cyrilzakka/clinical-trials huggingface dataset:
Effect of Daily Glucomannan in Overweight Patients

Glucomannan is a dietary supplement that has been marketed for weight loss. There is some research that supports this claim but more research is necessary. This is research study is being conducted to determine if the dietary supplement glucomannan is effective for weight loss in adults greater than 18 years of age who are overweight.

Participants will be randomized in a 1:1 manner (like the flip of a coin) to receive either glucomannan 575 milligrams, 2 capsules three times daily or placebo, 2 capsules three times daily. The study will last for 12 weeks.

At the start of the study participants will be asked questions about current medications and diet/exercise regimen, a weight and height will be obtained, and they will be given a one-month's supply of study supplement. An investigator will call each participant after they have been taking the supplement for 2 weeks to ensure that the participant is tolerating the supplement and answer any questions. Throughout the study, participants will be required to follow-up with investigators in the office every 4 weeks (a total of 3 follow-up appointments). Every 4 weeks, the investigators will weigh participants, count the leftover capsules from the previous month, and ask about any adverse effects you may be experiencing. At the conclusion of the study, a final weight will be compared with the baseline weight to determine if the medication had an effect on weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old
* Overweight (BMI ≥ 25 kg/m2)

Exclusion Criteria:

* Pregnant or nursing women
* Women of childbearing age will be excluded unless they are on some form of contraception
* Participation in any other formal or informal weight reduction program

  1. Currently enrolled in another weight loss study
  2. Currently enrolled in a weight loss program
  3. Active attempt to lose weight with diet and/or exercise within the last month
  4. Currently on one of the following medications known to cause weight loss:

     * Alli/Xenical(orlistat)
     * Adipex-P (phentermine)
     * Bontril (phendimetrazine)
     * Dexoxyn (methamphetamine)
     * Didrex (benzphetamine)
     * Tenuate (diethylpropion)
     * Meridia (sibutramine)
     * Byetta (exenatide) or Victoza (liraglutide)
     * Stimulants
* Recently (within the last three months) started on any medication that may cause weight gain
* A diagnosis of heart failure
* Structural abnormalities of the esophagus or gut
* Previous GI surgery for weight reduction
* Inflammatory bowel or irritable bowel disease
* A life expectancy of \<6 months
* Allergy to glucomannan or any component of the placebo
The Effect of Platelet-rich Plasma in Patients With Osteoarthritis of the Knee

Osteoarthritis is the most common type of arthritis. The prevalence of osteoarthritis of the knee has significantly elevated in the elderly population and youth due to age and sport activities respectively. Our aims to treat the knee osteoarthritis are including; reduce knee pain and improve its function; return patients to normal daily activities and reduce health care costs.

The current treatments which are already being used for osteoarthritis of the knee patients include:

1. Symptomatic therapy: conservative therapies, physiotherapy, analgesics and non-steroidal anti-inflammatory drugs.
2. Intra-articular injections of corticosteroids and hyaluronic acid.
3. Current Surgical Therapy: knee arthroplasty, osteotomy, arthrodesis and debridement.

As the low mitotic activity and lack of blood supply cause little ability for the articular cartilage to repair itself, so injection of platelet-rich plasma (PRP) has recently received much more attention due to its capacity to do self-healing in treatment of osteoarthritis of the knee.

PRP consists of several concentrated growth factors in platelets of autologous blood that are applied to the different parts of medicine such as reconstruction of damaged tissue. Although platelets are well-known to involve in the blood clots formation, but current studies have shown that they secrete many bio-proteins which attract macrophages, mesenchymal stem cells and osteoblasts to remove necrotic tissue in addition to participate in healing procedure.

This study is a prospective, randomized, controlled trial to assess The positive effects of platelet-rich plasma injection in 244 patients with osteoarthritis of the knee

In this study all eligible patients (Based on the inclusion and exclusion criteria) were randomly allocated into two study groups by a Stratified Permuted Block randomization method: group A received platelet rich plasma, group B (control group) received only placebo.

All of the patients underwent a standard long protocol for knee osteoarthritis. All patients with grade II,III and IV of radiographic knee OA are selected. On average, in each instance, the amount of platelets in the peripheral blood is 4 to 6 times the baseline level.

