cyrilzakka/clinical-trials huggingface dataset:
Transit Bipartition After Sleeve Gastrectomy

Retrospective analysis of 100 morbidly obese patients who underwent a transit bipartition (TB) procedure ("Single Anastomosis Sleeve Ileal bypass") for inadequate weight loss or weight recidivism after a previous sleeve gastrectomy. Data were collected prospectively in strictly pseudonymous form. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux) as well as safety.

Prospective data base of 100 consecutive morbidly obese patients who had undergone transit bipartition (TB, also termed "Single Anastomosis Sleeve Ileal bypass") after a previous sleeve gastrectomy (LSG). Inclusion criteria were TB for excess weight loss (EWL) \< 50% ≥ 12 months post LSG or weight recidivism of \> 5 kg/qm with a body mass index (BMI) \> 30 kg/qm. Patients with endocrine disorders other than type 2 diabetes mellitus (T2D), major psychiatric disorders, American Society of Anesthesiologists (ASA) III and higher or pregnant patients were excluded from the study. Data were prospectively collected in strictly pseudonymous form. Follow up time points were at 1, 3, 6 and 12 months following TB. The primary endpoint of the study is weight loss at 1, 3, 6 and 12 months after TB. A subgroup analysis evaluates the effect of the length of the common channel. Secondary endpoints include impact on obesity related comorbidities such as T2D, hypertension, sleep apnea, gastroesophageal reflux as well as safety.

Eligibility Criteria:
Inclusion Criteria:

* TB for excess weight loss (EWL) \< 50% ≥ 12 months post LSG or weight recidivism of \> 5 kg/qm with a body mass index (BMI) \> 30 kg/qm.

Exclusion Criteria:

* endocrine disorders other than T2DM, major psychiatric disorders, ASA ≥ III, pregnancy.
A Pharmacokinetic Study of Erlotinib in Cancer Patients With Advanced Solid Tumors, With Adequate and Moderately Impaired Hepatic Function

This is a multicenter, open-label, 2-arm study comparing erlotinib exposure in cancer patients with adequate hepatic function versus cancer patients with moderate hepatic impairment. All patients will receive a single 150 mg dose of erlotinib on Day 1 followed by 96 hours of plasma sampling for PK and protein binding studies. Patients may then enter the maintenance phase of the study and continue to receive erlotinib until disease progression or unacceptable toxicity.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced solid tumor (measurable or nonmeasurable) that is potentially responsive to erlotinib or for which no effective therapy is available,
* Cohort 1: Adequate hepatic function: bilirubin \<= ULN, ALT (SGPT) and AST (SGOT) \<= 1.5 x ULN or Cohort 2: Moderate hepatic function: 7-9 as assessed by the Child-Pugh System, ECOG Performance Status 0-2
* Life expectancy \>= 12 weeks,
* Prior radiation permitted provided that 4 weeks (or 2 weeks for palliative radiation) has elapsed and patients have recovered from acute toxic effects of radiotherapy,
* Prior chemotherapy permitted provided that 4 weeks has elapsed and patients have recovered from acute toxic effects of chemotherapy,
* Adequate hematopoietic and renal function: ANC \>= 1.5 x 10\^9/L, platelets \>= 75 x 10\^9/L, and creatinine \<= 1.5 x ULN,

Exclusion Criteria:

* Use of tobacco or nicotine-containing products within 4 weeks of Day 1 and while on study,
* Use of a CYP3A4 inhibitor or inducer within 14 days prior to Day 1 and until Day 5,
* Use of a warfarin-derivative anticoagulant within 14 days prior to Day 1 and until Day 5,
* Encephalopathy \>= grade 2,
* Significant history of cardiac disease unless well-controlled,
* Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with the patient's ongoing participation,
* Concurrent anticancer therapy or any other investigational agents within 4 weeks of Day 1 and while on study,
* Symptomatic brain metastases that are not stable, require steroids, are potentially life-threatening, or that have required radiation within the last 4 weeks,
* Gastro-intestinal abnormalities, including inability to take oral medication, requirement for IV alimentation, active peptic ulcer or prior surgical procedures affecting absorption.
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)

The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases. This study is supporting the clinical evaluation report. From the standard-of-care perspective, the results of The Degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).


