cyrilzakka/clinical-trials huggingface dataset:
Haploidentical Bone Marrow Transplant With Post-Transplant Cyclophosphamide for Patients With Severe Aplastic Anemia

Severe aplastic anemia is a rare and serious form of bone marrow failure related to an immune-mediated mechanism that results in severe pancytopenia and high risk for infections and bleeding. Patients with matched sibling donors for transplantation have a 80-90% chance of survival; however, a response rate with just immunosuppression for those patients lacking suitable HLA-matched related siblings is only 60%. With immunosuppression, only 1/3 of patients are cured, 1/3 are dependent on long term immunosuppression, and the other 1/3 relapse or develop a clonal disorder. Recent studies have shown that using a haploidentical donor for transplantation has good response rates and significantly lower rates of acute and chronic GVHD.

Mismatched haploidentical donors will be identified for patients with severe aplastic anemia. These patients will undergo a preparative regimen of Fludarabine/Cyclophosphamide/TBI followed by haploidentical bone marrow transplantation. Post-transplant Cyclophosphamide will be administered on Days 3 \& 4. Immunosuppression with Tacrolimus and MMF will begin on Day +5; MMF will be discontinued on Day +35 while Tacrolimus continues until Day +180. Investigators hypothesize that haploidentical transplantation with the above-mentioned preparative regimen will have a \<30% graft failure rate. The one-sided exact Binomial test at 5% significance level will be used to test this hypothesis. The size of 20 patients provides the power of 92.5% for confirming the 30-day graft failure rate \<30%.

Eligibility Criteria:
Inclusion Criteria:

* Availability of 3/6 - 5/6 matched (HLA-A, B, DR) related donor who must have negative HLA cross-match in the host vs. graft direction
* Age \<= 65 years for previously treated and \<= 75 years for previously treated patients
* KPS \>= 70%
* Aplastic Anemia that meets the following criteria:

Peripheral Blood (must fulfill 2 of 3):

* \<500 PMN/mm3
* \<20,000 platelets
* absolute reticulocyte count \<40,000/microL

Bone Marrow (must be either):

* markedly hypocellular (\<25% of normal cellularity)
* moderately hypocellular with 70% non-myeloid precursors and patient meets peripheral blood criteria above

Exclusion Criteria:

* poor cardiac function (LVEF \<40%)
* poor pulmonary function (FEV1 \& FVC \<50% predicted)
* poor liver function (bili \>= 2mg/dL)
* poor renal function (creatinine \>= 2.0mg/dL or creatinine clearance \<40mL/min)
* prior allogeneic transplant
The Final Diagnosis and Treatment Result of Metastatic Cervical Carcinoma of Unknown Primary

Investigate the final diagnosis and treatment result of metastatic cervical carcinoma of unknown primary

Carcinoma of unknown primary (CUP) is defined as biopsy-proven metastasis of an epithelial malignancy in the absence of an identifiable primary site after complete history and physical examination, basic laboratory studies, chest X-ray and additional directed studies indicated by positive findings during the initial work-up. It is characterized by its slow local development and its high metastatic potential.1,2 Patients with CUP represent 4-10% of all new cancer patients.3,4 The presenting sites of metastasis identified pathologically, radiographically or by physical examination were found most frequently in the lymph nodes (37.1%), followed by the liver, bone, lung, pleura/pleural space, brain, peritoneum, adrenal and skin. Of the lymph nodes of metastasis, the supraclavicular cervical area is the leading site (31.3%), followed by the mediastinum, axilla, retroperitonium, and inguina.5 The incidence of metastatic cervical CUP (MCCUP) varies between 2% and 9% of all head and neck cancers.6-8 The level of cervical metastatic involvement may give some clue as to the likely primary site. A submandibular mass (level I) would most commonly be related to a primary in the oral cavity or skin. Level II nodes, including the jugulodigastric node, may point to a primary in the oral cavity, oropharynx, or supraglottic larynx. Tumours of the nasopharynx generally spread to level II or the posterior triangle, as well as retropharyngeal nodes. Middle and lower jugular nodes (levels III and IV) are more likely related to a laryngeal or hypopharyngeal cancer. Metastatic disease restricted to the supraclavicular region is often due to an infraclavicular primary site.9 The prognosis is different according to the involved lymph node level and possible primary site. Modern cancer management relies heavily on recognition of the primary tumor; thus the absence of a primary site poses major diagnostic and therapeutic problems. The patient benefits from identification of the initial tumor site because postoperative irradiation ports may be reduced and because surveillance for recurrence may be improved.10 In order to identify the likely primary site of MCCUP and compare the prognoses of known and unknown primary groups, we report the results according to the different levels of metastatic cervical lymph nodes.

