cyrilzakka/clinical-trials huggingface dataset:
Outcome Study of Total Knee Arthroplasty in Asian Patients

To determine how the LCS mobile bearing knee system works within the Asian Population.

The objective of this clinical evaluation is to compile a profile of the performance of the LCS Mobile bearing total knee system in normal clinical practice within the Asian Population. Performance will be assessed using specific surgeon and patient based outcome scores.

Total subject enrolled 505; 6 subjects did not receive device. Total subjects received device 499.

Among those who received devices, 391 subjects unilateral and 108 bilateral, therefore, total 607 knees in the study

Eligibility Criteria:
Inclusion Criteria:

* Administrative - the patient is able to understand the evaluation, is able to give consent and will comply with the postoperative follow up regime.
* Diagnosis - idiopathic osteoarthritis, rheumatoid arthritis, post traumatic arthritis or any other pathology that in the opinion of the clinical investigator requires a primary total knee arthroplasty.
* Implant suitability - patients who in the opinion of the Clinical Investigator are considered suitable for treatment with a mobile bearing knee system (the LCS Classic or Universal).
* Bilateral patients - simultaneous bilateral patients are included. Staged bilateral patients are included if the second procedure is performed within the one-year recruitment period. Staged bilateral patients where the second procedure is performed outside of the one-year recruitment period will only be included if the second procedure is performed within 6 months of the end of the one-year recruitment period.
* Age - the upper age limit is set at 75 years and expected to live through the 5 years study period.vi. Ethnic Origin - patients must be Asian in ethnic origin
* Unicondylar / High Tibial Osteotomy (HTO) conversion - patients that are being converted from a unicondylar / HTO procedure are included providing the reason for conversion is due to progression of the disease process affecting the other condyle. Patients that are converted and have evidence of infection / aseptic loosening / loss of bone stock are excluded.

Exclusion Criteria:

* Patients with a known history of poor compliance to medical treatment.
* Patients that require revision surgery
* Patients with gross ligamentous insufficiency.
* Patients with a severe valgus deformity (15 degrees or greater)
* Patients with a severe varus deformity (20 degrees or greater)
* Patients with a fixed flexion contracture (30 degrees or greater)
* Patients over the age of 75 years.
Effect of Citalopram on Reflux Episodes in Healthy Volunteers

Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years

Exclusion Criteria:

* history of upper GI symptoms
* history of upper GI surgery
* psychological disorders
* any drug history
* use of medication altering GI motility
* nursing and pregnant woman
Treatment of Apathy in Alzheimer's Disease With Modafinil

This study examined the effects of modafinil on apathetic symptomatology, performance of activities of daily living (ADLs) and caregiver burden in individuals with Alzheimer's disease (AD).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of mild to moderate stage Probable Alzheimer's disease
* on a stable dose of a cholinesterase inhibitor medication for at least 30 days
* clinically elevated levels of apathy as measured by the Frontal Systems Behavior Scale

Exclusion Criteria:

* diagnosis of Major Depression
* focal brain lesion on neuroimaging
* history of significant substance abuse
* history of significant head trauma with loss if consciousness \>10 minutes
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.

The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens.

The secondary objectives of this study are:

* To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens.
* To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens.
* To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients.
* To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.

Eligibility Criteria:
Inclusion Criteria:

* Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
* The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
* SCr\< 200 μmol/l ( 2.3 mg/dl)
* Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
* Understand and sign the approved informed consent form

Exclusion Criteria:

* Patients who have had other solid organ transplantations
* 24 hours proteinuria\>2g
* SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
* Patients suffering from serious infection lesions
* Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
* Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history
* Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients
* Pregnancy or lactating women
* Patients have participated in another clinical trial in the past month
* Patient refuses to sign informed consent form
* Patient not willing to continue in the study and wants to withdraw from the study
* Poor adherence or lost to follow-up
* Violation of protocol
* Severe adverse events occurred need to withdraw the study according to investigator's judgment
* Pregnancy
More Than Just p-Values: MCID for the VAS, MSQ and FEMD in Patients With Primary Dysmenorrhea

The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).

