cyrilzakka/clinical-trials huggingface dataset:
The Benefits of Vitamin D 5000 IU as Add on Therapy in the Management of Painful Diabetic Neuropathy Patient

Diabetic neuropathy is one of the micro-vascular complications of diabetes, 30-50% occurring in all diabetic patients. This complication is one of the major cause of morbidity and mortality in diabetic patientsand leading to a deterioration of their quality life. A deficiency of vitamin D \[25-hydroxyvitamin D, 25(OH) D\] is common in patient with diabetes and low concentrations are associated with the presence and severity of sensory neuropathy in diabetes. Vitamin D deficiency has been shown to be an independent risk factor for diabetic peripheral neuropathy (DPN). Topical and oral vitamin D have been reported significantly reduce the symptoms and the pain of DPN. However, no case control clinical trial have been reported that demonstrate the efficacy of vitamin D supplementation on the symptoms of DPN.

Painful in diabetic neuropathy is a major complication of diabetes, characterized by pain, tingling, burning and cramps in the lower legs and feet with a signification reduction in quality of life. Recently, there shown a significant reduction in the severity of painful diabetic neuropathy after treatment with vitamin D. Patient with diabetes have a poor quality of life compared to person without diabetes. The current study assessed the benefits of add on oral vitamin D 5000 IU on diabetic neuropathy patient to pain impact in daily life.

This was randomized clinical trial, active comparator, open label, controlled study from the period of November 2020 - November 2021 at Bethesda Hospital, Yogyakarta, Indonesia.

There were 60 painful diabetic neuropathy patients who fulfilled the inclusion and exclusion criteria. Each subject had been followed up from the first day of medication administration until 8 weeks after medication administration.

Ethical approval number ((kosong)) was obtained from Health Research Ethics Committee, Bethesda Hospital Yogyakarta.

The hypothesis of this study:

a. Add on oral vitamin D 5000 IU to standard treatment in patients with painful diabetic neuropathy is more effective in reducing pain and neuropathic symptoms in 8 weeks of treatment compared with standard treatment, b. Add on oral vitamin D 5000 IU to standard treatment in patients with painful diabetic neuropathy is as safe as standard treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Adult age (\>18 years old)
* Diagnosed as painful diabetic neuropathy based on validated Diabetic Neuropathy Symptoms (DNS) and Diabetic Neuropathy Examination (DNE)
* Low vitamin D status of \<30 ng/ml

Exclusion Criteria:

* Subjects with significant renal and liver problem
* Subjects with known hypersensitivity to vitamin D 5000 IU
* Pregnancy and breastfeeding patients
* Patients that enrolled any clinical trial within a month
* Not competent enough in giving approval and answering questionnaires
RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors

Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.


Eligibility Criteria:
Preoperative imaging diagnosis of periampullary tumor, or preoperative pathological diagnosis of periampullary tumor, preoperative evaluation can be performed pancreaticoduodenectomy; Serum bilirubin was less than 100 μ mol/L before operation; Sign a written informed consent form and agree to be randomly divided into groups for surgical treatment.
bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients

As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC in two dose groups to immune suppressed, kidney transplanted patients.


Eligibility Criteria:
Inclusion Criteria:

* Cutaneous warts on ingers and/or palms and/or toes and/or soles of feet
* Common warts and mosaic warts, diagnosed by an experienced dermatologist
* Solitary wart lesions or 2 or more lesions per patient
* Lesions present for more than 6 months
* Men or women, aged 18 or above
* History of kidney transplantation and immune suppressive therapy after transplant
* Concomitant immune suppressive therapy stable for 6 months prior to randomization
* Agreement from patient to allow photographs to be taken and used as part of trial data documentation (2 centres)
* Women of childbearing potential must have negative pregnancy test at screening and must use adequate contraception
* Ability to comply with requirements of trial
* Written informed consent

Exclusion Criteria:

* Verruca plana lesions
* Suspected allergy to milk verified by serum analysis of IgE towards cow milk
* Breastfeeding
* Any local medication for any purpose other than wart treatment in target area during 4 weeks prior to randomization and during treatment period
* Concomitant treatment with other wart therapies two weeks prior to randomization and during trial period
* Intolerance towards bovine alpha-lactalbumin, oleic acid or any excipient in the formulation
* Known HIV infection or any current uncontrolled infection
* Any chronic or acute skin condition susceptible of interfering with evaluation of drug effect in this trial
* Participation in any investigational trial or use of any investigational drug within 30 days prior to inclusion in this trial
* Any health problems which according to Investigator's clinical judgment will make the patient unsuitable for inclusion in the trial
ONO-4538 Phase I Study in Patients With Solid Tumor

The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.