Eligibility Criteria:
Inclusion Criteria:

* cases of metastatic cervical carcinoma of unknown primary

Exclusion Criteria:

-
Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.

Researchers are gathering information on one specific part of a feeding tube, known as the adjustable skin disk. Researchers are trying to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support adequate healing, and reduced complication rates.

During the procedure of placing a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube), the gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk (CPSD) by sliding the former off and the latter on to the feeding tube.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 22 years
* Undergoing PEG tube or PEJ tube placement

Exclusion Criteria:

* History of tobacco or illegal drug use in the past year
* History of an enteral tube
* History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)
Quality of Life in Parents of Adolescents With Spinal Deformities: Development of a New Questionnaire.

This study aims to develop a new instrument capable of providing an efficient measure of the quality of life of parents of conservatively treated patients with spinal deformity. The development of a questionnaire in a Rasch environment and specifically developed for parents of conservatively treated patients will ensure greater sensitivity and specificity of the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* have at least one child between the ages of 10 and 18 with adolescent idiopathic scoliosis of 10 degrees or more, or with Scheuermann's kyphosis or idiopathic hyperkyphosis
* prescription of a brace or specific exercises for the child's vertebral deformity.

Exclusion Criteria:

* Child with a history of spinal surgery
* Child with a history of significant diseases with possible impact on the quality of life of the parents
* Child with a history of spinal trauma
* Child with positive neurological evaluation
Vaccine Therapy in Treating Patients With Ovarian, Fallopian Tube, or Peritoneal Cancer

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to kill the tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian, fallopian tube, or peritoneal cancer.

OBJECTIVES: I. Determine the safety of immunization with glycosylated MUC-1-KLH vaccine plus adjuvant QS21 in patients with ovarian, fallopian tube, or peritoneal epithelial cancer. II. Determine the dose of this treatment regimen for optimal antibody response in these patients. III. Determine the effect of immunization with this treatment regimen on the T-cell response in these patients.

OUTLINE: This is a dose escalation study of glycosylated MUC-1-KLH vaccine. Patients receive glycosylated MUC-1-KLH vaccine and QS21 subcutaneously once a week on weeks 1-3, 7, and 19. Cohorts of 6 patients receive escalating doses of glycosylated MUC-1-KLH until the dose for optimal antibody response without unacceptable toxicity is determined. Patients are followed at 2 and 12 weeks, and then every 3 months thereafter as long as detectable immunity against MUC-1 persists.

PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed ovarian, fallopian tube, or peritoneal epithelial cancer (any stage at diagnosis) Prior cytoreductive surgery required Refractory or recurrent after at least one prior regimen of platinum based chemotherapy No evidence of disease following salvage chemotherapy, defined as: CA125 less than 35 units Negative physical examination No evidence of disease on CT scan of abdomen and pelvis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin, SGOT, and alkaline phosphatase less than 2 times normal Renal: Creatinine less than 1.6 mg/dL Creatinine clearance at least 50 mL/min Other: No other concurrent active invasive malignancy No seafood allergy No positive stool guaiac (excluding hemorrhoids)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
iECG: Recording Chest Leads Using a Smartwatch With a Digital Image Processing Algorithm

The purpose of this study is to evaluate the feasibility of a new method for self-recordable ECGs using a smartwatch coupled with an image processing algorithm. The long-term goal of this project is to establish such a method and to potentially integrate it into telemedical care.