100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PD according to the "No. 345-Primary Dysmenorrhea Consensus Guideline",
* Pain level of three or more according to VAS during activity (moderate to severe pain),
* Patients aged 18-35 years (when PD becomes more prevalent),
* Regular menstrual cycle with a duration of 28±7 days,
* Nulliparity.

Exclusion Criteria:

* Historical background of chronic urogenital infections or drug use,
* Pregnancy,
* Secondary dysmenorrhoea caused by gynaecological conditions such as endometriosis, adenomyosis and uterine fibroids.
Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage

This study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes to cover the donor site.In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site, whereas in Control Group hemostatic agents with oxidized and regenerated cellulosa were used.


Eligibility Criteria:
Inclusion Criteria:

* FMPS (Full Mouth Plaque Score) and FMBS (Full Mouth Bleeding Score) \< 20%,
* presence of two adjacent Miller's Class I and II recession defects on natural teeth (≥ 2mm in depth);

Exclusion Criteria:

* contraindications for periodontal surgery
* taking medications or having diseases known to interfere with periodontal tissue health or healing and coagulation.
* smoking more than 10 cigarettes a day
* Gingival recessions on molar teeth were excluded.
Mobile Weight-Support Therapy (MWeST) for Mobility After Geriatric Fracture

This is a two-year study proposal to assess feasibility of MWeST (Mobile Weight-Support Therapy) implementation after geriatric fracture and its effects on functional and patient-reported outcomes.

The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.

The goal of this study is to improve mobilization of geriatric lower extremity trauma patients, with the aim of improving overall functional and patient-reported outcomes while decreasing complications and readmissions. Almost 50% of the adult population in the United States has osteopenia or osteoporosis, with over 2 million fragility fractures per year and a projected $25 billion in costs by 2025. These patients are at high risk for readmission due to complications, and at increased risk of mortality with these complications. Sarcopenia, a generalized loss of skeletal muscle associated with aging, has also been associated with increased disability and increased risk of future fracture in these patients. The investigator's study aims to assess the value of weight-support therapy for geriatric patients with lower extremity trauma in improving their overall risk of future injury and disability.

Eligibility Criteria:
Inclusion Criteria:

* 55 and older
* distal femur fracture
* able to walk prior to fracture

Exclusion Criteria:

* patients unable to walk without any assistive devices post-injury
* patients too medically unstable to participate in physical therapy
A Randomized Controlled Trial of a Conservative Fluid Balance Strategy for Patients With Sepsis and Cardiopulmonary Dysfunction (BALANCE Study)

Sepsis is a common inflammatory response to infection characterized by hypovolemia and vasodilation for which early administration of intravenous fluids has been suggested to improve outcomes. The ideal fluid balance following initial resuscitation is unclear. Septic patients treated in the intensive care unit commonly receive significant volumes of intravenous fluids with resultant positive fluid balance for up to a week after their initial resuscitation. Observational studies have associated fluid receipt and positive fluid balance in patients with severe sepsis and septic shock with increased mortality but are inherently limited by indication bias. In order to determine the optimal approach to fluid management following resuscitation in patients with severe sepsis and septic shock, a randomized controlled trial is needed. The primary hypothesis of this study is that, compared to usual care, a conservative approach to fluid management after resuscitation in patients with sepsis and cardiopulmonary dysfunction will increase intensive care unit free days.


Eligibility Criteria:
Inclusion Criteria:

* ICU patients
* Adults
* Sepsis as defined by at least two systemic inflammatory response syndrome criteria and receipt of antimicrobial therapy
* Cardiopulmonary dysfunction as defined shock or respiratory failure

Exclusion Criteria:

* Inability to obtain consent
* Greater than 48 hours since inclusion criteria initially met
* Allergy to furosemide AND bumetanide
* Rhabdomyolysis with creatinine kinase \> 5000 U/L
* Hypercalcemia with calcium \>11 mg/dL
* Diabetic Ketoacidosis requiring continuous insulin infusion
* Tumor Lysis Syndrome diagnosed clinically
* Pancreatitis diagnosed clinically
* Chronic Hypoxic Respiratory Failure with Home Oxygen Use of FiO2≥0.3
* Chronic ventilator dependence
* cervical spinal cord injury at level C5 or higher
* amyotrophic lateral sclerosis
* Guillain-Barré Syndrome
* myasthenia gravis
* Renal failure requiring renal replacement therapy
* Burns \>20% of body surface area
* Pregnant
* Preexisting pulmonary hypertension with PAPmean\>40 on RHC
* Severe chronic liver disease with Childs-Pugh Score \>11
* Moribund and not expected to survive an additional 24 hours
* Actively withdrawing life support or transitioning to comfort measures only
* Unwillingness of treating physician to employ conservative fluid strategy
Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling

The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of olanzapine in treating pathological gambling.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female outpatients aged 18- 75 years of age.
2. Patients will have problematic gambling behavior of at least 6 months duration that meets the DSM-IV definition of pathological gambling and a South Oaks Gambling Screen Score greater than 5.
3. All patients will have a complete medical and psychiatric history, physical examination, laboratories, and ECG before study entry.
4. Baseline laboratory values and ECG must be normal, or abnormalities must be clinically insignificant.
5. Patients will not have received any psychotropic medication for at least one week prior to the first study visit.

Exclusion Criteria:

1. Patients who have any significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination.
2. Patients who are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit).
3. Patients who have ever had psychotic symptoms, who have ever met DSM-IV criteria for a manic episode (i.e., have bipolar I disorder), or who have met criteria for DSM-IV psychoactive substance dependence in the past 1 month.
4. Patients who meet DSM-IV criteria for antisocial or borderline personality disorder.
5. Patients who use any medications which, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with olanzapine. For example, patients taking diet pills or stimulants will not be enrolled.
6. Patients who have taken any psychiatric medication within 7 days prior to the screening assessment.
7. Patients who have a history of hypersensitivity to olanzapine.
8. Patients who display clinically significant suicidal ideation.
9. Patients who have recently (within the past 3 months) begun any type of non-pharmacologic treatment for pathological gambling (including psychotherapy, behavior therapy, group therapy, or family therapy). This does not exclude participation in support groups (e.g., Gamblers Anonymous.) Patients who have been involved in long-standing psychological therapies (e.g., psychotherapy for at least the last 3 months) will be permitted to continue in that therapy provided that no new therapeutic technique or increase in frequency of psychotherapy occurs concurrent with the study.
10. Patients who exhibit or suggest that they may display behavior that will not be conducive to the study procedures.
Intrathecal Chemotherapy for Central Nervous System Metastasis in Retinoblastoma

Retinoblastoma is the most common intraocular malignancy in infancy and childhood. The overall survival rate of retinoblastoma was reported to exceed 95% when children were early diagnosed with localized intraocular phase. The advanced retinoblastoma cases with central nervous system metastasis (CNS)is associated with exceedingly poor prognosis. CNS metastasis is the main cause of death in retinoblastoma. Meningeal involvement combined with spinal cord membrane involvement might be due to the meninges invasion and/or the spreading of CSF.

As the most sensitive drug to retinoblastoma tumor cells in vitro, melphalan is the most important drug in the local treatment of retinoblastoma, and it is also an irreplaceable drug in the current eye preservation treatment, which greatly improves the success rate of eye preservation for advanced retinoblastoma. According to the research and the practice of vitreous injection (melphalan), the drug concentration in vitreous can effectively kill retinoblastoma tumor cells.

It is reasonable to speculate that the tumor cells in CSF can be effectively killed by melphalan. Therefore, based on the above background, this study will explore the effectiveness and feasibility of intrathecal injection of melphalan in patients with CNS metastasis of retinoblastoma through a multicenter prospective study.


Eligibility Criteria:
Inclusion Criteria:

* The pathological diagnosis was retinoblastoma. According to the IRSs (International retinoblastoma staging system) staging system, the stage was IVB
* CSF tumor cells on cytology, or radiographic evidence of NM on MRI scans and histologic diagnosis of systemic malignancy needed
* KPS≥60%
* Adequate bone marrow and organ function
* The parents signed the informed consent and were willing to accept the treatment and follow-up.

