cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus Receiving Background Treatment With Glimepiride Alone or in Combination With Metformin or With Pioglitazone Alone

This study will evaluate the long-term safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Have successfully completed all required visits of a qualifying Phase 3 core protocol
* Be currently receiving treatment for T2DM as set forth in the qualifying Phase 3 core protocol

Exclusion Criteria:

* Any condition, disease, disorder or clinically relevant laboratory abnormality which, in the opinion of the investigator, would jeopardize the patient's appropriate participation in this study or obscure the effects of treatment
Mg Induced Changes From Day 0 to Day 28 on Serum and Urine Bone Metabolic Parameters in 70 y Old Females (no 50).

Calcium and vitamin D substitution has for a long time been used to improve osteoporosis.The main storage place for magnesium is in the bone. Magnesium is direct under calcium in the periodic system making it possible to interact with the crystal structure. Some small studies have shown beneficial effects of magnesium substitution on osteoporosis. Evidence has shown improvement with calcium, alcohol, fruit and vegetable nutrients on bone loss. It has been uncertain however, which of these factors can contribute to such a change. The effect of magnesium substitution 240 mg daily as therefore studied in two parallel groups where both received calcium carbonate 1000 mg/day and cholecalciferol 10 ug/day, one got placebo and the other received magnesium. This was studied on various expressions for bone metabolism after zero, seven and 28 days in elderly females aged 70 years old.

Elderly 70 year old ladies who had been to an outpatient X-ray investigation were invited to participate in this study. They were all healthy without any signs of osteoporosis, or fractures.They were stimulated to participate by having done bone density measurements free. Patients who had used biphosphonates, oestrogens, glucocorticoids , diuretics, immunomodulating agents, or prolonged use of heparin were excluded.

Patients with possible secondary osteoporosis due to primary hyperthyroidism or chronic lung disease were also excluded. The participants were randomized into placebo or Mg-treatment groups. They were seen by the dietician, and blood and urine samples were taken at day 0, 7 and 28 at the same time these days. Medicine was prepacked for intake twice daily. They received medicine for 30 days and should only take for 28 days. The number of tablets which should be left was controlled the last day. The participants were informed about the results of the bone density measurements taken the first and the last day. All the patient contacts were undertaken by the same dietician.

Eligibility Criteria:
Inclusion Criteria:

Homeliving healthy female volunteers aged 70 years old were recruited by phone.

Exclusion Criteria:

Persons who had used:

* biphosphonates,
* oestrogens,
* glucocortocoids,
* antiepileptic drugs,
* diuretics,
* immunmodulating agents,
* prolonged usage of heparin.
* patients with possible secondary osteoporosis and
* diagnosis as:

  * inflammatory bowel disease,
  * primary hyperthyroidisms,
  * chronic obstructive lung disease
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.

The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30% efficacy against clinical episodes of malaria and approximately 58% efficacy against severe malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B vaccine to the African adults to establish safety and immunogenicity in this population. Preliminary indication of vaccine efficacy with this adjuvant will be established by monitoring the time to the first infection with Plasmodium falciparum.

The study comprises of 3 groups and the participating subjects will be randomly allocated to one of the three groups. The first group will receive RTS,S/AS01B, the second group will receive RTS,S/AS02A and the third group will receive rabies vaccine. Immunization will be given by IM injection on 0, 1, 2 month schedule. Infants will be followed up daily for 7 days for solicited symptoms and 30 days for unsolicited symptoms after each vaccine dose. Serious adverse events will be recorded throughout the study period. A week prior to Dose 3, subjects will be treated with a licenced anti-malarial drug. Starting from two weeks after Dose 3, the subjects will be monitored for a 14-week duration for detection of malaria infection.

Eligibility Criteria:
Inclusion criteria:

* Healthy male or female volunteers aged between 18 and 35 years at the time of first vaccination who have given written consent for their participation in the study were included
* If the volunteer is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series

Exclusion criteria:

* If a subject plans to take vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid will be excluded
* Volunteers with any confirmed or suspected immunosuppressive or immunodeficient conditions
* Family history of congenital or hereditary immunodeficiency
* History of allergic reactions to previous immunizations
* HBsAg positive subjects
* History of splenectomy
* Pregnant or lactating females will be excluded from the study
PRO-STATE:Search for a Protein Profile Corresponding to Fast-developing Lesions and Characterization of Implicated Proteins in Prostate Carcinoma

The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.

In men, prostate carcinoma is the first cancer and the second cause of death by cancer. It is a slowly evolving disease with no prognostic marker of poor outcome.

Currently, the Prostate Specific Antigen (PSA) is the only available biological marker. It is a tissue marker and not a tumoral pathology control.

