cyrilzakka/clinical-trials huggingface dataset:
Protocol For the Treatment of Cryptosporidiosis in AIDS Patients With Diclazuril (R64,433)

To evaluate the safety and efficacy of diclazuril capsules compared with placebo capsules as treatment of cryptosporidial related diarrhea in AIDS patients. Treatment efficacy will be based on the drug's clinical results and on its anti-protozoan effects. Safety will be assessed by the occurrence of side effects as reported by patients at their visits and by frequent monitoring of hematology, biochemistries, and urinalysis.


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Patients who require anti-diarrheal medication must have received only one anti-diarrheal medication, loperamide, for at least 7 days prior to study entry. Dose of loperamide cannot be increased during study.
* Aerosolized pentamidine.
* Ganciclovir for cytomegalovirus (CMV) retinitis only but patient must be stable at least 4 weeks prior to study entry.
* Zidovudine (AZT).
* Nystatin for oropharyngeal infections if not taken within 2 hours of diclazuril.

Patients must have:

* Diagnosis of AIDS that is confirmed HIV positive by Western blot or AIDS defined diagnosis, or CDC defined AIDS. Stool specimens positive for cryptosporidium oocysts.
* Given written informed consent after the purpose and nature of the study, as well the possible drug-related adverse effects, have been explained.
* Ability to return for all subsequent applicable visits on days 8, 15, 21, and, if necessary, 28.

Prior Medication:

Allowed:

* Aerosolized pentamidine.
* Loperamide.
* Ganciclovir for cytomegalovirus (CMV) retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.
* Other treatable enteric pathogens including Clostridia must be treated and eradicated prior to study entry.
* Inability to swallow capsules.
* Uncontrolled vomiting.

Concurrent Medication:

Excluded:

* Trimethoprim/sulfamethoxazole (Bactrim).
* Ganciclovir for any other reason except cytomegalovirus (CMV) retinitis.
* Other antibiotics.
* Other anti-protozoal drugs.
* Anti-fungal drugs other than nystatin.
* Amphotericin B.
* Other investigational drugs.

Patients with the following are excluded:

* Diagnosis of cryptosporidiosis less than 4 weeks prior to study entry, unless patient has been diagnosed with AIDS for more than 4 weeks.
* Inability to swallow capsules.
* Uncontrolled vomiting.
* Life expectancy of \< 28 days.
* Can not be depended upon to follow the instructions of the investigator.
* Participation in an investigational study within 15 days of study entry.

Prior Medication:

Excluded within 15 days of study entry:

* Another investigational drug or device (except aerosolized pentamidine).

Prior Treatment:

Excluded within 15 days of study entry:

* Participation in an investigational study.
Steroids and Cross-linking for Ulcer Treatment

Steroids and Cross-linking for Ulcer Treatment (SCUT II) is an international, randomized, double-masked, clinical trial. The purpose of this study is to determine differences in 6-month visual acuity between medical antimicrobial treatments alone versus antimicrobial treatment plus collagen cross-linking (CXL), as well as to further evaluate findings from subgroup analyses of SCUT. Patients presenting to the Aravind Eye Care System (India), Kaiser Permanente Northern California (USA), or the University of California, San Francisco (USA) with smear-positive and/or culture-positive typical (i.e. non-Nocardia or Mycobacteria) bacterial corneal ulcers and moderate to severe vision loss, defined as Snellen visual acuity of 20/40 or worse, will be eligible for inclusion. Those who agree to participate will be randomized to one of three treatment groups:

Group 1: Standard therapy, topical 0.5% moxifloxacin plus topical placebo plus sham CXL Group 2: Early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus sham CXL Group 3: CXL plus early steroids, topical 0.5% moxifloxacin plus topical difluprednate 0.05% plus CXL


Eligibility Criteria:
Inclusion Criteria:

* Corneal ulcer that is smear positive and/or culture positive (within 24 hours) for typical bacteria (i.e. non-Nocardia or Mycobacteria)
* Moderate to severe vision loss, defined as Snellen visual acuity of 20/40 (6/12) or worse
* Corneal thickness ≥350 µm, as measured on AS-OCT
* Age over 18 years
* Basic understanding of the study as determined by the physician
* Commitment to return for follow up visits

Exclusion Criteria:

* Evidence of concomitant infection on exam, gram stain, or confocal microscopy (i.e. herpes, both bacteria and acanthameoba on gram stain)
* Impending or frank perforation at recruitment
* Involvement of sclera at presentation
* Non-infectious or autoimmune keratitis
* History of corneal transplantation or recent intraocular surgery
* Pinhole visual acuity worse than 20/200 in the unaffected eye
* Participants who are decisionally and/or cognitively impaired
Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.


