cyrilzakka/clinical-trials huggingface dataset:
Phase I Study of Sequential Cord Blood Transplants

The purpose of this study is to determine the safety of sequential cord blood transplantation (2 cord blood units) for patients who have diseases that are capable of being cured by allogeneic stem cell transplant but do not have a matched family or volunteer unrelated donor.

Eligible patients will receive conditioning therapy with fludarabine 30 mg/m2/day x 6 days, melphalan 100 mg/m2/day x 1 day, rabbit antithymocyte globulin 1.5 mg/kg/day x 4 days. GVHD prophylaxis will consist of cyclosporine starting on day -1 and mycophenolate mofetil starting on day 0. Sequential cord blood units will be infused on Day 0.

Eligibility Criteria:
Inclusion Criteria:

* Disease Status: NHL, HD, or MM refractory to chemotherapy or relapsed; CLL Rai Stage III/IV, or lymphocyte doubling time of 6 months, or Stage I/II resistant to 2 chemotherapy regimens; AML or ALL in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
* Estimated disease-free survival of less than one year
* ECOG performance status of 0, 1, 2
* Lack of 6/6 or 5/6 HLA matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
* 4/6 or greater HLA A, B, CRB1 cord blood units with a combined nucleated cell dose from of \> 3.7 x 10(7) NC/kg

Exclusion Criteria:

* Cardiac disease: symptomatic congestive hearth failure or RVG or echocardiogram determined left ventricular ejection fraction of \< 45%, active angina pectoris, or uncontrolled hypertension
* Pulmonary Disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO of \< 50%
* Renal disease: serum creatinine \> 2.0 mg/dl
* Hepatic disease: serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome), SGPT or SGOT \> 3 x normal
* Neurologic disease: symptomatic leukoencephalopathy, active DNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
* HIV antibody or Hepatitis B surface antigen positivity
* Uncontrolled infection
* Pregnancy or breast-feeding mother
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients

Neuromyelitis optica (NMO) is an autoimmune inflammatory demyelinating disease of the central nervous system that leads to blindness and paralysis. Since disability accrues incrementally related to attacks, attack prevention with immunosuppressive therapy is the mainstay of preventing disability. However, there is no standard immunosuppressive treatment strategy for NMO relapse prevention. In a previous study, the investigators provided evidence supporting the use of azathioprine plus a low dose corticosteroid as an effective strategy which is associated with a reduction in the risk of relapse in Chinese patients with NMO, but azathioprine has bone marrow suppression and other side effects. Mycophenolate mofetil (MMF) is a new immunosuppressant with rapid onset, fewer side effects and other advantages. In recent years, MMF has been used in different immune-related neurological diseases; some literature shown the possible efficacy of MMF in NMO treatment.

In this research, a multi-center (Third Affiliated Hospital of Sun Yat-sen University, Zhongshan Ophthalmic Centre of Sun Yat-sen University, Nangfang Hospital of Southern Medical University) study will carry out to evaluate the efficacy and safety of mycophenolate mofetil therapy in NMO spectrum disorders.


Eligibility Criteria:
Inclusion Criteria:

* Meet the 2006 Wingerchuk diagnostic criteria;
* NMO-immunoglobulin G seropositive;
* Between 18 to 65 years old;
* Relapse: more than 2 relapses in recent 2 years; more than 1 relapses in recent 1 years;
* Expanded disability status scale: expanded disability status scale≤7.0, and visual acuity ≥20 / 100 at least in one eye
* Understand the purpose and procedures of this study, and written informed consent is obtained.

