cyrilzakka/clinical-trials huggingface dataset:
Thymosin-α1 in Cancer-Related Fatigue

Cancer-related fatigue (CRF) is a distressing, persistent, subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportion to recent activity and interferes with usual functioning. Compared with general fatigue, CRF have the characteristics of long duration and generally cannot alleviate by rest or sleep, serious impact on the patient's work, study, entertainment and family life, and thus greatly affect the recovery, self-care ability and life quality of patients. Many dates showed that 70%\~100% of cancer patients experienced cancer-related fatigue.For cancer-related fatigue there is no good treatment and intervention, in recent years, many clinical trials are carried out; central nervous stimulant, such as methylphenidate; acupuncture, aerobic exercise. All those measures may have certain therapeutic effect for CRF, but don't have exact evidences from massive RCT to confirm.

Thymosin-α1 (T-α1), a synthetic 28-amino acid peptide with multiple biological activities primarily directed towards immune response enhancement, this drug is used for the treatment of HBV and hepatitis C virus (HCV) infections, and being developed for the treatment of non-small cell lung cancer (NSCLC), hepatocellular carcinoma, AIDS and malignant melanoma. T-α1 is able to potentiate the action of cytokines and also reduce the hematological toxicity of cytotoxic drug therapy, such as cyclophosphamide, 5-fluorouracil, dacarbazine.

In this studies, we want to demonstrated that the effectiveness of Thymosin-α1 for cancer-related fatigue in cancer patients who undergo chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18 years and older.
2. The life expectancy at least 6 months.
3. With a definite pathological diagnosis of cancer, and undergo chemotherapy.
4. Patients who are willing to participate in the study.

Exclusion Criteria:

1. Thymosin-α1 allergy.
2. Using the spirit excitement or stimulant drugs.
3. With brain metastasis or primary malignant brain tumors.
4. With mental disorders, such as suffering from dementia, delirium, obsessive-compulsive disorder, schizophrenia, epilepsy.
5. Other specific causes of fatigue: such as anemia, thyroid function is low, insomnia, uncontrolled pain.
6. Serious HRS cardiopulmonary function disorder.
7. Women during pregnancy and lactation.
Ultraslow SWL Versus Slow SWL for Ureteric Stones With High Attenuation Value

Ultraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high attenuation value

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL

Eligibility Criteria:
Inclusion Criteria:

* single upper ureteric stone less than or equal to 2 cm
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria:

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization
Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury

Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.

Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.

Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section
* No medical disorders during pregnancy ( Hypertension, DM , ..)
* No coagulation disorders either congenital nor acquired.

Exclusion Criteria:

* Urgent or emergency cesarean section.
* Multiple pregnancy.
* Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
* Presence of coagulation disorders either congenital nor acquired.
Opioid-free Anesthesia in Gynecologic Surgery

Post-operative nausea and vomiting (PONV) is common for the patients undergoing laparoscopic gynecologic surgery. PONV is a major factor for patient dissatisfaction, delayed patient recovery and increased medical expenses. Opioid-reducing anesthetic regimen is known to decrease PONV and facilitate early recovery after surgery (ERAS) and has been widely accepted recently. In this study, the researchers intend to investigate whether opioid-free anesthesia effectively reduces PONV, and whether it is clinically safe and feasible.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for laparoscopic gynecologic surgery (≥90 min) for benign or malignant uterine/ovarian disease
* Age ≥ 19
* ASA (American Society of Anesthesiologists) class I-II

Exclusion Criteria:

* Uncontrolled hypertension
* Untreated intracranial aneurysm
* Severely impaired renal or hepatic function
* Pregnancy
* History of hypersensitivity for drugs used in the study
* Patients not using NSAID-containing IV PCA (patient controlled analgesia) device post-operatively
Prevention of Dialysis Catheter Malfunction With Prophylactic Use of a Taurolidine Containing Urokinase

The objective of our study is to investigate whether the substitution of the standard locking solution with a locking solution containing taurolidine and urokinase weekly (Taurolock ™ U 25,000 - www.taurolock.com ) reduces the rate of catheter dysfunction in hemodialysis patients with a history of TCC dysfunction requiring urokinase therapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult, prevalent hemodialysis patients
* Informed and consented
* Hemodialysis 3x/week via a tunneled cuffed catheter
* Urokinase administration at least two times during the previous 6 months (with more than a week between 2 administrations)
* Adequate catheter function during the week before inclusion (defined by blood flow more than 250ml/min on each dialysis session and blood flow within 15% of the maximal blood flow after the last Urokinase administration)

Exclusion Criteria:

* Presence of heparin-induced thrombocytopenia
* Major hemorrhage or intracranial bleeding in the previous 3 months
* Pericarditis
* Intolerance to Taurolidine, citrate or to Urokinase
* Active catheter-related infection
* Catheter in the femoral vein
Moleculight i:X™ in Wound Healing

Diabetic foot disease is a global health problem. Diabetes affects over 450million people worldwide, expected to rise to 1 in 10 people by 2040. 60-70% will lose sensation in their feet and up to 25% will develop a diabetic foot ulcer (DFU - a wound on the foot). More than half of DFUs become infected requiring hospitalisation and 20% of infections result in amputations contributing to 80% of non-traumatic amputations performed in the developed world. DFUs cost the NHS £1billion in financial year 2014-15.

