cyrilzakka/clinical-trials huggingface dataset:
Litramine for Weight Loss

Safety and Efficacy of Litramine in weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects ≥18 and ≤ 60 years of age
* Body mass index (BMI) ≥ 25 and ≤35 kg/m2
* Judged by the Investigator to be in general good health on the basis of medical history
* Judged by the Investigator to be motivated to lose weight
* Accustomed to 3 main meals per day
* Consistent and stable body weight 3 months prior to study enrollment (±5%)
* Consistent regular physical activity
* Agree to stop all medications and supplements during the entire length of the study
* Commitment to adhere to diet and lifestyle recommended for the study
* Females of child bearing potential must agree to use appropriate birth control methods during the entire study period
* Stable concomitant medications
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator

Exclusion Criteria:

* Presence of any active gastrointestinal disease

  * Malabsorption disorders
  * Pancreatitis
  * Stenosis in the GI tract
  * Bariatric surgery/Lapband and bypass surgery
  * Abdominal surgery within 6 months prior to the study
* Subjects whose weight increases 1.5 pounds from screening to the baseline visit
* History of eating disorders like bulimia, anorexia nervosa, binge-eating
* Renal conditions / disease, history of nephrolithiasis
* Cardiac diseases requiring drug therapy
* Other serious organ or systemic diseases such as diabetes mellitus, standard laundry list of cardiac diseases
* Osteoporosis or on medications for osteoporosis
* Known sensitivity to the ingredients of the study medication
* Vegetarian or Vegan
* Daily use of dietary supplement (2 week washout is allowed)
* Any medication that could influence gastrointestinal functions such as antibiotics, laxatives, opioids, anticholinergics, or anti-diarrheals (must have stopped at least 3 months before study start)
* Subjects who are pregnant or lactating
* Any medication or use of products for the treatment of obesity (e.g., Xenical, other fat binder, fat burner, satiety products etc.)
* Subjects who are currently on carbohydrate and protein diet, or low fat diet
* More than 3 hours of strenuous physical activity per week
* History of abuse of drugs, alcohol or medication
* Smoking cessation within the 6 months prior to this study
* Subjects unable to understand or follow the study protocol
* Participation in similar study or weight loss program within 6 months prior to this study
* Participation in other studies with in the last 4 weeks
Evaluation of the Safety and Efficacy of Voice Prosthesis in Voice Reconstruction After Total Laryngectomy

The objective of the study is to evaluate the clinical safety and efficacy of voice prosthesis for voice reconstruction after total laryngectomy in China.

Main outcome will be the assessment of pronunciation effect (subjective auditory assessment).


Eligibility Criteria:
Inclusion Criteria:

* The age is greater than 18 years; the gender is not limited
* Performed total laryngectomy;
* No voice prosthesis has been installed
* Be able to take care of themselves mentally and physically, and have good hand coordination ability
* With healthy wall sharing with trachea and esophagus
* The patient has a desire to restore articulation function
* Can speak Mandarin and have a certain reading ability (equivalent to primary school education)
* The subject is fully aware of the benefits and risks of this trial and is willing to participate in and sign the informed consent form

Exclusion Criteria:

* There is serious respiratory system disease or defect
* There is a serious skin disease in the tracheostoma
* Obvious intelligence and mental disorder
* Tracheostoma is narrow and needs cannula implantation
* Patients with limitation of mouth opening and other subjects with dyslalia or language disorders (such as subjects with sequelae of cerebral infarction, etc.)
* Patients with severe respiratory disease, cardiopulmonary disease (e.g., severe arrhythmia, persons with slow ventricular rate (ventricular rate \<50 beats/ min), acute phase of myocardial infarction and severe heart failure), disturbances of blood coagulation (coagulation index PT, APTT, INR\> 1.5 times of the normal upper limit), septicemia and other patients not suitable
* Patients with severe diseases of liver and renal function (liver function index, alanine aminotransferase (ALT), aspartate aminotransferase (AST)\> 2 times of normal upper limit, renal function index, urine creatinine (Cr), blood urea nitrogen (BUN)\> 2 times of normal upper limit);
* Patients with local recurrence of tumor or metastatic tumor
* If the patient has received esophageal articulation training, the time of training and using esophagus to speech should be less than 6 months
* Women planning to have child, in lactation or pregnancy during the whole clinical study
* Participated in other clinical trials within 1 month
* Other candidates the investigators think not appropriate
BioPoly RS Knee Registry Study for Cartilage Defect Replacement

Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.

Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device. Patients will be followed for 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical)
* Lesion classified as ICRS Grade 2, 3, or 4

Exclusion Criteria:

* Body mass index (BMI) of 30 or more
* Osteoarthritis or rheumatoid arthritis
* Gout
* Uncorrected mal-alignment, ligamentous instability, or meniscal tear
* Total meniscectomy
* Kissing lesion on tibia
Effect of Right Ventricular Lead Position on Defibrillation Threshold

The purpose of this study is to determine how the position of the right ventricular (RV) coil of an implantable cardioverter defibrillator (apex versus septum) affects the defibrillation threshold; specifically, can defibrillator threshold be improved by implantation site selection.

The investigators propose a prospective, pseudo-randomized study of patients who are electing to undergo implantation of an implantable cardioverter defibrillator (ICD).

There are two locations in the heart in which ICDs are normally implanted: the apex and the septum. The purpose of this study is to determine whether the ICD performs better in one location or the other, as measured by defibrillation threshold. In this study, both locations will be tested in each patient. The final location will be determined by the implanting physician as the location that is best for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient indicates for single-chamber (VR), dual-chamber (DR) or resynchronization CRT-D) implantable defibrillator
* Left-sided implant
* Single coil or dual coil (single coil for testing)
* Age ≥ 18 years of age
* Ability to consent
* Medically stable, in the opinion of the implanting physician, to undergo defibrillation safety margin testing
* Procedure performed under conscious sedation
* English-speaking

Exclusion Criteria:

* Patient unable to understand and consent to the procedure on his or her own
* Pregnant or breastfeeding patients
* New York Heart Association (NYHA) Class IV
* Patients with pre-existing RV leads
* Pacemaker dependent
* Patient medically unstable to undergo defibrillation testing (e.g., high risk for deep sedation; patients that develop respiratory compromise or hemodynamic instability from the sedation)
* Patients that require general anesthesia instead of conscious sedation
* Patients \<18 years of age
* Non-English-speaking
Efficacy and Safety of XG-102 in Reduction of Post-cataract Surgery Intraocular Inflammation

The purpose of this study is to evaluate the clinical efficacy and safety of XG-102 (900µg) compared to vehicle in the treatment of subjects with inflammation and pain following cataract surgery.


Eligibility Criteria:
Key Inclusion Criteria:

* Have provided written informed consent, approved by the appropriate institutional review board;
* Be greater than or equal to 18 years of age of either sex or any race;
* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
* Have a pin-hole visual acuity (VA) \< 1.0 logarithm of the minimum angle of resolution (logMAR) in the operative eye and fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1;
* (For females of childbearing potential) agree to have urine pregnancy testing performed at Visit 1 (must be negative) and at exit visit; must not be lactating; and must agree to use a medically acceptable form of birth control1 throughout the study duration. Women of childbearing potential include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).

Key Exclusion Criteria:

* Have a known sensitivity or allergy to the class of medication of the active ingredient in the study medication or any of the study medication's components;
* Have any intraocular inflammation (e.g., white blood cells or flare) present in the study eye at the Visit 1slit lamp examination;
* Have a score greater than "0" on the Ocular Pain Assessment at Visit 1 or 2 in the study eye;
* Have an immunosuppressive or an autoimmune disease that in the opinion of the Investigator could affect intraocular inflammation or the normal healing process of the eye;
* Have active or chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect wound healing;
* Currently have suspected or known malignancy or be currently receiving antineoplastic therapy;
* Be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration, or have a positive urine pregnancy test at Visit 1;
* Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics and other pain medications) or immunomodulating agents, systemically, or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study
Vascular Function in the Framingham Third Generation

To investigate the role of endothelial dysfunction and increased vascular stiffness as contributors to the pathogenesis of cardiovascular disease.

BACKGROUND:

Increasingly, researchers understand that endothelial dysfunction and increased vascular stiffness contribute to the pathogenesis of cardiovascular disease (CVD). The Framingham Heart Study (FHS) has been examining vascular function in about 3600 middle-aged and elderly participants of the FHS Offspring and minority OMNI cohorts.

DESIGN NARRATIVE:

The study characterizes vascular function by performing noninvasive studies of endothelial function with brachial ultrasound flow-mediated dilation, and of vascular stiffness with arterial tonometry, in 3850 adult offspring of the FHS Offspring and OMNI cohorts. The total of over 7000 vascular examinations in an extensively studied multi-generational community-based cohort provides the opportunity to characterize the environmental and genetic determinants, and the prognosis of altered vascular function. The study hypotheses are: vascular function is determined by both environmental and genetic factors; endothelial function and vascular stiffness phenotypes are associated with each other: and vascular dysfunction predisposes to the development of hypertension (HTN) and cardiovascular disease.