This is why new tissue markers are urgently needed to select patients with unfavourable evolution, in order to treat them rapidly by more effective methods such as chemotherapy, hormonotherapy or radiotherapy. This could improve survival time and quality of life.

Proteomic and clinical data comparison could point to new relevant molecules and permit the development of new biological tests for routine use.

SELDI-TOF-MS (Surface Enhanced Laser Desorption/Ionisation Mass Spectrometry) permits an extremely sensitive analysis of proteins. This method has been substantially ratified by the literature and a number of markers have already been identified, particularly for several cancer pathologies.

As far as prostate carcinomas are concerned, previous proteomic researches on serum have led to diagnostic parameters, differentiating healthy patients, patients with benign lesion and patients having malignant lesions. However, at present, no relevant protein has been identified. Moreover, no study has been carried out to characterize fast-developing lesions, in order to anticipate response to treatments.

The main objective of this study is to realise serum protein profiles for each patient undergoing a prostate biopsy and to identify relevant proteins.

The main judgement criteria will be intensity peaks in the protein profile (area and height) with reference to combined criteria (PSA rate, clinical stage, Gleason score).

Two groups will be compared:

* Group 1: Control (negative biopsy).
* Group 2: Prostate carcinoma (positive biopsy).

This group will be subdivided:

* Group 2a : favourable prognostic according to AMICO classification
* Group 2b : intermediate or unfavourable prognostic according to AMICO classification

This will contribute to setting up an aftercare database combining clinical data with biological data and protein profile.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing a prostate biopsy or a prostatectomy(according to common criteria).

Exclusion criteria:

* Patient refusing to take part in the study.
Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors

In this study, we want to continuously record the interaction of 50 stroke survivors with their smartphones during the first 3 months after discharge. The linkage of smart phone use to function and quality of life will be assessed with standardized outcome measures at defined time points.

People with stroke are among the most relevant target groups for unobtrusive monitoring. Worldwide, stroke is the second most frequent cause for lasting disability and causes a substantial burden for the individual, caregivers and society. Thanks to improved treatment, many stroke survivors can be discharged to their homes. However, many have to live with disabilities and are prone to declining function, cognitive impairment and depression. With the acquired data, we want to create a database where digital behavior is analyzed with advanced computational methods. In collaboration with the Department of Cognitive Psychology, University of Leiden, Netherlands, these data will be used to discover specific features for different health issues and to develop tools for the early detection of functional decline for different populations.

Eligibility Criteria:
Inclusion Criteria:

* New or recurrent stroke, admitted to rehabilitation, discharge to own home
* Owns an Android smart phone
* Smart phone is used by the patient only

Exclusion Criteria:

* Severe cognitive impairments and / or psychiatric and behavioral conditions that interfere with compliance.
* Not able to provide informed consent
* Discharge to nursing homes or other care facilities
Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer

This is a randomized, open-label, two-arm study in patients with relapsed epithelial ovarian tumors. Patients will be randomized in a 1:1 ratio to receive olaparib or standard chemotherapy with the possibility of crossover at the time of progression.


Eligibility Criteria:
Inclusion Criteria:

* with recurrent epithelial carcinoma of the ovary, fallopian tube or primary peritoneum
* At least 1 previous line of chemotherapy
* Measurable disease
* Patients have a normal organ and bone marrow function measured within 28 days of randomization
* WHO 0-2

Exclusion Criteria:

* Primary platinum-refractory disease
* Known hypersensitivity to olaparib
* Resting ECG with QTc \> 470 msec
* Concomitant use of known potent CYP3A4 inhibitors
* Symptomatic uncontrolled brain metastases
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication
Safety and Efficacy of Endoscopic Full Thickness Biopsy in Patients With Chronic Intestinal Pseudo-obstruction

To evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction
* Patients who are 18 years of age or older at the time of obtaining consent
* Gender: Any

Exclusion Criteria:

* Patients for whom it is difficult to perform endoscopy
* Patients who cannot obtain consent
* Patients with serious renal, hepatic, or cardiac disease
* Patients who are participating in other clinical research, except for observational research.
* Other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.
To Assess the Efficacy of the LYMPHA in the Prevention of Lymphedema Following Axillary Dissection for Breast Cancer

Lymphedema is the Build-up of Lymph Fluid in the Body's Tissue Causing Chronic, Debilitating Swelling. This Commonly Occurs as a Result of a Disruption of the Lymphatic System During Lymph Node Dissection Surgeries. LYMPHA (LYmphatic Microsurgical Preventive Healing Approach) is an Innovative Microsurgical Technique Where Blocked Lymphatic Vessels Are Drained Into the Blood Circulation by Surgically Creating a Shunt Between a Lymphatic Channel and a Blood Vessel Called a Lymphatic-venous Bypass. Recently, LYMPHA Technique Has Been Shown to Prevent Lymphedema When Performed at the Time of Nodal Dissection. We Propose a Prospective Study Evaluating the Effectiveness of LYMPHA Technique Using Objective Clinical Protocol.

