cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients

The purpose of this study is to see if it is safe and effective to treat cryptosporidiosis in AIDS patients with nitazoxanide.

Patients take nitazoxanide daily for 8 weeks with a dose escalation after the first 4 weeks. Patients return to the hospital for examinations every 2 weeks during the 8-week treatment period and 6-week follow-up. Nitazoxanide therapy is discontinued in patients showing a complete clinical and parasitologic response (therapeutic cure) after 8 weeks of treatment and in patients showing a therapeutic cure at two consecutive visits (Weeks 2 and 4 or Weeks 4 and 6). These patients undergo a physical examination including stool analysis for Cryptosporidium parvum oocysts and routine laboratory tests at Weeks 2, 4, and 6 after completion of nitazoxanide therapy. Patients who do not show a complete clinical and parasitologic response (therapeutic failure) after 8 weeks of treatment are allowed to remain on nitazoxanide therapy through the Open Label Compassionate Use of Nitazoxanide in Treatment of Cryptosporidiosis in AIDS Patients (UMD-95-009) protocol.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a CD4 cell count of 50 cells/mm3 or less.
* Have evidence of cryptosporidium infection in their stool sample within 10 days of study entry.
* Have watery stools at least three times a day at least 5 days a week for 21 days prior to enrollment.
* Are able to take medications by mouth.
* Are at least 13 years old (consent of parent or guardian required if under 18).
* Agree to use an effective method of birth control (such as condoms) during the study.

Exclusion Criteria

Patients will not be eligible if they:

* Have certain diseases or infections of the intestines.
* Have ever taken nitazoxanide.
* Have taken certain experimental drugs within 14 days of enrollment.
* Will need to take certain other medications during the study such as paromomycin, azithromycin, and clarithromycin.
* Have started a new anti-HIV therapy within 4 weeks of study entry or plan on starting one during the study.
* Are pregnant or breast-feeding.
Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Children

A Phase III, Observer-blind, randomized, active-controlled prospective intervention study

This trial is randomized, prospective intervention study. A total of 1,050 subjects aged 12-17 years (COVID-19 vaccine naive) who are willing to participate in the study by signing the consent form, will be involved in this trial.

The subjects will be divided into twostudy subsets, namely Main Study and Exploratory Study.

Main Study for immunogenicity and safety evaluation.

Exploratory Study for cellular immunity evaluation,

Eligibility Criteria:
Inclusion Criteria:

1. Clinically healthy children aged 12-17 years.
2. Parent and/or legal guardian has been informed properly regarding the study and signed the informed consent form (and assent for subjects aged 12-17 years).
3. Parent and/or legal guardian will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. History of vaccination with any COVID-19 vaccine (based on anamnesis).
3. Subjects who have history of COVID-19 in the last 3 months (based on anamnesis).
4. Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
5. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
6. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
7. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
8. Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
9. Subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre Syndrome.
10. Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
11. Female who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).

11. Subjects plan to move from the study area before the end of study period.
Unity Total Knee Replacement Using Two Different Surgical Techniques

This study will compare two different surgical methods used in total knee replacement with the Unity Total Knee Replacement System. The study will evaluate these two methods based on patients' ability to perform various tasks prior to surgery and at 4 time points during the first 12 months after surgery.

This study will be conducted at a single centre. The study has two treatment groups. One group of 50 knees (approximately 50 subjects) will have a surgical method that uses mechanical alignment (alignment based on how the leg and knee joint move) to determine the proper position of the knee replacement device. The other group of 50 knees (approximately 50 subjects) will have a surgical method that uses anatomical alignment (alignment based on how the anatomy/structure of the leg and knee joint) determine the proper position of the knee replacement device. Subjects will be randomly assigned to one of the two groups. Clinical and functional tests will be conducted pre-operatively and at 6 weeks, 3 months, 6 months and 12 months to determine overall knee function. In addition, a CT scan will be completed pre-operatively and at 6 weeks to assess changes in alignment.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be listed for a primary total knee replacement using the Corin Unity Total Knee Replacement System, according to the product 'Instructions For Use'
* The patient must give signed informed consent to participate in the study
* The patient must be able to understand all that is expected of them and be able to comply with the study protocol
* Male and female patients who are skeletally mature

Exclusion Criteria:

* Any patient with a total knee replacement not implanted with a Corin Unity Total Knee Replacement
* Any patient with a revision total knee replacement or conversion of a Unicondylar replacement to a total knee replacement on the operative knee
* Any patient with fixed flexion contracture greater than 20 degrees
* Any patient with varus/valgus deformity greater than 15 degrees
* Any case not described in the inclusion criteria
* Any patient who cannot or will not provide signed informed consent for participation in the study
* Any patient whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
* Any patient with a known sensitivity to device material
* Any patient who is pregnant
* Any patient currently a prisoner
* Any patient known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
* Any patient currently involved in any personal injury litigation, medical-legal or worker's compensations claims
* Any patient unable to read and understand English
Open-Label Study to Evaluate Safety of A Single Dose of SYM-1219

This is a Phase 3, multi-center, prospective, open-label study to evaluate the safety of SYM-1219 granules containing 2 grams of secnidazole in women and postmenarchal adolescent girls with bacterial vaginosis.

Approximately 325 patients will be enrolled. Patients determined to be eligible for the study will receive SYM-1219 granules containing 2 grams of secnidazole orally as a single dose.

Patients determined to be eligible at the Baseline visit will receive a single dose of SYM-1219 granules containing 2 grams of secnidazole in 4 ounces of unsweetened applesauce to be self-administered on Day 1. Patients will be contacted by telephone once between Days 8 to 10 to inquire about possible adverse events. A final study visit will occur on Day 21 to 30 to assess the patient for safety.

Eligibility Criteria:
Inclusion Criteria:

* Are adult females or postmenarchal adolescent girls ≥ 12 years of age.
* Are in good general health as confirmed by a medical history and physical examination, with no known medical or mental health conditions that, in the Investigator's opinion, may interfere with study participation.
* Have a negative urine pregnancy test result prior to study treatment initiation. In addition, female patients of childbearing potential must be using an acceptable form of birth control as determined by the Investigator
* Agree to abstain from alcohol for 3 days following study treatment.
* Have a clinical diagnosis of bacterial vaginosis
* Agree not to use vaginal douches or similar products for the duration of the study.

Exclusion Criteria:

* Are pregnant, lactating, or planning to become pregnant during the study.
* Are menstruating or have vaginal bleeding at the Baseline visit (Day 1).
* Are menopausal as determined by the Investigator
* Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including candidiasis, Chlamydia trachomatis, Trichomonas vaginalis, Neisseria gonorrhoeae or Herpes simplex
* Have active genital lesions, including active Herpes simplex lesions, or other vaginal or vulvar conditions which could confound the interpretation of the clinical response, as determined by the Investigator
* Have consumed any alcohol within 12 hours prior to treatment with study medication.
* Have a history of an abnormal Pap smear which required cervical biopsy or cervical cauterization within 3 months of the Baseline visit (Day 1).
* Have any history of cervical carcinoma or other carcinomas of the vagina or vulva.
Hydrogen-Infused Water for Endurance Performance, Body Hydration Biomarkers, and Health-Related Quality of Life

The study investigates the impact of 4-week hydrogen-infused water consumption on various health and performance outcomes. Conducted with healthy young adults, the trial assesses endurance performance, hydration biomarkers, and health-related quality of life. Participants are randomized into intervention and control groups, with outcomes measured over a specified period. The findings aim to elucidate whether hydrogen-infused water water provides significant benefits for physical performance, hydration status, and overall well-being compared to standard hydration methods.


Eligibility Criteria:
Inclusion Criteria:

* Age 18.0 - 29.9 years
* Body mass index 18.5 - 24.9 kg/m2
* Collegiate athletes with training experience \>3 years
* Weekly exercise \> 5 hours
* Given written informed consent

Exclusion Criteria:

* Major chronic diseases or acute disorders
* History of dietary supplement usage in the 4 weeks preceding the study initiation
* Unwillingness to return for a follow-up
* Participation in other clinical trials
BMS-582664 in Combination With Erbitux in Patients With Advanced Gastrointestinal Malignancies

This is a phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in combination with full dose erbitux in patients with advanced colorectal cancer who have received no more than 2 prior regimens for metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced or metastatic (tumor has spread) gastrointestinal malignancy
* Feeling well other than cancer diagnosis (ie lab work, no infection, etc)
* Available tumor tissue sample from prior surgery
* Measurable disease on scans
* 4-6 weeks since prior therapy and recovered from the effects of prior therapy
* Men and women, ages 18 and above
* Women must not be pregnant or breastfeeding
Study to Education Childhood Cancer Survivors About Survivorship Care