Exclusion Criteria:

* Using immunosuppressive agents and other drugs affect evaluation, and drug withdrawal less than 3 months;
* Patients with any of the following diseases: transaminases elevation exceed 2 times of the normal upper limit; white blood cell \<4 × 109 / L, Hemoglobin \<80g / L, platelet \<100 × 109 / L;
* With serious cardiovascular, liver, kidneys and other vital organs and blood, endocrine system diseases, cancer history;
* With immunodeficiency, uncontrolled infection and active gastrointestinal diseases (such as gastric ulcer, etc.);
* Pregnancy, breast-feeding women and male or female who plans to conceive recently;
* Allergy to mycophenolate mofetil and prednisone.
Investigation on Safety, Tolerability, and Pharmacokinetics of Single Doses of NNC0113-0987 in Healthy Male Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of single doses of NNC0113-0987 in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with good general health as judged by the investigator, based on medical history, physical examination including 12-lead electrocardiogram (ECG), vital signs, and blood assessments at the screening visit
* Body mass index (BMI) above or equal to 18.5 and below 30 kg/m\^ 2

Exclusion Criteria:

* Male subjects who are sexually active and not surgically sterilised, who or whose partner is unwilling to use two different forms of effective contraception, one of which has to be a barrier method (e.g., condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 12 weeks following the last dose of trial medication
* Participation in another trial within 90 days prior to screening
* Subjects with a history of or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal (including gastroesophageal reflux disease and irritable bowel syndrome), endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorders that might have an impact on the current trial, as judged by the investigator
* Subjects who are known to have hepatitis or who are carriers of the Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies, or have a positive result to the test for Human Immunodeficiency Virus (HIV) antibodies
* History of acute idiopathic or chronic pancreatitis
MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects

The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers 18 - 70 years of age.
* Subjects able to give written informed consent and comply with study requirements.
* Subjects willing and able to safely discontinue all current prescription therapies.
* Subjects who will agree not to participate in other clinical trials.
* Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.

Exclusion Criteria:

* Persons who would be put at risk by discontinuing prescription therapies.
* Subjects with a known allergy to nitroglycerin.
* Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
* Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
* Subjects who have participated in a study of an investigational drug within two weeks of visit 1.
* Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unwilling to comply with the contraceptive requirements.
The Effect of Andullation Therapy on Pain and Anxiety After Oocyte Retrieval

The goal of this clinical trial is to evaluate the effect of andullation therapy in the management of pain and anxiety that occur in the patient follow-up after oocyte retrieval. The main questions it aims to answer are:

* Does andullation therapy after oocyte retrieval reduce pain measured immediately after the end of therapy?
* Does andullation therapy after oocyte retrieval reduce anxiety measured immediately after the end of therapy?

Researchers will compare experimental and control groups to see if andullation therapy reduce pain and anxiety after oocyte retrieval.

Participants will:

* Take State Anxiety Inventory before oocyte retrieval.
* Take andullation therapy or not after oocyte retrieval
* Take the State Anxiety Inventory and Visual Analog Scale at 1 hour, 1.5 hours, 6 hours, and 24 hours after oocyte retrieval.

During the oocyte retrieval procedure, midazolam, propofol, and remifentanil were administered intravenously by the anesthesia technician at doses determined by the anesthesiologist. During the two-hour period in which the women were closely monitored the procedure, 1 g of paracetamol vial recommended by the physician was administered intravenously by a reproductive health nurse to the women who stated that they had a lot of pain. Medical and technical details about the procedure and the patient, including the sedation protocol applied during oocyte retrieval, the number of oocytes collected, and whether a painkiller was administered was determined by the researcher based on information obtained from the physician and the patient's medical records.

In this study, the P05 relaxation program, one of the 10 different health programs of the andullation therapy bed, was used. Using the device control, the regional vibration intensity was set to 4, ensuring consistency across all regions. Infrared heat was activated in the neck and spine area with the H1 button and in the leg area with the H2 button. With this program, it was aimed to reduce anxiety by providing deep relaxation in the body and to provide the necessary energy for the body to repair itself.

to clearly show the duration of the effect of andullation therapy on pain and anxiety, intermittent scale applications were performed starting from before oocyte retrieval, when anxiety was thought to be the highest, until 24 hours after oocyte retrieval, when we expected the pain to gradually disappear.

Eligibility Criteria:
Inclusion Criteria:

* Having an oocyte retrieval procedure regardless of the cause of infertility,
* Being at least literate,
* Being between the ages of 18-49,
* Accepting to participate in the study,
* Pain level above 0, as measured by the VAS scale, applied after the oocyte retrieval procedure.