Consenting patients will have the LYMPHA procedure at the time of planned axillary dissection surgery for the prevention of upper and extremity lymphedema. The node dissection will be performed by Dr. Kang while the LYMPHA technique will be performed by the plastic surgeon, Dr. Kim. The LYMPHA procedure consist of performing LVA at the time of the node dissection. Patent blue dye will be injected in the volar surface of the upper third of the arm in a quantity of about 1-2 ml intradermally, subcutaneously, and under muscular fascia into patient approximately 10 minutes before skin incision. This will allow mapping of the lymphatic channels for identification for bypass. The node dissection will then be performed with preservation of the anterior branch of the axillary vein in the axilla. Afferent lymphatic vessels will be sutured into a branch of the axillary vein distal to a competen valve. The total duration of the surgery is approximately 3 hours. The LYMPHA technique accounts for an additional 30 min to the standard 2-2.5 hours allocated to the node dissection.

Pre-surgery, patients will have baseline limb circumference measurements of both the surgery-affected and unaffected arms and by lymphoscintigraphy. Patients will be followed up clinically at every 6 months up to a year. At each follow-up visit, patients will have a physical examination and their circumference of their limbs taken. Patients will also fill out a LyQLI, SF-36, DASH administered by the Clinical Research Coordinator pre-and post-surgery. Each patient will have a total of 1 years of participation time.

Eligibility Criteria:
Inclusion Criteria:

* Node-positive cancer requiring an axillary or lymphadenectomy
* Below 30 Body Mass Index

Exclusion Criteria:

* Patients receiving a sentinel lymph node biopsy
* Patients with established preoperative lymphedema
* Patients with post-thrombotic syndrome, peripheral vascular disease
* Pregnant patients
Virtual Reality Mindfulness in Preoperative Anxious Patients

The goal of this interventional study is to reduce preoperative anxiety by Virtual Reality mindfulness.

Population: all adults, able to give their consent and scheduled for surgery with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) score \> 10. The study will recruit 100 patients in one university teaching hospital.

The main question it aims to answer is: may mindfulness by Virtual Reality reduce preoperative anxiety in patients particularly anxious for the surgery? Participants will be asked to undergo to a single mindfulness virtual reality session before the surgery.


Eligibility Criteria:
Inclusion Criteria:

* adults able to give their consent, scheduled for elective surgery and with high preoperative anxiety defined by Amsterdam Preoperative Anxiety and Information Scale (APAIS) \> 10

Exclusion Criteria:

* Pregnancy
* Epilepsy
* Pacemaker wearers
* Mental diseases
* Alcohol or drug addiction
* Severe hearing loss or blindness
* Simultaneous participation to other studies
Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients

Objectives: This study is looking at the level of vascular endothelial growth factor (VEGF) circulating in the blood stream of patients diagnosed with either a meningioma or a glioma. The questions that will be addressed include:

1. Can VEGF level alert us to tumor progression or recurrence before MRI changes occur?
2. Is the VEGF level an indicator of the response to treatment?
3. Does the VEGF level correlate with tumor histology and behavior?
4. Is there a relationship between VEGF level and outcome?


Eligibility Criteria:
Inclusion Criteria:

* any patient presenting with glioma or meningioma

Exclusion Criteria:

* a different type of brain tumor
HLA-A*0201 Restricted Peptide Vaccine Therapy With Gemcitabine With Gemcitabine in Patient Pancreatic Cancer (Phase1)

The purpuse of this study is to assess toxicities of angiogenic peptide vaccine therapy with gemcitabine in treating HLA-A\*0201 restricted patient with non-resectable pancreatic cancer.

The prognosis of pancreatic cancer is extremely poor even with extensive surgery, chemotherapy or radiation. It has been required development of new treatment modalities. Immunotherapy is one of the encouraging modalities for cancer patients. The investigators have to assess its toxicities and immune responsiveness.

