cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Abelmoschus Manihot for IgA Nephropathy

-IgA nephropathy is the most common primary glomerular disease in China, Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating IgA nephropathy in large scale samples with long time take.

The test has not been completed .

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed as chronic nephritic syndrome
* IgA nephropathy diagnosed by kidney biopsy
* Aged from 18 to 65 years，male or female
* Blood pressure of ≤140/90mmHg
* Estimated Glomerular Filtration Rate (eGFR)≥45ml/min/1.73 m2
* 24-hour proteinuria ranged between 0.5g-3.0g
* Obtaining the signed informed consent from patients

Exclusion Criteria:

* Secondary IgA nephropathy
* Be allergic to Huangkui Capsule or Losartan potassium tablet
* Taken Huangkui Capsule or ACEI or ARB in last 6 weeks
* Taken the glucocorticoids, immunosuppressants or common threewingnut root and such as drugs with immunosuppressive actions in the last 12 months
* Blood pressure \<90/60mmHg
* Serum potassium level \> 5.5mmol / L
* Serum albumin level \<30g / L
* Lactation, pregnancy or plans pregnancy during the study period
* Unilateral or bilateral renal artery stenosis
* Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
* Participating in another clinical study in the same period
Feasibility Study of an Adapted and Supported Water Polo Program to Reduce Fatigue Related to Cancer and Improve Psychological and Social Recovery in Patients With Breast Cancer Remission

The main objective of the study is to assess the feasibility of a coached physical activity program in the form of an accompanied and adapted water polo program by evaluating the interest aroused in patients for this proposal. treatments (number of participants and sessions performed).

Prospective, non-randomized, monocentric study, which aims to show that physical activity carried out within a high-level structure and coached by elite trainers contributes to psychological and social recovery and to the reduction of fatigue in patients in remission breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Woman aged 18 to 65, with a good understanding and good practice of the French language.
2. Having been diagnosed with breast cancer: any type of cancer, any type of treatment. Inclusion from 3 weeks to 3 months after the end of treatment (excluding hormone therapy and immunotherapy) Patients who have undergone surgery may be included from 6 weeks post-operative.
3. Signed consent to participate.
4. Affiliation to a social security scheme or beneficiary of such a scheme.
5. Live within a maximum radius of 40 km around Marseille.
6. Swimming skills (basic level).

Exclusion Criteria:

1. Being undergoing chemotherapy treatment
2. Unacquired healing
3. Metastatic cancers
4. Proven psychological pathology proven according to diagnostic criteria (DSM-V)
5. Pregnant or lactating woman
Eeva™ Continued Access Study: Assessing the Usability of Eeva in a Clinical Setting

User questionnaire of Eeva System usability and reports of device malfunctions.

This study is designed to evaluate the use of Eeva by IVF laboratory staff during routine procedures. The fertilized eggs will be placed in an Eeva dish and the development of the embryos will be monitored by the Eeva system in a standard incubator. On day 3 of embryo culture, Eeva blastocyst prediction data will be printed from the system to be used to assist the embryologist in selecting the best embryo(s). The performance of the system will be summarized and the user feedback from the embryologists will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs
* Subject is ≥ 18 and ≤ 40 years of age.
* Subject has basal antral follicle count (AFC) ≥ 8 prior to stimulation cycle.
* Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
* Subject has ≥ 5 normally fertilized eggs (2 PN)
* Willing to have all 2PN embryos monitored by Eeva
* Willing to comply with study protocol and procedures and able to speak English.
* Willing to provide written informed consent.

Exclusion Criteria:

* Reinseminated eggs.
* History of cancer.
* Gestational carriers.
* Planned preimplantation genetic diagnosis or preimplantation genetic screening.
* Previously enrolled in this study
* Concurrent participation in another clinical study.
A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD)

This study is designed to evaluate the efficacy, safety and pharmacokinetics of crovalimab compared with placebo as adjunct therapy in the prevention of VOEs in participants with SCD.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>=40 kg.
* Male or female with confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSβ0 (SCD genotype of sickle cell beta zero thalassemia).
* Two or more (\>=2) to \<=10 documented VOEs in the 12 months prior to randomisation.
* If receiving concurrent SCD-directed therapy, the participant must have been on a stable dose for a minimum of 3 months prior to study enrollment. There should be no plans to modify the participants' dosing throughout the study duration, other than for safety reasons.
* If receiving erythropoietin, the participant must have been prescribed this medication for the preceding 3 months and be dose-stabilised for at least 3 months prior to study enrollment.
* Vaccination against N. meningitides serotypes A, C, W, and Y and Vaccinations against H. influenza type B and S. pneumonia.
* Participants who have been vaccinated (partially or in full) against SARS-CoV-2 with a locally approved vaccine are eligible to be enrolled in the study, 3 days or longer after inoculation.
* Adequate hepatic and renal function.
* For women of childbearing potential: agreement to remain abstinent or use contraception during the treatment period and for 10.5 months after the final dose of study treatment.