Eligibility Criteria:
Inclusion Criteria:

* Patients of at least 18 years old
* Patient suffering from a spinal degenerative disease.
* Patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease
* Patient implanted with MEDICREA's products, or patients who are candidate to receive including at least the PASS LP and/or PASS DEGEN and/or PASS TULIP Prime implants
* Patient affiliated to a national insurance system

Exclusion Criteria:

* Patient unable or unwilling to sign and understand an information note with proof of patient consent
* Patient unable to complete a self-administered questionnaire
* Patient presenting contra-indications to a Xray follow-up
* Patient of more than 18 years old under a protection procedure
* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits up to 2 years
Study of a Therapy Without Drugs, Supplementary to an Usual Treatment for the Pains Caused by Removing the Redon's Drain From a 7 to 17 Years Old Child in Pediatric Surgery.

The 3rd governmental plan of fighting against the pain favored the development and the evaluation of the efficiency of the non pharmacological methods. Its results always showes a lack of knowledge of these methods and the utility to pursue the researches.

In the department of pediatric surgery of the university hospital of Limoges, the relaxing-touch is one of these methods which is more and more used. The healthcare staff noticed the beneficial effects of such an empirical method in terms of comfort and quality of life for the children.

In 2011, a pilot study led in this department showed that, in spite of the usual treatment, the removal of the Redon's drain remains painful for 25 % of the children (score on the pain scale \> or = 4). This result convinced the medical team to write a protocol of research from the following hypothesis: the implementation of a protocol of the Redon's drain removal associated to the relaxing touch and usual treatment could lead to a decrease of the acute pain for a 7 to 17 years old child.


Eligibility Criteria:
Inclusion Criteria:

* Children \> or = 7 and \< 18 years old
* Hospitalization for surgery having required the settle of a Redon's drain during surgery.
* The presence of at least one of the legal representatives with the child during the care.
* The consent of at least one of the legal representatives and agreement of the child for the relaxing-touch method.
* The affiliation of one of the legal guardian to the social security.

Exclusion Criteria:

* Children with an intellectual deficiency preventing the use of the scale EVA from the pain.
* Children having already had one or several removal of the Redon's drain: the negative memory of the pain for a similar act could falsify the score of pain
* Children refusing the usual care of the pain in the department by the MEOPA.
Studying Normal Breast Tissue and Cancer Risk

Breast cancer is the most common cancer among women in the United States. Breast cancer research has been hampered by the difficulty in collecting normal breast tissue. In this study, researchers will obtain samples of normal breast tissue from organ donors and will collect risk-factor data from next-of-kin.

The purpose of this study is to learn how normal breast develops and responds to stresses that are known to increase a woman s chance of developing breast cancer.

Following the breast-tissue donation from 20 volunteers, surgical technicians will make small incisions in the skin and tissue of the breast and remove several samples measuring about one-inch. Technicians also will take samples of the uterine lining to estimate the date of the last menstrual period. The tissue will then be sent to the National Cancer Institute for laboratory research studies. Steps will be taken to ensure that the identity of the participants remains confidential.

This pilot project, funded by a Breast Cancer Faculty Infrastructure Award, would determine the feasibility of obtaining samples of normal breast tissue from organ donors and collecting risk factor data from next-of-kin. The underlying goal of this initiative is to determine the associations between stages of breast development, risk factors for breast cancer, and gene expression. The study investigators are members of DCEG, CCR and the Transplant Resource Center of Maryland (TRC), a non-profit organization certified by HCFA and the state that processes most organ and tissue donations in Maryland. Trained staff or social workers employed by TRC who routinely obtain consent for donation from next-of-kin will also obtain consent for this study. The existing consent form for organ or tissue donation also includes informed consent for donation of tissue for research. Following organ procurement from 20 volunteers, trained surgical technicians employed by TRC who routinely assist intra-operatively, will sterilely remove tissue from each breast quadrant and split the samples; one portion will be embedded in OCT and snap frozen in liquid nitrogen and the other fixed in 10% buffered formalin. Samples of adipose tissue, blood, urine and endometrium (for menstrual dating) will also be obtained. MES in conjunction with SMH and BKV will assess the samples histopathologically and determine the quantity and quality of macromolecules (RNA, DNA, protein) contained within the tissues. Pending demonstration of the feasibility of this general approach, we will pursue additional funding for a larger study with optimized procedures. We have stopped recruiting patients.

Eligibility Criteria:
* INCLUSION CRITERIA

The study will enroll girls or women aged 11 years or older.

EXCLUSION CRITERIA

Men are excluded.
Antitussive Effect of Single-dose Dexmedetomidine With Low-dose Remifentanil Infusion

After thyroid surgery, the incidence and severity of coughing is important because it may cause serious complications, such as bleeding in the surgical field, laryngospasm, and cardiovascular disturbance. Several studies have shown that the single-dose of dexmedetomidine is effective for reducing cough and agitation during emergence from general anesthesia.

