cyrilzakka/clinical-trials huggingface dataset:
Iscador Qu as Supportive Treatment in Colorectal Cancer (Union International Cancer Control, UICC Stages II-IV)

Efficacy and safety of a supportive treatment with European mistletoe extract Iscador® Qu ("quercus", i.e. from oak tree) in patients with colorectal cancer (Union for International Cancer Control, UICC stages II-IV), in addition to post-operative conventional oncological therapy (radio-, chemo-, targeted therapy) as compared to a parallel group with conventional therapy only.

Primary Endpoints: Reduction of adverse effects of conventional therapy; reduction of therapy or disease induced symptoms (both are quality of life parameters and evaluated after 1 year); prolongation of disease free and/or overall survival (DFS, OS) after 5 years.

Prospective observational confirmation study of previous retrospective cohort study.

As this is a non-interventional cohort study, all therapies and measurements are performed on directive by the treating physician and/or request by the patient only.

see summary

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of colorectal cancer, UICC stage II-IV
* Age between 18 (Austria: 19) and 85 years
* No previous malign tumor
* Surgical resection of the tumor if indicated
* (Post-operative) conventional oncological therapy and measurements, or passive after-care ("best care")
* Follow-up for several years feasible
* Patient gives written consent to use the anonymized date for evaluation

Exclusion Criteria:

* Anal cancer
* Other Iscador® sorts than Qu in the test group
* Other mistletoe preparations in the test group
* Any mistletoe preparation in the control group
* Non-oncological immunomodulating, -stimulating or -suppressive drugs (e.g. Echinacea, interferons, Polyerga®, BCG, azathioprine). Allowed are approved tumor inhibiting immuno- or targeted therapies (e.g. bevacizumab, cetuximab) and tumor specific vaccines
* HIV infection, Aids, organ transplantation
* High-dose systemic glucocorticoids
* Contraindications for Iscador® Qu (allergy against mistletoe, acute inflammatory disease or fever \> 38.5°C, active tuberculosis, hyperthyreosis with not-adjusted metabolism, primary brain or spinal tumor, brain metastases)
* Known mistletoe intolerance
* Patients participating in another clinical study with non-approved substances
Clinical and Surgical Outcomes of Thyroid Carcinoma in Children and Adolescents

This study aims to investigate the differences in clinical characteristics, causes of death, long-term survival, and surgical approaches between pediatric and adolescent follicular and papillary carcinoma by exploring data from the SEER database. The research is designed as a retrospective cohort study, primarily focused on collecting and comparing data to identify key disparities and outcomes between these two patient groups. It is anticipated that the findings will provide valuable insights into the management and prognosis of these cancers in younger populations, contributing to more targeted and effective treatment strategies.

This study is a retrospective cohort analysis aimed at elucidating the differences between pediatric and adolescent patients diagnosed with follicular and \[specific type\] carcinoma, utilizing data sourced from the SEER (Surveillance, Epidemiology, and End Results) database. The focus of the research is on a comprehensive comparison of various clinical aspects, including demographic characteristics, tumor features, treatment modalities, and survival outcomes.

Key areas of investigation include the examination of clinical characteristics such as tumor size, location, and stage at diagnosis, as well as treatment approaches including surgery types and their impact on patient outcomes. Additionally, the study will assess the causes of death and overall survival rates among these young patients, aiming to identify any significant prognostic factors.

By leveraging the robust and extensive data available in the SEER database, this study seeks to uncover critical insights into the management of follicular and \[specific type\] carcinoma in pediatric and adolescent populations. The findings are expected to contribute to the development of more tailored and effective therapeutic strategies, ultimately improving long-term survival and quality of life for affected patients.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed diagnosis of Follicular Thyroid Carcinoma (FTC) or Papillary Thyroid Carcinoma (PTC).
* Age range: Pediatric and adolescent patients (ages 1-18 years).