Eligibility Criteria:
Inclusion Criteria:

* locally advanced or metastatic pancreatic cancer precluding curative surgical resection and recurrent pancreatic cancer
* Measurable disease by CT scan
* ECOG performance status 0-2
* Life expectancy \> 3 months
* laboratory values as follows: 2,000/mm3 \< WBC \< 15,000/mm3, Platelet count \>75,000/mm3, Total Bilirubin \<1.5 mg/dl, Asparate transaminase \<150IU/L, Alanine transaminase \< 150 IU/L, Creatinine \< 3.0mg/dl
* HLA-A\*0201
* Able and willing to give valid written infromed consent

Exclusion Criteria:

* Pregnancy (women of childbearing potential: Refusal or inability to use effective means of contraception)
* Breast-feeder
* Active or uncontrolled infection
* Prior chemotherapy, radiation therapy, or immunotherapy within 4 weeks
* Serious or uncured wound
* Active or uncontrolled other malignancy
* Steroids or immunosuppressing agent dependent status
* Interstitial pneumonia
* Ileus
* Decision of unsuitableness by principal investigator or physician-in-charge
Phase I Study of the Safety, Tolerance, and Pharmacokinetics of 9-[2-(Bispivaloyloxymethyl)Phosphonylmethoxyethyl]Adenine (Bis-POM PMEA; Adefovir Dipivoxil) in HIV-Infected Patients

To study the safety, tolerance, and pharmacokinetics of a single dose of bis-POM PMEA (adefovir dipivoxil) when administered by the oral route in patients with HIV infection.

Five patients are entered at each of three dose levels of bis-POM PMEA administered orally in a single dose.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* AZT, ddI, or ddC (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).
* Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone (provided patient has been on a stable regimen for at least 4 weeks prior to study entry).

Patients must have:

* Documented HIV infection or diagnosis of AIDS.
* Life expectancy of at least 3 months.

Prior Medication:

Allowed:

* Prior AZT, ddI, or ddC.
* Prophylactic aerosolized pentamidine, fluconazole, ketoconazole, trimethoprim/sulfamethoxazole, or dapsone.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Active, serious infections (other than HIV infections) that require parenteral antibiotic therapy.
* Clinically significant cardiac disease, including symptoms of ischemia, congestive heart failure, or arrhythmia.
* Gastrointestinal malabsorption syndrome or inability to receive oral medication.

Concurrent Medication:

Excluded:

* Diuretics.
* Amphotericin B.
* Aminoglycoside antibiotics.
* Parenteral antibiotics.
* Other nephrotoxic agents.
* Other investigational agents.
* Non-steroidal anti-inflammatory drugs.
* Aspirin.

Prior Medication:

Excluded within 2 weeks prior to study entry:

* Diuretics.
* Amphotericin B.
* Aminoglycoside antibiotics.
* Parenteral antibiotics.
* Other nephrotoxic agents.
* Other investigational agents.

Excluded within 3 days prior to study entry:

* Non-steroidal anti-inflammatory drugs.
* Aspirin. Active substance abuse (including alcohol or drug abuse).
Autologous Mesenchymal Stem Cells Transplantation In Women With Premature Ovarian Failure

Stem cells (SC) are the foundation cells for every organ, tissue and cell in the body. They are undifferentiated "blank" cells that do not yet have a specific function. Under proper conditions, they begin to develop into specialized tissue and organs. They are self-sustaining and can replicate themselves for long periods of time. They have the remarkable potential to develop into many different cell types in the body. They serves as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person is still alive. Premature ovarian failure (POF) is the loss of ovarian function in women less than 40 years. It is associated with sex steroid deficiency, amenorrhea, infertility and elevated serum gonadotropins. POF occurs in 1 % of women. In majority of cases the underlying cause is not identified. Management essentially involves hormone replacement and infertility treatment. This work aimed to evaluate the therapeutic potential of Autologous MSC transplantation in women suffering from Premature Ovarian Failure.

Sample of 60 ml is aspirated from the bone marrow of the iliac crest and prepared in the lab and injected in the ovaries through laparoscopy. Endometrial fractional biopsy was taken, stained with H\&E stain and by IH staining by stem cell marker OCT4. Immunohistochemical expression of stem cell marker OCT4 was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). Participants were followed up monthly for a period of six months by hormonal (FSH, LH and E2), clinical (resuming menstruation), US (folliculometry), histopathological (HP), and IH expression of stem cell marker OCT4 of the endometrial biopsy (stem cell positivity according to ESS) outcome.

Eligibility Criteria:
Inclusion Criteria:

* Post-menarche female less than 40 years old.
* Follicle-stimulating hormone (FSH) more than or equal to 20 IU/L.
* Female with normal karyotyping.
* Agree to sign the designed consent for the study.

Exclusion Criteria:

* Pregnancy and lactation.
* Autoimmune diseases.
* Breast cancer, ovarian cancer.
* Female with abnormal karyotyping (e.g. turner syndrome, fragile X syndrome....).
* Hypersensitivity to any Gonadotropin-releasing hormone (GnRH) analogs.
* Patients with secondary ovarian failure (e.g. hypothalamic causes)
* Those with major medical problems such as malignancy, hepatitis, etc.