A diabetic foot ulcer is a form of chronic wound. Chronic wounds are wounds that fail to progress through the normal phases of wound healing in an orderly and timely manner and become hard to heal. Almost all chronic wounds are known to have bacteria within and this is termed colonisation. Wounds can progress from being colonised to becoming infected. The concentration of bacteria can predict delayed healing or infection.

This study aims to use a novel hand held device, Moleculight i:X™, in a pilot study to investigate the clinical effectiveness and decision making associated with its use in the assessment of DFUs. Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.

Patients attending a specialist DFU clinic will be screened and if eligible and consenting will be recruited. Patients will be randomised into two groups; those who receive treatments as usual (TAU) alone (in line with NICE guidelines) and those that receive TAU plus Moleculight i:X™ imaging. The main objective is to describe the proportion per group with healed DFUs at 12week follow up in these two comparable groups of 30 patients each.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 years
2. Diagnosis of Diabetes (according to WHO criteria)
3. Has ulceration of the foot below the malleoli
4. Expected to comply with the treatment strategies and follow up schedule
5. Consent to foot and wound photography
6. Consent to participate (written/witnessed verbal consent)

Exclusion Criteria:

1. Has any current clinically infected diabetic foot ulcer (as per IDSA guidelines).
2. Estimated glomerular filtration rate (eGFR) \<20mL/min/1.73m2 (measurements taken within 3 months of randomisation can be used if no change in intervention or vascular events have occurred)
3. Has ABPI \<0.5 or opening toe pressure \<30mmHg (measured within 3 months of randomisation)
4. Planned or previous treatment with corticosteroids to an equivalent dose of Prednisolone \>10mg per day or other immunosuppressive therapy within 4 weeks prior to randomisation
5. Has evidence of connective tissue disorders (e.g. vasculitis or rheumatoid arthritis) and has planned or is under active treatment.
6. Has evidence of dermatological disorders (e.g. pyoderma gangrenosum or epidermolysis bullosa)
7. Has previously been randomised to the Moleculight i:X™ study
8. Lacks mental capacity and is unable to provide informed consent.
InFlux System for Nasal Breathing Improvement

Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing

This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with history of Chronic nasal obstruction and Poor nasal breathing

Exclusion Criteria:

* Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study
Massage Technique for Pain, Anxiety and Delirium in SAH Patients

This research study seeks to explore the effects of massage techniques on pain and anxiety relief among patients with subarachnoid hemorrhages in the ICU setting in comparison to subarachnoid hemorrhagic patients using standard medical therapy. In addition, our aim is to decrease the overall medication use to treat pain and anxiety, and to determine the impact of massage on sleep duration, quality, and breathing. Our goal is to improve and promote comfort during the ICU stay as well as decrease the need for narcotic medication usage.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

* Upper extremity deep vein thrombus
* Active alcohol or drug withdrawal
Perception of Intonation by Bimodal and Bilateral Cochlear Implant Users

The purpose of this study is to evaluate the benefit of bimodal hearing and bilateral cochlear implant hearing in comparison to unilateral cochlear implant hearing in the perception of speech intonation.

Bilateral hearing which is a fundamental characteristic of normal auditory system provides significant advantages in adverse listening conditions. In cochlear implant users, binaural hearing can be achieved via bilateral cochlear implant (CI/CI) or binaural-bimodal stimulation, i.e. a cochlear implant in one ear and a hearing aid in the other (CI/HA). It is assumed that CI/CI hearing and CI/HA hearing differ with respect to their physiological sources and functional benefit. Although both hearing prosthesis (CI/CI or CI/HA) lack several of the features needed to allow listeners to experience the full binaural advantage conferred by a normal-hearing auditory system it can, however, provide significant advantages over the use of a unilateral hearing prosthesis. Most of the accepted assessment clinical materials are not sensitive enough to evaluate the contribution of binaural hearing rehabilitation via CI/CI or CI/HA hearing for the perception of intonation. In a previous study the perception of intonation was evaluated in 29 adults CI/HA users via a closed-set format design with the same target talker. The results of the study showed small bimodal benefit. The test paradigm was apparently an easy task for the adult listeners and not sensitive enough to show the expected CI/HA bimodal benefit over cochlear implant alone.

