cyrilzakka/clinical-trials huggingface dataset:
Effect of Exercise on Bowel Function in Colorectal Cancer Survivors

The survival rate of colorectal cancer patients is increasing due to the development of medical technology. However, many colorectal cancer survivors (CRCs) have bowel dysfunction unlike other cancer survivors. After bowel dysfunction of CRCs was known, many previous studies were conducted to improve bowel dysfunction. Medication, probiotics, Biofeedback training (BFT), Kegel exercise, and sacral nerve stimulation were the methods of intervention research to improve bowel movements in CRCs. Research on randomized control trial of BFT and Kegel exercise is very insufficient. Surgery, chemo, and radiation have a lot of influence on the bowel process of CRCs. In particular, damage to the abdominal muscles, pelvic floor muscles, and autonomic nervous system can also be caused by secondary symptoms such as increased fatigue, reduced physical strength, and musculoskeletal diseases. Therefore, the investigators examine that exercise which can improve fatigue, physical fitness, and musculoskeletal disease affects bowel symptoms of colon cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 19 to 70 who have been diagnosed with Sigmoid colon cancer or rectal cancer have surgery for 6 months or more to less than 3 years
2. Three months after chemo and radiation therapy.
3. Six month after stoma take-down
4. Colorectal cancer patients with a LARS (Low Anterior Reservation Syndrome) questionnaire score of 21 or higher

Exclusion Criteria:

1. Subjects who have problems reading or understanding Korean or who have problems communicating with researchers
2. Subjects who plan to undergo surgery at the same time other than colorectal cancer surgery
3. Metastatic colorectal cancer patients.
4. Subjects who have stoma
5. People who are difficult to exercise in the judgment of the medical staff
Assessment of the Association Between Visceral Obesity and the Progression of Diabetic Nephropathy

Assessment of the association between visceral obesity and the progression of diabetic nephropathy

Type 2 diabetes mellitus is a disorder of diverse aetiology characterised by hyperglycemia resulting from abnormalities of insulin action, insulin production, or both, and the global population with diabetes mellitus is expected to be around 439 million by 2030 . Diabetic nephropathy is the most prevalent microvascular consequence of DM. It develops in around 40% of DM patients.

Obesity, which has now reached pandemic ratios, is frequently accompanied by diabetes mellitus type 2 because they share common pathophysiological pathways . Abdominal obesity is found to be a negligent form of obesity with dangerous consequences. It has been identified as potentially hazardous factor for diabetic complications. Several abdominal obesity measures have been developed including the visceral adiposity index (VAI) , lipid accumulation product (LAP) , neck circumference (NC), waist-to-hip ratio (WHR) Lipid accumulation product (LAP) and visceral adiposity index (VAI) are new, non-imaging indicators of visceral adiposity measured using body mass index (BMI), waist circumference (WC), and serum lipid profile. It was predicted in some studies that LAP and VAI have a stronger association with poor renal outcomes than BMI and WC.

Eligibility Criteria:
Inclusion Criteria:

- 1. Diabetic patients either type 1 or type 2 diabetes aged \> 18 years whether known to have diabetic nephropathy or not.

2. BMI is ≥ 25 kg/m2

Exclusion Criteria:

* 1. Patients age \< 18 years. 2. BMI \< 25 kg/m2 3. Nondiabetic patients 4. Patients with non-diabetic kidney disease. 5. Patients with AKI 6. Patients with CKD stage 5 either on dialysis or not.
NOA-12: BIBF1120 and R-RT in Glioblastoma

Patients with glioblastoma at first or second progression who have failed standard treatment that must have included radiochemotherapy with temozolomide and who are a candidate for a reirradiation can be included into the trial. In the phase I part the minimal tolerated dose (MTD)of BIBF 1120 in combination with radiotherapy will be investigated. Subjects in phase II will be randomised to receive reirradiation alone or reirradiation + 2 x MTD BIBF1120.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with a recurrence / progression of glioblastoma either not being eligible for tumour resection or having macroscopic residual tumour after resection of the recurrence
* Diagnosis of glioblastoma must be proven histologically and progress must be documented by MRI. MRI images must not be older than 2 weeks before first dosing/start of RT
* Not more than two prior therapy regimens including one or two resections, one or two chemotherapies (one temozolomide containing concomitant to radiotherapy) and one radiotherapy (RT) for the brain tumour
* Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at least 8 months since the end of preirradiation
* Candidate for reirradiation with recurrent tumour visible on MRIT1 (Gd) and with the largest diameter measuring 1 cm to 5 cm
* Informed consent
* Age ≥ 18 years, smoking or non-smoking, of any ethnic origin
* Karnofsky performance index (KPI) ≥ 60%
* Neutrophile counts \> 1500/μl / Platelet counts \> 80.000/μl /Haemoglobin \> 10 g/dl / Serum creatinine \< 1.5-fold upper normal range / Bilirubin, AST or ALT \< 2,5-fold upper normal range unless attributed to anticonvulsants / Alkaline phosphatase \< 2,5-fold upper normal range
* Adequate contraception
* If on steroids, stable or decreasing treatment with steroids within 5 days before treatment start