Exclusion Criteria:

* Patients with incomplete survival and clinical information.
ZIKAlliance Children Cohort (ZIKAllianceCH)

The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV) infections in pregnancy and congenital malformations. The study will estimate the absolute and relative risks of congenital malformations and other adverse outcomes of pregnancy among women who become infected with ZIKV during pregnancy compared to uninfected pregnant women, also leading to further validation of the Congenital Zika Syndrome.

The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV) infections in pregnancy and congenital malformations. The study will estimate the absolute and relative risks of congenital malformations and other adverse outcomes of pregnancy among women who become infected with ZIKV during pregnancy compared to uninfected pregnant women, also leading to further validation of the Congenital Zika Syndrome.

The study will also determine the ZIKV maternal to child transmission rate and evaluate co-factors or effect modifiers that account for the large variability seen in the preliminary absolute risk estimates derived from population figures and reporting of microcephaly in different states in Brazil and across Latin America.

The study will carry out a pregnant women (PW) multicentre cohort study in areas across Latin America and the Caribbean. Women will be enrolled early in pregnancy and followed every 4 weeks, in connection with their routine antenatal care visits. At each visit, urine and blood samples will be collected, tested and stored.

Among PW reporting recent or current undifferentiated fever/rash syndrome at any point in time, the acute illness episode will be characterized in greater detail. PW with suspected ZIKV infection (i.e. meeting the Pan American Health Organization (PAHO) clinical case definition) during pregnancy will be managed according to national protocols. Irrespective of symptoms, pregnant women will be followed prospectively and revisited at birth (or after abortion) for a detailed documentation of the outcome of their pregnancy.

Live newborns will receive a detailed neonatal examination. In the course of examination of the newborns, biological samples will be collected and stored. Other potential causes of congenital abnormalities (TORCHS infections in the mother, toxic substances, chromosomal abnormalities), and potential effect modifiers (for example past flavivirus infections/vaccinations, socio-economic status) will also be assessed.

With appropriate counselling and consent, biological samples of newborns with severe abnormalities, deceased newborns, stillborn babies, and aborted foetuses from ZIKV-infected mothers will be collected to help elucidate the aetiological contribution of ZIKV in neurological and other congenital malformations.

Children of women infected with ZIKV during pregnancy - and a subset of the children born to uninfected women - will be followed prospectively after birth for the assessment of neuro-developmental milestones.

Eligibility Criteria:
Inclusion Criteria:

* Born within the Pregnant Woman cohort
* Born to mothers with confirmed ZIKA

Exclusion Criteria:

-
Hydromorphone Hydrochloride Epidural Preemptive Analgesia for Postoperative Pain After Cesarean Section

Acute pain often occurs after cesarean section, which can lead to stress and inflammatory response in the body, which will not only affect the postpartum recovery speed of the puerpera, but also inhibit the secretion of prolactin to a certain extent and reduce the secretion of milk. Epidural anesthesia is a common anesthesia method for cesarean section, which has the advantages of easy operation and little influence on the fetus. Preemptive analgesia can effectively block the transmission of harmful stimuli and reduce the degree of pain after cesarean section. Hydromorphone hydrochloride is a derivative of morphine, which has the advantages of rapid onset and good analgesic effect, and has been widely used in clinic. However, it is not clear whether epidural injection of hydromorphone hydrochloride for preanalgesia can bring clinical benefits to puerpera, and the optimal dose of hydromorphone hydrochloride for cesarean section is also unclear.