The perception of correct intonation identification will be computed for each listener in each of the listening conditions. The amount of change in the fundamental frequency that was required in order to identify a question will be computed for each listener in each of the conditions. ANOVA with repeated measures will be used to assess the differences among the conditions for each group as well as the differences among the groups.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral cochlear implant users
* Bilateral-bimodal users who use hearing aids for at least 75% of their waking hours.

Exclusion Criteria:

-
Adjunctive Use of Dermal Matrix to Compensate Dimensional Changes in the Reconstructive Therapy of Peri-implantitis

One critical element regarded to successfully resolve peri-implantitis is to efficiently decontaminate the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy. Recently, the electrolytic approach has been indicated for the surgical detoxification in the management of peri-implantitis. For the electrolytic approach (EA) the implant has to be loaded negatively with a voltage and a maximum current of 600 mA. This is achieved by a device (GS1000, GalvoSurge Dental AG, Widnau, Switzerland) providing the voltage and pumping a sodium formiate solution through a spray-head, which has to be pressed into the implant by finger pressure to achieve an electrical contact.

Another critical aspect in the management of peri-implantitis is related to the esthetic sequelae associated with disease resolution. Sanz-Martin et al. in a systematic review demonstrated that reconstructive therapy is less prone to exhibit mucosal recession when compared to resective therapy. Nonetheless, it seems to be unavoidable no matter the surgical intervention. Aiming at attenuating these changes, Schwarz et al. noted that the adjunctive use of connective tissue grafts may enhance the height of the mucosal level, which in turn may impact upon the esthetic outcome. Therefore, the research question is the following: What is the clinical, radiographic and 3D volumetric effectiveness of dermal matrix to improve the outcome of reconstructive therapy of peri-implantitis-related bone defects? The study is to be performed in two centers: Center of Implantology, Oral and Maxillofacial in Badajoz (Spain) and Clinical PerioCentrum Ortiz-Vigon in Bilbao (Spain)


Eligibility Criteria:
Inclusion criteria:

* Diagnosed with peri-implantitis-related intrabony defects
* All subjects had dental implants with screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
* All patients in age of 18 to 80, non-smokers
* With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.

Exclusion criteria:

* Peri-implantitis-related supra-crystal or combined defects
* Pregnancy or lactation
* History of or current smokers
* Uncontrolled medical conditions,
* Cement-retained restorations,
* Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
Adalimumab in Adult Japanese Subjects With Psoriasis

To evaluate efficacy, safety, and pharmacokinetics of adalimumab in Japanese participants with psoriasis

This was a continuation trial of adalimumab in participants with moderate to severe chronic plaque psoriasis who had completed Study M04-688 (NCT00338754), a 24-week, double-blind, placebo-controlled study. This study was an open-label extension study that continued until the approval of adalimumab for the treatment of psoriasis in Japan.

During Study M04-688 (NCT00338754), participants received 24 weeks of treatment with adalimumab 40 mg every other week (eow) with or without a loading dose, adalimumab 80 mg eow, or placebo.

At the start of this study, participants who had received adalimumab 40 mg eow or adalimumab 80 mg eow in Study M04-688 (NCT00338754) continued on the same treatment regimen. Participants who had received placebo during Study M04-688 (NCT00338754) were re-randomized at the start of this study to receive adalimumab 40 mg eow or adalimumab 80 mg eow.

Participants in the adalimumab 40 mg eow treatment group who failed to achieve a PASI50 response (\>= 50% reduction in the Psoriasis Area and Severity Index score from Baseline of Study M04-688 \[NCT00338754\]) at or anytime after Week 12 of this study were given the option to increase their dose to adalimumab 80 mg eow. Once the dose was escalated, there was no option to de-escalate dosing back to 40 mg eow. Participants who failed to achieve PASI50 responses while receiving adalimumab 80 mg eow may have been discontinued from the study after evaluating the risk/benefit of further treatment with adalimumab.

At Week 28 of this study, it was mandatory for all participants who started the study in the adalimumab 80 mg eow treatment group (i.e., not including the dose escalators described above) to reduce their dose to adalimumab 40 mg eow, regardless of their response status. Following this mandatory dose reduction, if these participants failed to achieve or maintain PASI50 response, they were permitted to escalate their dose to adalimumab 80 mg eow. There was no option to de-escalate dosing back to 40 mg eow following dose escalation.

Data in this clinical trial results disclosure are analyzed as observed according to treatment received at the start of this study (i.e., adalimumab 40 mg eow or adalimumab 80 mg eow) regardless of subsequent dose escalation. Data are summarized according to participants' cumulative exposure to adalimumab in Study M04-688 (NCT00338754) and this study.