Exclusion Criteria:

* More than one RT of brain, prior first radiotherapy with more than 60 Gy
* Cumulative total dose on the optical chiasm \>54 Gy for 2 Gy/fraction, α/β=2
* Prior treatment with bevacizumab, iodine seeds and/or brachytherapy
* Unable to undergo MRI
* Past medical history of diseases with poor prognosis according to the judgement of the Investigator, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
* HIV or hepatitis infection
* Pregnancy or breast feeding
* Treatment within any other clinical trial parallel to the treatment phase of the current study or within 30 days before inclusion
* Known coronary artery disease, significant cardiac arrhythmias or severe congestive heart failure (NYHA class III - IV)
An Epidemiology Study of Treatment Resistant Depression in the United States (US)

The purpose of this study is to describe the epidemiology of Treatment Resistant Depression (TRD) in the US, including the population incidence of TRD, and TRD as a proportion of Pharmacologically Treated Depression (PTD), and stratify the estimates by sex and age group, with separate estimates for the Medicaid population, the Medicare population, and the privately insured population. Anonymized participants data will be used for the analysis.


Eligibility Criteria:
Inclusion Criteria:

* Have been in the database for the past year (ignoring breaks of \< 30 days)
* Have not had, an excluded diagnosis or dispensing of an AD medication during the past year
* Are aged 14 to 60 years (if in the CCAE or MCDC databases), or are aged greater than or equal to (\>=) 65 years (if in the MCDR database). Age is defined as age on Jan 1, 2011. The boundary at age 60 for the first two databases is intended to avoid loss to follow-up due to transfer to Medicare at age 65. The boundary at age 65 for the MCDR database reflects the fact that very few people described by that database are aged less than 65

Exclusion Criteria:

- Participants will be excluded when they receive diagnoses Schizophrenia, Bipolar disorder including mania or Dementia
Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223

This registry aims to evaluate the efficacy of Rad-223 treatment in a non-study population of CRPC patients treated earlier with Docetaxel and patients not treated earlier with Docetaxel and efficacy of the first subsequent therapy. The indication for treatment with Radium-223 will be at the physician's decision. All patients treated with Radium-223 can be included in this registry. The registry only dictates the collection of base line characteristics, expansion of regular blood tests and patient reported pain scores.

Serum and blood markers of bone metabolism will be evaluated at Base Line, 1st, 2nd, 3rd and 6th (or last) Radium- 223 treatment. Every blood draw prior to Radium-223 treatment At baseline, tests include (but not restricted to): Testosterone, vitamin D-25-OH (Calciferol), C-reactive protein, Rank Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centres). Before 2nd, 3rd, 4th and 6th (or last) Radium-223 treatment, tests include (but not restricted to): C-reactive protein, Rank, Ligand, IL6, BSAF, P1NP and CTX. Patients need to be fasting when blood is collected. (2x8,5 ml gel tube; Limited to 100 patients in selected centers).

Moreover, levels of osteoclast precursors (CD34+) will be evaluated (10 ml heparinized blood) prior to the first Radium-223 treatment, 3rd and last treatment (Limited to 100 patients in selected centres).

All above-mentioned blood collections will be from the same venipuncture as standard clinical labs. Experimental assessments will be evaluated for their value as biomarkers of treatment outcome.

Eligibility Criteria:
Inclusion Criteria:

* At the physicians discretion
* Age 18 year and older.
* Written informed consent

Exclusion Criteria:

* Previous treatment with Radium-223.
* Participation in another Radium-223 study.
Role of Calcium Channels in Vascular Function

The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.