Eligibility Criteria:
No eligibility criteria
Comparison of Atomoxetine Versus Placebo in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

This is a two-arm, parallel, randomized, double-blind, placebo-controlled Phase 4 multicenter trial to compare the whole day efficacy of atomoxetine versus placebo in children aged 6 through 12 years with Attention-Deficit/Hyperactivity Disorder (ADHD) treated in an inpatient, day-patient and outpatient setting in Germany. Core symptoms will be measured during once or bi-weekly visits, three times per visit-day, by a computer based Continuous Performance Test. Following an initial 3-28-day screening and washout phase, patients will be assigned to double-blind treatment with atomoxetine or placebo. In the verum arm, a one-week atomoxetine treatment period with the 0.5 mg/kg per day lead-in dose will be succeeded by a 7 week period at the target dose of 1.2 mg/kg per day.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients who are at least 6 years of age, and who will not have reached their 13th birthday
* Diagnosis of ADHD
* Normal intelligence
* Able to swallow capsules

Exclusion Criteria:

* Weight less than 20 kg or more than 60 kg at study entry
* Prior treatment with atomoxetine
* History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3 months
* History of severe allergies or multiple adverse drug reactions
* Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT prolongation, inherited cardiac disorders
Subclinical Hypothyroidism and Normogonadotropic Anovulation

Thyroid hormones (TH) can modify the functioning of the hypothalamic-pituitary-ovarian axis, affecting the functions of granulosa cells and the development and apoptosis of preantral follicles. TH receptors are present within the oocytes, and TH and anti-thyroid antibodies (ATA) are present in the follicular fluid. Improper thyroid function can cause ovulation disorders, luteal phase failure, impaired endometrial receptivity and result in implantation failures and recurrent miscarriages. While overt hypothyroidism is treated to improve fertility, the effect of subclinical hypothyroidism (SCH) and the presence of circulating ATAs on fertility and obstetric outcomes is uncertain and data on ovarian reserve rates are conflicting. Among the causes of ovulation disorders (group II according to the WHO classification), polycystic ovary syndrome (PCOS) dominates, found in 3-15% of women of reproductive age, and the remaining group of causes is the so-called Hypothalamic-Pituitary-Ovarian Axis Dysfunction (HPOD). The exact etiology of both entities is unknown.

Purpose of the study

Evaluation of ovarian reserve indices in women with normogonadotropic anovulation with SCH and without thyroid disease.

Detailed objectives

i) Assessment of AMH, FSH, LH, estradiol, astral follicle count (AFC)/ovarian volume in the subpopulation of women with PCOS and SCH compared to women with PCOS without thyroid disease ii) Assessment of AMH, FSH, LH, estradiol, AFC/ovarian volume in the subpopulation of women with HPOD (other than PCOS) with SCH compared to women with HPOD without thyroid disease iii) Comparison of AMH, FSH, LH, estradiol, AFC/ovarian volume in women with PCOS and HPOD with and without thyroid disease and evaluation of correlation with US ovarian morphology iv) Calculation of the cut-off point of AMH concentration correlating with a high probability of PCOS diagnosis and TSH correlating with unfavorable parameters of ovarian function/HPO axis.

Eligibility Criteria:
Inclusion Criteria:

* age 18-45
* irregular periods
* infertility due to ovulation disorders
* euthyreosis

Exclusion Criteria:

* diagnosed and treated thyroid dysfunction,
* history of thyroidectomy
The Effect of Share Care Model in the Improvement of Diabetes Management

The situation of diabetes management in China is serious. To set up hierarchical medical system is necessary, though there was no mature or effective diabetes management model in the mainland. To explore a new path for hierarchical medical system, we would localize the share care model of diabetes management in Taiwan. Diabetic experts, diabetic educators and community doctors would use interactive information platform and self-glucose monitor with application on mobile phone to manage diabetic patients together. The model will be applied in six diabetic centers, and patients we will be managed in the new model and followed, and at the same time patients that managed in the conventional model in the real world, the differences of proportion who achieve a composite goal will be compared yearly for 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients

Exclusion Criteria:

* Patients had not signed the consent form
* Patients with sever hart failure, hepatic failure, renal failure
Comparing Two Treatment Modalities of Peri-implantitis - Blue Laser (445 nm) and Conventional Flap Surgery

A clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. The main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.

The present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. Peri-implantitis has a direct influence on both physical and psychological well-being and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. Therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches.