Exclusion Criteria:

* History of hematopoietic stem cell transplant.
* Participating in a chronic transfusion program and/or planning on undergoing an exchange transfusion during the duration of the study.
* History of hypersensitivity, allergic, or anaphylactic reactions to any ingredient contained in the study treatment.
* Received active treatment on another investigational trial within 28 days (or within five half-lives of that agent, whichever is greater) prior to screening visit, or plans to participate in another investigational drug trial.
* Hemoglobin \<6 g/dL.
* Known or suspected hereditary complement deficiency.
* Active systemic bacterial, viral, or fungal infection within 14 days before first drug administration.
* Presence of fever (\>=38 degrees Celsius) within 7 days before the first drug administration.
* Immunised with a live attenuated vaccine within 1 month before first drug administration.
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 10.5 months after the final dose of study treatment.
* Known HIV infection with documented CD4 count \<200 cells/microliter within 24 weeks prior to screening.
* History of N. meningitidis infection within the prior 6 months.
Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery

This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, conscious;
2. ASA class Ⅰ \~ Ⅲ;
3. Thoracoscopic lobectomy was proposed;
4. The han nationality;
5. Native speaker of Chinese;
6. Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

1. Patients allergic to meccobalamin or ropivacaine;
2. Patients with previous history of chest surgery;
3. Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
4. Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
5. Diabetic patients;
6. Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.
A Study to Explore Clinical Characteristics and Prognoses of N2 Patients With Non-small Cell Lung Cancer

A study to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases

A multi-centre real-world non-interventional observational study to retrospectively collect the study data on patient demographic/tumor biological characteristics and clinical treatments to compare patient survivals in the N2 patients with non-small cell lung cancer in the subgroups of lymph skip metastases and non-skip metastases.

Eligibility Criteria:
Inclusion Criteria:

* Patients with surgeries from 2014 to 2017;
* Pathologically diagnosed patients with non-small cell lung cancer;
* Age \> 18 years old;
* Patients with chest surgeries before hospitalization;
* Patients with N2 lymph nodes (+) after surgeries who received lymphadenectomy (Group 10 and 11 lymph nodes);

Exclusion Criteria:

- Patients with radiotherapies, chemotherapies and biological therapies for tumors
Median and Paramedian Anesthesia in Cesarean Section

The number of cesarean sections worldwide has markedly been increasing since 1985.Intrathecal anesthesia is preferred by most anesthesiologists over general anesthesia

Complications with spinal anesthesia are not common which makes it difficult to detect its incidence and one of the most serious complications is nerve injury.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-42 years
* Scheduled for elective cesarean section
* ASA II

Exclusion Criteria:

* -Age \<18 years or \>42 years
* ASA \>II
* Emergency cesarean section
Clinical Research on the Treatment Model of Ambulatory Surgery for Colorectal Cancer

To investigate the postoperative complication incidence and long-term efficacy between ambulatory surgery for colorectal cancer and traditional laparoscopic colorectal surgery in patients with colorectal tumor who are generally in good health and have sufficient organ functions。


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily joined this study and signed an informed consent form；
2. Age: 18-75 years old；
3. The patient should have a good general condition and no serious internal medicine comorbidities (ASA classification of the American Anesthesiology Association is Grade I\~III)；
4. Complete colonoscopy and colonoscopy biopsy, and the pathology is confirmed to be adenocarcinoma/high-level intraepithelial neoplasia；
5. Enhanced CT or MRI examination before surgery, indicating that the tumor diameter is ≤5.0 cm；
6. Preoperative staging: cT1-3NanyM0;
7. Strictly follow the colorectal day surgery plan, and micro-laparoscopic radical colorectal cancer treatment can be adopted；
8. There are no contraindications for abdominal wall nerve block anesthesia or non-opiate analgesic drugs;
9. Does not require conventional anticoagulant therapy or antiplatelet therapy；
10. Relatives or co-residents should be able to provide 24 hours of full escort within at least 72 hours after the operation, the place of residence is not more than a 30-minute drive from the hospital, and they can understand and follow the phased treatment plan of diet, analgesic drugs, etc. after the operation.

