cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal Low-intensity Shockwave in Diabetic Nephropathy

In the current study, we use extracorporeal low-intensity shockwave therapy (ESWT) to treat on patients with type 2 diabetes in stage 3-4 chronic kidney disease and see whether it can improve the proteinuria, renal function, and blood pressure compared to baseline and control group.

Diabetic nephropathy is the major contributor to end stage renal disease worldwide. Extracorporeal shock wave treatments (ESWT) with low-intensity was reported to be beneficial in inducing cell regeneration and reducing inflammation and have been successfully used for bone fracture, cardiac ischemia, and erectile disorders. In this study, sixty patients with stage III \& IV (15\<=estimated glomerular filtration rate (eGFR)\<60 ml/min/1.73m2) will be recruited and allocated to control and experimental groups in a 1:1 ratio. In experiment group, a total of 1200 shockwaves, with low energy density 0.1mj/mm2 and a frequency of 120 shocks/min, will be applied per kidney per treatment session. The treatment will be given twice a week for 3 consecutive weeks, followed by 3 weeks of recess and an additional series of 6 sessions (totally 12 times). Patients in each group will be evaluated with eGFR, urine protein-creatinine ration, blood pressure, and biochemistry data at the beginning (index day) and 12 months after starting of the therapy. (Outcome time point: 12 months)

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 y/o or \<80 y/o
2. Diagnosed as type 2 diabetes.
3. Baseline HbA1C \<7.5%
4. Baseline glomerular filtration rate (eGFR) ≧15 and \<60 ml/min/1.73m2
5. Baseline urine albumin-to-creatinine ratio (UACR) \>30 and \<3000 mg/g
6. Subject receives ACEi or ARB for 3 months before enrollment
7. Subject is willing to sign the permit and receive 12 times shockwave therapy

Exclusion Criteria:

1. Subject is pregnant or breast feeding
2. Subject has cancer or chronic inflammatory disease
3. Subject has bleeding tendency, eg thrombocytopenia, PT INR \> 2.5
4. Subject has active urinary tract infection or other active infections
5. Subject's sBP\>160mmHg or dBP\>100mmHg
6. Subject has stroke, cardiac infection or arrhythmia in 6 months before enrollment
7. Subject has local inflammation or infection over treatment areas
8. Subject has pacemaker or other metal implants.
Analgesic Effect and Plasma Concentration of Epidural Versus Intravenous Fentanyl

CONTEXT AND OBJECTIVE: Controversies exist regarding the site of action of Fentanyl after epidural injection. The objective of this investigation was to compare the analgesic effect of epidural and intravenous Fentanyl for lower limb orthopedic surgeries.

DESIGN AND SETTING: A randomized and double-blind study was performed in Hospital São Paulo.

METHODS: 29 patients were divided into two groups. During the postoperative period, in the presence of pain, group 1 (n = 14) patients received 5 mL of a 100 mcg Fentanyl solution in saline without preservative by the epidural route and 2 mL saline intravenously. Group 2 (n = 15) patients received 5 mL saline by the epidural route and 2 mL (100 mcg) Fentanyl intravenously. Analgesic supplementation consisted of 40 mg intravenous Tenoxicam and 5 mL epidural 0.25% bupivacaine (if pain relief was not achieved with Tenoxicam). Pain intensity was evaluated by numerical scale and plasma concentrations of Fentanyl were measured simultaneously.


Eligibility Criteria:
Inclusion Criteria:

* Both genders ranging in age from 18 to 65 years, American Society of Anesthesiologists (ASA) Physical Status 1 or 2, scheduled for orthopedic bone surgery of the lower limbs

Exclusion Criteria:

* Patients with infection in the puncture area and coagulation disorders, pregnant patients, and patients using opioids
OVERWEIGHT AND OBESITY ADVERSELY AFFECT IVF OUTCOMES IN WOMEN WITH PCOS

The effect of overweight and obesity on IVF outcomes is still questionable. The purpose of this study was to determine if overweight/obesity in women with PCOS were associated with an adverse IVF outcome compared to those with normal weight.