Group A: 1-3 cc injection of placebo Group B: 1-3 cc injection of PRP All patients received monthly injection for 3 times.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 65 years
2. Body mass index (BMI) ≤33 kg/m2
3. Grade 2And above imaging of osteoarthritis
4. History of knee pain or swelling should have at least 4 months

Exclusion Criteria:

1. treated with steroids and Anti-coagulant or anti-platelet aggregation
2. history of infectious, systemic diseases, Immune deficiency and coagulation disorders
3. Patients with Hb ≤11, Plt ≤ 150000
4. Varus \> 10 , valgus \> 10
Aromatase Inhibitors in the Treatment of Male Infertility

Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors such as anastrozole work to decrease the production of estrogen and increase testosterone in the body. By decreasing the level of estrogen, sperm production should improve. In this study, the investigators will try to determine the benefit of anastrozole in obese men and follow pregnancy outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Male partner of a couple presenting for infertility work up after one year of unprotected intercourse
2. Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 × 106/mL) of at least two separate occasions spanning a minimum of two weeks
3. Obese men BMI ≥ 30
4. FSH and LH levels \< 10 mIU/mL

Exclusion Criteria:

1. Severe Oligozoospermia: Sperm count \< than 3 × 106/mL, including azoospermia
2. Age less than 18 or greater than 65 years
3. Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per milliliter of semen
4. Cryptorchidism
5. Vasectomy reversal
6. Regular use of tobacco products
7. BMI \< 30
8. Use of anabolic steroids or testosterone replacement
9. All patients with abnormal initial liver function tests "AST or ALT" will be excluded form the study
Impact of Group Participation on Adults With Aphasia

The purpose of the study is to examine the impact of group participation on adults with aphasia. Participants will complete a standard pre-and post-assessment of language abilities (speech, comprehension, reading, and/or writing). Then participants will attend 90-minute weekly reading group sessions during an academic semester.

The objective of this research is to determine if attendance in groups positively impacts language skills, activity/participation, and/or quality of life in persons with aphasia.

This study will employ a university-clinic based outpatient group to administer language intervention. The specific aims of this study are to determine if group participation improves (1) life participation as measured by self-report questionnaires, (2) intervention-specific language skills as measured by treatment-related measures (e.g., reading comprehension and written expression), and (3) performance on non-treated language test scores as measured by a language assessment battery.

Participants will complete 4-5 individual testing sessions (e.g., initial assessment and pre-/post-testing), 7-12 group sessions (90-minute weekly reading group session), and 7-12 independent sessions at home (e.g., completion of weekly reading assignments).

The participants will read through a designated book incrementally across multiple weeks. The activities completed during the group sessions will focus on improving reading comprehension and written expression skills. Participants will read assigned passages at home and during the group sessions. Participants will complete a Copy and Recall Treatment (CART) worksheet independently to facilitate improvements in writing keywords related to the reading materials. CART involves copying target words and progresses to writing words from recall (Beeson, et al.). Participants will complete a reading comprehension worksheet and engage in discussion regarding the assigned book chapter.

Reading comprehension and written expression data will be collected and analyzed to compare the pre-treatment baseline performance from the first treatment session to the post-treatment performance from the last treatment session. Pre-and post-testing scores will be analyzed to investigate the change in scores across the 2-time points to determine the relative effectiveness of book club participation for improving reading comprehension, written expression, and life participation.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Pre-morbid proficient speaker of English
* Diagnosis of adult-onset aphasia
* Vision and hearing sufficient to complete assessments

Exclusion Criteria:

* No history of childhood speech or language difficulties
* No history of major psychiatric illness, cognitive impairment, or neurological disorders such as seizures
Body Composition in Systemic Amyloidosis

Malnutrition is a prominent clinical feature of patients affected by systemic immunoglobulin light-chain amyloidosis (AL), with a prevalence ranging between 25-50%. Although the prognosis predominantly depend on the presence and severity of cardiac involvement, it was shown that malnutrition is an independent predictor of survival and quality of life. However, the assessment of nutritional status by common indices based on anthropometry is not always feasible and accurate due to reduced performance status and/or the presence of fluid imbalances (for example edema and ascites). Several recent studies have demonstrated the prognostic value of the phase angle. Moreover, the value is supported by its applicability to patients who are bedridden or present alterations in the state of hydration.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of systemic immunoglobulin light-chain (AL) amyloidosis
* Written informed consent

Exclusion Criteria:

* Age \<18 years
* Ongoing artificial nutrition
* Unavailability to planned measurements
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-062)(COMPLETED)

A clinical study to determine the efficacy and safety of MK0869 in the treatment of depression

The duration of treatment is 8 weeks.

