cyrilzakka/clinical-trials huggingface dataset:
Trial of Vitamin D3 Supplementation in Paediatric Asthma

Epidemiological and observational studies have linked vitamin D deficiency with increased asthma/allergy incidence . Vitamin D insufficiency (\<75nmol/L) has been associated with increased incidence of severe childhood asthma. Further, high 25(OH)D levels were associated with reduced risk of recent hospitalization, lower use of anti-asthmatic medication and lower airway hyper-responsiveness in childhood asthmatics. The association between vitamin D and allergy and asthma appears to be stronger in children than adults, with some even suggesting that childhood asthma may may be caused by VDD.

Asthmatic children will be recruited in winter. After baseline testing, children will be randomized to take 2,000iu vitamin D or placebo daily for 15 weeks. After the 15 weeks, testing will be repeated. Tests involve blood draws, questionnaires and breathing tests.

Eligibility Criteria:
Inclusion Criteria:

* Previous clinical diagnosis of asthma
* Ability to perform pulmonary function tests
* Established on anti-asthmatic pharmacotherapy with no expected change

Exclusion Criteria:

* Use of medications that influence vitamin D metabolism or absorption
* Chronic, non-asthma medical issues e.g. endocrine, hepatic, renal, or bone-disease
A Comparative Analysis Between College Park Sidekick Feet and Conventional Stubby Prosthesis

The purpose of this study is to compare the College Park Sidekicks to conventional stubby prosthetics to investigate their effects on bilateral above-knee-amputee gait velocity, exertion, and balance. The investigators aim to demonstrate that: (i) greater balance will be observed and reported on a level and gravel surface with the Sidekicks; (ii) time to complete the 10-meter walk test will be decreased wearing Sidekicks compared to the conventional stubby prosthesis; and (iii) subjects will report feeling less exerted with the sidekicks.


Eligibility Criteria:
Inclusion Criteria:

* bilateral transfemoral amputee
* own a pair of conventional stubby prosthesis with standard adaptation

Exclusion Criteria:

* dependence on assistive walking device or wheelchair (may use devices occasionally but should be able to ambulate without them)
* use of prosthesis that do not allow change of feet with standard adapters
* any medical condition that may put an individual in greater risk of injury than normal daily activity.
Effects of an HIV Intervention Among Sex Workers in the Philippines

This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information and condom use and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.

This study will implement a socio-behavioral intervention in Quezon City, the Philippines, using a community-based participatory approach. The intervention involves 1-2 psychosocial and health education training workshops for the establishment managers and their workers, focusing on HIV/AIDS risk reduction information, condom use, and condom negotiation skill-building. Participants will also be invited to do dream-building activities that explore their personal goals and goals for their organization of peers.

The intervention involves targeted and tailored bio-psycho-educational interventions directed at organizational behavior change and social influence modeling through training peers and managers. The intervention site will receive peer and manager trainings consisting of specific information on STIs along with standard care, held on a day convenient to the participants and at the establishment or neutral location.

In addition to quick pre-post tests before and immediately after the intervention, participants will be interviewed 6-12 months after the intervention to evaluate the effects of the intervention on their STI/HIV knowledge, attitudes, beliefs, safer sex practices, and social support.

Eligibility Criteria:
Inclusion Criteria:

* self-identification as conducting sex work or working in a venue where sex work occurs.

Exclusion Criteria:

* those not actively engaging in sex work activities or working in a venue or area where sex work occurs.
Omega 3 Polyunsaturated Fatty Acids (PUFA) or Magnesium in Obese Polycystic Ovary Syndrome Patients

Polycystic ovary syndrome (PCOS) is the most prevalent endocrine disorder in reproductive age women. PCOS is usually characterized by an excessive androgen production, menstrual irregularities, and polycystic ovaries. Women with PCOS are often obese and have a varying degree of insulin resistance (IR). Weight reduction constitutes the initial treatment for these patients. Metformin has proven to be useful in IR and is frequently used in PCOS. However metformin use may be accompanied by gastrointestinal discomfort, and a high abandon rate. Other therapeutic alternatives such as magnesium and polyunsaturated fatty acids have been used in other IR states and may be useful in PCOS. The aim of this study is to asses the efficacy of these alternatives in obese PCOS patients.