Exclusion Criteria:

* 1.Eye diseases other than retinoblastoma
* The eyes were infected within 30 days before screening
* There was a history of surgery and / or unhealed wound within 1 month before enrollment .
* Those who have allergic reaction or allergic history to chemotherapeutic drugs.
* Infectious diseases requiring oral, intramuscular or intravenous administration.
* Patients with systemic immune diseases.
* Active disseminated intravascular coagulation.
* Abnormal coagulation function.
* Abnormal bone marrow and organ function.
* Uncontrollable clinical problems.
* The researchers believe that those who need to be excluded.
Effects of Speech-therapy in Hypertensive Patients

Anthroposophic speech therapy (ATS) has been shown to positively influence heart rate variability (HRV) and heart rate - respiration coordination in healthy volunteers. This study was performed to learn more about such improvements and possible alteration in baroreflex sensitivity (BRS) in hypertensive patients, which characteristically differ in those regulatory parameters from normotensive patients

In this prospective, primarily pre-post study, patients received three ATS treatments in alternation with three control sessions (casual talking with the therapist). In order to perform HRV-analysis and BRS determination blood pressure and ECG were continuously recorded during the sessions. Changes in subjective well-being and perceived health were assessed by questionnaire before and after the various sessions (mood questionaire).

Thirty-one patients participated in this study, the majority diagnosed with arterial hypertension (22 out of 31).

Eligibility Criteria:
Inclusion Criteria:

* Indication for speech therapy
* Willing and able to perform speech therapy
* Out-patient treatment or planned hospitalisation for at least 14 days.
* Diagnosed with hypertension (I 10, either on drug therapy or verified by 24h blood pressure measurements), with tension headache (G 44.2) or with anxiety (F 41) confirmed by the recruiting physician
* No alteration in medication affecting HRV for the last 2 months before and during the study

Exclusion Criteria:

* Comorbidity strongly influencing HRV
* Too weak to participate in an active therapy
* Pacemaker
* Skin disease or allergies preventing the use of ECG electrodes
Dipeptidyl Peptidase-4 Inhibition on Glucagon-like Peptide-1 (GLP-1)

This research is being done to evaluate the effect of glucagon-like peptide-1 (GLP-1, a naturally occurring hormone) on insulin release and to examine whether there is extra insulin release when GLP-1 is not allowed to be rapidly inactivated.

The purpose of the present proposal is to 1) examine the role of dipeptidyl peptidase (DPP-4) inhibition on insulin release during a hyperglycemic clamp while GLP-1 is being infused and, 2) further elucidate the role of the metabolite of GLP-1, that is GLP-1 9-36 amide (GLP-1m). During stable and very reproducible elevated plasma glucose levels the effect of increased active incretin levels with DPP-4 inhibitors should result in increased plasma insulin levels. Therefore the aim of this protocol is to document whether plasma insulin levels are increased following GLP-1 infusion in the presence or absence of DPP-4 inhibitors. Additionally, the investigators have shown that some improvement in glucose homeostasis during GLP-1 administration is due in part to the metabolite of GLP-1, i.e. GLP-1 (9-36) amide (GLP-1m). Therefore, the investigators will also test the role of the latter by infusing GLP-1m when the volunteers are being treated with DPP-4 inhibitors.

Eligibility Criteria:
Inclusion Criteria:

* Hct level of at least 34% for women and 36% for men
* Women of non-bearing potential and women of childbearing potential using adequate contraception
* Serum creatine level of less than 1.7 mg/dl
* Four groups:

  * Age 21-45 (BMI between 18.50-24.99) \& (BMI between 30-35)
  * Age greater than 65 years (BMI between 18.50-24.99) \& (BMI between 30-35)

Exclusion Criteria:

* Pregnant and/or lactating females
* Women of childbearing potential not willing to use adequate contraception
* Hct below inclusion criteria
* Serum creatine level greater than 1.8 mg/dl
* Age less than 21 and age between 46-64
* Diabetes mellitus
* BMI less than 18 and BMI greater than 35
MSC and Kidney Transplant Tolerance (Phase A)

The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in good manufacturing practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.

The proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).


Eligibility Criteria:
Inclusion Criteria:

* First single kidney transplant;
* Capable of understanding the purpose and risk of the study;
* Written informed consent.

Exclusion Criteria:

* PRA \>10%;
* Specific contraindication to MSC infusion;
* Any clinical relevant condition that might affect study participation and/or study results;
* Childbearing potential without effective contraception;
* Pregnant women and nursing mothers;
* Unwillingness or inability to follow study protocol in the investigator's opinion.