Eligibility Criteria:
Inclusion Criteria:

- Participants who completed Study M04-688 (NCT00338754)

Exclusion Criteria:

- Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study
R-BL-M-04 Versus R-(DA)-EPOCH and Autologous Stem Cells Transplantation in Patients With High-Grade B-cell Lymphoma Double-hit (HGBL DH) and High-Grade B-cell Lymphoma Not Otherwise Specified (HGBL NOS)

Purpose: to evaluate an efficacy of chemotherapy regimens R-DA-EPOCH-21 and R-BL-04 with and without autologous hematopoietic stem cells transplantation (auto-SCT) in newly diagnosed patients with High-Grade B-cell Lymphoma Double-hit and High-Grade B-cell Lymphoma Not Otherwise Specified.

Patients initially are randomized into 4 arms:

the first arm R-DA-EPOCH-21 the second arm R-BL-M-04 the third arm R-DA-EPOCH-21 + auto-SCT the fourth arm of R-BL-M-04 + auto-SCT Patients who achieved complete remission after 6 cycles of R-DA-EPOCH-21 or 4 cycles of R-BL-M-04 immunochemotherapy continue to be under observation (1st and 2nd arms) or continue treatment with Rituximab + BCNU+Etoposid+Ara-C+Melphalan (R-BEAM) followed by auto-SCT (3rd and 4th arms).

Patients who did not achieve complete remission with PET-CT data (4-5 Deauville points) are removed from the protocol and undergoing second-line therapy.

Eligibility Criteria:
Inclusion Criteria:

1. First established the diagnosis of HGBL DH or HGBL-NOS.
2. No previous treatment with chemotherapy and/or radiation therapy of DLBCL
3. Informed consent of the patient.

Exclusion Criteria:

1. Pretreated lymphoma.
2. HIV-associated lymphoma
3. Congestive heart failure, unstable angina, severe cardiac arrhythmias and conduction disturbances, myocardial infarction.
4. Renal insufficiency (serum creatinine greater than 0.2 mmol/L) (except cases with specific kidney infiltration, urinary tract compression by tumour conglomerate or presence of uric acid nephropathy due to massive cytolysis syndrome).
5. Liver failure (except cases with liver tumour infiltration), acute hepatitis or active phase of chronic hepatitis B or C with serum bilirubin greater than 1.5 standards, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) greater than 3 standards, prothrombin index less than 70%.
6. Severe pneumonia (except cases with specific lungs infiltration), accompanied by respiratory failure (dyspnea \> 30 in min., hypoxemia less than 70 mm Hg, when it is impossible to compensate situation in 2-3 days).
7. Life-threatening bleeding (gastrointestinal, intracranial), with exception of bleeding due to tumour infiltration of organs (stomach, intestines, uterus, etc.) and disseminated intravascular coagulation due to underlying disease complications after their successful conservative treatment.
8. Severe mental disorders (delusions, severe depressive syndrome and other manifestations of productive symptoms) not related to specific infiltration of a central nervous system.
9. Decompensated diabetes.

11. Pregnancy.
Natives Engaged in Alzheimers Research - 'Ike Kupuna

This study will conduct a group randomized trial to test the effects of a hula-based intervention in improving vascular risk factors for ADRD and cognitive complaints and function over 12 months.

This study will conduct a pragmatic group-randomized trial (GRT) with NHPIs aged 50-75 years with at least 1 of 4 modifiable vascular risk factors for ADRD (hypertension, hyperglycemia, obesity, or dyslipidemia) and either SCI or MCI using a wait-list control design to test the effects of the hula-based intervention. The primary outcomes will be vascular risk factors for ADRD and subjective cognitive complaints. Secondary outcomes will include measures of cognitive performance, physical function, and mental health.

Eligibility Criteria:
Inclusion Criteria:

1. self-reported Native Hawaiian or other Pacific Islander ancestry;
2. ages 50+ but not older than 75 (optimal age range for preventing future dementia in people with cognitive impairment, above 75 is not likely to benefit from this study given their advance age);
3. has subjective cognitive impairment (SCI) or mild cognitive impairment (MCI);
4. have a diagnosis of hypertension, diabetes, dyslipidemia, or obesity (body-mass-index ≥ 30 kg/m2);
5. physically able and willing to engage in moderate physical activity necessary for Hula; and
6. physician's approval to participate in moderate physical activity

Exclusion Criteria:

1. currently pregnant;
2. already actively practicing Hula at least once per week; or
3. clinical diagnosis of ADRD (mild to severe); or
4. current diagnosed major depressive disorder at moderate or greater stage, or moderate or greater depression on the Center for Epidemiological Studies Depression Scale (CES-D).