Eligibility Criteria:
Inclusion Criteria:

* 1. Histologically confirmed melanoma with metastases and has no received any systemic treatment.
* 2.At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
* 3.Estimated life expectancy of 12 weeks or greater
* 4. ECOG performance status 0, 1
* 5.Adequate organ function
* 6.Without symptoms of brain metastases and stable in neuro-functions

Exclusion Criteria:

* 1. Pregnant or lactation women
* 2. Acute infections without control.
* 3. Heart disease history, cardiac function class≥NYHA II.
* 4. HIV positive or chronic HBV/HCV in active stage.
* 5. Brain metastases or primary tumor with positive symptoms
* 6. Need anti-epileptic treatments
* 7. Organ transplantation history
* 8. Hemorrhagic tendency or related history
* 9. Renal dialysis patients
* 10. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
* 11. Current treatment on another clinical trial
* 12. The other improper situations which investigator judged.
A Real-world Study of Long-acting Growth Hormone Injection for Turner Syndrome

This study is divided into two parts:

Part A: A multicenter, retrospective, observational study to evaluate the effectiveness of PEG-rhGH in the treatment of Turner syndrome with domestic real-world data on rhGH as external controls. The collection and arrangement of real world data is the content of the real world study (RWS); Part B: Meta analysis (MA) was conducted based on the previous literatures on rhGH in the treatment of Turner syndrome, and MA results were used as external controls to evaluate the effectiveness of PEG-rhGH.

Real-world data on rhGH treatment of Turner syndrome in China were obtained from the HIS system and/or paper medical records of participating domestic centers and/or photocopied/printed medical records of other hospitals. Data on the efficacy of PEG-rhGH injection in the treatment of Turner syndrome were obtained from the 0.2mg /kg/ week group in the Phase II clinical trial of PEG-rhGH injection in the treatment of Turner syndrome (multicenter, randomized, blank control, superior efficacy) conducted by Changchun GeneScience Pharmaceutical Co., Ltd (Protocol number: GenSci032-02, version date: April 27, 2015). The MA study data of rhGH in the treatment of Turner syndrome in foreign countries came from the relevant literature retrieved from the approved drug database of FDA, PubMed and Web of Science database.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Turner syndrome by a clinician;
* The first treatment was short-acting rhGH, and the first administration date was not earlier than July 1, 2008;
* Follow-up data are available at the center before the first dosing and after at least one dosing.

Exclusion Criteria:

● None.
A Study of Long-term Treatment With Deferasirox in Patients With Beta-thalassemia and Transfusional Hemosiderosis

Because patients with beta-thalassemia are unable to actively eliminate iron from the body, toxic and eventually lethal levels of iron can accumulate as a result of repeated blood transfusions. This study will evaluate the efficacy, safety and tolerability of deferasirox.


Eligibility Criteria:
Inclusion Criteria:

* Beta-thalassemia outpatients with transfusional hemosiderosis and unable to be chelated with deferoxamine (DFO) due to DFO being contra-indicated and/or due to documented unacceptable toxicity of DFO or documented poor response to DFO despite proper compliance, or documented non-compliance to DFO, with serum ferritin ≥ 500 ng/ml and LIC ≥ 2 mg/Fe/g dw liver
* Beta-thalassemia outpatients with transfusional hemosiderosis treated with deferiprone

Exclusion Criteria:

* Means levels of ALT \> 300 U/L
* Serum creatinine above upper limit of normal
* Active hepatitis C or chronic hepatitis B receiving specific treatment
Efficacy of MYCOBIOTIC® in Children and Adults With Abdominal Symptoms.

This is a prospective, randomised, double blind, placebo controlled, parallel arm, cross-over, multicentre study conducted in a population of children and adults with abdominal symptoms observed at outpatient primary health care centres.


Eligibility Criteria:
Inclusion criteria

1. Children and adults age \>3 up to ≤ 75 years old. Boys and girls aged 3-15 years
2. Presence of abdominal symptoms
3. Informed consent for participation in the study signed by children' parents/ legal caregivers and child above 13 years old, all adults patients.

