cyrilzakka/clinical-trials huggingface dataset:
Enterra Therapy Clinical Study (Gastric Stimulation for Gastroparesis)

This study is to evaluate the safety and effectiveness of gastric stimulation in the reduction of nausea and vomiting in patients with gastroparesis using an approved Humanitarian device. There are two cohorts in this study based on etiology, one for diabetic and one for idiopathic.

A maximum of 150 patients (75 diabetic and 75 idiopathic) from up to 15 centers in the United States will be followed closely for twelve months and then once a year after that until the study closes.

If you are someone suffering with symptoms of gastroparesis despite trying oral medications, you may be eligible to participate in a clinical study using a surgically implanted gastric stimulator.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female at least 18 years of age
* Diagnosed with gastroparesis due to diabetes or an unknown cause (idiopathic)
* Have tried prokinetic (help the stomach empty quicker) and antiemetic (help decrease symptoms of nausea and vomiting) medications for a minimum of one month, unless you're unable to take these types of medications
* Have symptoms of gastroparesis that have required treatment for at least one year
* Experience at least 7 episodes of vomiting during a seven consecutive day period on a 28-day diary
* Willing and able to completely and accurately fill out a diary and questionnaires throughout the study
* Have gastric retention of greater than 10% at four hours, or greater than 60% at two hours (if unable to complete the four-hour test) on a Gastric Emptying Test (GET)

Exclusion Criteria:

* Gastroparesis caused by a specific diagnosed illness other than diabetes
* Current eating disorder or diagnosed swallowing disorder
* Previous stomach surgeries
* Taking narcotic pain-relievers daily for abdominal pain
* Diagnosed with drug or alcohol dependency within 1 year before the study
* Life expectancy less than one year
* Have other implantable devices such as pacemakers
* Pregnancy or planned pregnancy
* Plan to receive diathermy treatment
* Have had radiation therapy of the upper abdomen
* Plan on having an MRI performed
* Currently participating in another investigational device or drug study
Inpatient Closed-loop Glucose Control

The purpose of this study is to test an experimental medical device designed to automatically control blood sugar. This device was designed for use by patients with diabetes while they are in the hospital, and others who may develop high blood sugar as a result of their medical problems.

The goal of this first-in-man trial is to test the safety and efficacy of the automated, closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin sensitive subjects with type 2 diabetes (TTD \> 1u/kg/day), and subjects with type 2 diabetes and substantial insulin resistance (\<2 u/kg/day). The results of this study will help to design future studies, exploring the use of the closed-loop system for BG control in hospitalized patients, including those with diabetes or hyperglycemia of critical illness.

Eligibility Criteria:
Inclusion Criteria

Subjects with type 1 diabetes

* Age 21 to 75 with clinical type 1 diabetes for at least one year
* Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins
* Total daily dose (TDD) of insulin that is \< 1 u/kg

Subjects with type 2 diabetes

* Age 21 to 75 with clinical type 2 diabetes for at least one year
* Diabetes managed using NPH as the basal insulin, which may be supplemented with regular or rapid-acting insulin
* Total daily dose (TDD) of insulin that is \> 1 u/kg/day but \< 2 u/kg/day or \> 2 u/kg/day

Exclusion Criteria:

* Pregnancy
* Renal insufficiency
* Cancer
* Abnormal EKG suggestive of coronary artery disease or increased risk of malignant arrhythmia
* Acute illness or exacerbation of chronic illness at the time of the study procedure
* Use of non-insulin, injectable anti-diabetic medications or oral anti-diabetic medications other than metformin
* History of allergy or adverse reaction to aspirin, peptic ulcers or bleeding disorders
* Known history of coronary artery disease, TIA or stroke
* History of seizures
* Transaminitis
* Stage 2 hypertension at the time of screening
Infections and Pregnancy Loss: Correlation Between Abortion and Silent Infections.

Correlation between the presence of intracellular viruses/bacteria and the incidence of miscarriage during the first trimester of pregnancy.

In this study we will analyse chorionic villi derived from abortion during the first trimester of pregnancy (spontaneous abortion vs voluntary pregnancy interruption), in order to correlate the presence of infective viruses/bacteria and the incidence of miscarriage.

The first objective of this project will be to find the viral DNA of HPV, BK and JC polyomaviruses and bacterial DNA of Chlamydia trachomatis, Ureaplasma parvum, Ureaplasma urealyticum, Mycoplasma hominis in the aborted tissues collected from spontaneous abortions, and to compare the prevalence of these DNAs to those derived from elective specimens.

Acronyms:

DNA: deoxyribonucleic acid HPV: human papillomavirus PCR: polymerase chain reaction HPyV: human polyomavirus PBMC: peripheral blood mononucleated cell BKV: BK polyomavirus JCV: JC polyomavirus

Eligibility Criteria:
I.Inclusion and exclusion criteria

Inclusion criteria:

* age of the patients range from 18 to 42 years old;
* gestational age ranging in the first 12 weeks.

