cyrilzakka/clinical-trials huggingface dataset:
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

This is an expanded access program (EAP) for eligible participants designed to provide access to autologous muscle derived cells (AMDCs). Treating physicians may submit requests for expanded access to Cook MyoSite's investigational product by email to MYO-ExpandedAccess@CookMyoSite.com.

Cook MyoSite, Inc. (Cook MyoSite) is committed to conducting rigorous, controlled clinical trials with variable inclusion and exclusion criteria based upon the indicated use under investigation. Participation in our clinical trials is the first and most preferable route to access our investigational product.

We understand that there may be patients with a serious, life-threatening disease or condition that have explored all other treatment options and are unable or ineligible to participate in our clinical trials. Expanded access, otherwise known as "compassionate use" or "pre-approval access," is a potential pathway to access an investigational product that a patient may otherwise be unable to receive.

Cook MyoSite will consider providing an investigational product to a qualified requesting physician currently licensed within the United States via the United States Food and Drug Administration's (FDA's) expanded access pathway outside of an active clinical trial when eligibility criteria are met.

Eligibility Criteria:
Eligibility Criteria:

1. The patient has a serious or life-threatening disease or condition with no satisfactory alternative.
2. Positive assessment that the anticipated benefits outweigh the risks to the patient.
3. Positive assessment that Cook MyoSite has an adequate supply of resources for producing the investigational product.
4. A determination that expanded access will not interfere with Cook MyoSite's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.
5. The patient can undergo a muscle biopsy procedure(s).
6. The patient can undergo Cook MyoSite's required donor screening and testing.
Neuropathic Pain Symptoms in Arthritis

It was aimed to compare neuropathic pain symptoms in hand osteoarthritis and rheumatoid arthritis.

The patients with hand osteoarthritis or neuropathic complaints accompanying rheumatoid arthritis who applied to the Physical Medicine and Rehabilitation Clinic of our hospital will be included. In both patient groups, the duration, character and treatments of their complaints will be compared. Neuropathic pain will be evaluated with the Visual Analog Score (VAS), Dolor Neuropathic 4 Questions (DN-4) and Pain Detect pain questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Presence of Hand Osteoarthritis and Rheumatoid Arthritis
* Presence of neuropathic complaints

Exclusion Criteria:

* History of hand injury, peripheral nerve injury, fracture, and hand operation in the last 3 months
* Do not want to participate in the study
Rehabilitation in Parkinson Disease Cyclone in Life

Comparison of two rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

* Improved joint function and gait pattern
* Reduction of the risk of falling or reduction of energy expenditure during physiological gait

Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

rehabilitation protocols in patients with Parkinson's disease and, therefore, identification of innovative rehabilitation protocols of proven and validated efficacy, through which it is possible to achieve:

Improved joint function and gait pattern Reduction of the risk of falling or reduction of energy expenditure during physiological gait Evaluation of the increase in maximal effort tolerance

· Improved cognitive performances

Evaluation of the impact on the quality of life of the patient and family members

Identification of morpho-functional markers predictive of clinical and rehabilitative out-come through neuroimaging study.

Eligibility Criteria:
Inclusion Criteria:

* Hoehn \& Yahr between 2.0 and 3.0;
* No need for a walking aid;
* Mini-Mental State Examination (MMSE) score \>24;
* Effective dopaminergic pharmacological control;
* Absence of other relevant neurological comorbidities;
* Absence of postural deformities (and/or Pisa syndrome);
* Absence of severe cardiological pathologies (exertional angina, severe decompensation).
* Ability to travel to the rehabilitation treatment site independently or with support

Exclusion Criteria:

* presence of Deep Brain Stimulation (DBS);
* presence of severe heart and/or lung disease;
* presence of therapeutic regimen in the definition phase;
* impaired joint and/or motor function to follow a proposed rehabilitation treatment programme
* contraindications to performing MRI scans
* undergoing rehabilitation therapy in the 3 months preceding enrolment.
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men With Benign Prostatic Hyperplasia Symptoms

