cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Implants Placed Immediately or Delayed Into Extraction Sites

IRB4729 Study Hypothesis: Is there a significant difference in the hard and soft tissue response comparing immediate with delayed implant after tooth removal, with immediate provisionalization, in maxillary anterior sites.

The purpose of this study is to determine and compare the crestal bone levels as the primary endpoint variable for implants placed and temporized in extraction sites, to implants placed into extraction sites after the extraction site has been grafted and healed for 4 months, all immediately restored with an anatomic provisional restoration.


Eligibility Criteria:
Inclusion Criteria:

* All patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleaning twice a year 3 months prior to the data collection visit
* All patients will be free of uncontrolled diabetes (any type, existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage
* Need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain and swelling).
* Patients will have bone present on all surfaces of the tooth within 3mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant.
* all patients will have adequate space for satisfactory restoration of the edentulous space.
* each patients dentition will be free of active periodontal disease or exhibit controllable periodontal disease such that their teeth will clinically be non-mobile and have probing depths less than 3mm.
* All prospective sites will have at least 2mm of attached or keratinized gingiva.
* The crestal bone width should be enough to accommodate either a 3.75mm diameter implant for the central incisor, canine, and premolar sites or a 3.25 mm diameter implant for the lateral incisor tooth sites. Bone heights should be at least 14mm for accommodation of the implant.

Exclusion Criteria:

* Patients with labial dehiscence defects greater than 3mm from the proposed gingival margin of the planned restoration will be excluded from this study.
* Patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study.
* Patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an ASA III or IV rating will be excluded. Post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. Patients with known alcohol abuse will be excluded.
A Registered Cohort Study on SMA

Spinal muscular atrophy (SMA) is an autosomal recessive disease that causes progressive muscle wasting and weakness due to loss of motor neurons in the spinal cord. This is a registered cohort of spinal muscular atrophy (SMA) type I，II and III in China. This study will provide further insights into the clinical course of SMA including overall survival, demographic characteristics, motor function, respiratory support, feeding and nutritional support, growth and development. The correlation of genotype and phenotype will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* Patients with SMA types I, II and III
* Asymptomatic SMA carriers
* Relatives of SMA patients or carriers
* Unrelated healthy controls
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

\* Participants are unable to comply with trial procedures and visit schedule
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload

To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload


Eligibility Criteria:
Inclusion Criteria:

* Patients with volume overload despite having received any of the following diuretic therapies in whom sufficient effects cannot be expected even if the dose of the diuretics is increased or in whom the investigator or subinvestigator judges that increasing the dose of the diuretics is difficult due to concerns regarding electrolyte abnormalities or other side effects

  * Furosemide (oral administration) ≥0.5 mg/kg/day. Azosemide 30 mg and torasemide 4 mg will be calculated as equivalent to furosemide 20 mg.
  * Hydrochlorothiazide ≥2 mg/kg/day
  * Trichlormethiazide ≥0.05 mg/kg/day
  * Spironolactone ≥ 1 mg/kg/day
* Patients capable of complaining of thirst. Patients unable to complain of thirst due to their young age can also be enrolled in the trial if strict management of fluid intake and excretion is conducted. However, even if such fluid management is possible, the patients in whom the investigator or subinvestigator judges that tolvaptan cannot be safely administered are to be excluded
* Patients who can be hospitalized from at least 3 days before start of tolvaptan administration until 2 days after the final administration.

others

Exclusion Criteria:

* Patients whose volume overload status shows improvement during the screening period or pretreatment observation period
* Patients who are unable to drink fluid (including patients who are unable to sense thirst)
* Patients whose circulatory blood flow is suspected to be decreased
* Patients with an assisted circulation apparatus
* Patients with hypernatremia (serum or blood sodium concentration exceeding 145 mEq/L) others
Efficacy and Safety of TJ-100 in the Treatment of Chronic Constipation

TJ-100, a Japanese herbal medicine, is clinically effective in postoperative ileus. So it may activate bowel movement. This study will test the efficacy and safety of TJ-100 in the treatment of patients with chronic constipation.


Eligibility Criteria:
Inclusion Criteria:

* chronic constipation defined as less than 3 spontaneous bowel movement frequencies per week
* had symptoms of abdominal bloating or discomfort

Exclusion Criteria:

* mechanical bowel obstruction
* clinically systemic disease-induced constipation
* pregnancy
Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study

The primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.

Our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis. We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.

