cyrilzakka/clinical-trials huggingface dataset:
Implementation of a Prehabilitation Program for Surgical Patients

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥18 years old
2. Evaluated at Maine Medical Center by surgical oncology service
3. Planned surgical intervention for gastrointestinal oncologic condition
4. Score ≥40 on Risk Analysis Index frailty screening
5. Physically able to participate in prehabilitation exercises
6. Home internet access and established email account
7. Able to understand the English language

Exclusion Criteria:

1. Patients unable to participate in exercises included in prehabilitation program
2. Patients with impaired decision making capacity
3. Those in a high risk community: prisoners and pregnant women
4. Those who do not meet the above inclusion criteria
ELND005 in Patients With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the dose-related safety and efficacy of multiple oral dosages of ELND005 as treatment for Alzheimer's disease (AD).

ELND005 (formerly known as AZD-103), scyllo-inositol, is being investigated as an orally administered treatment for AD. ELND005 may prevent or inhibit the build up of amyloid protein in the brains of AD patients.

This is a randomized, double-blind, placebo-controlled, dose-ranging, safety and efficacy study of oral ELND005 in male and female participants aged 50-85 years with mild to moderate AD. Approximately 340 patients will be enrolled into the study at approximately 65 study sites. Patients will be randomized to receive either ELND005 or placebo. Each patient's participation will last approximately 18 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Age 50 to 85 years, inclusive
* Mini-Mental Status Exam (MMSE) score of 16-26, inclusive
* Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
* Fluency in English, French, or Spanish
* Stable doses of medications (cholinesterase inhibitors and memantine allowed)
* Caregiver is able to attend all study visits

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric disorder
* Significant medical illness
* History of stroke or seizure
* History of a heart attack within the last 2 years
* Prior treatment with certain experimental medicines
* Presence of pacemakers or foreign metal objects in the eyes, skin, or body that would prevent patient from having MRI scan
Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

This is a Phase 3 study to evaluate the efficacy, safety, and tolerability of crinecerfont versus placebo administered for 24 weeks in approximately 165 adult participants with classic CAH due to 21-hydroxylase deficiency. The study consists of a 24-week randomized, double-blind, placebo-controlled period, followed by 1 year of active treatment with crinecerfont. Subsequently, participants may elect to participate in the open-label extension (OLE) period. The duration of participation in the study is approximately 20 months for the core study and will be a variable amount of time per participant for the OLE (estimated to be approximately 3 years).


Eligibility Criteria:
Inclusion Criteria:

1. Be willing and able to adhere to the study procedures, including all requirements at the study center and return for the follow-up visit.
2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency.
3. Be on a stable steroid regimen.
4. Participants of childbearing potential must agree to use an acceptable method of contraception during the study.

Exclusion Criteria:

1. Have a diagnosis of any of the other known forms of classic CAH.
2. Have a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.
3. Have a clinically significant unstable medical condition or chronic disease other than CAH.
4. Have a history of cancer unless considered cured.
5. Are pregnant.
6. Have a known history of clinically significant arrhythmia or abnormalities on ECG.
7. Have a known hypersensitivity to any corticotropin releasing hormone receptor antagonists.
8. Have received any other investigational drug within 30 days before initial screening or plan to use an investigational drug (other than the study drug) during the study.
9. Have current substance dependence, or current substance (drug) or alcohol abuse.
10. Have had a blood loss ≥550 mL or donated blood or blood products within 8 weeks prior to the study.
Direct Measurement of Ideal Depth of Central Line

Total of 89 patients undergoing elective cardiac surgery will be enrolled.

Right CVC insertion begins at their intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head. After insertion the central venous catheter through the right internal jugular vein and positioning it, the location of the tip of the central venous catheter will be confirmed by TEE.

Investigator confirms the location of the 2 cm from the junction between right atrium and superior vena cava to the end of the tip of the catheter using TEE, and measures the insertion depth of the catheter at insertion point. It is possible to find the ideal central venous catheter insertion depth in actual clinical practice in adult patient.

The ideal central venous catheter insertion depth can be measured accurately when the end of the central venous catheter is monitored with transesophageal ultrasonography, and it can be derived a meaningful formula for predicting the ideal central venous insertion depth from the patient's height .