Eligibility Criteria:
Patients with Major Depressive Disorder
A Comparison Between Neurostimulation and Loss of Resistance for Cervical Paravertebral Blocks

Cervical paravertebral blocks (CPVBs) target the brachial plexus from a puncture site situated in the posterior aspect of the neck and represent an alternative to interscalene blocks (ISBs) for shoulder and proximal humeral surgery. Randomized controlled trials comparing CPVB and ISB have found no significant differences in success rate, onset and offset times. Because of the reliability of their cutaneous landmarks, CPVBs have become part of the investigators' standard practice. With this approach, the brachial approach can be identified either with loss of resistance to air (LOR) or nerve stimulation (NS). While some authors have used only LOR and reported good success rates, others have hypothesized that NS may increase the reliability of the block. In the proposed study, for the first time, the 2 methods will be formally compared.


Eligibility Criteria:
Inclusion Criteria are:

* age between 18 and 70 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 28

Exclusion criteria are:

* adults who are unable to give their own consent
* pre-existing obstructive or restrictive lung disease (assessed by history and physical examination)
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie platelets≤ 100, International Normalized Ratio≥ 1.4 or prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie creatinine≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up ie transaminases≥ 100)
* allergy to local anesthetic agents (LA)
* pregnancy
* prior cervical spine surgery
The Effect Of Fesoterodine On Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects

This is an open-label, randomized, two-way crossover study to evaluate the steady-state effect of fesoterodine (8 mg QD) on the pharmacodynamics and pharmacokinetics of a single supratherapeutic dose of warfarin (25 mg) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Not healthy subjects--subjects with acute or chronic medical or psychiatric conditions or laboratory abnormality
Single Ascending Dose Study With BPL-003 in Healthy Subjects

The study will evaluate safety, tolerability and PK profile of BPL-003 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Medically healthy based on medical records and study specific assessments

Exclusion Criteria:

* Presence or history of severe adverse reaction to any drug or drug excipient
Firmagon (Degarelix) Intermittent Therapy

Men with localized prostate cancer requiring intermittent androgen deprivation therapy for biochemical recurrence following radical therapy will be asked to participate in a phase 4 safety and efficacy clinical trial comparing 10 months versus 4 months of degarelix (Firmagon®) therapy with the endpoint of prolonging the off treatment interval.

This is an open-label, multi-centre, randomised trial with subjects receiving subcutaneous (s.c.) monthly injections of degarelix depot. All patients will be treated with a one-month starting dose of 240mg on Day 0. Subjects are then randomized to receive either nine or three maintenance doses of one month duration. The primary objective is to determine the effect of degarelix therapy on the length of the off treatment interval (defined as serum Prostate-specific antigen (PSA) increasing to 5 ng/ml) following completion of the androgen deprivation therapy. The trial will also assess the effect of degarelix therapy on PSA kinetics (specifically PSA doubling time), PSA nadir, and effect on quality of life as well as other measures. The efficacy and safety of these two treatments will also be reported.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed adenocarcinoma of the prostate for which intermittent endocrine treatment therapy is indicated
* PSA level meeting both of these criteria:
* PSA level of ≥ 5 ng/mL.
* For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir.
* screening serum testosterone level above the lower limit of normal range defined as \>2.2 ng/mL.

Exclusion Criteria:

* Has had previous or is currently under hormonal management of prostate cancer (surgical castration or other hormonal manipulation)
* Has received therapy with the 5-alpha reductase inhibitors finasteride or dutasteride within 12 weeks and 25 weeks, respectively, prior to screening
Bioequivalence Study of NPC-12 (Sirolimus) Granules and Tablets

The purpose of this study is to evaluate the bioequivalece of NPC-12 granules in compare with NPC-12T tablets in Japanese healthy Adults


Eligibility Criteria:
Inclusion Criteria:

1. Japanese healthy subjects aged 20 to 39 years of age
2. Subjects with BMI ≥ 18.5 kg/m2 and \< 25.0 kg/m2
3. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results at screening
4. Subjects who are considered by the investigator as suitable for participation in the trial from lab test results on the day before administration
5. Subjects who write informed consent
6. Subjects who are able to comply with the study requirements during the study period

