (type, time it takes, cost incurred)
* Accessibility to a telephone/cell phone
* Provisions of alternative child care during site visits if there are other children under the subject's care


Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women with gestational age of greater than or equal to 24 weeks at the time of enrollment
2. Subject / subject's parents or a legal representative who has given written consent after the nature of the study has been explained according to local regulatory requirements
3. Pregnant women of gestational age between 28 weeks and 34 weeks 6/7 days

Exclusion Criteria:

None
Intratendinous Genipin Injection in Horses With Tendon Injuries

Our study is the first to use genipin, a naturally occurring collagen cross-linking agent, as a therapeutic agent to treat superficial digital flexor tendon (SDFT) injuries in horses. The promising approach of intratendinous genipin injection and tendon mechanical enhancement could be a viable alternative to current therapies for SDFT injuries.

Tendon injuries are a career limiting or ending condition in horses. Genipin (GP), an exogenous collagen crosslinker, provides ex-vivo tendon mechanical augmentation and excellent biosafety. The main objective of this study is to investigate treatment success of GP-induced collagen crosslinking in a clinical application in horses with superficial digital flexor tendon (SDFT) injuries. Horses with an AAEP (American Association of American Practitioners) lameness score \> 0 and sonographically confirmed tendinopathy are treated with intratendinous GP injection (IGI) and controlled exercise. Minimal follow-up was set at 12 months. Outcome factors are lameness (AAEP lameness score), soundness, assessment of return to previous use, and re-injury. Additionally, adverse effects are recorded.

Eligibility Criteria:
Inclusion Criteria:

* clinical and sonographic evidence of a tendon injury

Exclusion Criteria:

* in the final analysis, only superficial digital flexor tendon injuries were included
* if follow-up was less than 12 m due to euthanasia, death or other reasons, horses were excluded from the study
PNF and BFR Affect on Pain, ROM & Functional Outcome in Post-op ACL

A randomized controlled trial investigated the effects of Hold Relax Technique (HRT) with and without Blood Flow Restriction (BFR) on pain, range of motion (ROM), and functional disability in patients with post-operative ACL rehabilitation. This study includes all types of genders with age limit is 25-45 years. But the aim is to infer the answers to the following questions; Does HRT has better effects than HRT with BFR? How much effect should be noted ? The research will show that if both HRT and HRT with BFR groups had significant pain reduction, the HRT with BFR group demonstrated greater ROM improvement and significant enhancement in functional ability compared to the HRT and control groups.

A randomized clinical trial will be conducted under Riphah International University guidelines and nonprobability convenient sampling will be used to collect data from the 48 participants from the Ghurki trust and teaching hospital setting. Participants will go through ACL reconstruction specifically the usage of a hamstring graft. The participants were allocated into two groups by using randomization through computer-generated software A and B. In A group only HRT will be applied to check the effects on pain, ROM, and functional disability. In the B group HRT with BFR will be utilized to note the effects on pain, ROM, and functional disability.

Eligibility Criteria:
Inclusion Criteria:

* Age group 25-45 years.
* Both gender male and female.
* Patient underwent arthroscopic ACL repair procedure.
* Patients in 6 weeks of rehabilitation phase.
* Grafts of hamstring muscle were used in repair.
* Max range achieved after post-op day 1.
* Low- moderate pain intensity.

Exclusion Criteria:

* Any form of bone carcinoma.
* Any Post-OP active infectionous Patients.
* Any circulatory effects.
* DVT and pulmonary embolism.
* Loose Implant placement.
* Non co-operative Patient.
* Hyperasthetic Patient.
* Polytraumatic Post-OP Patient.
Discoloration of Endosequence and Mineral Trioxde Aggregate in Revascularization of Necrotic Immature Permanent Teeth

the objective of this study is to evaluate post operative pain after using Endosequence versus Mineral Trioxide Aggregate as coronal plug material in revascularization of non vital immature anterior teeth

The treatment of immature young permanent anterior teeth is challenging because in addition of the need of elimination of bacterial infection; the lack of natural apical constriction against which a suitable filling material can be placed is considered the main problem.

In the past many different treatments have been proposed for immature permanent teeth with necrotic pulps such as:Custom fitting of filling materials like gutta percha, Periapical surgeries, apexification. The disadvantages of these treatments are: the compromised Crown/root ratio, possibility of vertical fracture.

Pulp revascularization is dependent on the ability of residual pulp and apical and periodontal stem cells to differentiate. These cells have the ability to generate a highly vascularized and rich living tissue.

MTA was chosen as coronal seal to be placed over the blood clot due its a biocompatibility, bio-inductivity. However, the disadvantages of MTA are: discoloration of the coronal dentine when placed in the canal and the difficult handling properties.

Recently, a new bioceramic material has been introduced to the market, namely, EndoSequence which is bioactive, has antibacterial activity, less cytotoxic effect and similar antimicrobial properties, maintain color stability of the tooth when compared to MTA

Eligibility Criteria:
Inclusion Criteria:

* Age of patient range from 8-14 y.
* Patients are free from any systemic diseases that may hinder the normal healing process.
* Non vital permanent anterior teeth with open apex.
* Pulp space not needed for post and core for final restoration.
* Compliant patient/parent.

Exclusion Criteria:

* Patients having allergy to medicaments and antibiotics necessary to complete the procedure.
* Tooth with vital pulp or complete root formation.
* Teeth with internal or external root resorption.
* Un-cooperative patients