Eligibility Criteria:
Inclusion Criteria:

* adult patient over 18 years of age undergoing cardiac surgery under general anesthesia, requiring central venous catheter insertion through the right internal jugular vein and insertion of a TEE probe

Exclusion Criteria:

* Patients who disagree with the study.
* Patients who had difficulty in inserting the central line through the right internal jugular vein.
TD-1607 MAD Study in Healthy Subjects

TD-1607, administered intravenously as multiple ascending doses, will be investigated in healthy subjects to assess its tolerability, safety, and pharmacokinetics.


Eligibility Criteria:
Inclusion Criteria:

* Subject is a healthy nonsmoking male or a female (of non-childbearing potential) and 18 to 55 years old, inclusive, at Screening.
* Subject has a body mass index (BMI) of 19 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Subject has no clinically significant abnormalities in the results of laboratory evaluations at Screening and Day -1.

Exclusion Criteria:

* Subject has evidence or history of clinically significant, relevant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (except for untreated, asymptomatic seasonal allergies at time of dosing).
* Subject has a history of allergies or hypersensitivities to glycopeptide (e.g., vancomycin) or beta-lactam (e.g., penicillin or cephalosporin) antibiotics.
* Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days (or 5 half-lives, whichever is longer) prior to Screening or is currently participating in another trial of an investigational drug (or medical device).
* Subject has previously participated in a trial for TD-1607.
REFORM Clinical Study: Treatment of Renal Artery Stenosis With the Formula Balloon-Expandable Stent

The purpose of the study is to evaluate the safety and effectiveness of the Formula Balloon-Expandable Stent in treatment of renal artery stenosis.


Eligibility Criteria:
Key Inclusion Criteria:

* renal artery stenosis
* appropriate size and location of the lesion
* suboptimal angioplasty

Key Exclusion Criteria:

* less than 18 years old
* failure or inability to give informed consent
* simultaneously participating in another drug or device study
Adding Phosphorus to Osteoporosis Drug Treatment

Osteoporosis causes bones to weaken and break more easily. Calcium and phosphorus are two minerals that are essential for normal bone formation. Unfortunately, calcium salts commonly prescribed in anti-osteoporosis treatment bind phosphorus from food and restrict phosphorus available for bone building. Teriparatide is a drug that reduces the risk of fractures by increasing bone thickness and strength. Vitamin D is also necessary for strong bones and teeth. The purpose of this study is to evaluate the bone-building effectiveness of two calcium supplements, one with a source of phosphorus and one without, in combination with teriparatide and vitamin D in women with osteoporosis.

Osteoporosis is the most common type of bone disease. Calcium supplements normally used in anti-osteoporosis treatment are calcium salts of carbonate or citrate; however, these salts bind phosphorus from food in the intestine and restrict phosphorus available for bone building. This study will evaluate the efficacy of adding calcium phosphate to a regimen of teriparatide and vitamin D in increasing bone mineral density in women with osteoporosis. It is hypothesized that the group taking the phosphate-containing calcium supplement will have greater gains in bone mineral density (BMD) during the course of the study than the group not receiving phosphate.

All participants will receive teriparatide and vitamin D during the course of the 12-month study. Participants will be randomly assigned to one of two groups. One group will receive calcium phosphate and the other will receive calcium carbonate. BMD will be measured at spine and hip at baseline and at 3, 6, and 12 months of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Bone mineral density (BMD) T-score less than -1.0
* One or more vertebral fractures
* Serum creatinine less than 1.3 mg/dL
* Serum phosphorus less than 3.6 mg/dL
* Daily phosphorus intake below NHANES-III median
* Body mass index (BMI) less than 30 kg/m2

Exclusion Criteria:

* Paget's disease or history of osteosarcoma
* Systemic corticosteroid therapy
* Hyperparathyroidism
* Recent history of kidney stone
* Anticonvulsant therapy known to alter vitamin D metabolism
* Radiation therapy to bone
Nebivolol, Lifestyle Modification and Arterial Stiffness

Numerous anti-hypertensive drugs have been reported to be efficacious in reducing central arterial stiffness and these effects may contribute to improved outcomes in hypertensive patients. However, the results of several studies suggest that beta-blockers may actually increase arterial stiffness. In contrast, there is limited evidence to suggest that nebivolol, a third generation beta-blocker that augments release of vascular nitric oxide, reduces central arterial stiffness in hypertensive individuals. Unfortunately, only a few studies have addressed this issue and all of these studies relied on indirect, blood pressure dependent measures of arterial stiffness. In addition, none of these studies focused on middle-aged and older, obese hypertensives, a population with accelerated arterial stiffening and at risk for cardiovascular diseases. Thus, the potential utility of nebivolol as a therapy to reduce large artery stiffness, particularly among the latter population, remains unclear.