There is an increasing availability of smartwatches worldwide. Health-related features of these wearables such as heart rate and -rhythm analysis have become increasingly recognised. Some smartwatches are capable of recording an electrocardiogram (ECG) which yields important information about electrical heart activity. Recording a complete ECG with a smartwatch is challenging if the user has no prior medical experience. In this feasibility study we introduce a novel image processing tool that instructs the user to record an ECG using the front camera of an iPad. In a second step, a standard ECG will be recorded by medical staff. The ECGs will then be compared by two board certified cardiologists. The aim of the study is to evaluate the feasibility of self-recorded smartwatch ECGs. If this method can be established, it could markedly expand the diagnostic options for heart and vascular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Participant ≥ 18 years
* Ability to record a smartwatch ECG
* Written informed consent as documented by signature from the participant

Exclusion Criteria:

* Smartwatch ECG or conventional ECG cannot be recorded due to comprehensible reasons (allergic reactions, wounds, etc.)
* Unable or not willing to sign informed consent
* Significant mental or cognitive impairment that could interfere with the measurements (e.g.

delirium, acute psychotic episode, etc., assessed by recruiting physician)

· Prior knowledge or experience in recording ECGs
Plantar Fasciitis and Therapeutic Ultrasound

The purpose of this study is to determine whether Therapeutic Ultrasound is effective in the treatment of Plantar fasciitis (PF).

Plantar fasciitis (PF) is the main cause of pain in the bottom of the heel. According to the American Physical Therapy Association guidelines since 2008, many treatments have been described to correct the problem, but there are very few high level randomized trials that proved them. Although not mentioned even in clinical treatment guidelines in PF, one of the most common conservative treatments for use, in general and Israel in particular, is a therapeutic ultrasound device. Despite this widespread use, there are very few research evidence which examining the effectiveness of this device for the treatment of PF. The purpose of this study is to evaluate the effect of therapeutic ultrasound versus sham ultrasound on pain, function and quality of life of patients with PF. Our hypothesis is that the use of ultrasound parameters that cause an increase in the target tissue heat (from 1.75 to 1 W/cm2, Continues intensity of 1 MHZ) will result in a significant improvement than placebo. To evaluate this hypothesis, we will do a prospective, controlled, randomized, double-blind interventional clinical study. The study population will include 60 patients, aged 18 or older, suffering from PF and meet inclusion criteria. Subjects will be divided randomly into study or control group, Both groups will receive stretching Instructions, when the study group will Receive active ultrasound and the control group will Receive sham ultrasound. Both groups will receive 8 treatments, twice a week.

Eligibility Criteria:
Inclusion Criteria:

* Worsening symptoms first steps in the morning or at the beginning of walking after sitting for long periods, and after long walking or standing.
* Pain at the bottom of the heel produced by weight bearing or local press.
* Pain level 3 or higher on NPRS at first steps in the morning.
* Tenderness, swelling, or both in the region of proximal plantar fascia and at medial plantar tuberosity of the calcaneous.
* Gradual development of pain at the bottom of the heel.

Exclusion Criteria:

* Peripheral neuropathy.
* Tarsal tunnel syndrome (TTS) \\ Fat Pad Syndrome (FPS).
* Calcaneal cyst, Fracture or bone cancer.
* Osteo Arthritis (OA) of the foot fingers or Rheumatoid arthritis (RA).
* Foot surgery at the last year.
* Steroid injections at the last six months.
* Pregnancy.
* Foot infection or diabetic foot.
* Stress fractures of the heel.
* Unavailability in advance to participate in research.
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability of DC371739 Treatment in Hypercholesterolemic

This study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DC739 after multiple-dose oral administration, to explore the clinical effective dose, and to initially explore the efficacy and safety in hypercholesterolemia subjects.

Totally about 30-50 qualified subjects were assigned to one of the following dose groups：20mg, 40mg, 60mg, 80mg, 120 mg (60mg and 120mg is the optional dose group). Each of the dose groups will include 10 subjects (8 for DC739 and 2 for placebo).