The parturient women who met the inclusion criteria were randomly divided into 3 groups: control group, hydromorphone hydrochloride low-dose administration group and hydromorphone hydrochloride high-dose administration group. All women received epidural combined subarachnoid anesthesia. 15min before the end of the operation, the low-dose hydromorphone hydrochloride group was injected with 0.1mg hydromorphone hydrochloride in the epidural space, the high-dose hydromorphone hydrochloride group was injected with 0.3mg hydromorphone hydrochloride in the epidural space, and the control group was injected with 0.9% sodium chloride injection. Post-obstetric visual analogue scale (VAS) was followed up to record PCA compression times, gastrointestinal peristalsis recovery time, getting out of bed time, lactation time, and related adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* Parturients with indications for cesarean section;
* American Association of Anesthesiologists (ASA) Grade I - II;
* No history of sedative drugs or opioid abuse;
* Volunteer to join the study

Exclusion Criteria:

* People with coagulation disorders;
* preoperative use of analgesia, non-steroidal drugs;
* Abnormal liver and kidney function;
* Postoperative drainage is urgently needed.
Identification and Referral of Women at Risk for Hereditary Breast/Ovarian Cancer

The purpose of this study is to identify the most effective means of follow-up for women who screen positive on B-RST (Breast Cancer Genetics Referral Screening Tool) applied in the standard clinical setting of mammography, to maximize the number who are referred to and receive cancer genetic counseling services. The clinical utility of B-RST 3.0 will also be evaluated by determining the number seen who are appropriate for genetic testing, undergo genetic testing and are found to carry a hereditary cancer gene mutations with medical management implications for the patient and family. The long-term goal is to reduce the morbidity and mortality associated with hereditary causes of breast and ovarian cancer among patients seen in the Emory/Winship system.

The three aims for this study are: 1. To develop an electronic version of the revised B-RST (Breast Cancer Genetics Referral Screening Tool) with a HIPAA compliant database for integration within the Winship Cancer Institute at Emory website. 2. To identify the most effective means of follow-up to maximize the number of screen positive individuals who are referred to and complete cancer genetics counseling. 3. Evaluate the clinical utility of B-RST 3.0 by analyzing the number of individuals who were referred to and received genetic counseling and were considered appropriate for genetic testing and underwent genetic testing, and were identified with a BRCA1/2 mutation, and/or were identified with a mutation in a different hereditary cancer gene, or were not appropriate for genetic testing, but were appropriate for referral to high-risk follow-up services.

The B-RST is a simple yet effective screening tool to identify individuals who may be at risk for hereditary breast and ovarian cancer. This study will seek to determine the most effective method of follow-up to maximize referral to and completion of cancer genetic counseling services following a screen positive result on the B-RST tool, and to understand clinical outcomes following participation in genetic counseling (i.e., whether patients who receive counseling undergo genetic testing, genetic testing results, and recommendations for enhanced screening and preventions).

Eligibility Criteria:
Inclusion Criteria:

* Patient at one of the participating clinics (Winship Cancer Institute and Emory University Hospital Midtown) who arrive for a screening mammogram appointment.

Exclusion Criteria:

* Patients receiving a diagnostic mammogram will not be invited to participate in the study.
The Effects of Bifidobacterium Breve Bif195 for Small Intestinal Crohn's Disease

The purpose of this study is to investigate if the probiotic Bifidobacterium breve Bif195 (Bif195) will result in improvement in clinical outcome in patients with small intestinal Crohn's disease.

Crohn's disease (CD) is a chronic inflammatory bowel disease (IBD) with an incidence rate at 11/100 000 per year in Denmark.

The disease can potentially affect the entire gastrointestinal tract, though the most common affected area is terminal ileum and the adjacent part of colon.

CD is a result of both genetic and environmental factors together with the intestinal microbiota, however the precise etiology is unclear.

A change of the intestinal microbiota with a reduced occurrence of e.g. Bacteroides species, Firmicutes and the anti-inflammatory bacteria Faecalibacterium prausnitzii is found in CD patients compared to healthy controls. Also a reduction of the mucosa-associated Bifidobacteria has been associated with the risk of mucosal inflammation.

The hypothesis that an imbalance between potentially beneficial and pathogenic bacteria contribute to the pathogenesis of IBD, including CD, has led to the suggestion that manipulation of the microbiota may be an attractive target for therapeutic interventions in IBD.