Polycystic Ovary Syndrome (PCOS)

Eligibility Criteria:
Inclusion Criteria:

* Polycystic Ovary Syndrome according to Rotterdam criteria,
* BMI ≥ 27 Kg/m2

Exclusion Criteria:

* Type 2 diabetes mellitus,
* in treatment for polycystic ovary syndrome features
A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.

This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥20 years old
* Written informed consent obtained
* Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)
* The ESSPRI score of the patient of Sjogren's syndrome at least\> 3

Exclusion Criteria:

* Have association disease about heart, lung, nerve or mental
* Pregnant or breastfeeding women
* Laboratory abnormality:

  1. Serum creatinine ≥2.0 mg/dl
  2. Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
  3. Neutrophil or lymphocyte\<0.5 x 109/l
Repair of Groin Hernias After Abdominal Prostatectomy With Robotic TAPP

This retrospective study investigates if robotic assisted groin hernia repair in patients who previously underwent abdominal prostatectomy has an equal or more favorable clinical outcome, compared to open repair in those patients.

In the personal practice of the investigators, there has been a decrease in open groin hernia repair from 17% to 6% since the introduction of robotic assisted surgery. This reflects a change in indication for complex hernias from an open to a minimal invasive approach. One of the typical indications for open approach before adopting the robotic platform were groin hernias after previous abdominal prostatectomy. Since prostatectomy results in scarring of the retropubic area where we need to dissect during MIS groin hernia repair, an open anterior approach is often suggested. With the enhanced view and instrument dexterity of the robotic platform, the investigators have now changed to a minimal invasive approach in these patients.

Therefore, this study will evaluate the clinical outcome after robotic assisted repair of groin hernias in patients who previously underwent an abdominal prostatectomy in comparison to open groin hernia repair.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Underwent uni-or bilateral groin hernia repair in the period March 2015 - March 2020
* Groin hernia repair via robotic assisted laparoscopy or open surgery
* History of abdominal prostatectomy before the groin hernia repair

Exclusion Criteria:

* Age below 18
* Groin hernia repair via conventional laparoscopy
* Groin hernia repair via open surgery other than Liechtenstein method
* Groin hernia repair without mesh placement
Study Comparing Bioavailability of Oral Formulations of Vabicaserin

The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men aged 18-50 years.

Exclusion Criteria:

* Any significant disease state.
* History of drug or alcohol abuse within 1 year.
* Abnormal liver function tests.
Stem Cell Transplant From Matched Unrelated or Partially Matched Related Donors

To evaluate the use of unrelated donors for hematopoietic cell transplantation in the treatment of hematologic and lymphoid malignancies.

Stem Cell Transplantation from Matched Unrelated or Partially Matched Related Donors Using a Preparatory Regimen Consisting of Fractionated Total Body Irradiation (FTBI) and Cyclophosphamide (CY). To administer high dose radio-chemotherapy followed by stem cell transplantation from a matched unrelated donor or a partially matched related donor.

Eligibility Criteria:
Inclusion Criteria:- acute leukemia

* chronic leukemia
* lymphoblastic lymphoma
* MDS
* MPS Exclusion Criteria:- organ dysfunction
* HIV positive
Performance Evaluation of the NaviCam SB Capsule Endoscope System for the Diagnosis of Small Bowel Diseases

This study uses a comparative method to evaluate the performance of the NaviCam SB capsule endoscope system in comparison to the PillCam SB3 capsule system for the diagnosis of small bowel diseases.

This study adopts a prospective and self-controlled design. The subjects are adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding; Subjects swallow two types of SB capsules approximately 40 minutes apart in a randomized order. During the capsule endoscopy, the doctor can view the small bowel images taken by the capsules in real time. This study adopts a method of independent image reading in the participating centers. Two physicians of digestive endoscopy respectively review the images captured by the experimental capsule and the control capsule for normal versus abnormal findings, type of findings and categorization (lesions, polyps, bleeding, etc.), capsule transit time, reading time, and image quality.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years old) who have symptoms of small bowel disease or suspected GI bleeding;
2. Those need capsule endoscopy because the recurring GI symptoms cannot be explained by other imaging methods;
3. Those can understand and accept this study protocol and voluntarily sign an informed consent.