Design: Retrospective cohort study.


Eligibility Criteria:
Inclusion Criteria:

* All women within the age limit
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence

The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel.

The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months
* Have a history of at least 1 - 2 urge episodes and 8 or more voids per day

Exclusion Criteria:

* Incontinence that is predominantly stress, insensate, or overflow in nature, or incontinence related to chronic illness, anatomical weakness/abnormalities or concomitant medications
* PVR volume \> 200 mL or relative PVR \> 50% of pre-void volume as determined by bladder ultrasound
* History of urinary retention, gastric retention, or uncontrollable narrow-angle glaucoma, or patients who are at risk for these conditions
Trabeculectomy Versus 2-iStent and Prostaglandin Study

Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.

This will be a prospective randomized controlled study.

20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have mental capacity to give consent
* Age \>= 21 years
* Pseudophakic or phakic without visually significant cataract
* Open angle glaucoma
* IOP in the range of 18-30 mmHg with 2 or more topical medications
* Cup-disc ratio =\< 0.9
* Best corrected visual acuity of 20/100 or better

Exclusion Criteria:

* Inability to give consent
* Inability to tolerate or presence of allergy to prostaglandin analogs
* Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study
* Age \< 21 years
* Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient
* Secondary glaucoma or angle closure glaucoma
* Aphakia
* Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy)
* Prior laser trabeculoplasty \< 90 days prior to screening or absolute failure of prior laser trabeculoplasty.
Askina Calgitrol Paste Burns

The purpose of the study is to demonstrate that Askina® Calgitrol® Paste is safe to use on III degree burns by quantifying the concentration of silver in the blood during treatment and thus to show that the amount of silver absorbed will be no greater than those reported in the literature.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥\>18 years age). No upper age limit
* III degree thermal burns from 2-30% TBSA as determined by the Rule of Nines
* Patients who underwent initial treatment within 24 hours after the injury at the latest
* Patients who underwent initial treatment directly at the Burn Centre of FNKV or the initial treatment was in accordance with the standard of care of the Centre
* All patients will have been hospitalised
* Patients who are capable of giving signing informed consent and have done so.

Exclusion Criteria:

* Patients with electrical or chemical burns
* Patients with already infected wounds
* Patients taking systemic antibiotics on admission
* Patients pregnant or lactating
* Patients who fall into "vulnerable population" group with respect to informed consent or who are not capable of giving informed consent
* Patients who used or were treated with silver products for other reasons than treatment of the acute burn in the last 3 months
* Patients whose other burn wounds are being treated with silver products.
* Patients receiving renal dialysis
* Known allergy or sensitivity to any of the ingredients in Askina® Calgitrol® Paste.
* Simultaneous participation in another interventional clinical trial
Effect of Modeling Resin on Anterior Direct Composite Veneer

the study will be conducted to evaluate the clinical performance of direct Nanohybrid resin composite veneer restorations applied with or without modeling resin

ChatGPT This study aims to investigate the impact of modeling resin on the clinical performance of direct nanohybrid resin composite veneer restorations in anterior teeth. Resin composites are widely used in dental restorations due to their aesthetic qualities, but issues like discoloration and surface roughness can affect their longevity and patient satisfaction. Modeling resin, used to aid in composite placement and sculpting, has become common, but concerns exist regarding its effects on composite properties, particularly long-term color stability.

The research will employ a randomized controlled trial design with a two-arm parallel approach. Adult patients (18-45 years) with anterior tooth defects suitable for composite veneer restoration will be recruited. The intervention group will receive nanohybrid resin composite with modeling resin, while the comparator group will receive the composite without modeling resin. Outcomes will be assessed using modified USPHS criteria, including color stability, color match, anatomical form, marginal adaptation, marginal discoloration, retention rate, presence of secondary caries, and postoperative sensitivity, at baseline and at follow-up intervals of 1, 3, 6, and 12 months.

Statistical analysis will involve independent t-tests for intergroup comparisons and repeated measures ANOVA for intragroup comparisons, with a significance level set at 0.05. The study aims to determine if the use of modeling resin influences the clinical outcomes of resin composite veneer restorations. Ethics approval will be obtained, and confidentiality of participant data will be strictly maintained throughout the study period.

Overall, this research seeks to provide insights into optimizing the application of resin composites in dental practice to enhance patient outcomes and satisfaction

Eligibility Criteria:
Inclusion Criteria:

* • Adults (18-45Ys) with anterior tooth defects indicated for direct composite veneer restoration.

  * Males or females.
  * Community-dwelling
  * Have all his/her anterior teeth with sufficient enamel structure
  * With ≥ 1 anterior tooth defect
  * Have sufficient cognitive ability to understand consent procedures
  * Anterior tooth defect indicated for direct composite veneer
  * Vital upper or lower anterior teeth with no signs or symptoms of irreversible pulpitis.
  * Mobility grade: no clinical mobility
  * Plaque index ≤ 2

Exclusion Criteria:

* Patients younger than 18 or older than 45 years old • Disabilities.
* Systemic diseases or severe medically compromised.
* Lack of compliance.
* Evidence of severe bruxism, clenching or temporomandibular joint disorders.
* Cognitive impairment

Periapical pathosis or signs of pulpal pathology.

* Malocclusion
* Possible prosthodontic restoration within 1 year.
* Non-vital tooth.
* Endodontically treated tooth.
* Severe periodontal affection or tooth indicated for extraction.
Self-determination Enhancement Group for Adults With Mild Intellectual Disability and Their Caregivers in Hong Kong

Background Self-determination is regarded as an adult outcome for people with intellectual disability (ID). Students with ID in western countries learn self-determination knowledge and skills through the systematic curriculum in schools. However, the curriculum for adults with ID is still underdeveloped in the West. In Hong Kong, the self-determination curriculum is rarely available in any setting.

Objective The proposed study aims to develop a culturally-tailored self-determination enhancement group intervention for adults with ID and to evaluate its effectiveness.

Method The proposed study will consist of two phases. Phase one will develop the protocol for the self-determination enhancement intervention and establish its implementation fidelity through a panel review and pilot study. This phase will last eight months. Phase two will adopt a randomised controlled trial with pre-test, post-test and three-month follow-up. A total of 120 participants will be randomly assigned to three conditions: Self-determination enhancement group, Self-determination enhancement PLUS group (+ parents' involvement) and leisure activity group as a control condition. Five groups will be organised for each of the three conditions over 18 months. There will be 10 sessions per group covering the self-determination core components such as self-understanding, goal-setting and attaining, self-regulating and plan adjusting. Components for parents include understanding self-determination and skills in supporting people with ID to exercise self-determination through positive interaction. Validated instruments in Chinese will be filled in by participants. Statistical analyses will be conducted to examine if the effectiveness of this group intervention can be found and sustained over a three-month period, and the magnitude of change in self-determination competencies and quality of life.

Implications The proposed study is the first evidence-based local study aimed at examining a culturally-tailored self-determination enhancement intervention for people with ID. If the intervention demonstrated as effective, it will be used or modified for use with Chinese-speaking people with ID in different parts of the world.


Eligibility Criteria:
Inclusion Criteria:

* Chinese people who have mild intellectual disability (i.e., assessed in their most recent psychological report)
* Aged 18 or above
* Able to master basic comprehension and verbal communication skills
* Willing to complete the group intervention.

Exclusion Criteria:

* Those who demonstrate severe challenging behaviours will be excluded
A Phase III Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution Compared With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Glaucoma or Ocular Hypertension - Spectrum 4 Study

This is a Phase III, randomized, double-masked, active-controlled, parallel-group, multi-center study. Subjects diagnosed with glaucoma or OHT who meet eligibility criteria at Visit 1 (Screening) will washout of their current topical IOP-lowering medication(s), if any. After completing the required washout period, subjects will return for Visit 2 (Baseline, Day 1). Subjects who meet all eligibility criteria at baseline will be randomized to receive double-masked treatment for 3 months.

Approximately 400 adult subjects and up to 30 pediatric subjects with glaucoma or OHT who meet all eligibility criteria will be randomized in a 1:1 ratio to receive either:

* DE-117 Ophthalmic Solution once daily and Vehicle once daily, or
* Timolol Maleate Ophthalmic Solution 0.5% twice daily. The study will evaluate the efficacy and safety of DE-117 Ophthalmic Solution compared with Timolol Maleate Ophthalmic Solution 0.5% in subjects with glaucoma or OHT through Month 3.


Eligibility Criteria:
Inclusion Criteria:

• glaucoma or ocular hypertension

Exclusion Criteria:

* Females who are pregnant, nursing, or planning a pregnancy
* Any corneal abnormality or other condition interfering with or preventing reliable tonometric measurements
The Role of Artery-Preserving Varicocelectomy in Subfertile Men With Severe Oligozoospermia.

A male factor is responsible for almost half the cases of subfertility. Varicocele is a major cause of impaired spermatogenesis and potentially a correctable cause. It affects up to 40% of men with primary subfertility and 80% of men with secondary subfertility. Varicocelectomy is now accepted as a cost effective treatment in subfertile men with clinically palpable varicocele and impaired semen parameters. Recently, Varicocelectomy is reported to improve fertility potential in patients with severe oligozoospermia. In one such study, Varicocelectomy was associated with a statistically significant increase in sperm density and motility. Spontaneous pregnancy was achieved in16.7% of cases. In a recent meta-analysis, Varicocelectomy in men with severe oligozoospermia showed a strong trend toward improvement in pregnancy rate (PR) \[OR= 1.69, 95% CI (0.951, 3.020), p= 0.073\] and statistically significant increase in live birth rate (LBR)\[OR=1.699, 95%CI (1.020, 2.831), p= 0.04\].

The impact of ligation of internal spermatic artery (ISA) during Varicocelectomy is a matter of debate. Conventional view is arterial ligation can negatively affect testicular function and decrease the likelihood of post-operative paternity. Other investigators reported that ligation of ISA was not associated with significant changes in postoperative semen parameters, testicular size or PR in comparison to artery preservation. Moreover, laparoscopic artery-ligating Varicocelectomy was proved to be superior in the form of shorter operative time and lower recurrence rates with no difference in semen parameters or PR in comparison to laparoscopic artery-preservation varicocelectomy.

Also, isolation of ISA is not an easy task during subinguinal Varicocelectomy due to compression by external oblique aponeurosis and its inherent anatomical variation. In 29 % and 57% of the cases, the ISA is surrounded by the varicose vessels and adherent to the veins respectively. Thus, the ISA is liable to a substantial risk of accidental ligation during subinguinal Varicocelectomy.

Whether or not ligation of the ISA has a deleterious effect on the fertility outcomes in patients with severe oligozoospermia; this is not clear in the literature. This prospective randomized study was conducted to assess the impact of ISA ligation during subinguinal Varicocelectomy on fertility outcome in patients with severe oligozoospermia.


Eligibility Criteria:
Inclusion Criteria:

* adult sub-fertile male
* with clinical varicocele (grade 2,3) severe oligozoospermia (\<5 million/ml)

Exclusion Criteria:

* patients' age \< 18 years, recurrent varicocele, sperm concentration \>5 million/ml, history of previous inguinal surgery, concomitant female factor subfertility and refusal to participate in the study.
Study to Investigate the Optimal Dose of Org 36286 to Induce Monofollicular Ovulation in Women With WHO Group II Anovulatory Infertility (P07016)

The objectives of this trial were to investigate the feasibility and the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility and to assess the safety (including the absence of antibody formation) of Org 36286.

This was a phase II, randomized, double-blind, placebo controlled, comparative trial to investigate the optimal dose of a single administration of Org 36286 to induce monofollicular ovulation in women with WHO Group II anovulatory infertility.

Treatment injection was given on Day 1-3 after the onset of a spontaneous or progestagen induced withdrawal bleeding. After injection, ultrasound monitoring and sampling for serum hormones were done on treatment Days 3, 5, and daily from Day 7 to 21 or until a urinary luteinizing hormone (LH) peak was detected. From treatment Day 7 the urinary LH response was assessed to detect the preovulatory LH peak. In case of hyperstimulation, production of endogenous gonadotropins could be suppressed by giving daily injections of GnRH antagonist.

Post-treatment assessments were done in the third week after the urinary LH peak. If no LH peak was detected, posttreatment assessments were performed four to five weeks after Org 36286 or placebo injection.

Eligibility Criteria:
Inclusion Criteria:

* Wish to conceive;
* Oligomenorrhea (cycle length \>=41 days) or amenorrhea (no menstrual cycle for \>6 months);
* Body Mass Index (BMI) \>=18 and \<=32 kg/m\^2;
* Serum FSH levels within normal limits (1-10 IU/L);
* Normal serum prolactin and thyroid stimulating hormone (TSH) levels;
* Progestagen induced withdrawal bleeding or spontaneous menstrual bleeding;

Exclusion Criteria:

* Tumours of the ovary, breast, uterus, pituitary or hypothalamus;
* Pregnancy or lactation;
* Undiagnosed vaginal bleeding;
* Ovarian cysts or enlarged ovaries not related to polycystic ovarian disease (PCOD);
* Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
* Malformations of the sexual organs incompatible with pregnancy;
* Clomiphene resistance with documented anovulation (treated with 150 mg clomiphene for five days and no ovulation);
* Treatment with metformin, gonadotropins, or GnRH analogs within 90 days prior to the start of Org 36286 treatment;
* Treatment with clomiphene citrate within 42 days prior to the start of Org 36286 treatment;
* Alcohol or drug abuse within the 12 months preceding signing of informed consent;
* Any clinically relevant abnormal laboratory value;
* Hypersensitivity to any of the substances in Org 36286;
* Hypersensitivity to Orgalutran® or any of its components;
* Use of any investigational drugs during 90 days before screening or previous participation in this trial.
Docetaxel Plus Capecitabine in Newly Diagnosed Localized or Locally Advanced Prostate Cancer

Purpose: The purpose of this clinical trial is to look at the chemotherapy combination of docetaxel and capecitabine in the treatment of newly diagnosed or locally advanced prostate cancer, and to determine if this treatment is an acceptable, effective and a safe treatment option. In addition, this clinical trial will evaluate how this treatment affects chemicals (enzymes), and other cancer related genetic changes in the tumor. Optional: This clinical trial will conduct extra imaging studies for research purposes including combined endorectal prostate magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRSI) and diffusion weighted imaging (DWI) to evaluate prostate cancer and response to study treatment.


Eligibility Criteria:
Patients must have newly diagnosed prostate cancer with at least one of the following criteria:

* Clinical Stage \> T2
* PSA \> 15 ng/ml
* Biopsy Gleason's sum \> 8
* All patients must have a minimum PSA value of \> 5 ng/ml.
* Patients may not have evidence of distant systemic metastasis.
* Patients may not undergo concurrent hormonal, biologic, or chemotherapy.
* Patients may not have prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
* Patients with a history of severe reaction to docetaxel or other drugs formulated with polysorbate 80 will not be eligible.
* Patients may not have an underlying cardiac disease.