The goal of this study is to determine the safety and effectiveness of the FloStent, a medical device used to treat men with symptoms of Benign Prostatic Hyperplasia, compared to sham (procedure without deployment of the FloStent). All participants will undergo a flexible cystoscopy and those randomized to the treatment arm will receive the FloStent, while those randomized to the sham arm will not receive the FloStent.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects \> 45 years of age who have symptomatic BPH
* International Prostate Symptom Score (IPSS) score \>13
* Peak urinary flow rate (Qmax): \>5 mL/sec and \<13 mL/sec with minimum voided volume of \>125 mL
* Post-void residual (PVR) \<250 mL
* Prostate volume 25 to 80 mL
* Prostatic urethral length 20-50 mm
* Able to complete the study protocol and visits

Exclusion Criteria:

* Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
* Prior minimally invasive intervention or surgical intervention of the prostate or urethra
* PSA \>10 ng/mL
* Bladder cancer or bladder stones
* Active urinary tract infection (UTI)
* Uncontrolled diabetes
* Part of a vulnerable population (cognitively challenged or are incarcerated)
Comparison of Open Laparoscopic and Robotic Surgery in Gastric Cancer Resection.

Gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. Reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer. Although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy. In recent years, the Da Vinci robot assisted gastric resection has become a new way to treat gastric cancer. Compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect. The aim of the study is to compare value (outcomes/costs) of surgery in patients with Gastric Cancer by 3 approaches: open, laparoscopic, and robotic.First of all, the investigators will collect 500 cases of Gastric Cancer patients, randomly assigned for the open, laparoscopic, and robotic group. Secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.


Eligibility Criteria:
Inclusion Criteria:

* Patients without contraindications gastroscope，surgery and anesthesia;
* There is no history of abdominal surgery, no severe abdominal cavity adhesion
* Patients signed informed consent

Exclusion Criteria:

* Patients with preoperative assessment of distant metastasis;
* Patients with preoperative radiation and chemotherapy or hormone therapy;
* Patients with acute obstruction, bleeding or perforation of the emergency surgery
* Patients with a history of abdominal trauma or abdominal surgery.
* Patients with contraindications gastroscope，surgery and anesthesia;
Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts

The primary purpose of this study is to evaluate the effectiveness of destructive therapy for anogenital warts in combination with the use of Ingaron in comparison with destructive therapy.

Literature data and the results of preclinical studies of interferon-gamma, as well as the features of HPV immunopathogenesis, show the expediency of studying the use of Ingaron in this pathology.

The study was planned to include 50 outpatients of both sexes aged 18 to 50 years with a confirmed diagnosis of anogenital warts.

In the course of the study, Ingaron was administered at a dose of 100,000 IU once a day every other day in the period of 10 days.

Patients were divided into 2 groups: study and control.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts".
2. The diagnosis "Anogenital warts" was made for the first time at least one year before inclusion in the study.
3. During the last year prior to inclusion in the study, the patient had at least 2 recurrences of anogenital warts.
4. The diagnosis is confirmed by the detection of HPV by polymerase chain reaction (PCR).
5. Negative pregnancy test in women.
6. Availability of written informed consent to participate in the study.

Exclusion Criteria:

1. Positive test results for syphilis, hepatitis (HbsAg, anti-HCV), HIV infection, gonococcal infection, urogenital trichomoniasis, chlamydial infection, inflammatory diseases of the urogenital system caused by genital mycoplasmas.
2. Unsystematic use of barrier methods of contraception.
3. Pregnancy and lactation.
4. Known allergic reactions to interferons and / or other significant allergic diseases.
5. Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
6. The need to take drugs prohibited during the study.
7. Condition after organ transplantation, constant intake of immunosuppressive drugs.
8. Severe pathology from the cardiovascular system (uncontrolled arterial hypertension, unstable angina pectoris, congestive heart failure, cardiac arrhythmias), a history of myocardial infarction or cerebrovascular accident within the last 6 months.
9. Severe pathology on the part of the liver (increased content of AST, ALT 2 times higher than the upper limit of the norm, the content of total bilirubin\> 2 mg / dL), kidney (content of creatinine\> 1.5 mg / dL); signs of hepatic and / or renal failure.
10. The presence of severe pathology on the part of the respiratory system, gastrointestinal tract, hematopoietic system.
11. Other serious (acute or chronic) pathological conditions, including mental illness, as well as abnormalities in laboratory parameters, which, in the opinion of the investigator, may increase the risk associated with participation in the study or affect the interpretation of efficacy and safety data obtained in this research.
12. Alcohol and / or drug dependence.
13. Participation in other clinical trials in the last three months prior to inclusion.
Impact of Palliative Catheter Placement on the Quality of Life of Patients With Refractory Ascites

The purpose of this study is look at how treatments for ascites affect quality of life. Your quality of life is the ability for you to enjoy the normal things you do. Ascites (pronounced as-ī-tees) is the presence of extra fluid in the abdomen. Sometimes ascites is caused by cancer, also called malignancy.