Eligibility Criteria:
Inclusion Criteria:

* The treatment phase has been completed in the ONO-4538-13 study

Exclusion Criteria:

* The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
* It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.
Dexamethasone in Herpes Simplex Virus Encephalitis

Encephalitics is a serious condition in which the brain becomes inflamed (swollen). It usually happens as a direct result of virus, such as herpes simplex virus (HSV).

HSV encephalitis is often treated with the drug acyclovir (an antiviral drug which slows the growth and spread of HSV in the body). Despite this however, around 2 out of every 3 people will have memory difficulties long term. Dexamethasone is a corticosteroid medication, which works by preventing the release of natural chemicals in the body which cause inflammation. It is possible that dexamethasone could help to reduce in swelling of the brain may improve the recovery of patients with HSV encephalitis. The aim of this study is to find out whether treatment with dexamethasone can improve long-term health outcomes in adults with HSV Encephalitis.


Eligibility Criteria:
Inclusion Criteria:

- Suspected encephalitis criteria: Acute or subacute (up to 4 weeks) alteration in consciousness, cognition, personality or behaviour\* persisting for \> 24 hours Laboratory confirmed HSV by positive PCR on CSF sample.

* Receiving intravenous aciclovir dosed at 10mg/kg TDS or at a reduced dose in renal impairment
* Age ≥ 18 years
* Person affiliated to social security
* Written informed consent has been given by the patient or their legal representative

Exclusion Criteria:

* Currently receiving oral or injectable corticosteroid therapy; including treatment with oral or injectable corticosteroids in the last 30 days.
* History of hypersensitivity to corticosteroids
* Immunosuppression secondary to:

  * Known HIV infection \& CD4 count under 200cell/mm3
  * Biologic therapy or other immunosuppressive agents \[azathioprine, methotrexate, ciclosporin\]
  * Solid organ transplant on immunosuppression
  * Bone marrow transplant
  * Currently undergoing a course of chemotherapy or radiotherapy
  * Known immunodeficiency syndrome \[other than HIV\]
  * Known haematological malignancy
* Pre-existing indwelling ventricular devices
* Peptic ulcer disease in the last 6 months: defined as a peptic ulcer seen at previous endoscopy or an upper gastrointestinal bleed causing ≥ 2 unit haemoglobin drop
* Currently on an antiretroviral regime containing rilpivirine
* Patients under legal protection, administrative or judicial control
* Pregnancy / Breast feeding and parturient
* Subject in exclusion period of another study
Efficacy of Walking Exercise With Dog on Tinnitus Complaints in Sleep Apnea (Obstructive Sleep Apnea)

there is evidence that tinnitus (chronic subjective form) is highly prevalent among patients with obstructive sleep apnea. exercise is recommneded in chronic subjective form) and obstructive sleep apnea. walking with dog increase adherence to walking to maintain continuity of physical activity

the total participants will be forty in number.. those participants will complain form tinnitus (chronic subjective form) and obstructive sleep apnea (mild degree).. the particiapnts will divided to groups.. the number of subjects in each group will be 20. The groups (both groups) will follow low calorie diet.. this diet will be applied for 12 weeks.. during this period the study group will receive free walking (30 min) with dog three timmes weekly. the control group will not receive free walking with dog

Eligibility Criteria:
Inclusion Criteria:

* obese persons
* bilateral chronic subjective tinnitus
* mild obstructive sleep apnea (mild apnea hypopnea index)
* forty participants

Exclusion Criteria:

* body mass index more than 40 kg/m2.
* cardiovascular problems
* hepatorenal probelms
* autoimmune problems
* orthopedic probelms
A Trial of ABI-007 in Patients With Advanced Non-Hematologic Malignancies

This trial will treat patients with advanced (metastatic) cancer with a new chemotherapeutic agent that may be more readily tolerated than some standard therapies. Patients will be given the new chemotherapeutic medicine once a week, by intravenous route, for three weeks, followed by a rest week. Treatment will be repeated in four week cycles if the patient improves on the therapy, and if there are no adverse events that require withdrawal of medication.