Eligibility Criteria:
Inclusion Criteria:

1. Unstable distal radius fracture
2. Fracture type AO B1, B2, B3, C1, C2 or C3.
3. 18-65 years old
4. Understand and read English
5. Community dwelling (not in assisted living or NH)

Exclusion criteria:

1. Open or bilateral DRF
2. Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation.
3. Greater than 2 weeks post injury
4. Neurologic disorders affecting the hand, wrist or arm.
5. History of permanent dementia, Alzheimer's or other neurologic dx
6. Substance abuse
7. Pathologic fractures
8. Known pregnancy
9. Radiocarpal joint arthritis
Enteral Glutamine in Reducing Bloodstream Infections in Short Bowel Syndrome Infants

The purpose of this research study is to evaluate the effects (good and bad) of supplementation with Glutamine to that of a placebo (L-alanine), on your child and their Short Bowel Syndrome. Researchers are doing this study to see if the addition of Glutamine to oral/tube feeding (nutrition therapy) will work better by preventing bloodstream infections, improving growth, and/or changing the make-up of bacteria in your child's intestine. Glutamine is approved by the FDA for use in adults with Short Bowel Syndrome. In this study, the investigators will be assessing how well Glutamine affects Short Bowel Syndrome in children.

This is a double-blind, randomized placebo-controlled pilot study to investigate the efficacy of enteral glutamine (GLN) supplementation in 36 infants, ≤ 12 months of age with parenteral nutrition (PN)-dependent short bowel syndrome (SBS) due to massive small bowel resection for NEC and/or atresia on improving weaning of PN and preventing infections. The investigators intend to evaluate the effect of enteral feeding and GLN supplementation on the gut bacteria. The investigators will also recruit 12 age-matched controls to evaluate the normal gut bacteria.

Eligibility Criteria:
Inclusion Criteria for Controls:

* Less than or equal to 12 months of age
* Normal small bowel length without any intestinal resection or primary intestinal disease
* Not currently on Total Parenteral Nutrition (TPN) and if ever on TPN this should have been discontinued for at least 4 weeks.

Exclusion Criteria for Controls:

* Major congenital or chromosomal anomalies
* Inability to tolerate enteral nutrition/regular cow's milk, breast milk or formula
* History of liver/intestinal transplantation

Inclusion Criteria for Glutamine and Placebo Group of Short Bowel Syndrome (SBS) Patients:

* Less than or equal to 12 months of age
* Patients who have undergone small bowel resection due to necrotizing enterocolitis (NEC) or intestinal atresia with known small bowel length
* Patients who have been Parenteral Nutrition (PN) dependent for more than 42 consecutive days and currently on TPN at time of enrollment
* Patients who have the ability to take partial enteral nutrition or breast milk or elemental formula to allow the appropriate dose of glutamine or placebo
* Signed informed consent for the use of Glutamine or placebo

Exclusion Criteria for Glutamine and Placebo Group of SBS Patients:

* Major congenital or chromosomal anomalies
* Inability to tolerate enteral nutrition that will preclude treatment with enteral Glutamine or L-alanine placebo for \> 2 weeks
* Liver/Intestinal transplantation
TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* 1. The Patients (or legally authorized representative) Patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an Institutional Review Board/Independent Ethics Committee (IRB/IEC), must have the ability to understand the requirements of the study;
* 2.Must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor;
* 3.At least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. The separated tissues mass weighing ≥0.5cm (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. Minimally invasive treatment where possible;

Exclusion Criteria:

* 1. Patients who have symptomatic and/or untreated CNS metastases (Except stable brain metastases, no medication required within 3 months, no hormone dependence);
* 2.The patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone);
* 3. Arterial/venous thrombotic events within 5 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring;
* 4.Active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever;
* 5. Patients who have refractory or intractable epilepsy, hydrops abdominis, active gastrointestinal bleeding or IL-2 contraindications;
* 6. Patients who have received allogeneic bone marrow transplantation or an organ allograft;
* 7.Patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, IL-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients with biopsy proven advanced melanoma are eligible if there is measurable disease.
* Patients must have a life expectancy of at least 12 weeks.
* Prior surgery, immunotherapy, minimal chemotherapy (1 drug for less than 4 months), or radiotherapy for primary tumor is acceptable but must be completed at least 4 weeks from study entry, and patient should have completely recovered from such procedures.
* Patients must have a Zubrod performance status of 0-2.
* Patients must sign an informed consent.
* Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1500 cells/mm3, hemoglobin \> 8 g/dl, platelet count ≥ 100 000/mm3.
* Patients should have a normal hepatic function with a total bilirubin \< 1.5 the upper limit of normal (ULN) and serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase (SGPT) \< 2 times the upper limit of normal (ULN),and adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN.
* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and at least for 3 months.
* Patients with brain metastases are eligible if they have been appropriately treated, are asymptomatic

Exclusion Criteria:

* Pregnant women or nursing mothers are not eligible.
* Patients must not receive any other concurrent chemotherapy or radiation during this trial.
* Patients with severe medical problems that would interfere with the therapy are not eligible.
Neural Correlates of Acute Pain Dynamics

This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Pregnant
* History of chronic pain
* History of neurological diagnosis
* History of psychiatric diagnosis
Partnership for a Hispanic Diabetes Prevention Program

The aims of the study are to investigate

1. the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (\>6.0%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.
2. the effects of the intervention vs control on consumption of fresh fruit and vegetables
3. the effects of the intervention vs control on levels of physical activity


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Haemogloblin A1c ≥ 6.5%
* Hispanic Ethnicity
Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion

The purpose of the study is to prospectively measure pain, function, and patient satisfaction in 70 consecutive patients treated by lumbar fusion using the Triad allograft. Results of the Triad allograft will be compared to those of other anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), and posterior lumbar interbody fusion (PLIF) surgeries. Patient participation is based on the physician determination that the patient requires one of these surgeries. Participants will be evaluated pre-operatively and post-operatively at 3, 6, 12,and 24 month intervals. Clinic procedures will be related to standard of care except for the completion of several study questionnaires:

1. Back Pain Questionnaire;
2. Oswestry Disability Index Questionnaire;
3. Short Form-36 (SF-36) Survey;
4. Visual Analog Pain Scale (VAS); and
5. The Modems Patient Satisfaction Survey.

Outcome Measurements:

1. The patient's pain is scored by a VAS normalized to 100;
2. Patient function is based on Oswestry scores;
3. General health is assessed by SF-36 completion; and
4. Overall patient satisfaction will be determined by the completion of the Modems.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary consent for an observational study
2. One of the following diagnoses:

   * isthmic spondylolisthesis,
   * degenerative spondylolisthesis,
   * pseudoarthritis,
   * severe foraminal stenosis, and
   * prior failed discectomies
3. Single, two, or three level fusions
4. Patients require treatment by TLIF or PLIF posterior fusion as determined by surgeon. Pedicle screw instrumentation will be placed in all cases.

Exclusion Criteria:

1. Infection at operative site
2. Severe osteoporosis
3. Inability to return for follow-up.
Hemopatch for Prevention of Bile Leaks After Liver Resection

In liver surgery bile leaks are still a major cause of postoperative morbidity with the need for additional diagnostic tests, additional interventions, prolonged hospital stay, mortality and higher costs. Efforts to further reduce the rate of postoperative biliary morbidity are therefore important.A new polyethylene glycol (PEG)-coated collagen pad (Hemopatch®) showed faster and more sustained hemostasis, less blood loss, and lower hematoma formation than the fibrin-coated collagen patch in an animal model. This might be attributed to an improved tissue adherence of the PEG-coated pad. We hypothesize that this strong adherence to the hepatic resection surface may also serve as a mechanical sealant of bile ducts thus preventing biliary leakage.

To date, there exists no study including a sufficient number of patients to clarify whether sealing of the hepatic resection surface with Hemopatch® can reduce the rate of biliary leaks and data regarding the expected difference in the incidence of biliary complications are lacking.


Eligibility Criteria:
Inclusion Criteria:

* Elective hepatic resection

Exclusion Criteria:

* Minor atypical hepatectomy without a plain cut surface
* Contraindications to the application of Hemopatch®
Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer

The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects received screening questionnaire and had been defined as high risk.
2. Subjects haven't received any treatment under colonoscopy within 10 years.

Exclusion Criteria:

1. Subjects are under the usage of specific drugs which might affect the screening test.
2. Subjects had the contraindication for colonoscopy.
Longitudinal Study of Cognition With Niemann-Pick Disease, Type C

Niemann-Pick Disease, Type C (NPC) is a rare neurodegenerative disorder with a wide clinical spectrum and variable age of onset. Classically, children with NPC demonstrate neurological dysfunction with cerebellar ataxia (an inability to coordinate balance, gait, extremity and eye movements), dysarthria (difficulty speaking), seizures, vertical gaze palsy (ability to move eyes in the same direction) motor impairment, dysphagia (trouble swallowing), psychotic episodes, and progressive dementia. There is no curative treatment for NPC and it is a lethal disorder. The purpose of this protocol is to obtain both baseline and rate of progression data on a clinical and biochemical markers that may later be used as outcome measures in a clinical trial. Specifically, this study will examine and characterize the longitudinal progression of neurocognitive symptoms of NPC with the goal of identifying early markers of disease progression that may be utilized in later trials to evaluate treatment efficacy.


Eligibility Criteria:
Inclusion Criteria:

All individuals between the ages of 2 years and 99 with an established diagnosis of Niemann-Pick Disease, Type C (biochemical or molecular) will be considered for this study. Patients with both Niemann-Pick Disease, Type C1 (NPC1) and Niemann-Pick Disease, Type C2 (NPC2) mutations are eligible to participate.

Exclusion Criteria:

Participants with at least one of the following will not be eligible for this study:

1. Individuals that cannot travel because of their medical condition or are too ill to be cared for at home,
2. Individuals with stage 4 disease (non-ambulant with vegetative disturbances)
3. Individuals will be excluded if English is not their primary language
Fetal Cardiac Magnetic Resonance in Detection of CHD

The aim of this clinical prospective study is to investigate the value of fetal cardiac magnetic resonance imaging using a new Doppler ultrasound based gating method for the detection of congenital heart desease.


Eligibility Criteria:
Inclusion Criteria:

* fetuses in third trimenon
* congenital heart defect suspected by obstetric ultrasound

Exclusion Criteria:

* pregnant women with contraindication for native MRI