The proposed study is part of a career development award. The first two phases of research involve collaborating with adult survivors of childhood cancer representing both sexes and three ethnic/racial groups (African American, Hispanic, and White). THe collaboration will focus upon developing educational material that is helpful in teaching survivors about health risks related to cancer treatments and about survivorship care. The third phase is a randomized controlled trial that will randomly (like a flip of coin)place survivors into one of two groups. One group will meet in -person with a group leader three times, once each week over three weeks. The other group will receive an information packet that contains websites, books, and resources similar to content provided in-person within a group format to the other group. The goal is to help adult survivors get involved in specialized healthcare so they can remain healthy. This involves getting a copy of their medical record to understand what treatments they received and working with health providers to get an individualized survivorship care plan.

The proposed study includes three aims: intervention development using focus groups, intervention refinement based upon a pre-pilot, and a randomized controlled pilot study of the final intervention. All participants are adult survivors of childhood cancer, males and females from three ethnic backgrounds (Black, Hispanic, White). The randomized control pilot is designed to assess the acceptibility/feasibility of a community-based intervention to engage childhood cancer survivors more actively in cancer follow-up care. Pilot data on outcome measures will provide data parameters (e.g. means and variances of groups) for accurate power analyses and sample size calculation to support a subsequent efficacy trial.

Relevance: This project is a critical initial step towards addressing systemic problems in transition of care and has the potential to decrease morbidity of adult childhood cancer survivors.

Outcomes include: knowledge of late effects and follow-up care, uncertainty related to 1) relapse, 2) secondary cancers, and 3) late effects, perceived efficacy to communicate with physician, access to childhood medical records, self-efficacy to obtain medical records, and the number of completed health care visits at a six month follow-up interview.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with any childhood cancer excluding CNS prior to age of 18 years
* Completed treatment at least 5 years ago
* Currently cancer free and 18 years or older
* Self-identifies as African American, Hispanic/Latino, or White

Exclusion Criteria:

* Ever seen for risk-based follow-up care as an adult (18 or older)
Vaginal Prolapse Surgery Accompanied by Mid Urethral Sling Versus no Sling for Reduction of Postoperative Incontinence

Prevalence of pelvic organ prolapsed is high in Nepal. After prolapse surgery many patients are affected with incontinence. Incontinence has physical, social and mental effect to the individual. This study is designed to know the role for mid urethral sling during vaginal prolapse surgery to decrease the rate of incontinence after the surgery.

Aim: To de termine the effect of mid urethral sling in reducing postoperative incontinence after vaginal prolapse surgery.

General Objectives: To compare the risk of de novo postoperative incontinence between prolapsed surgery with mid urethral sling versus no sling.

Specific Objectives: to compare the change in score of BFLUTS-SF (Bristol Female lower urinary tract symptoms- sexual function) and UDI-6 (Urinary distress inventory-6) pre and post surgery between the two groups.

Research Hypothesis: The use of mid urethral sling after vaginal prolapse surgery has role in reduction of postoperative incontinence.

Materials \& Methods:

1. Whether study involves humans/animals or both : Humans
2. Population/ participants: Patients with pelvic organ prolapse who are planned for vaginal prolapse surgery in BPKIHS (BP Koirala Institute of Health and Sciences).
3. Type of study design: a randomized controlled trial

(e) Expected sample size: 54 Sample size calculation: Previous study done by Control groups: Patient undergoing vaginal prolapse surgery only without mid urethral sling. There will be small incision in the suprapubic region that mimics the TVT incision.

(f) Probable duration of study: one and half year (g) Setting: BPKIHS, Department of Obstetrics and Gynecology (h) Parameter/Variables to be applied/ measured: Age, BMI, POPQ (Pelvic organ prolapse quantification) stage, menopause, ESST (Empty supine stress test).

(i) Outcome measures: LUTS score, UDI-6 score, SUI (stress urinary incontinence), Voiding dysfunction, dyspareunia, satisfaction, Complications like bladder injury, hemorrhage.

(j) Rationale for statistical methods to be employed: attached (k) Ethical clearance: Study will be started after getting clearance from the IRC (Institutional review committee) of BPKIHS .