Exclusion criteria:

* medical history or laboratory tests positive for sexually transmitted diseases (HIV, HBV, HCV, LUE) during the last year;
* Congenital or Acquired Immunodeficiency diseases, or immunosuppressive therapies during the last year;
* Therapeutic abortion (voluntary interruption of pregnancy, law 194 art 6 comma b)
* well known causes responsable for spontaneous abortions such as genetic, severe uterine or hormonal abnormalities and use of teratogenic drugs.
A Study of Oral LGH447 in Patients With Relapsed and/or Refractory Multiple Myeloma

The primary purpose of this dose escalation study is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of LGH447 as a single agent when administered orally once daily to adult patients with Multiple Myeloma (MM).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of multiple myeloma that is relapsed and/or refractory for which no curative option exists.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* During the dose expansion part of the study patients must have measurable disease defined by at least 1 of the following 2 measurements:

  * Serum M-protein ≥ 0.5 g/dL
  * Urine M-protein ≥ 200 mg/24 hours
  * Serum free light chain (FLC) \> 100 mg/L of involved FLC

Exclusion Criteria:

* Patients who are currently receiving treatment with medications that meet one of the following criteria and that cannot be discontinued at least one week prior to the start of treatment with LGH447:

  * Strong inhibitors or inducers of CYP3A4
  * CYP3A4 substrates with narrow therapeutic index

Other protocol-defined inclusion/exclusion criteria may apply.
Positronic Emission Tomography (PET) Imaging in Post Radiation Evaluation of Head and Neck Tumours (PET PREVENT Trial)

The purpose of this trial is to determine the ability of positron emission tomography (PET) to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy for squamous cell cancer arising in the head and neck.

Patients with head and neck cancer (HNC) undergo treatment of curative intent; patients who are node positive (N2 N3 stages) undergo standard management which includes post-radiation planned neck dissection but two thirds of patients end up not having evidence of residual disease in neck dissection specimens; these patients could have avoided surgery. However, currently used standard tests, like computed tomography (CT) and/or magnetic resonance imaging (MRI) cannot reliably predict who is post-radiation disease free.

PET-Fluorodeoxyglucose scanning is an imaging test based on the increased uptake of radiolabelled glucose by tumour cells. PET might detect neck tumours better than other imaging tests. This is a cohort study in which patients with N2 N3 squamous cell carcinoma of the head and neck undergo a PET and a CT scan at baseline and then post-radiation therapy and chemotherapy. Then, they undergo neck dissection surgery. The PET and CT results are compared with the presence or absence of tumours in the neck nodes. If PET is sufficiently accurate in predicting the presence or absence of tumours in the neck nodes, then a neck dissection could be avoided.

Eligibility Criteria:
Inclusion Criteria:

All of the following criteria must be satisfied:

1. Histological evidence of squamous cell carcinoma of the head \& neck (T1-T4 arising in either the oral cavity, larynx \& pharynx, except Nasopharyngeal carcinoma);OR patients with histological evidence of squamous cell carcinoma metastatic to the neck and an unknown primary site after conventional workup without any of the following: i). Clinically suspected skin primary or previous diagnosis of skin cancer arising in the head and neck area; ii). Patients of Asian or African decent -possible nasopharynx primary; iii). Patients whose malignant adenopathy is confined to zone V -possible nasopharynx primary; and iv). Patients whose malignant adenopathy is confined to zone IV (supraclavicular)-possible lung primary.
2. Presence of advanced N2 or N3 neck disease.
3. Planned for primary curative radiation therapy (± chemotherapy) followed by neck dissection eight to twelve weeks after completion of treatment.

Exclusion Criteria:

1. Presence of distant metastasis
2. Recurrent tumour
3. Prior neo-adjuvant chemotherapy
4. Previous radiation therapy to intended treatment volumes
5. Other active malignancy
6. Surgically inoperable neck disease
7. Unable to remain supine for 60 minutes
8. Unfit to undergo general anesthetic or neck dissection for medical reasons
9. Known hypersensitivity to CT contrast
10. Pregnancy
Does Zumba Improve Cognition in Healthy APOE e4 Carriers and Noncarriers

The main purpose of this study is to compare the effects on attention and memory functioning to participating in an aerobic and dance exercise called Zumba to educational program on exercise that encourages regular stretching and walking.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women between the ages of 55-80 without cognitive complaints

Exclusion Criteria:

* History of significant health conditions
Immunoevasive Tactics Employed by Myeloid Malignancy After Allogeneic Stem Cell Transplantation