A new probiotic bacterium, Bifidobacterium breve Bif195 (Bif195) has been identified and has shown great effects on preventing enteropathy and ulcers on the gut mucosa in healthy volunteers given acetylsalicylic acid (13), and thereby Bif195 has also shown a potential in reducing gut permeability defects. This bacterium has not yet been investigated in CD patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with small intestinal CD
* Fecal calprotectin ≥ 250 ug/g
* IUS evidence of small bowel inflammation with wall thickness ≥ 4 mm
* At least 3 months af stable medical treatment
* Able to read and speak Danish

Exclusion Criteria:

* Positive rectal swab for pathogenic microorganisms
* Use of antibiotics, probiotics and systemic glucocorticosteroids within 4 weeks prior to inclusion
* Participation in other clinical trials within 30 days prior to inclusion
* Pregnancy, planned pregnancy or breast feeding
* Psychiatric disease
* Abuse of alcohol or drugs
Althera® Versus Nutramigen / Cow's Milk Intolerance

The primary objective of this study is to demonstrate that ALTHERA® is equal or superior in efficacy than NUTRAMIGEN®


Eligibility Criteria:
Inclusion Criteria:

* Infants from few days of life until 6 months of age
* Birth weight : between 2.500g and 4.500g
* Full term: gestational age between 37 and 42 weeks
* Singleton birth
* Suspicion of a mild/moderate Cow's Milk Proteins Intolerance (CMPI)
* Having obtained the Informed Consent by the Parents or the legal guardian

Exclusion Criteria:

* Exclusive breastfeeding at time of enrolment
* Having been treated before enrolment with an extensively hydrolysed formula
* Disease impairing a normal gut transit (like pyloric stenosis)
* Intolerance to lactose (if already known)
* Receiving an antibiotic treatment at the time of enrolment
* Severe or chronic diarrhea
* Failure to thrive
* Neurologic diseases
* Receiving a medical treatment which could interfere with the protocol or after a surgical intervention
* Infants whose parents / caregivers who cannot be expected to comply with treatment
* Currently participating or having participated in another interventional clinical trial
Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy

Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Occurrence rate of Lumbosacral radiculopathy is 3-5% distributed equally in men and women affecting more men than women. It commonly occurs in late 40s in men and late 50s-60s in females. Men are more prone to develop lumbosacral radiculopathy due to mechanical disturbance during routine work.

* William flexion exercises: Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).
* Mckenzie extension exercises: The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone

A randomized controlled trial.

Group 1 Group 2 55 patients 55 patients

Standard treatment:

TENS (4-pole) + Hot pack for 15 minutes Standard treatment:

TENS (4-pole) + Hot pack for 15 minutes

New Intervention:

Mckenzie Extension

* Prone press-ups
* Head life in prone
* Prone on elbow
* Prone on hands
* Prone on pillow New Intervention:

William Flexion

* Single knee to chest
* Double knee to chest
* Straight Leg Raise
* Bridging
* Pelvic tilt

Each exercise will be repeated 5 minutes with 10 seconds hold and 5 sec rest. The duration of intervention will be four weeks, 3 sessions a week on alternate days and total of 12 sessions will be given. Data will be collected in three phases Pre-Treatment at end of second week and at the completion of treatment time i.e end of 4th week.

Eligibility Criteria:
Inclusion Criteria:

* • Males and females with age between 40-60 years

  * Patients referred from neuro and orthopedic departments with diagnosed lumbosacral radiculopathy.
  * Complaint of low back pain on walk, bending and after long sitting with positive slump test.
  * Complaint of low back pain, and numbness and tingling in leg with positive SLR test

Exclusion Criteria:

* • Lumbar Trauma

  * Any other orthopedic and neurological conditions of hip and lumbosacral spine.
  * Hip Fracture
  * Malignancy
Effectiveness of a Telephone Intervention Program in Improving Depression, Coping, and Family Functioning in HIV-Infected Individuals and Caregivers

This study will evaluate the effectiveness of the Family Intervention: Telephone Tracking (FITT) program in improving depression, coping, and family functioning in HIV-infected individuals and their caregivers.