This will be a dose-escalating study. ABI-007 will be administered as an outpatient infusion for three weeks followed by a week of rest. The treatment course will repeat every 28 days. No pretreatment will normally be considered necessary. Patients will have white blood cell and platelet counts monitored as will indications of performance (Karnofsky Performance Status), and will be asked to describe adverse events, if present. Patients will be treated for a minimum of two cycles to be evaluable for the study, and may continue in the study for four cycles within the study, if tumor response and safety parameters warrant continuing. Patients may continue on study medication beyond this at the investigator's discretion.

Eligibility Criteria:
* At least 18 years of age
* Life expectancy of at least 2 months
* Off all therapy for at least 3 weeks prior to study drug administration
* Biopsy-proven diagnosis of advanced malignancy
* Patients with solid tumors who have failed standard therapy
* Karnofsky Performance Status of 70% or 0-2 SWOG Performance Status
* Hemoglobin at least 9
* White Blood Cell count of at least 3000/mm3 with absolute neutrophil count of at least 1500/mm3
* Platelet count of at least 100,000/mm3
* Serum Creatinine less than 2 mg/dL
* Transaminases less than 3X the upper limit of normal
* Patient must provide informed consent
* Serum Bilirubin less than 1.5 mg/dL
Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism

The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.

Graves' disease (GD) is the most frequent cause of hyperthyroidism, affecting mainly women aged 40-60 years. Radioiodine (¹³¹I), introduced in 1941, has become a cornerstone in the treatment of GD hyperthyroidism. Because of its safety, low costs and rapid effect, it is considered a first line therapy in the United States. However, treatment failure occurs in about 15-25% of patients treated with radioiodine. Patients not cured with the first dose of radioiodine usually present severe hyperthyroidism, characterized by large goiter, high 24-hour radioiodine uptake (24h-RAIU) and very high levels of thyroid hormones. We have previously shown that large goiter (≥48ml) is an independent predictor of treatment failure. In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished). It is generally accepted that higher doses of radioiodine improves cure rates. Indeed, a recent meta-analysis found a correlation between radioiodine dose and therapeutic success in GD patients. To our knowledge, there are no published studies evaluating cure rates with different radioiodine doses in severe GD.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with a recent diagnosis of Graves' disease and goiter ≥ 48 ml, attending the Endocrine Division at Hospital de Clinicas de Porto Alegre are eligible.

Exclusion Criteria:

* Patients with previous treatment with radioiodine or thyroidectomy,
* Signs of moderate or severe ophthalmopathy (proptosis \> 22 mm, ophthalmoplegia, chemosis, or lagophthalmos),
* Severe heart disease (symptomatic coronary heart disease, class III heart failure, New York Heart Association criteria),
* Debilitating conditions, and
* Large and compressive goiters (\> 150 g).
Efficacy of Pain Neuroscience Education in Genito-Pelvic Pain/Penetration Disorder. A Randomized Controlled Trial.

Patients suffering pelvic persistent pain deal with significant pain that affects their quality of life. Often, conservative treatment interventions are scarce for these patients and are therefore not considered. Education has been developed as a relevant tool in the treatment of patients who suffer from chronic pain or any other pain processing alterations, and has the potential to become a powerfull treatment alternative.

In this intervention, the effects of implementing educational programs in patients suffering from pelvic persistent pain will be assessed.

Patients with pelvic persistent pain have both problems directly related with their pain and other issues that appear derived from suffering pain over a determined period, such as alterations in the sexuality or overall quality of life. Facing these patients is a challenge for professionals, and many can't find the treatment that properly fits the patient's clinical presentation.