Exclusion Criteria:

1. Chronic intestinal disease, immunodeficiency or immunosuppressive treatment.
2. Chronic or acute diarrheal disease.
3. Use of laxatives or antydiarrhoeal treatment within the week before inclusion in the study.
4. Antibiotic treatment for the last four weeks before inclusion in the study.
5. Intake of probiotic products for the last two weeks before inclusion in the study
6. Known hypersensitivity to any of the ingredients in the probiotic product or the placebo (corn starch, magnesium stearate ± bacterial culture).
Red Clover and Lifestyle Changes to Contrast Menopausal Symptoms in Premenopausal Breast Cancer Patients Given Tamoxifen

A prospective double-blind randomized trial of red clover extract (Promensil) vs placebo in surgically-treated premenopausal women with estrogen receptor-positive breast cancer taking tamoxifen

Premenopausal women with ER-positive breast cancer treated by surgery and receiving postoperative tamoxifen with or without LHRH analogues, who may have received pre or postoperative chemotherapy, or immunotherapy (for HER2-positive disease), are recruited to a double-blind randomized clinical trial, to receive either a dry extract of red clover (Promensil) as one tablet/day orally containing 80 mg isoflavones (treatment group), or one oral tablet/day without active principle (placebo group) for 24 months. All patients receive a diet-lifestyle intervention involving meetings with a dietician (physician) scheduled once a month for the first 6 months, and every 3 months thereafter. The dietician encourages patients to adhere to a macronutrient-balanced, low glycaemic load Mediterranean-type diet with personalized recommendations to increase intakes of unrefined cereals, pulses, vegetables, unrefined vegetable fats (e.g. olive oil, nuts, oil-containing seeds), and fish, and reduce intake of high-glycaemic-index foods and saturated animal fats. Patients are also encouraged to undertake regular physical activity. Outcomes are Menopausal Rating Score (MRS), body mass index (BMI), waist and hip girth, insulin resistance, and levels of cholesterol, triglycerides, and sex hormones.

The safety of the red clover preparation is assessed by pelvic ultrasound and mammograms for endometrial thickness and breast density, and by evaluation of the effects of the serum from treated and placebo patients on ER-positive BC cell lines.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed operable ER-positive breast cancer
* Can be ductal carcinoma in situ (DCIS)
* Absence of locoregional relapse or distant metastasis
* Normal ovarian function
* Menopause Rating Score \> or equal to 8
* Signed informed consent to participate

Exclusion Criteria:

* Menopause Rating Score \<8
* Menopausal at diagnosis or at surgery
* Previous malignancies other than in situ cervical carcinoma or non-melanoma skin cancer
* Breast cancer recurrence
* Metastatic breast cancer
* Non-epithelial breast cancer at histological examination
* In situ lobular breast cancer
* Participation in other randomized clinical trials that could interfere with current study
* Living distant from center and unable to attend for check-ups and meetings.
Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)

The investigators are comparing post operative analgesia provided for caesarean section patients, with the quadratus lumborum type 2 block and intrathecal morphine.

In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.

The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.

In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* Anaesthetist trained in QLB and ITM techniques available
* American Society of Anaesthesiologists PS category client I or II
* 18 years of age or older
* Ability to read and understand English
* Uncomplicated pregnancy at term (\>37 weeks completed gestation)
* Booked elective CS

Exclusion Criteria:

* Contraindications to spinal anaesthesia
* History of chronic opioid consumption / chronic pain conditions
* Known allergy to study drugs
* Weight more than 95kg or body mass index (BMI) more than 35 pre operative
* Placenta Previa / accreta
* Obstructive Sleep apnoea
* Severe asthma unable to tolerate Non steroidal anti inflammatory agents
A Study on the Effects of Valproate on the Pharmacokinetics of RO4917838 in Healthy Volunteers

This open-label, fixed-sequence, two-period study will assess the effect of multiple dose valproate on the pharmacokinetics of RO4917838 at steady state and vice versa in healthy male volunteers. In Period 1, subjects will receive valproate for 5 days. After a washout period of 5 days to 2 weeks, subjects will receive, in Period 2, RO4917838 for 15 days with concomitant valproate on Days 11-15. Anticipated time on study is up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, 18 to 65 years of age inclusive
* Body mass index (BMI) 18 to 30 kg/m2 inclusive
* Healthy as determined by the investigator on the basis of medical/surgical history, physical examination, clinical laboratory test results, vital signs, and a 12-lead electrocardiogram (ECG)
* Non smoker or smoker of fewer than 10 cigarettes per day

Exclusion Criteria:

* History of alcoholism, drug abuse or addiction within the last year prior to Day -1 of the study
* Alcohol consumption averaging more than 24 g of alcohol per day
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, psychiatric disease, or cancer
* Any major illness within the 4 weeks prior to dosing or any acute disease state (e.g. nausea, vomiting, fever, diarrhea) within 7 days of study Day -1
* Any confirmed allergic reactions against any drug, or multiple allergies in the judgment of the investigator
* Positive for hepatitis B, hepatitis C or HIV infection
* Involvement in other investigational studies of any type within 90 days of first study drug administration or within 5 times the elimination half-life of the tested drug, whichever is longer
Low-Protein Diet with Low-Protein Foods Versus a LPD Without LP Foods in Patients with Chronic Kidney Disease (CKD)