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is still the only treatment available to cure acute myeloid leukemia and high risk myelodysplasia. Allo-HSCT has an anti-tumor effect (called the graft versus leukemia effect= GVL) mediated by donor lymphocytes. This GVL effect is often associated with graft-versus-host disease (GVHD). Several studies have shown that the relapse incidence is lower in patients developing chronic GVHD. These studies confirm the impact of donor immune system on leukemic residual cells. In fact, the relapse incidence increased in patients with no sign of GVHD. The investigators assume that leukemic cells probably use mechanisms to inhibit the allogeneic response. These escape mechanisms to immunosurveillance have been described in other malignancies. Out of context of the allo-HSCT, in acute myeloid leukemias and myelodysplasia, correlations between the severity of the disease and the presence of regulatory T cells (Tregs) or exhausted T cells (PD1 positive) in the bone marrow and in the blood of patients were described at the time of diagnosis or relapse. Myeloid Derived Suppressive Cells (MDSCs) have been described as capable of inducing Tregs and exhausted T cells in the tumor microenvironment.The investigators want to evaluate the role of myeloid suppressive cells in bone marrow after allo HSCT. They hypothesize that their presence in bone marrow and / or blood recipient is correlated to the relapse incidence.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myeloid leukemia in complete cytological remission with intermediate or high risk prognosis according to ELN 2017
* Patients with myelodysplasia according to the WHO 2016 definition, with IPSS ≥1.5 and disease status is : stable or in partial response or complete response according to IWG 2006.
* Patients with indication of first allo-HSCT with a matched related or unrelated donor
* Patients receiving non-myeloablative or reduced toxicity conditioning
* Patients affiliated to a social security scheme
* Patients who have received a complete information on the organization of the research and signed his informed consent

Exclusion Criteria:

* Patients with an alternative donor (HLA 5/10 or unit cord blood)
* Patients with another active cancer or a history of cancer diagnosed in the previous 5 years
* Patients with uncontrolled infection at the time of inclusion, or with positive HIV (1 + 2) or HTLV (1 + 2), Hepatitis C or active hepatitis B
* Patients referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
Pregnancy Rate in Women With Normal Uterine Cavity and Those With Corrected Uterine Lesions in ICSI Cycles

The aim of the current study is to investigate the pregnancy rate in women with normal uterine cavity and those detected or corrected uterine cavitary lesions, assessed by hysteroscopy in ICSI cycles.

Intrauterine pathology has been reported in up to 25% of infertile women having IVF treatment and in as many as 50% of women with recurrent implantation failure, leading to suggestions that correction of such pathology could improve treatment outcome. Hysteroscopy allows visual assessment of the cervical canal and uterine cavity and provides the opportunity to operate in the same setting. Routine outpatient hysteroscopy before starting IVF has been postulated to diagnose and treat abnormalities of the cervix and uterine cavity and hence improve IVF outcome.

A systematic review of published studies suggested that outpatient hysteroscopy in the menstrual cycle preceding an IVF treatment cycle could significantly increase the clinical pregnancy rate in women who had previously had recurrent implantation failure, even when no hysteroscopic abnormality was detected.

However, the result of the TROPHY study - published in the Lancet in 2016 concluded that Outpatient hysteroscopy before IVF in women with a normal ultrasound of the uterine cavity and a history of unsuccessful IVF treatment cycles does not improve the livebirth rate and they recommended that further research into the effectiveness of surgical correction of specific uterine cavity abnormalities before IVF is warranted.

An MD thesis done in our department on the evaluation of the endometrial cavity in infertile patients and prior to IVF recommended that there is an urgent need to RCT to emphasize the benefit of removal of the detected intrauterine lesions before proceeding to IVF.

Eligibility Criteria:
Inclusion Criteria:

* Women between 18 and 38 years old.
* An indication for IVF/ICSI.
* Normal 2D transvaginal U/S assessment of the uterine cavity, or abnormal cavity detected by 2D ,3D and HSG.
* Women with primary or secondary infertility.
* Women with BMI between 20 \& 35.

Exclusion Criteria:

* Refusal to join the study.
* Untreated tubal hydrosalpinges.
* Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).
Results of Arthroscopic Massive Rotator Cuff Tears Repair With or Without Using Long Head of Biceps Tendon

The Goal of this clinical trial is to asses the function of arthroscopic repair with or without superior capsular augmentation using biceps tendon .

All patients included in this clinical trial Will be informed by written consent will undergo a one week screening to determine the eligibility for study entry. Patients who meet the eligibility requirements Will be randomised in a single blinded manner ( patients).

Eligibility Criteria:
Inclusion Criteria:

* age 40 to 80 years old
* Patients with massive rotator cuff tear

Exclusion Criteria:

* patients with glenohumeral arthritis
* Acromioclavicular arthritis that requires distal clavicle resection
* Patients with other intra articular pathology like slap lesion
* Neural damage( brachial plexus injury)
* Revision cases
A Study of Taspoglutide Versus Sitagliptin for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin.