Subjects will be admitted for treatment on day -1 and receive the first dose of study drug or placebo on day 1 and then treat for 28 days. Subjects from different dose groups were enrolled in turn, the next dose group is conducted on the premise that the D15 safety evaluation was completed after the administration of the previous dose group with the result was tolerance.

Blood samples will be collected on day 1 for 48 hours and day 28 for 72 hours after administration for pharmacokinetic data analysis. Blood lipid will be collected for effectiveness evaluation. PCSK9 and ANGPTL3, Urine and feces were collected for explore analysis.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 65 years (inclusive 18 and 65);
* Body mass index of 18 to 32 kg/m2(inclusive);
* Hypercholesterolemia subjects with LDL-C≥2.6mmol/L(100mg/dL);
* Male or female subjects who had no immediate plans to have children, the serum pregnancy test of women was negative at the time of screening, and agreed to use strict contraceptive measures throughout the study period and up to 6 months after the last dose;

Exclusion Criteria:

* ECG confirmed that the QT interval was prolonged \> 450ms (QT interval corrected for heart rate by Bazetts formula \[QTCB\]);
* Use of statins (lovastatin, simvastatin, pravastatin, mevastatin, fluvastatin, atorvastatin, cerivastatin, rosuvastatin, pitavastatin, etc.) , ezetimibe, Xuezhikan, and other lipid-lowering treatment within 2 months prior to screening; use of PCSK9 monoclonal antibodies , fibric acid drugs (such as fenofibrate, gemfibrozil) and probucol within 3 months prior to screening;
* Use of warfarin, systemic steroids, cyclosporine, or other immunosuppressive therapy within months prior to screening;
* Subjects with HIV-AB , HBsAg, ANTI-TP , HCV-AB positive;
* A history of prescription drug abuse and illicit drug abuse within 6 months prior to screening;
* A history of alcohol abuse within 6 months prior to screening;
Serum Concentration of Adalimumab as a Predictive Factor of Clinical Outcomes in Rheumatoid Arthritis (AFORA)

Adalimumab is a fully human monoclonal antibody to tumor necrosis factor-alpha (TNF-α) approved in rheumatoid arthritis (RA) refractory to disease modifying anti rheumatic drugs (DMARDs) and for the treatment of severe, active and progressive RA in adults not previously treated with methotrexate.

However, almost one third of patients have no response and approximately 15% develop antibodies towards adalimumab (ATA) after a 6 month course of treatment. There is a relationship between adalimumab concentration and clinical response obtained after 6 month of treatment. Furthermore adalimumab concentration measured 3 months after initiation seems to predict the clinical response at 6 months.

There is an important inter individual pharmacokinetic variability of adalimumab. Side effects may occur at the recommended dose and more than 3 months of treatment are generally required to estimate the clinical response.

A therapeutic drug monitoring could help clinicians to early adjust the dose to optimize the response and to avoid dose related side effects. To date there is no definite adalimumab target concentration predictive of the clinical response to allow such a pharmacologic monitoring.


Eligibility Criteria:
Inclusion Criteria:

* RA according to the American College of Rheumatology (ACR) 1987 criteria
* Treatment with Adalimumab has been chosen by the physician / patient
* Treatment given in accordance to the SPC
* Stable Disease modifying anti rheumatic drugs (DMARDs) and glucocorticoids 4 weeks before enrollment and during the study period.
* Signed consent

Exclusion Criteria:

* more than one previous treatment with anti TNF-alpha
* Past history of malignancy, AIDS
* Pregnancy
* Change in DMARDS or glucocorticoid dose 4 weeks before entering the study
* Active or latent tuberculosis, other active infections
* Surgery scheduled during the study period
Variation of Echocardiographic Parameters After Red Blood Cell Transfusion in Emergency Department Anemic Patients

The goal of this interventional study is to asses echocardiographic variations in emergency department's elderly patients receiving red blood cell transfusion. The main questions it aims to answer are :

* is there a modification of echocardiographic parameters after red blood cell transfusion ?
* which parameter is the most impacted by red blood cell transfusion ? Participants will have a transthoracic echocardiography before, just after and 15 minutes after red blood cell transfusion.