(l) Permission to use copyright questionnaire/Proforma: Pre designed Proforma and questionnaire will be used to collect the data. The internationally valid questionnaire in English will be validated in Nepali language first and then it will be used.

(m) Maintain the confidentiality of subject: The confidentiality of the patients will be maintained throughout the research.

Eligibility Criteria:
Inclusion Criteria:

* Clinical POP-Q stage 3 or more
* Must have cell phone

Exclusion Criteria:

* Patient with POPQ stage less than stage 3
* Patient not giving consent
* Patient with previous pelvic and spine surgery
* Patient having positive cough stress test on examination
Realizing Effectiveness Across Continents With Hydroxyurea

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs. In the REACH prospective trial, the Original Cohort will receive long-term treatment while for the New Cohort, treatment will continue at least 4 years using PK-guided dosing after an initial 3-month screening period.

Eligibility Criteria:
Inclusion Criteria

1. Pediatric patients with documented sickle cell anemia (typically HbSS supported by hemoglobin electrophoresis, complete blood count, and peripheral blood smear)
2. In the Original Cohort, age range of 1.00-9.99 years, inclusive, at the time of enrollment (now age 5.5 - 17.5 years); age range 3.0-10.0 years for the New Cohort
3. Weight at least 10.0 kg at the time of enrollment
4. Parent or guardian willing and able to provide written informed consent, with child's verbal assent as per local IRB/Ethics Board requirements
5. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion Criteria

1. Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease, HIV, or malignancy)
2. Acute or chronic severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age \>3 z-scores below the median WHO growth standards.
3. Pre-existing severe hematological toxicity (temporary exclusions)

   1. Anemia: Hb \<4.0 g/dL
   2. Anemia: Hb \<6.0 g/dL with ARC \<100 x 109/L
   3. Reticulocytopenia: ARC \<80 x 109/L with Hb \<7.0 g/dL
   4. Thrombocytopenia: Platelets \<80 x 109/L
   5. Neutropenia: ANC \<1.0 x 109/L
4. Blood transfusion within 60 days before enrollment (temporary exclusion)
5. In the Original Cohort, hydroxyurea use within 6 months before enrollment (temporary exclusion). In the New Cohort, the children should be hydroxyurea naïve, without any prior treatment exposure.
High-dose FOLFIRI in Advanced Colorectal Cancer Patients With Wild-type UGT1A1*6 and *28

This trial aims to evaluate the efficacy, safety of high-dose FOLFIRI regimen in advanced colorectal cancer patients with wild-type UGT1A1\*6 and \*28.

Pharmacogenetic testing of uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) \*6/\*28 is recommended in clinical practice prior to the administration of irinotecan (CPT-11)-based regimens, such as FOLFIRI regimen in patients with advanced colorectal cancer. To avoid severe toxicity of irinotecan, such as severe neutropenia and diarrhea, patients with UGT1A1 \*6/\*28 mutation often start with a reduced dose of irinotecan. However, it remains unclear whether high-dose CPT-based regimen (FOLFIRI) could increase clinical efficacy in CRC patients when compared with standard-dose FOLFIRI or FOLFOX-6 regimens. This trial aims to compare the efficacy, safety of high-dose FOLFIRI and standard-dose FOLFIRI or FOLFOX-6 in advanced colorectal cancer patients with UGT1A1\*6 G/G and \*28 TA6/6.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence
* Patients should be with UGT1A1\*28 wild-type TA6/6 and UGT1A1\*6 wild-type G/G
* Patients have measurable lesions
* Patients are not available for targeted therapy or patients refuse to receive targeted therapy
* Age should be more than 18 years
* Performance status should be 0-2
* Hemoglobin should be more than 9.0 g/dL; Absolute Neutrophil Count should be more than 1,500/mm3; Platelet should be more than 80,000/mm3；Total Bilirubin should be less than 1.5 times of the upper limit of normal value; Alanine aminotransferase and Glutamic-oxaloacetic transaminase should less than 2.5 times of the upper limit of normal value (it can be 5 times if liver metastasis); Creatinine should be be less than 1.5 times of the upper limit of normal value

Exclusion Criteria:

* Patients with UGT1A1\*28 wild-type TA6/7, TA7/7 and UGT1A1\*6 wild-type G/A,A/A;
* Patients with brain metastases;
* Patients could not tolerate chemotherapy;
* Patients have secondary primary tumor;