Exclusion Criteria:

1. Elderly patients with multiple basic diseases；
2. Moderate to severe anemia；
3. Severe hypoproteinemia；
4. Diabetes that is not well controlled；
5. Contraindications to laparoscopic surgery；
6. Cases of emergency surgery due to acute intestinal obstruction, perforation or bleeding；
7. Patients with distant metastases；
8. Patients who are unwilling to sign informed consent or follow-up according to the research plan；
9. People with a history of psychotropic drug abuse and unable to quit or have mental disorders；
10. Patients who live alone or in psychosocial isolation, patients who cannot understand the postoperative nursing process；
11. After the operation, the place of residence is far away from the treated hospital or patients with insufficient medical resources and inconvenient transportation；
12. According to the judgment of the researcher, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the patient\&#39;s research.
Long Term Effectiveness and Safety Study for RWJ-333369 as Adjunctive Therapy in Korean and Japanese Patients With Partial Onset Seizures

The purpose of this study is to evaluate the long-term safety of RWJ-333369 at doses between 200-800 mg/day in Korean and Japanese patients who have completed the preceding study (333369-KJ-02).

Despite the introduction of new antiepileptic drugs into overseas clinical settings after 1990's, there still exist those patients who cannot control seizures, and thus the advent of newer antiepileptic drugs is being desired. This is a multicenter, open-label, extension study in patients who have completed the preceding study (333369-KJ-02) and scheduled to continue until the study drug is approved. This study consists of Period 1 (1 year) and Period 2 (only in Japan; planned to continue until the drug is approved Primary objective of this study is to evaluate the long-term safety (Adverse event, Lab test, Electrocardiogram, Vital signs, Pregnancy test, Physician Withdrawal Checklist) of RWJ-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. Secondary objective of this study is to evaluate the long-term effectiveness of RWJ-333369 at doses between 200-800 mg/day in patients who have completed the preceding study. Period 1:RWJ-333369 will be started at 400 mg/day. RWJ-333369 100 mg tablets or 200 mg tablets will be orally administered with noncarbonated water twice daily. The dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance. Period 2: The dose will be adjusted between 200 mg/day and 800 mg/day based on effectiveness and tolerance.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the preceding study (333369-KJ-02) who have completed Double-Blind Treatment Phase of preceding study

Exclusion Criteria:

* Considered ineligible as study patients by the investigator
College Mental Health Project

Depression is common and debilitating disorder which, among college students, is predictive of significant problems including higher rates of dropout and suicidal behaviors. Despite viable psychotherapeutic and pharmacological options, the majority of depressed college students, like others in the general population, do not pursue treatment. Further, barriers to care, both those involving practical issues and psychological factors, lead to high attrition rates from treatment, resulting in modest effect sizes in effectiveness trials. In reaction to these alarming figures and as a means of increasing accessibility and retention, effective internet-based treatment for depression have been developed and tested. Despite increased availability, response to internet-based treatment continues to vary substantially, yet, controlled trials show that a meaningful proportion of patients who receive internet-based therapy recover. Identifying individuals with a high likelihood of responding to internet-based treatment would enable clinicians to target this inexpensive treatment only to the patients with a high probability of responding; allowing more intensive treatments to be reserved for patients who would not respond to internet-based therapy. The development of a system to make this determination would represent a major advance and address an unmet need.

ICare is an online depression treatment that has been adapted for college students (e.g., language used, problems discussed, embedded images). Prior work by the developers of ICare have tested the internet-based treatment in diverse samples of depressed adults, and prior meta-analytic research has demonstrated that psychological treatments for depression in college students are as effective relative to trials carried out among depressed adults. The overarching goal of the study is to: (a) test whether depressed college students utilize ICare, (b) identify psychosocial and clinical characteristics that increase the likelihood of ICare utilization, and (c) identify multivariate characteristics that predict treatment response.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-25 years;
* Enrolled as a first year student at a participating institution;
* English fluency;
* Mild or Moderate Depression: (i) PHQ-9 score 10-14 or (ii) PHQ-9 score 15-19;
* Provide Online Consent Form.

Exclusion Criteria:

* Severe Depression: (i) PHQ-9 score ≥20;
* Endorse "3" (nearly every day) on item 9 of the PHQ-9;
* No internet access
Effects of Lactobacillus Plantarum PS128 on Symptoms of Early-onset Parkinson's Disease: a Pilot Study

This study is designed to examine L. plantarum PS128 can improve symptoms in early onset PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with early onset PD will receive PS128 treatment for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.