The study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). Assessment of clinical variables at baseline and after 6 months. Patient reported outcomes at baseline, directly after treatment and after 10 days.

Primary Objective:

To evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (SRP) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.

Secondary Objectives:

* To evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant.
* To evaluate the patient experience of a novel blue laser for treatment of peri-implantitis.
* To evaluate the inflammatory and microbial response after laser treatment

Eligibility Criteria:
Inclusion Criteria:

* Signs of peri-implantitis around one or more dental implants. All criteria below need to be fulfilled for inclusion.

  * Presence of pocket probing depth (PPD) \> 5 mm
  * Bleeding on probing/suppuration (BOP/Pus)
  * At least 2 mm loss of bone, visible on radiographs, after initial osseointegration.
* ≥ 18 years old.
* Patient able to understand Swedish.

Exclusion Criteria:

* Antibiotic treatment 6 months prior to baseline.
* Peri-implant treatment 6 months prior to baseline.
* Myocardial infarction 6 months prior to baseline.
* Previous radiation treatment in the affected jaw area.
* Previous i.v. bisphosphonate treatment.
* Moderate or severe impairment of cognitive function (e.g. dementia).
Sildenafil Citrate in Frozen Embryo Transfer

Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.


Eligibility Criteria:
Inclusion Criteria:

* all cases have at least 2 good quality blastocysts available for transfer

Exclusion Criteria:

* uterine structural abnormalities
* advanced uterine disease
* hydrosalpinx and pyosalpinx
Evolution of Bone Mineral Density (BMD) in Patients With Lymphoma Undergoing Chemotherapy

The purpose of this study is to assess changes of bone mineral density (BMD) at 12 months during the therapeutic management of patients with lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 to 80 with lymphoma,
* Histological diagnosis of Hodgkin's lymphoma (HL) or non-Hodgkin lymphoma (NHL) of follicular or aggressive (large cell or other),
* Patients who have not yet started their chemotherapy or who have started for less than a month
* Patient has signed informed consent.

Exclusion Criteria:

* Pathological fractures at the time of initial diagnosis of lymphoma,
* Compression of neurological epidural,
* Patients receiving treatment for osteoporosis (including bisphosphonates, selective modulators of estrogen receptor, calcitonin and parathyroid hormone Teriparatide).
* Discovery of osteoporosis or osteopenia fracture during the initial evaluation requiring the establishment of an osteoporosis treatment,
* Radiotherapy to the lumbar spine or hip studied,
* Location of bone lymphoma in the lumbar spine or hip studied,
* History of disorders affecting bone metabolism (prostate cancer with androgen, stomach cancer, hyperparathyroidism, hyperthyroidism, uncontrolled ...)
* A person incapable of giving consent personally,
* Pregnant or breastfeeding women,
* Protected Person (under guardianship)
* Patient not affiliated with a social security system.
STorz Against Glidescope Effectiveness

This study evaluates success rates of tracheal intubation (passing a breathing tube)for patients who may be more challenging to intubate while utilizing one of two devices that facilitate placement of the tube with video technology.


Eligibility Criteria:
Inclusion Criteria:

* adult 18 years of age
* Mallampati classification scale score of 3 or 4
* Neck circumference greater than 40cm for males, 38 cm for females
* mouth opening less than 3cm, but greater than 2cm

Exclusion Criteria:

* children
* prisoners
* history of easy intubation (success on first attempt with direct laryngoscopy)
* known unstable cervical spine injury
* emergency surgery
* nasal intubation route
* planned awake technique
Assistive Technology and Reduced Caregiver Burden

The study investigated a six-week randomized controlled trial study in a small cohort of 16 family caregivers of individuals living with Alzheimer's disease and related dementias. Family caregivers used assistive technology in the form of visual mapping software on smart devices in the experimental condition to support their care recipients in carrying out activities of daily living. Family caregivers in the control condition viewed educational videos about dementia care on their devices in supporting their individuals. The intervention was implemented for a total of 6 weeks. The investigators hypothesized that compared to the caregivers using educational videos, the caregivers using assistive technology will report improved quality of life and completion of activities of daily living for their care recipients, all the while reducing caregiver's burden and stress.


Eligibility Criteria:
Inclusion Criteria:

* Individual diagnosed with Alzheimer's disease or other related dementia (ADRD)
* Participating caregiver of individual with dementia must be the primary caregiver
* Proficient in English

Exclusion Criteria:

* Individual not diagnosed with ADRD
* Participating caregiver of individual with dementia is NOT the primary caregiver
* Not proficient in English