Exclusion Criteria:

* Having chronic pain problems,
* Having communication problems,
* Having any nervous or musculoskeletal disorders that would prevent them from lying flat on the massage bed,
* Having any diagnosed psychiatric illness,
* Refusal to participate in the study.
Learning Skills Together Family Caregiver Complex Intervention

Learning Skills Together (LST) is a 6-week psychoeducational intervention focused on complex care (nursing) tasks completed by family caregivers to persons living with Alzheimer's Disease and related dementias. This study aims to test the efficacy of LST at reducing caregiver depression and negative appraisal of behavioral symptoms of dementia by building caregiver self-efficacy. To do this, eligible participants will be randomized into an intervention group (LST) or a control group condition focused on healthy living for family caregivers. Participants will be asked to complete surveys before and after participating in the intervention or the control condition to determine whether change in hypothesized outcomes can be attributed to the intervention condition.


Eligibility Criteria:
Inclusion Criteria:

* Is aged 18 years or older
* Be a family member, including "families of choice," to an individual living with Alzheimer's disease or a related dementia who has received a diagnosis from a physician
* Provide assistance with at least two instrumental activities of daily living or one activity of daily living
* Report a Global Deterioration Scale (GDS) rating for care recipients between 4 to 6
* Commit to attending at least 5 of the 6 discussion sessions
* Has reliable access to the internet and email and be able to attend synchronous sessions using the Zoom videoconferencing platform

Exclusion Criteria:

* Unable to read and speak English
* Participated in Learning Skills Together in the past
* Plans to place the care recipient in a skilled nursing facility within the next 9 months (i.e., study duration)
* Was diagnosed with depression and/or started or significantly altered their depression treatment, including starting a pharmacological therapy or beginning therapy, in the previous 3 months
Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy

A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.

Daikenchuto (TJ-100), a traditional Japanese herbal medicine, is used for prevention and treatment of postoperative ileus. TJ-100 extract powder (Tsumura \& Co., Tokyo, Japan) is manufactured as an aqueous extract containing 2.2 % Japanese pepper, 5.6 % processed ginger, 3.3 % ginseng, and 88.9 % maltose syrup powder. A recent randomized, parallel-group, double-blind, placebo-controlled, dose-response trial demonstrated that TJ-100 accelerates colonic transit time, particularly in the ascending colon. Given its potential actions in the intestinal tract, it seems reasonable to postulate that TJ-100 may play a role in improving and preventing bowel dysmotility. This study was designed to investigate the effect of TJ-100 on intestinal dysmotility and for the prevention of postoperative paralytic ileus in patients undergoing pancreaticoduodenectomy.

The primary endpoint is the incidence of postoperative paralytic ileus. Secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change in ratio of abdominal circumference, the incidence of postoperative complications, the length of hospital day, and the incidence of surgical site infection. Two hundred patients are required for the study (100 patients per group).

Eligibility Criteria:
Inclusion Criteria:

* Patients with periampullary tumors (extrahepatic bile duct tumor, tumors of ampulla of Vater and duodenal tumor) and pancreatic tumors (pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, pancreatic endocrine tumor and pancreatic neuroendocrine tumor) of the head of the pancreas who are scheduled to undergo PD.
* Age of at least 20 years old at the time of registration.
* All patients provided written informed consent before initiation of study-related procedures.

Exclusion Criteria:

* Clinically problematic cardiac disease.
* Liver cirrhosis or active hepatitis.
* Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.).
* Chronic renal failure requiring hemodialysis.
* Other malignant disease that can influence the adverse effect.
* Patients with tumors requiring resection of colon.
* Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history.
* Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants.
* Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration.
* Pregnant or lactating women.
* Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Early Detection of Pulmonary- and Pulmonary Vascular Disease in Sjögren Syndrome

According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients.

This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.

Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.