Eligibility Criteria:
Inclusion Criteria:

* Early Onset Parkinson's Disease, EOPD
* at least 9 years education
* age between 20 and 80 years old

Exclusion Criteria:

* Patients on antibiotics within the preceding one month
* Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
* Have undergone surgery of liver, bladder, or gastrointestinal tract
* Have current or history of inflammatory bowel disease
* Have history of cancer
* Known allergy to probiotics
* Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
* Have received deep brain stimulation
* Patients receiving artificial enteral or intravenous nutrition
* Diagnosed before 40 years old
* Poor control of other chronic diseases
* Not eligible judged by PI
A Study To Investigate The Effect Of Solabegron (GW427353) On Gastrointestinal Transit In Healthy Volunteers

This study will test the hypothesis that GW427353, a beta-3 adrenergic agonist, retards the emptying of the colon and increases total colonic transit time.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with no evidence of current or past history suggestive of gastrointestinal disease or disorder or medical illness that could compromise interpretation of the study.
* no clinically significant laboratory results collected at the screening visit
* men: body weight greater than or equal to 50kg (110 lbs)
* women: body weight greater than or equal to 45kg (100 lbs)
* BMI between 18.5 - 35 kg/m2

Exclusion Criteria:

* Females who are nursing or pregnant.
* history of inflammatory bowel disease
* history of gastric ulcers within 12 months of signing the informed consent form
* tobacco users
Trial to Examine Text-message Based mHealth in Emergency Department Patients With Diabetes

The investigators propose an innovative, ED-based mHealth intervention: TExT-MED (Trial to Examine Text-Based mHealth for Emergency department patients with Diabetes). TExT-MED is a technologically simple solution using unidirectional daily text messages to consisting of educational materials, trivia questions and challenges promoting healthy lifestyle choices and reminders to check blood sugar, take medications and go to clinic appointments. The investigators believe TExT-MED will improve health outcomes including blood glucose control and encourage weight loss, healthy eating and exercise. TExT-MED is low cost, easy to use and can be quickly adapted to other practice environments.


Eligibility Criteria:
Inclusion Criteria:

1) ≥18 years old 2) have Type 2 diabetes 3) have a text message capable mobile phone 4) know how to receive text messages 5) speak and read English or Spanish and 6) have a HbA1C ≥8%.

Exclusion Criteria:

1) overt psychosis 2) unable to provide informed consent and 3) pregnancy.
Effectiveness of Training in Reading Rehabilitation for Patients With Diabetic Macular Oedema

Diabetic macular oedema (DMO) is a sight-threatening problem for diabetic patient who has swelling in macula. Patients with DMO can receive laser treatment and achieve good acuity finally. However, some patients still have difficulties in reading even after proper treatment.

In this project, the investigators aimed to explore the effectiveness of different training paradigms in improving reading performance in patients with DMO.

Patients with diabetic macular oedema (DMO), after receiving laser photocoagulation, achieved good outcomes in distance acuity. However, some patients, particularly those developing parafoveal scotoma, still had difficulty in reading. Inability to read or reading very slowly leads to the potential loss of job, as well as the enjoyment of reading for leisure.

In this study, the investigators aimed to investigate the effectiveness of reading rehabilitation using perceptual learning paradigms in enhancing reading performance in patients with reading difficulties due to DMO. Also, the fundamental mechanisms explaining the reading problems in patients with DMO reading Chinese will be examined.

The investigators hypothesize that the perceptual training would show an improvement in reading. The investigators' primary hypothesis is that temporal visual processing speed and spatial visual span will be improved after perceptual training. The investigators' secondary hypothesis is that the reading speed and fixation stability will be improved after training.

Eligibility Criteria:
Inclusion Criteria:

* Able to read Chinese.
* No formal vision rehabilitation training in reading after vision loss
* Diagnosis of diabetic macular oedema (DMO) and had previous treatment with laser and / or intravitreal injections
* Reasonable control of blood glucose level (HbA1c \<10) to minimize the impact of vision fluctuation
* Education level of 6 years or more (primary school or above)

Exclusion Criteria:

* Receive any types of eye treatments other than those mentioned above
* Any diagnosed ocular diseases other than DMO
* Severe medical problems or self reported neurological or cognitive disorders
* Serious hearing impairment
* Previously attended vision rehabilitation clinic