This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly). The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes receiving metformin (\>=1500mg/day) for at least 12 weeks;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening;
* stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion Criteria:

* history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
* evidence of clinically significant diabetic complications;
* clinically symptomatic gastrointestinal disease;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination

The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* septic shock
* acute renal failure with need for renal replacement therapy

Exclusion Criteria:

* pregnancy
* nursing
* impossibility to do transcranial Doppler ultrasound
Tele-Rehabilitation Home Exercise Program for Ambulatory Adults With Cerebral Palsy

This study aims to determine if a tele-rehabilitation home exercise program is feasible to promote adherence to a fitness and mobility exercise program in ambulatory adults with cerebral palsy (GMFCS I, II, III) aged 21- 60 year old, and second, to determine if a tele-health exercise program improves fitness and functional mobility for participants.

Cerebral palsy (CP) is a non-progressive neurologic condition caused by a brain lesion(s) that occurs in the prenatal, perinatal or early postnatal period. Ambulatory adults with CP are at risk for gait deterioration and increased sedentary lifestyles due to their diagnosis, associated conditions and the impact of aging. Adults with CP often have limited access to physical therapy (PT) and community-based programs to sustain ambulation, reduce pain, prevent falls risk and increase fitness and physical activity. This Tele-Rehabilitation Home Exercise Program (TRHExP) is a prospective cohort study

Participants in this feasibility study will engage in 150 minutes of exercise per week (30 min/day for 5 days/week) for 8 weeks and will have weekly virtual Exercise Coaching sessions with a trained project team member.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis: Spastic Cerebral Palsy (unilateral or bilateral)
* Gross Motor Function Classification System (GMFCS) Level I to III
* No orthopedic surgery in past year
* No Botox in past 3 months
* Able to follow directions \& attend for 20-30 minutes
* Able to stand independently up to 1 minutes with or without an assistive device
* Able to walk independently up to 2 minutes with or without an assistive device
* Must have a laptop, tablet or smart phone to do the program

Exclusion Criteria:

* Visual, cognitive or attentional deficit that makes it too difficult to participate
* No technology to participate in Zoom tele-rehabilitation sessions
* Medical contraindications to participate in an Exercise Program (e.g., uncontrolled hypertension, diabetes, syncope, uncontrolled seizures)
Pharmacokinetics of Naltrexone Following Intravenous and Oral Routes of Administration in Healthy Volunteers

The purpose of the study is to compare the pharmacokinetics of naltrexone following i.v. and oral administration in healthy volunteers, and to assess the bioavailability of naltrexone following oral administration. Moreover, safety is assessed.

Naltrexone blocks the effects of opioid (morphine-like) drugs by competitive binding at the opioid receptors in the brain. Naltrexone does not possess morphine-like properties and exhibits minimal pharmacologic activity. Naltrexone is marketed as an oral tablet. A wide range of oral bioavailability values have been reported for naltrexone. The wide range in oral bioavailability of naltrexone appears to be due to differences in assay specificity and the method of estimation of bioavailability (use of total drug, free drug, or urinary excretion data rather than plasma level). This was a single-center, randomized (study drug assigned by chance), open-label, 2-treatment, 2-period crossover study in healthy volunteers. Healthy volunteers were randomly assigned to 1 of 2 treatment sequences (AB or BA) with a washout period of 6 to 14 days between treatments. The washout period commenced the day of dosing, after drug administration. Blood samples for determination of blood naltrexone levels were collected at scheduled time points from the arm opposite to the 1 selected for naltrexone i.v. administration. Pulse, blood pressure, breathing rate, body temperature were measured at the times listed in the study schema. Healthy volunteers remained at the research facility for blood sample collection periods and were monitored for adverse events throughout the treatment periods.

Treatment A: 1 mg naltrexone HCl administered i.v. over 15 minutes (naltrexone i.v.). Treatment B: 50 mg naltrexone HCl administered orally (naltrexone oral).

Eligibility Criteria:
Inclusion Criteria:

* Healthy, non smoker, men and nonpregnant nonlactating women
* Weighing a minimum of 60 kg and were within 15% of ideal weight for height as described in the Metropolitan Life Insurance Height and Weight Standards
* Who did not have a history or show presence of drug or alcohol dependence or abuse

Exclusion Criteria:

* Known allergy or hypersensitivity to naltrexone
* Usage of prescription medication including opioids (except for birth control medications, sex-hormone replacement, vitamins) within 14 days prior to Day 1, over-the-counter medication (except for vitamin supplements or acetaminophen \[less than 2 g/day\]) or herbal medication within 3 days prior to Day 1, alcohol, grapefruit juice, or caffeine within 48 hours before dosing
* Consumption of more than 450 mg of caffeine per day (eg, approximately 5 cups of tea, 3 cups of regular coffee, or 8 cans of cola)