Eligibility Criteria:
Inclusion Criteria:

* patient needing red blood cell transfusion
* consent
* social protection

Exclusion Criteria:

* fluid filing over 500 mL of crystalloids
* transfusion in the last hour
Dose Response of Valsartan on Sitting Systolic Blood Pressure in Children 6 Months - 5 Years of Age With High Blood Pressure

The purpose of this study is to evaluate the safety and efficacy of three doses of valsartan (0.25, 1.0, and 4.0 mg/kg) on mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP) in 6 months - 5 year old children with hypertension (sitting systolic blood pressure \[SSBP\] ≥ 95th percentile ).


Eligibility Criteria:
Inclusion Criteria:

* Children aged 6 months - 5 years at Visit 1, with a documented history of hypertension
* Must be able to swallow liquid formulation
* Must be ≥ 6 kg or ≤ 40 kg at randomization
* Must have documented history MSSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at randomization
* If patients enter with uncontrolled BP they can remain on background antihypertensives with an unchanged dosing regimen
* If patients have had a solid organ transplant more than 1 year ago they must be on stable doses of immunosuppressive therapy
* Parent(s)/guardian(s) are able to follow verbal and/or written instructions in the local language

Exclusion Criteria:

* Patients with background ARB therapy
* Patients demonstrating any clinically significant abnormalities or clinically noteworthy abnormal lab values (other than those relating to renal function)
* AST/SGOT or ALT/SGPT \> 3 times the upper limit of the reference range
* Glomerular filtration rate \< 30 mL/min/1.73m²
* Serum potassium \> upper limit of the reference range
* MSSBP ≥ 25% above the 95th percentile
* Patients exhibiting clinically significant ECG abnormalities
* Patients that have coarctation of the aorta with a gradient of ≥ 30 mm Hg, or renal artery stenosis

Other protocol-defined inclusion/exclusion criteria may apply
Efficacy of Gabapentin in Alcohol Dependency Treatment

The study aims to study the effect of gabapentin on the number of alcohol drinking days and heavy drinking days in the Thai clinical alcohol-dependent population by using the double-blinded randomized controlled approach. One-hundred and twelve individuals with alcohol dependence were randomly assigned equally into two groups including treatment with gabapentin and placebo. Thirty-four patients (30.3%) completed the study protocol, i.e. treatment with gabapentin at least 300 mg per day or placebo orally once a day for twelve weeks. Pattern of alcohol drinking were obtained from the timelime followback. Drinking behaviors were compared between the two groups by poisson repeated measures model.


Eligibility Criteria:
Inclusion Criteria:

* current diagnosis of alcohol dependence

Exclusion Criteria:

* having major psychiatric disorders including schizophrenia, schizoaffective disorder, bipolar disorder, major depressive disorder, or suicide risk based on a clinical interview by attending psychiatrist
* receiving other medications not in the protocol of the study for any reasons or having history of using other substances including methamphetamine, heroin, cannabis, inhalants, mitragyna speciosa (or kratom in Thai), except tobacco based on self-report
* having a medical disease, e.g. essential hypertension, diabetes, renal (e.g., normal renal test) or liver disease (e.g., liver function test was not higher than two times of normal range and gamma-glutamyl transferase (GGT) is less than 800 U/L), epilepsy, stroke
* having history of alcohol withdrawal seizure or delirium based on clinical interview by attending psychiatrist
* having moderate to severe alcohol withdrawal symptoms based on score \>13 of the Clinical Interview for Withdrawal Alcohol Arlington (CIWA - Ar) at the time of recruitment
* having cognitive impairment based on score \< 24 from the Mini Mental State Exam (MMSE)
* having history of allergy to gabapentin
* pregnancy or breast feeding.
Phase 3 Study of OTO-201 in Acute Otitis Externa

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).


Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female age 6 months or older
* Subject has a clinical diagnosis of unilateral or bilateral acute otitis externa
* Subject or subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has tympanic membrane perforation
* Subject has eczematoid otitis externa
* Subject has diabetes mellitus