Exclusion Criteria:

1. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule;
2. Patient with known gastrointestinal motility disorders;
3. Patient with known or suspected gastrointestinal obstruction, stenosis or fistula;
4. Patient with known or suspected delayed gastric emptying;
5. Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions;
6. Patient has any allergy or other known contraindication or intolerance to the medications used in the study;
7. Patient has any condition, which precludes compliance with study and/or device instructions;
8. Women who are either pregnant or nursing at the time of screening;
9. Concurrent participation in another clinical trial using any investigational drug or device;
10. Patient suffers from a life-threatening condition;
11. Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters;
12. Patients with pace-maker or implantable cardioverter other implantable electronic medical device;
13. Patient with an easily magnetized metal part;
14. Patient requires endoscopic placement of the capsule;
15. Others considered by the investigator not suitable for this study.
Comparison of the Safety and Immune Response of an Influenza Vaccine Made by a New Manufacturing Process With a Vaccine Made by the Traditional Manufacturing Process for Season 2003/2004

The objectives of the study are to assess the immunogenicity and safety of the inactivated influenza vaccine (whole virion, Vero cell-derived) at Day 21 and Day 180 after vaccination.


Eligibility Criteria:
Inclusion Criteria:

Male and female subjects will be eligible for participation in this study if they:

* are \>= 18 and \<= 60 years old (for Stratum A only);
* are \> 60 years old (for Stratum B only);
* are in a physical condition such that the physician would have no reservations vaccinating with an influenza vaccine outside the scope of a clinical trial;
* will reliably keep a daily record of symptoms;
* understand the nature of the study, agree to its provisions, and give written informed consent;
* if female and capable of bearing children - show a negative pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

Male and female subjects will be excluded from participation in this study if they:

* have received any influenza vaccine for the 2002/2003 season and/or for the 2003/2004 season;
* suffer from any kind of immunodeficiency;
* suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions;
* have a history of inflammatory or degenerative neurological disease (e.g. Guillain Barré, multiple sclerosis);
* have received a blood transfusion or immunoglobulins within one month of study entry;
* have a history of any vaccine-related contraindicating event (e.g. anaphylaxis);
* have a rash or dermatological condition which may interfere with injection site reaction rating;
* have a known or suspected problem with drug or alcohol abuse;
* are unable to lead an independent life either physically or mentally;
* had administration of an investigational drug within six weeks prior to the study start;
* are concurrently participating in a clinical trial;
* are pregnant or lactating.
Effect of Vascular Inflow Occlusion in Open Liver Resection for Hepatocellular Carcinoma

Bleeding is a major problem during liver resection. Vascular inflow occlusion, also known as Pringle maneuver, has been commonly employed to reduce blood loss during liver surgery. However, Pringle maneuver might cause ischaemic insult to the remnant liver and lead to post-operative liver dysfunction.

The investigators hypothesize that liver resection without the use of vascular inflow occlusion (Pringle maneuver) is associated with lower postoperative complications rate.

The aim of this study is to evaluate whether elective open liver resection without vascular inflow occlusion (Pringle Maneuvre) would lead to a reduction of post-operative surgical complications in patient with hepatocellular carcinoma.

Eligible patients undergoing liver resection in the Prince of Wales Hospital will be recruited and randomized into 2 study arms comparing the effect of Pringle maneuver.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18
* Child's A or B cirrhosis

Exclusion Criteria:

* Informed consent not available
* Presence of portal vein thrombosis, portal vein tumor thrombus, or previous portal vein embolisation
* Presence of hepatic artery thrombosis, previous transarterial therapy like TACE, lipiodol-ethanol mixture injection or transarterial internal radiation
* Anticipation of portal vein resection
* Emergency hepatectomy
* Ruptured HCC
* Adhesion or anatomical variation that preclude safe and successful application of Pringle maneuver
* Anticipation of concomitant bowel or bile duct resection
Audio-based Mental Health Intervention Study