Exclusion Criteria:

1. Subjects who have a history of hypersensitivity to sirolimus or sirolimus derivative
2. Subjects who have a history of hypersensitivity or allergies to other drug
3. SUbjects who have an acute or chronic infectious diseases
4. Subjects who have a current or a history of disease which is considered inappropriate to be involved in the study, or who has any current disease to require treatments
5. Subjects who have diagnosed with alcoholism or a history of alcoholism
6. Subjects who have an abnormal findings (pneumonia, etc) from the result of chest CT at screening
7. Subjects who have been administered other investigational drug within 12 weeks before the initial administration
8. Subjects who have performed blood collection or donation as follows

   * Collected or donated 200 ml or more whole blood within 4 weeks before the initial administration
   * Male subject; collected or donated more than 400 mL whole blood within 12 weeks before the initial administration
   * Female subjects; collected or donated more than 400 mL whole blood within 16 weeks before the initial administration
   * Collected or donated blood component within 2 weeks before the initial administration
9. Subjects who have positive results for HBs antigen, HBs antibody, HBc antibody, HCV antibody, HIV antigen/antibody, or syphilis
10. Subjects who received any non-prescription or prescription drug within 12 weeks before the initial administration
11. Subjects who are pregnant/lactating, or do not agree to contraception during the period from the screening until 8 weeks after the final administration due to planning to become pregnant
12. Subjects who cannot speak, read and write in Japanese
13. Subjects who are considered by the investigator as unsuitable for participation in the trial
Social Participation and Healthy Aging

The research aims to promote active aging through a pilot study. The design will be crossover with two groups. Intervention will consist of presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five. The outcomes will be quality of life, presence of depressive symptoms, and regularity of biological and social rhythms.

In 2050, 36% of the Italian population will be over 65 years old. The European Union has identified as a priority the increase in research on active aging, promoting activities that can maintain and enhance the health and social engagement of individuals aged 65 and above.

This pilot study aims to assess feasibility a preliminary measure of effectiveness of a psychosocial intervention focused on intergenerational exchange on quality of life, biological and social rhythms, and mood in a group of elderly

The outcomes will include quality of life, presence of depressive symptoms, and regularity of biological and social rhythms, assessed before the intervention, immediately after intervention and at a follow-up four months after the intervention's conclusion.

The psychosocial intervention will consist of sessions on a weekly basis and delivered both in-person and remotely. The sessions will include presentations and interactive debate sessions, with a central focus on intergenerational exchange covering cultural, historical, and health-related topics. A key aspect is the active involvement of beneficiaries, individuals over sixty-five, who will be asked to prepare presentations with the support of project-provided facilitators. Simultaneously, the project will promote social inclusion, enhance skills, organizational capabilities, and computer literacy.

Eligibility Criteria:
Inclusion Criteria:

* people who are 65 years of age or older

Exclusion Criteria:

* have serious problems with independent walking,
* have serious neurological conditions or serious disabilities that make it impossible to participate in the intervention in person or remotely
Supplemental Benefit of Angiotensin Receptor Blocker in Hypertensive Patients With Stable Heart Failure Using Olmesartan

The purpose of this study is to investigate whether an angiotensin II receptor blocker (olmesartan), in addition to conventional treatment, will reduce the mortality and morbidity in hypertensive patients with stable chronic heart failure.


Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following criteria.

* Patients with NYHA class II through IV chronic heart failure.
* Patients who have a history of hypertension or those who have antihypertensive medications.
* Patients who are aged 20 years or older and less than 80 years at the entry.
* Stable patients who have angiotensin converting enzyme inhibitor and/or beta-blocker.
* Patients who do not have angiotensin II receptor blocker.

Exclusion Criteria:

* Patients who have renal dysfunction (serum creatinine \>=3.0mg/dL) or those who are receiving chronic hemodialysis.
* History of drug hypersensitivity to olmesartan.
* Patients who have severe liver dysfunction.
* History of angioedema.
* History of malignant tumor or life-threatening illness of poor prognosis.
* Pregnant or possibly pregnant patients.
* Cardiovascular surgery within 6months prior to the date of the entry.
* Acute myocardial infarction within 6 months prior to the date of the entry.
* Percutaneous coronary intervention or stent implantation within 6 months prior to the date of the entry.
* Other patients deemed unsuitable as subjects of the study by the treating physician.