Eligibility Criteria:
Inclusion Criteria:

* informed Consent
* diagnosis of Sjögren Syndrome
* age: 18 - 90 yrs

Exclusion Criteria:

* uncontrolled systemic hypertension (at rest \>150 mmHg systolic or 95 mmHg diastolic)
* relevant systolic (EF\<50%) or diastolic (\>Grade 1) left ventricular dysfunction
* uncontrolled ventricular arrhythmias
* uncontrolled supraventricular bradycardia or tachycardia
* myocardial infarction within the last 12 months
* pulmonary embolism within the last 6 months
* larger surgical interventions within the last 12 months
* musculoskeletal or vascular disease, that may affect ergometric investigations
* pregnancy (anamnesis)
Methodology and Clinical Value of RIT in Intestinal Obstructive Diseases Mediated by Colonic TET

The etiology of bowel obstruction is usually diagnosed by imaging techniques such as MSCTE,MRE, et al, which have some disadvantages. For example, in order to obtain better image quality, MSCTE（Multi-slices spiral computed tomography enterography） and MRE（ Magnetic resonance enterography）require patients to take a large amount of intestinal contrast solution orally, while for patients with intestinal obstruction, which may further aggravate the disease. Our study team had confirmed the mid-gut TET could serve as the delivery way of contrast solution for MRE bowel preparation with better accuracy of lesion detection and lower reduction of pain in CD（Crohn's Disease） patients. In this study, contrast solution will be delivered by colonic TET placed by lower GI-endoscopy, then we will evaluate the methodology and clinical value of this kind retrograde imaging technique in patients with intestinal obstructive diseases.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms of intestinal obstruction such as abdominal pain, abdominal distension, nausea, vomiting, cessation of anal exhaust and defecation；
* Abdominal X-ray or plain CT showed signs of intestinal obstruction;
* Participants suspected with intestinal stricture according to the recent lower GI endoscopy；
* Voluntarily sign written informed consent.

Exclusion Criteria:

* Signs of peritonitis, perforation or massive hemorrhage of digestive tract;
* Accompanied with severe heart, brain, lung and kidney dysfunction, unable to take lower GI endoscopy;
* Allergic to laxatives or iodine contrast agents;
* Pregnant women;
* Confirmed or suspected claustrophobia;
* Inability to understand or provide informed consent
Desmopressin Monotherapy for Monosymptomatic Nocturnal Enuresis

Nocturnal Enuresis (NE) is defined as the involuntary passage of urine during sleep past the age of usual control, which is considered a developmental age of 5 to 7 years.

NE is a common problem that causes distress to both children and their families. It has an adverse impact on behavior and social life, affects self-esteem, and can result in poor emotional well-being. In Egypt, the prevalence of NE in primary school children is about 15.4%. The family history was seen to have had a markedly significant impact on the occurrence of NE in the studied children. The mainstay of treatment is urotherapy with information and psychoeducation about normal lower urinary tract function, the underlying cause of MNE, disturbed bladder dysfunction in the child with NMNE, and instructions about therapeutic strategies. Alarm therapy and desmopressin are effective in randomized trials. Children with NMNE first need treatment of the underlying daytime functional bladder problem before treatment of nocturnal enuresis.


Eligibility Criteria:
Inclusion Criteria:

* School age group (from 7 to 14 years)
* Primary monosymptomatic nocturnal enuresis

Exclusion Criteria:

Patients with one or more of the following will be excluded from the study.

* Diurnal enuresis
* Urinary tract infection within the preceding 3 months
* Diabetes mellitus
* History of renal disease, hypertension or genitourinary abnormality, neurological disease, or psychological disease.
* Post-micturition residual urine \>1/3 expected bladder capacity.
* Each patient will be subjected to the following.
Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.

One of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight below 1000 gram
* Diagnosed patent ductus arteriosis by Echocardiographic examination

Exclusion Criteria:

* Accompanied other congenital cardiac anomalies
* Severe thrombocytopenia \< 60.000
* Severe intracranial bleeding (Grade 3-4)
* Intestinal abnormality and necrotising enterocolitis