Education, and educating patients on their problem, is an exponentially growing alternative used in Physical Therapy involving patients who suffer from a dysfunctional pain, chronic pain, or any kind of pain presentation that affects the patient's well-being.

This study will assess firstly if the implementation of a pain-related education program is relevant in the treatment of pelvic persistent pain, and will further observe which modality (presential workshops or online-accessed material) is the most effective involving adherence and improvement.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years-old suffering from dyspareunia for more than 3 months

Exclusion Criteria:

* Patients suffering from a previous medical condition that explains logically the presence of pain
Pain Control After Lumbar Spine Fusion

The purpose of this randomized controlled trial is to determine if patients who receive non-steroidal anti-inflammatory medications (NSAIDs) following elective lumbar spinal fusion have increased rates of symptomatic nonunion requiring revision spinal surgery at two-years follow-up, compared to those who do not receive NSAIDs.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age, ≥1-level planned lumbar spinal fusion
* Capacity to enroll
* English speaking

Exclusion Criteria:

* Chronic kidney disease (preoperative creatinine ≥1.4)
* History of gastrointestinal bleed or peptic ulcer disease
* History of spinal fusion nonunion
* Non-steroidal anti-inflammatory drug allergy
* Previously diagnosed coagulopathy
* Preoperative thrombocytopenia (platelets \<100,000)
* Connective tissue disease
* Operative indication due to infection, neoplasm, or trauma
* Currently pregnant
Tympanostomy Tube Placement in Children in the Office (Inova Study)

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled to undergo tympanostomy tube insertion
2. At least 6 months old and younger than 22 years old
3. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
4. No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria:

1. Pregnant or lactating females
2. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
3. Otitis externa
4. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
5. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
6. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
7. Anatomy that precludes sufficient visualization of and access to the tympanic membrane
8. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Trial of an Investigational Drug After Rejecting the Relapse of an Allogeneic Transplant

Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment, including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been developed, with the aim of using it in patients with MM who relapse after Allogeneic Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the efficacy of the procedure.

This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity is identified (up to a maximum dose of 6x106 CAR-T/kg divided over 2 days), phase II of the trial will begin to assess the efficacy of the procedure.

A number of 25 patients will be included to evaluate.

Eligibility Criteria:
Inclusion Criteria:

1. Patients \> 18 years old with a diagnosis of post-allogeneic transplant relapse multiple myeloma.
2. Measurable disease at the time of screening
3. Previous treatment with ≥2 lines before and/or after allogeneic transplant.
4. Patients who are not receiving immunosuppressants at least 1 month before inclusion and who do not have active graft-versus-host disease.
5. Eastern Cooperative Oncology Group functional status from 0 to 1.
6. Life expectancy greater than 3 months (at the time of screening)
7. Patients who give their consent by signing the Informed Consent document.

Exclusion Criteria:

1. Active systemic immunosuppressive treatment
2. Patients who have previously received treatment with CAR-T Anti-BCMA.
3. Absolute lymphocyte count \<0.2x109/L
4. Previous neoplasm, except if it has been in complete remission \>3 years, with the exception of skin carcinoma (non-melanoma)
5. Active infection requiring treatment.
6. Active HIV, hepatitis B virus or hepatitis C virus infection.
7. Uncontrolled medical illness.
8. Severe organic disease that meets any of the following criteria: left ventricular ejection fraction \<40%, carbon monoxide diffusion test \<40%, glomerular filtration rate \<50 ml/min, bilirubin \>3 normal value (except Gilbert syndrome).
9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS Syndrome.
10. Pregnant or lactating women.
11. Women of childbearing age, unable or unwilling to use highly effective contraceptive methods.
12. Men who cannot or do not wish to use highly effective contraceptive methods. The partner of the male participants, if they are women of childbearing age, must also use highly effective contraceptive methods during the study period.
13. Contraindication to receive lymphodepleting chemotherapy.
14. Patients with known hypersensitivity to the active ingredients or any of the excipients of the product to be infused.