To test the hypothesis that single-dose of dexmedetomidine combined with a low-dose remifentanil infusion during emergence from general anaesthesia could reduce coughing as good as high-dose remifentanil infusion, we will evaluate the efficacy on cough suppression and reduction of side effect of remifentanil using non-inferiority trial.


Eligibility Criteria:
Inclusion Criteria:

* Thyroid disease undergoing thyroidectomy
* age 20-65
* Amerian society of anesthesgiologist class 1 or 2

Exclusion Criteria:

* chronic cough
* difficult intubation
* liver disease
* uncontrolled hypertension
Clinical Applications of Round Window Imaging Anatomy in Cochlear Implant Surgery

The purpose of this study is to measure the size of the round window niche and its relation to the mastoid segment of the facial nerve and the mastoid cortex, using high resolution computerized tomography of the temporal bone, in order to assess preoperatively what is the extent of obstruction of the round window membrane and whether there is a surgical possibility of round window approach in the insertion of electrode array into the cochlea

The assessment of the anatomy of the round window will be executed using the stractured measuring software used for imaging of the Bnai Zion medical center (CARESTREAM PACS Ver. 11.0, CARSTREAM HEALTH INC.) in IAC window (centered at 700 with a total width of 4000) in the available zoom by the software (usually 400-800%).

Measuring the length (mm) and angle will be executed by the software's structured rulers.

Measuring protocol:

1. Measured scans: one taken in an orbito-meatal plane
2. Chosen slices: where both the round window niche and the external ear canal are seen on the same slice
3. Distances measured:

   1. Distance 1: between the anterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.5mm to the posterior wall of the external ear canal
   2. Distance 2: between the posterior edge of the round window niche and the cortex of the mastoid, with a minimal distance of 0.3mm to the anterior edge of the mastoid segment of the facial nerve.
   3. Distance 3: the size of the round window niche (from its anterior to posterior edges)
   4. Distance 4: between the anterior (most medial) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve.
   5. Distance 5: between the posterior (most lateral) edge of the round window membrane to a point at least 0.3mm anterior to the mastoid segment of the facial nerve
   6. Distance 6: size of round window membrane (anterior/medial to posterior/lateral)
   7. Distance 7: between the lateral edges of distance 1 and 2 marking the cortical size of the "working channel" created between the lines (from the cortex to the round window).
4. Angles measured:

   1. Between distance 1 and 7 - marking the angle of the "working channel" relatively to the cortex
   2. Between distance 1, passing in the middle of distance 3 to the middle of distance 6 - marking the angle of possible insertion from the working channel into the cochlea

Eligibility Criteria:
Inclusion Criteria:

* age 20 years old or older
* high resolution computerized tomography of the temporal bone (slices ≤1mm) before the surgery
* on the measured slices both the round window niche and the posterior wall of the external ear canal are seen

Exclusion Criteria:

* inner, middle or external ear malformation
* temporal bone malformation
* status post cochlear implant
* status post temporal bone trauma
* slices were the round window niche and the posterior wall of the external ear canal are not seen on the same slice
Study of Gralise to Treat Fibromyalgia Patients

To determine Gralise in treating fibromyalgia pain:

* efficacy
* safety

Subject must carry a diagnosis of fibromyalgia based on American College of Rheumatology (ACR) criteria for fibromyalgia

* Patient may be gaba-analogue (Pregabalin, trade name: lyrica, or Gabapentin, trade name: Neurontin) naïve, or had been on other gaba analogue before, and discontinued for lack of efficacy.
* Patient who had allergic reaction or serious adverse reactions will not be included in this study.
* Patient will start with starter pack of Gralise and will reach therapeutic dose of 1800 mg per day by end of 2 weeks.
* Drug is to be taken with meal, once a day in the evening; once patient has reached the therapeutic dose of 1800 mg, patient will come in for visit, at which point the PI will evaluate the patient and may increase or decrease the dosage, but patient may not increase or decrease the dose of medication at his /her discretion.
* During study, patient will have total of 5 visits, 4 of which will be for duration patient will be on Gralise, and the last visit will be for tapering off the medication.
* During study, patient is asked keep a paper diary on which patient will record the numeric pain scale from Fibromyalgia, time the medication was taken, dose of medication, and any side effects.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be 18 years and older.
* Subject carries Fibromyalgia diagnosis based on American College of Rheumatology criteria.
* Fibromyalgia patients who are gamma-aminobutyric acid (GABA)-analogue (gabapentin or pregabalin) naïve, or those who have been on gamma-aminobutyric acid (GABA)-analogue, but discontinued due to side effects or having difficulty maintaining dosing schedule due to multiple doses per day, or those who are currently on immediate release gamma-aminobutyric acid-analogue (GABA).
* Able to distinguish pain from fibromyalgia and pain from other sources. (subjects with other rheumatic disease or medical conditions that contributed to the symptoms of fibromyalgia will be excluded)
* Subject pain scores \>4 on Numeric pain rating scale (NPRS)