Eligibility Criteria:
Inclusion Criteria:

* age 20 - 30 and 60-70
* BMI \< 30

Exclusion Criteria:

* Hypertension (\>150/90 mmHg)
* Smoking
* Physical activity \>2 hours/week
* Known chronic diseases
* Pregnancy or birth within 3 month
* Alcohol misuse
Pigtail Catheter for Drainage of (Pneumothorax/Simple Effusion) is a Effective Procedure

Assessment and evaluation of Pigtail application in drainage of pneumothorax and haemothorax.

Chest injuries are common following blunt and penetrating trauma. Fewer than 10 per cent of blunt injuries and 15-30 per cent of penetrating injuries require surgical management1. Most can be managed with tube thoracostomy to expand the lung (pneumothorax) or to drain blood (haemothorax)2. Although tube thoracostomy is fairly effective, it can be associated with complications such as mispositioning, malfunction, or injury by insertion through the diaphragm or liver3-5. The standard tube size.

Has usuallybeen32-40Fr.Insertion of such a large -calibre tube requires a cut-down technique, can be traumatic, and is often associated with signiﬁcant pain and discomfort. Pigtail catheters, originally used by cardiologists to drain chronic pericardial effusion6, were later modiﬁed and adapted for pleural drainage7. Because of their small size and reduced trauma during placement, patients may experience signiﬁcantly decreased pain and discomfort. Pigtail catheters are frequently used in the paediatric population8-10, as well as in adult, non-traumatic situations11-17 Pigtail catheters inserted at the bedside have similar efﬁcacy to traditional chest tube.

Eligibility Criteria:
Inclusion Criteria:

* iatrogenic pneumothorax

Exclusion Criteria:

* Age less than 18 years.
* refused to participate.
* Unconscious.
* spontaneous pneumothorax.
An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients

This is an observational study designed to learn more about how COVID19 convalescent plasma works in patients with COVID19 compared to those patients who did not receive convalescent plasma treatment. Information about patient recovery will be collected from participants' electronic medical records to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with convalescent plasma under a separate expanded access protocol, NCT04372368.

This a prospective, observational cohort trial to evaluate safety, clinical outcomes, and SARS-CoV2 antibody responses in patients who were treated with anti-SARS-CoV-2 convalescent plasma under Expanded Access protocol, NCT04372368. Hospitalized patients with acute respiratory symptoms with or without confirmed interstitial COVID-19 pneumonia will be enrolled. The investigators anticipate that a minimum of 150 eligible subjects will be enrolled to receive COVID19 convalescent plasma over the 12 month period for the FDA IND expanded access protocol, NCT04372368, to provide COVID19 convalescent serum, which is a separate treatment trial. This observational protocol will co-enroll patients in parallel with the expanded access protocol and expects to enroll approximately the same number of patients but no treatment will be provided as part of this protocol. Additionally, the investigators will use Compass data with identifiers to pull information on hospitalized control COVID19+ patients from hospital admission date 4/20 to current for comparison.

This protocol is limited to data collection using the EMR to evaluate outcomes following COVID19 convalescent plasma treatment. Patient-linked specimens will not be obtained and analyzed outside of the expanded access protocol for distribution of COVID19 convalescent plasma. For this protocol, only de-identified, discarded samples may be obtained during routine patient care. Thus, consent will only be obtained from patients/subjects for participation in data abstraction/analysis from the electronic medical record.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 SARS-CoV-2 RT-PCR testing.
* Patient treated with COVID19 convalescent plasma.
* Patient or surrogate designated decision maker is willing and able to provide written informed consent.

Exclusion Criteria:

* Receipt of pooled immunoglobulin in past 30 days
* Contraindication to transfusion or history of prior reactions to transfusion blood products
A Study of a Whole-Body Balm on Newborn Babies

The purpose of this study is to evaluate the skin tolerance, instrumental efficacy, and perceived product efficacy of a whole-body balm on newborns (0-28 days old).


Eligibility Criteria:
Inclusion Criteria:

Newborn participants only:

* Male or Female
* 0 to 3 months old, targeting at least 15 subjects in the 0 - 28 days age range at time of enrollment.
* Has Parent Participant-reported Natural Skin tone/skin Color As Follows, including: (a) Skin tones "Pale/fair to light white" and/or "White to light beige" approximately 10 participants; (b) Skin tones "Beige to light tan/light olive" and/or "Medium tan/medium olive to light brown" approximately 10 participants; (c) Skin tones "Medium brown to dark brown" and/or "Darkest brown to darkest black" approximately 10 participants
* Full term (37 plus weeks of gestation, both vaginal and Caesarean mode of delivery can be included) newborn

Newborn participant and parent participant:

* Generally, in good health based on medical history reported by the parent participant

Parent participant only:

* Able to read, write, speak, and understand English
* At least 18 years old and is the parent (adoptive or biological), legal guardian, and primary caregiver of the newborn participant
* Has signed the informed consent document (ICD) including Health Insurance Portability and Accountability Act (HIPAA) disclosure
* Intends to complete the study and is willing and able to follow all study instructions

Exclusion Criteria:

Newborn participant only:

* Presents with a skin condition that may influence the outcome of the study or increase risk to the newborn participant (example , psoriasis, eczema, atopic dermatitis, cutaneous xerosis, erythema, or active skin cancer)
* Has a family history of (defined as having a biological parent or full sibling with) eczema/atopic dermatitis
* Has been bathed within 3 hours prior to Visit 1
* Has a clinical grade greater than 0 for rash/irritation, or greater than or equal to 1 for any of the other clinically assessed tolerance parameters at Visit 1

Newborn participant and parent participant:

* Has known allergies or adverse reactions to common topical skincare products
* Has self-reported (for the parent participant) or parent participant reported (for the newborn participant) Type 1 or Type 2 diabetes or is taking insulin or another anti-diabetic medication
* Is taking a medication that would mask an AE or confound the study results, including (a) Immunosuppressive or steroidal drugs within 3 months before Visit 1; (b) Non-steroidal anti-inflammatory drugs within 5 days before Visit 1; (C) Antihistamines within 2 weeks (14 days) before Visit 1
T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD

This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.

This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with:

* Resistance to countertorque testing (mobility)
* Implant Stability Quotient (ISQ)
* Changes in peri-implant crestal bone levels
* Confirmation of clinical benefits

A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either sex and greater than 18 years of age
2. Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
3. Immediate extraction or a prior extracted site
4. Patients must be physically able to tolerate conventional surgical and restorative procedures.
5. Presence of opposing dentition
6. Patients who provide a signed informed consent.
7. Patients who agree to be evaluated for each study visit.
8. Minimum primary stability, insertion torque \> 35Ncm

Exclusion Criteria:

1. Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
2. Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
3. Patients with active infection or severe inflammation in the areas intended for implant placement.
4. Patients with a \> 10 cigarette per day smoking habit.
5. Patients with a history of therapeutic radiation to the head or jaw.
6. Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
7. Patients with evidence of severe parafunctional habits such as bruxing or clenching.
8. Patients with HIV or Hepatitis infection
Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* enlarged discrete N2/N3 lymph nodes
* central tumor with normal mediastinal lymph nodes
* enlarged N1 lymph nodes with normal mediastinal lymph nodes

Exclusion Criteria:

* metastatic disease
* severe co-morbidity that disqualified surgical treatment
* mediastinal infiltration by tumor
* small peripheral lung tumor with normal-sized mediastinal lymph nodes
An Observational Study of Lymphoma in Patients With Rheumatoid Arthritis or Crohn's Disease.

The purpose of this study is to examine the association with EBV infection, monitor the occurrence of lymphoma and assess lymphoma risk in patients with rheumatoid arthritis and/or Crohns disease and you have taken infliximab.

This is an observational (review of records), retrospective (research activity that is performed after the events under the study have occurred), registry study where data was collected from 3 different registries sponsored or supported by Centocor. Registries are Centocor-sponsored Therapy Resource Evaluation and Assessment Tool (TREAT™) Registry of Crohn's Disease, and in the following two Centocor-supported registries the Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) registry and the Infliximab RA Registry, a subset of the National Database Registry of Rheumatoid Arthritis (NDBRRA) and of the National Databank for Rheumatic Diseases (NDB). A registry is data collection in a real life physician-patient setting. Physicians prescribe medications for rheumatoid arthritis and/or Crohns disease in accordance with their usual clinical practice and then record this information and provide it to Centocor. For this registry study, Centocor collected data from 3 registries to evaluate the risk of getting lymphoma if you have rheumatoid arthritis and/or Crohns disease and you have taken infliximab. Patients who were in one of the 3 registries and had rheumatoid arthritis and/or Crohns disease and did not take infliximab were also evaluated. This registry study does not involve the use of any investigational drugs.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Crohns disease or rheumatoid arthritis who participate in the specified registries will be included in the analysis. For the lymphoma analysis, patients must be recorded as having a lymphoma during their participation in one of these registries

Exclusion Criteria:

* Patients who do not have Crohns disease or rheumatoid arthritis and who did not participate in one of the identified registries will be excluded from the study