Eligibility Criteria:
Inclusion Criteria:

* Stage 1 hypertension
* 40-75 years
* Weight stable (+/-2 kg)
* Sedentary to recreationally active
* Willing to be randomized to one of three arms
* Verbal and written consent
* Approval by medical director

Exclusion Criteria:

* Blood pressure outside stated range
* Diabetes or taking diabetes medications
* Total cholesterol \>6.2 mmol/L; triglycerides \>4.5 mmol/L
* Past or current ischemic heart disease, stroke, respiratory disease, endocrine or metabolic disease, neurological disease, or hematological-oncological disease
* Medications (including but not limited to antihypertensives, statins or other with anti-inflammatory actions) or antioxidant vitamins or supplements
* Known allergy or hypersensitivity to nebivolol or any of its components
* Inability to perform regular physical activity or participate in other components of lifestyle modification
* Pregnant or planning to become pregnant
Evaluation of Ipsilateral Tubal Patency After Conservative Medical or Surgical Treatment.

Ectopic Pregnancy is an entity in which a fertilized ovum is implanted outside its normal place, is considered a public health problem worldwide and is one of the main causes of maternal mortality in the first trimester. The availability of high sensitivity methods of detection of gonadotrophins and the use of high resolution transvaginal ultrasonography have allowed an earlier diagnosis of the same, enabling less aggressive treatments such as the use of parenteral MTX, with the intention of avoiding mutilating surgical treatment , preserving the tube and eventually improving future fertility expectations. The surgical treatment is of choice, this can be laparoscopically or by laparotomy. In this case, we need to preserve fertility, the most indicated is linear salpingostomy; In spite of the existence other techniques.

The EP constitutes a frequent obstetric emergency in Angola and the province of Benguela is not exempt from this health problem. Every day we see women with this pathology, to which, most of them, they undergo a mutilating surgical treatment (salpingectomy) that impedes their future reproductive capacity. The procreation in the African continent and especially in Angola, has great social and family implications that can reach the breaking of marriages and family (broadcast and study of the Public Television of Angola in the program "Na lente" no year 2018 Taking into account the importance of procreation in the welfare and stability of the marital relationship.Main Objectiv: To demonstrate the non-inferiority of conservative treatment with MTX in ipsilateral tubal patency after an uncomplicated ectopic pregnancy compared with surgical treatment with linear salpingostomy in the Hospital General, Angola

Eligibility Criteria:
Inclusion Criteria:

Patient presenting with Ectopic Pregnancy, associated with quantitative titers of βHCG ≥ 100 mUI / ml, without intrauterine gestational sac.

Patient presenting uncomplicated Ectopic Pregnancy with an adnexal mass diameter ≤4 cm diagnosed by abdominal and / or transvaginal ultrasonography.

Absence of heartbeat. No toxicity to MTX. Normal laboratory tests (blood count, coagulogram, liver and kidney function). Hemodynamic stability.

Exclusion Criteria:

* Complicated Ectopic Pregnancy.
* Ectopic pregnancy is out of the tuba on ultrasound
* Patients with Immunosuppression.
* Allergy to MTX.
* Patients with Active Respiratory Disease, Blood Dyspasia, Peptic Ulcer, Renal Insufficiency and Hepatic Insufficiency.
* Do not accept to participate in the study.
Nucleotides and B Vitamins in the Treatment of Low Back Pain

This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.

This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12. The aim of this study is to evaluate and compare the therapeutic effect of the combination of nucleotides + vitamin B12 with that of the combination of vitamins B1, B6 and B12 in low back pain. Safety and efficacy will be monitored throughout the treatment period. Subjects will be randomized in a double-blind fashion to either treatment group.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders, at least 18 years of age
* Clinical presentation of acute lumbago (\<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
* Female subjects should be post-menopausal or using birth control
* Subjects must sign informed consent document

Exclusion Criteria:

* Intolerance to any component of the study treatments
* Pregnancy or breastfeeding
* Need for surgical treatment
* Use of other analgesic drugs
* dyshematopoiesis or coagulation disorder
* Gastric or intestinal ulcer
* Gastrointestinal, cerebrovascular, or other bleeding
* Creatinine \>3x% reference range
* Urea, ALT, AST, or GGT \>2x% reference range
* Any other disease or condition that in the investigator's opinion should exclude the subject from the study
Effects of Bin Therapy on Finger Gnosia And Fine Motor Skill

Down syndrome is a hereditary disorder resulting from the occurrence of an additional copy of chromosome 21, resulting in discernible variations in cognitive and physical characteristics. Finger gnosis pertains to the capacity to identify and discriminate among individual fingers. Tactile perception and body awareness are both encompassed by this particular component. Finger gnosis encompasses the sensory and cognitive mechanisms that enable an individual to recognize, label, and differentiate between their own fingers and those belonging to others. The therapeutic approach known as BIN Therapy is a non-invasive and pharmacologically unassisted intervention that use electrical stimulation as a means to enhance manual dexterity in individuals afflicted with neurological conditions

It will be a randomized controlled trial. 30 patients fulfilling the inclusion and exclusion criteria will be recruited by non-probability convenience sampling and then randomly divided in two groups using lottery method. Group A will receive will receive conventional physical therapy exercise program including core strengthening, balance and coordination exercise, fine motor skills activities with 2-3 times a week, with 20-50 minutes of each session with each set comprises of 10-12 repetitions of each exercise. And the group B will receive BIN therapy and finger gnosia. Sensory assessment will be assess by Revised Nottingham sensory assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age range between 5-13 years
* Children with Down syndrome who are able to follow simple instructions.
* Medically stable participants can participate in therapeutic procedures.
* Participants and their families should be able to attend Bin Therapy weekly.

Exclusion Criteria:

* Any other medical conditions or cognitive impairments that could affect their participation in the study.
* History of seizures.
* History of heart problems
Repetitive Acute Intermittent Hypoxia for Spinal Cord Repair

Our goal is to enhance repeated exposure to acute intermittent hypoxia (rAIH)/training-induced aftereffects on upper and lower limb function recovery in humans with chronic spinal cord injury (SCI).

The experiments in this study will test the following: Hypothesis 1.1(Experiment 1) that rAIH will enhance corticospinal excitability and upper and lower limb function in humans with incomplete SCI. Hypothesis 1.2 (Experiment 2) that enhancing the aftereffects of rAIH with exercise training will further enhance upper and lower limb motor function in humans with incomplete SCI. Measurements of corticospinal, cortical, and motoneuron excitability will be tested to further understand the mechanisms of this induced-plasticity. Persons with chronic (\>6 months) spinal cord injury between the levels of C2 and T2. SCI subjects must possess either the ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. Additionally, subject must possess the ability to perform a small visible contraction with dorsiflexion and hip flexor muscles. Controls must be right handed due to potential differences in the organization of the brain in right handed and left handed individuals.

Eligibility Criteria:
Inclusion criteria for SCI:

1. Males and females between 18-85 years
2. Chronic SCI (≥ 6 months post injury)
3. SCI at or above L2
4. ASIA A, B, C, or D, complete or incomplete
5. Possess the following: The ability to produce a visible precision grip force with one hand, and/or the ability to perform some small wrist flexion and extension. The ability to perform a small visible contraction with dorsiflexion and hip flexor muscles.

Inclusion criteria for controls:

1. Males and females between 18-85 years
2. Right-handed (Only right-handed individuals will be accepted into this group because of the potential differences in the organization of the brain in right handed and left handed individuals)

Exclusion criteria for SCI and for controls:

1. Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
2. Any debilitating disease prior to the SCI that caused exercise intolerance
3. Premorbid, ongoing major depression or psychosis, altered cognitive status
4. History of head injury or stroke
5. Metal plate in skull
6. History of seizures
7. Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressant
8. Pregnant females
9. Ongoing cord compression or a syrinx in the spinal cord or a spinal cord disease as spinal stenosis, spina bifida or herniated cervical disk.

AIH exclusion criteria (in addition to the above listed exclusion criteria)

1. Resting heart rate ≥120 BPM
2. Resting systolic blood pressure \>180 mm Hg
3. Resting diastolic Blood Pressure \>100 mmHg
4. Self-reported history of unstable angina or myocardial infarction within the previous month
5. Resting SpO2 ≥ 95%
6. Cardiopulmonary complications such as COPD