Exclusion Criteria:

* Creatinine clearance of \< 30mg/ml
* Pain from Traumatic injury or structural or regional rheumatic disease
* Unstable medical or psychiatric illness
* Lifetime history of psychosis, hypomania, or mania.
* Epilepsy, or dementia
* Substance abuse in the last 6 months
* Suicidal tendencies
* Pregnant or breastfeeding
* Not on contraception for those of childbearing age. (Barrier methods, oral contraception, hormone injections, or surgical sterilization)
* Subjects who are, in the opinion of the principle investigator, are treatment refractory
* Treatment with investigational drug within 30 days of screening.
* Concomitant medication exclusions consisted of medications or herbal agents with Central Nervous System (CNS) effects with exception of episodic use of sedating antihistamines
* Subject who are on more than one additional class of concomitant fibromyalgia medications i.e. non-selective serotonin reuptake inhibitor (SSRI) antidepressants, topicals, opioids.
Telephone-Based Support Programs for People With Epilepsy

This is a two-arm randomized controlled trial to compare telephone-based depression self-management (UPLIFT) to telephone-based support groups (BOOST). A sample of 120 English- and Spanish-speaking people with epilepsy (PWE) with elevated depressive symptoms will be enrolled. Both interventions are 8-week programs delivered in one-hour weekly sessions to groups of about 6 participants. Changes in depressive symptoms, quality of life and seizures will be assessed over 12 months. The trial will also examine mediators and moderators of treatment effects.

The objectives of the trial are:

1. To test effects of UPLIFT versus BOOST on changes in depressive symptoms (primary outcome) in PWE over 12 months.
2. To test effects of UPLIFT versus BOOST on changes in quality of life and seizures (secondary outcomes) in PWE over 12 months.
3. To test whether intervention effects are mediated by increases in mindfulness and decreases in rumination.
4. To test whether intervention effects are moderated by participant characteristics and facilitator characteristics.

Eligibility Criteria:
Inclusion Criteria:

* adult (≥18 years of age);
* diagnosed with epilepsy for at least one year;
* fluent in English or Spanish;
* elevated depressive symptoms (PHQ-9 score ≥10);
* willing to participate in audiotaped group telephone sessions

Exclusion Criteria:

* severe depressive symptoms (PHQ-9 ≥20);
* active suicidal ideation (PHQ-9 item #9 ≥1 or otherwise reported during screening);
* active psychotic disorder (psychiatric diagnosis or antipsychotic medications in the EHR);
* significant cognitive impairment (indicated in EHR or evident during screening)
Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
* Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.

  * The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.

Exclusion Criteria:

* Concurrent participation or participation in the last thirty days in any other clinical trial.
* Known steroid IOP responder
* Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.)
* Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
* Uncontrolled systemic or ocular disease
* Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
* Pseudoexfoliation
* Ocular hypertension IOP \>25 mmHg by tonometry or glaucomatous changes in the optic nerve
Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+

In the vast majority of those infected with HIV virus who are untreated, there is deterioration in immune health over a period of months or years inevitably leading to full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if started before a certain degree of progression occurs and has saved millions of lives. The investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.

The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating qualities in very low dosage and may offer an alternative to ARV drugs that is effective, non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration. LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due to toxicity of current ARV drugs and need for special medical management young HIV infected children are largely neglected particularly in developing countries; LDN can also be made available in a transdermal cream for infants and children who are HIV infected.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected
* CD4 count over 350 (arm 1/group 1)
* CD4 count over 200 and on ARV's (arms 2,3/groups 2,3)
* Age between 18 \& 60
* Males or females

Exclusion criteria:

* HIV-1 seronegative
* HIV-2 infected
* CD4 count lower than 200
* patients under age 18
* Those refusing to be in study
* Pregnant or breast-feeding women
* Patients under immuno-suppressor therapy
* Those with renal or hepatic dysfunction
* Malaria or tuberculosis