The KDOQI 2020 - Clinical practice guideline for nutrition in chronic kidney disease (CKD) -recommends protein restriction to reduce the risk of end-stage renal disease/death and improve quality of life, a low protein diet providing 0.55-0.60g dietary protein/ kg body weight/day is recommended. FLAVIS® is a product line of hypoprotein foods specially developed for the treatment of CKD.The use of low-protein foods may facilitate the achievement of nutritional goals in terms of protein intake and help patients to follow a low-protein diet.


Eligibility Criteria:
Inclusion Criteria:

* CKD patient stage 3a-5 (\<60 ml/min/1.73 m² estimated by CKD-EPI formula) and not on dialysis,
* With a good nutritional status (i.e., absence of malnutrition according to albumin, pre-albumine, BMI and no clinical and paraclinical criteria of malnutrition),
* Above 1g protein/ kg bw (ideal body weight),
* LPD-naïve patient,
* Motivated to LPD introduction (ensure during screening phase patient willingness to modify diet habits with counselling accurate follow-up),
* Available to attend the visits planned by the protocol and able to complete the data collection documents (diet record and self-administered questionnaires),
* Subject affiliated to a health insurance system or is a beneficiary (art. L.1121-11, Code of Public Health, France),
* Having given their informed written consent regarding its participation to the protocol.

Exclusion Criteria:

* Patient for whom dialysis or transplantation is planned/expected within the next 12 months
* Known allergic reactions to the ingredients present in FLAVIS products (milk, eggs, soy, nut),
* Uncontrolled Diabetes (HbA1C \>8.5%),
* Active cancer (including a 5 years remission period),
* Psychiatric disorders or inability to follow the protocol,
* Evidence of any active infectious or uncontrolled inflammatory diseases,
* Inability to provide blood samples (poor venous capital),
* Inability to perform correct 24-hours urine collection,
* Any change of the chronic medication within 1 month before screening,
* Presence of any significant medical finding or significant history such as uncontrolled systemic diseases that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator,
* Patient with an active implanted medical device
* Simultaneous participation in another clinical trial or subject still within the exclusion period of a previous clinical trial.
* Vulnerable subjects (art. L. 1121-5 à 8 et L. 1122-1-2, Code of Public Health, France) are also excluded from the clinical trial.
Advanced Cooking Education Pilot Study

The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.

The ACE program is conducted with 7th and 8th grade students attending New York City (NYC) Title I middle schools. Participants attend weekly sessions (2hour) after school to participate in mindfulness, nutrition lessons, and professional development activities. On another day in the week, students participate in cooking labs at their own time at their homes. The investigators hypothesize that after the program, adolescents' diet quality, cooking-related skills, stress levels will be improved compared to prior of the program.

Eligibility Criteria:
Inclusion Criteria:

* 7th and 8th grade students attending Title I funded schools in New York City
* Caregivers of the 7th and 8th grade students attending Title I funded schools in New York City

Exclusion Criteria:

* Do not speak/understand English
* Those who have previously participated in the Virtual ACE program (Feasibility Study)
Mutation Detection of EBUS-TBNA Specimens Using NGS

The objective of the study was to compare the value of routine gene testing and next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge of how many EBUS-TBNA samples were adequate for NGS.

Some gene mutations can direct individualized treatment. The routine gene testing of EGFR, ROS1 and ALK is direct sequencing, Reverse transcription quantitative real-time polymerase chain reaction (RT-QPCR) and fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC). Next-generation sequencing (NGS) is a new technique, which is more sensitive than routine techniques. So we decided to compare the value of gene testing between routine method and NGS in EBUS-TBNA specimens and get the knowledge of how many EBUS-TBNA samples were adequate for NGS.

The study was designed as a prospective and single center study. Seventy patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the lymph nodes suspected to be malignant will be obtained by EBUS-TBNA. Samples will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, routine gene testing of EGFR, ROS1 and ALK will be performed. And the rest tissues will be extracted with DNA and performed gene mutations using NGS for these qualified DNA samples.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who are suspected with nonsquamous non-small cell lung cancer according to the clinical, lab examination and imaging data and had never been diagnosed as primary lung cancer before will be enrolled into the study.
2. The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially.

4. There exist at least one lesions that can be obtained by EBUS-TBNA.

Exclusion Criteria:

1. The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data.
2. Surgery was considered to be the primary treatment.
3. Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded.
4. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.