This is a study on an audio-based digital intervention designed to reduce symptoms of depression. Participants who experience at least moderate symptoms of depression will be invited to participate in the study. Participants will be randomly assigned to receive one of two audio-based digital interventions. The experimental intervention based on behavioral activation treatment for depression. The control intervention is based on self-monitoring. Depression symptoms and related mental health symptoms, as well as experiences with the intervention, will be assessed at baseline (pre-randomization), mid-intervention (1 week post-randomization), post-intervention (2 weeks post-randomization) and follow-up (5 weeks post-randomization)


Eligibility Criteria:
Inclusion Criteria:

* Adult age 18 or older
* Score in the moderate or higher range on the BDI-FastScreen
* Moderate or higher depression confirmed by DIAMOND interview
* Proficient English reading, writing, and speaking ability
* Able to provide consent
* Provide informed consent

Exclusion Criteria:

* Below 18 years of age
* Score below the moderate range on the BDI-FastScreen
* DIAMOND interview does not confirm moderate or higher depression
* Unable to read, write, and speak in English
* Unable to provide consent
* Do not provide informed consent
Circulating Fibrocytes in Non-small Cell Lung Cancer.

The investigators will collect fibrocytes (CD45+Col-1+) in patients with non-small cell lung cancer (NSCLC). The investigators hypothesize that patients with NSCLC experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in NSCLC patients.

Fibrocytes have been described in both mice and humans, where they bear a hematopoietic progenitor phenotype (CD45+Col-1+). Fibrocytes have previously been described in murine cancer, implicated as mediators of tumor immune escape. In this study, the investigators will collect fibrocytes including CD45+Col-1+ expression. The cells express indoleamine oxidase, which is primarily responsible for their immunosuppressive properties. The investigators hypothesize that patients with non-small cell lung cancer experience expansion of immunosuppressive fibrocytes, which are predicted to augment tumor growth by mediating immune escape in non-small cell lung cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer (NSCLC).

Exclusion Criteria:

* Combination of other malignancy.
* Age less than 20 years (not include 20 years).
* Pregnancy.
Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression

Depression is a common mental disorder in patients undergoing maintenance hemodialysis (MHD), which increases the risk of cardiovascular events, hospitalization rates, and mortality, but has not received enough attention from patients and medical staff. Sertraline is a selective serotonin reuptake inhibitor with fewer adverse reactions and higher safety compared to other antidepressants. This study aims to investigate the efficacy and safety of sertraline in patients undergoing MHD with depression.

This study used a randomized controlled design and evaluated the depression status of the patients using the Hamilton Depression Scale (HAMD). MHD patients with comorbid depression were recruited and divided into the treatment group and the control group. The treatment group received sertraline for antidepressant therapy, while the control group did not receive any antidepressant medication. To investigate the efficacy and safety of sertraline before and after intervention.

The HAMD, the Medication Adherence Report Scale-5 (MARS-5), the Mini Nutritional Assessment short-form (MNA-SF) and the Kidney Disease Quality of Life-36 (KDQOL-36) scales were used to evaluate changes in depression status, quality of life, medication adherence and nutritional status before and after the intervention. Clinical and laboratory indicators were collected before and after the intervention. Adverse reactions during the intervention were also recorded.

The initial dose ranged from 25 to 50 mg, taken orally once daily, and the dosage was adjusted based on the patient's response to the medication. In the control group, no antidepressant treatment was given.

Eligibility Criteria:
Inclusion Criteria:

1. Long-term MHD patients in the blood purification center of our hospital, older than 18 years old, maintenance dialysis for at least 3 months, 2-3 times a week, 3-4.5 hours each time;
2. Meet the CKD5 diagnostic criteria;
3. The cardiopulmonary function was relatively stable before enrollment, and the life expectancy was more than 1 year;
4. The clinical data were basically complete;
5. Consciousness, intelligence is normal, can understand the questionnaire content.

Exclusion Criteria:

1. Communication, communication disorders or other psychiatric history;
2. Combined with active pulmonary tuberculosis, AIDS, severe infection patients;
3. Pregnant or lactating women;
4. Those who are taking antidepressants or other antipsychotic drugs;
5. Unable or unwilling to cooperate with the researcher.