Individuals who are newly diagnosed with HIV often experience a variety of social and psychological problems, which can leave them depressed and unable to cope with their disease. The complex financial, legal, and psychiatric issues that many HIV-infected individuals must face can be stressful and can negatively affect their health; they may miss doctors' appointments or fail to adhere to a strict HIV medication regimen. The combination of stress and inconsistent medical care can affect the immune system and potentially worsen HIV symptoms.

Because of the multitude of stressors associated with HIV, HIV-infected individuals often rely on a network of family and friends for support; these caregivers, however, are often overwhelmed by their caregiver roles. They may experience helplessness, fear, and depression as a result of their added responsibilities. Family Intervention: Telephone Tracking (FITT) is a telephone-based intervention program that assists in identifying problems and resolving them through referrals to medical and community organizations that provide HIV-related support and services. It is also an educational resource that provides information on the many medical and psychological aspects of HIV infection. The main goal of FITT is to alleviate stress in both the HIV-infected individual and their support network by providing information and resources to help cope with HIV. The purpose of this study is to evaluate the effectiveness of FITT in improving family functioning, enhancing coping skills, and reducing depression in HIV-infected individuals and their caregivers.

This 12-month study will enroll recently diagnosed HIV-infected individuals and one family member or friend who is identified as their primary caregiver. Each pair will be randomly assigned to either the FITT intervention group or to an assessment-only group that will not receive FITT. Individuals who are assigned to receive FITT will utilize the service for Months 1 through 6. HIV-infected participants in both groups will also receive regular medical care throughout the study. Outcome measurements will include self-assessments of depression, coping, and family functioning. In addition, participants receiving FITT will be asked to evaluate the effectiveness of the telephone intervention. All measurements will be assessed at baseline, and Months 3, 6, and 12.

Eligibility Criteria:
Inclusion Criteria:

* Recently began HIV care
* Currently undergoing HIV care in one of the BRUNAP clinics
* Ability to co-enroll with a primary HIV informal caregiver
* English- or Spanish-speaking

Exclusion Criteria:

* Schizophrenia
* Lacks regular access to a telephone to receive calls
Investigation of the Effect of Specially Designed Insoles for Flat-footed Patients

In our study, it was aimed to investigate the effect of insoles specially designed for each patient and printed with 3D printers on the physical activity levels, balance and functional performances of those patients.

Our study, B.A.İ.B.Ü. İzzet Baysal Physical Therapy Training and Research Hospital and Fizyotermal Corp. It will be carried out as a dual center on individuals between the ages of 18-45 who apply to our clinic. It will be carried out by selecting 48 people who are suitable for the study among the flat-footed patients who applied to the clinics.

Patients will be evaluated before they start using the insoles, and immediately after using it , also after wearing the insoles for 8 weeks.

Patients will be randomized according to the order of their arrival at the clinic.

Eligibility Criteria:
Inclusion Criteria:

* 1. Having a minimum 5 degree subtalar pronation angle while standing,
* 2. A minimum score of +6 from the Foot Posture Index (API) scale
* 3. Being between the ages of 18-45
* 4. Not having received any treatment from the foot area in the last 6 months
* 5. To have cognitive competence

Exclusion Criteria:

* 1. End of volunteering
* 2. Having a history of surgery of the lower extremity
* 3. Being an active athlete
* 4. Being pregnant or diagnosed with malignancy
* 5. Having a dysfunction such as severe neurological involvement, immobility, cooperation deficits that will limit physical activity
* 6. Lower extremity inequality greater than 1 centimeter (cm)
* 7. Having a different orthopedic disease that may affect lower extremity biomechanics
* 8. Receiving a different treatment for pes planus