All people who participate in this study have ascites associated with cancer. Ascites can cause symptoms that make it difficult for the patient to do simple things. Patients with ascites often report:

Abdominal swelling Difficulty walking. Difficulty breathing. Feeling full when eating. Clothes not fitting due to a swollen abdomen. Swelling in the legs. It is hoped that this catheter will relieve the symptoms of the ascites. The goal of the investigators study is to understand the quality of life before the procedure and after the procedure. Since the patient is having this procedure to make their symptoms better, the investigators want to hear from the patient of how the procedure has affected their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with a stage IV malignancy or end-stage disease documented in patient's chart.
* Patients referred to interventional radiology for treatment of refractory ascites with the placement of a permanent catheter including, but not limited to, a Tenckhoff catheter, a PleurX catheter, or a Denver Shunt.
* Fluency in English to enable instrument and interview completion.
* Patients must be at least 18 years of age.
* Patients must be physically capable of completing instruments and/or interview.
* Patients must be able to comprehend and execute informed consent.

Exclusion Criteria:

* Unable to complete questionnaire due to a significant physical or mental deficits as assessed by the consenting professional.
* Proxy completion is not accepted
* Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument
Comparison of Nebulized Neostigmine/Atropine Versus Lignocaine in Treating Acute Post-dural Puncture Headache Following Subarachnoid Block in Parturient Undergoing Elective Cesarean Section. A Randomized, Clinical Trial.

Post-dural puncture headache (PDPH) is a common and debilitating complication of spinal anesthesia in pregnant patients undergoing cesarean sections, with an incidence ranging from 0.5% to 2% (1). The International Headache Society (IHS) defines PDPH as a headache occurring within 4 days of a lumbar puncture, caused by cerebrospinal fluid (CSF) leakage through the dural puncture (2). Although the exact cause of PDPH is not fully understood, it is thought to occur due to cerebrospinal fluid loss through dural tears, which leads to tension on pain-sensitive intracranial structures and reflex, uncontrolled cerebral vasodilation leading to severe agonizing tension headache (3). Treatment options include proper hydration, maintaining a supine position, caffeine, paracetamol, nonsteroidal anti-inflammatory drugs (NSAIDs). Many adjuvants have been questioned for their therapeutic effectiveness in enhancing conservative medical treatments, with conflicting results (4). For example, sumatriptan, theophylline and dexmedetomidine have been extensively studied. Neostigmine has emerged as a promising pharmacological adjuvant for conservative management. Neostigmine increases the serum level of acetylcholine via inhibition of cholinesterase (5). This action mediates cerebral vasoconstriction via nicotinic receptors, thus antagonizing the unopposed vasodilatation occurred due to dural tear. Lidocaine, on the other hand, can mediate sphenopalatine ganglion block which is responsible for pain signals transmission from the face (6).


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years old parturient with post partum headache after elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 \[14\] and Lybecker classification score ≥ 2

Exclusion Criteria:

* Pregnancy induced hypertension
* Emergency C.S
* Asthmatic candidates
* Previous history of migraine or trigeminal neuralgia
* History of bronchial asthma
* Post partum hemorrhage
* Need for GA , failed spinal anesthesia
* Patient refusal
ACTH in Progressive Forms of MS

This is a phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and efficacy of adrenocorticotropic hormone (ACTH, Acthar gel) administered as a pulsed regimen consisting of injections on three consecutive days per month in patients with progressive forms of Multiple Sclerosis (MS). Patients will be randomly assigned to either an ACTH arm or a placebo arm. The main hypotheses are that 1) pulsed ACTH will be safe and well-tolerated, and 2) pulsed ACTH will slow progression of clinical and paraclinical measures of MS progression compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with a confirmed diagnosis of MS by McDonald criteria
* Age \>/= 18 years
* SPMS, PPMS, or PRMS phenotype, according to Lublin and Reingold criteria
* EDSS 2.0 - 6.0, inclusive
* Able to understand the consent process

Exclusion Criteria:

* Known intolerance of ACTH or corticosteroids
* Diabetes mellitus, defined as pre-existing diagnosis, fasting blood glucose \> 125 mg/dl, or glycosylated hemoglobin \>/= 6.5%
* Osteoporosis, defined as pre-existing diagnosis or T-score on dual-energy x-ray absorptiometry (DEXA) scan of \</= -2.5.
* Current serious medical condition which may interfere with subject's ability to complete the study, or for which pulsed ACTH therapy is contraindicated or might complicate current therapy (e.g., cancer, severe psychiatric illness, chronic infections, autoimmune disorders)
* Treatment with cytotoxic agents (including but not necessarily limited to mitoxantrone, cyclophosphamide, alemtuzumab, or rituximab) within 3 years prior to randomization
* Treatment with non-cytotoxic immunosuppressive agents (including but not necessarily limited to corticosteroids, ACTH, azathioprine, mycophenolate mofetil, methotrexate or natalizumab) within 3 months prior to randomization
* Treatment with FDA-approved first-line MS disease-modifying therapies (B-interferon, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) will be permitted, as long as treatment has been ongoing and stable for at least 3 months prior to randomization
* Treatment with dalfampridine or compounded 4-aminopyridine (4-AP) will be permitted as long as treatment has been ongoing and stable for at least 3 months prior to randomization
* Stimulant medications for fatigue (such as methylphenidate, modafinil, armodafinil, amantadine or dextroamphetamine) will be permitted, but subjects will be asked to not take these medications on study visit days until all study procedures/assessments are completed.
Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers

The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters


Eligibility Criteria:
Inclusion criteria:

* patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
* Patients must have a diagnosis of COPD and must meet the following spirometric criteria:

Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1\>30% and \< 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC \<70% at Visit 1

* Male or female patients, 40 years of age or older.
* Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
* Patients who have never smoked cigarettes must be excluded.
* Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary
* Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).

Exclusion criteria:

* Significant disease other than COPD
* Clinically relevant abnormal lab values.
* History of asthma.
* Diagnosis of thyrotoxicosis
* Diagnosis of paroxysmal tachycardia
* History of myocardial infarction within 1 year of screening visit
* Unstable or life-threatening cardiac arrhythmia
* Hospitalization for heart failure within the past year
* Known active tuberculosis
* Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
* History of life-threatening pulmonary obstruction and patients with chronic respiratory failure
* History of cystic fibrosis
* Clinically evident bronchiectasis
* History of significant alcohol or drug abuse
* Thoracotomy with pulmonary resection
* Patients treated with oral or patch ß-adrenergics
* Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent
* Regular use of daytime oxygen therapy for more than one hour per day
* Pulmonary rehabilitation program in the six weeks prior to the screening visit or patients currently in a pulmonary rehabilitation program
* Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
* Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA
* Pregnant or nursing women
* Women of childbearing potential not using a highly effective method of birth control
* Patient who have previously been randomized in this study or are currently participating in another study
* Patients who are unable to comply with pulmonary medication restrictions prior to randomization
Ottawa Nutritional Guidelines for Nausea and Vomiting

Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)

Studying the Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial) using no pharmacological agents and life style modification in addition to acupressure to treat nausea and vomiting of pregnancy

Eligibility Criteria:
Inclusion Criteria:

1. primigravida
2. gestational age of 7-13 weeks
3. singleton pregnancy
4. having a score of 7-12 on the (PUQE 24)
5. can read and write
6. having phone number
7. not receiving medications for reducing NVP, except for vitamin B6
8. wanted pregnancy.

Exclusion Criteria:

1. subject's unwillingness to continue the study
2. occurrence of obstetric complications during the study
3. hyper-emesis gravidarum
4. having physical or mental disorders
5. having oral/speech impairments
6. having assisted reproductive techniques for the present pregnancy
7. having two consecutive miscarriages before the current pregnancy
8. old primigravida
9. narcotic use or alcohol drinking
10. and subjects who will show signs and symptoms of hyperemesis gravidarum during the study will be dropped out and referred to medical care.
Intestinal Microflora in Lung Cancer After Chemotherapy

Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. Probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for chemotherapy of lung cancer

Exclusion Criteria:

* Antibiotic, probiotic or prebiotic usage within 1month
* Other malignancy
* History of abdominal surgery
* Pregnant or breast-feeding (for females)
* Impaired liver or renal function
* Diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder