cyrilzakka/clinical-trials huggingface dataset:
Fertility and Cardiovascular Risk in Men With Metabolic Syndrome

Men diagnosed with metabolic syndrome (MetS) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. The eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. The aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years, wish for fatherhood in stable partnership, metabolic syndrome according to guidelines (minimum 3 out of 5 criteria), ready to participate in 1-yr lifestyle program

Exclusion Criteria:

* Not conforming to MetS diagnosis criteria, sterilisation, promiscuous behaviour, contraindications against established medical or surgical treatment of obesity, participation in another weight-loss program
Presentation of Lumbar Disc and Reduction of Symptoms

The trial aims to assess the hypothesis that presentation of the disc material to the patient following a lumbar microdiscectomy would positively influence the improvement in their leg and back symptoms.

Objective. The trial aims to assess the hypothesis that presentation of removed material to the patient following a lumbar microdiscectomy would positively influence the improvement in their radiculopathic and degenerative symptoms.

Design. Data will be collected prospectively. Patient allocation to treatment groups will be by simple randomization using a computer generated sequence of random numbers. Trial participants will be blinded as to the trial hypothesis and investigators blinded to patient allocation.

Setting. Patients will all be treated in a single secondary care unit.

Participants. All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc over a six month period will be considered for entry into the trial. Exclusion criteria: inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.

Intervention. Patients allocated to the experimental arm will be given the removed disc fragments to keep once they have recovered from anaesthesia. Those in the control arm will not be shown disc fragments (best available treatment).

Main outcome measure. The degree of improvement in radiculopathic and degenerative symptoms reported by the patient at 2-3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients undergoing a planned lumbar microdiscectomy for radiculopathy due to a prolapsed intervertebral disc

Exclusion Criteria:

* inability to give verbal consent, age less than 18, previous spinal surgery, emergency discectomies, patients having spinal fusions and those with no radiculopathic symptoms.
Internet-based Support in Cancer Rehabilitation

This 2-arm randomized trial assessed the incremental effect of providing a lecture on Internet use followed by participation in an Internet-based peer support group following a week-long rehabilitation program, over and above any possible general effect of participation in the rehabilitation program.

Primary outcome measures are adjustment to cancer and mood disturbance.


Eligibility Criteria:
Inclusion Criteria:

* Cancer survivors who were randomized for or self-selected to a rehabilitation course at the Dallund Rehabilitation Centre were included in the study.

Exclusion Criteria:

* Rehabilitation course weeks in which cancer survivors over 50 years of age were targeted specifically were excluded.
An Observational Study of Tarceva (Erlotinib) in Participants With Locally Advanced or Metastatic Adenocarcinoma Non-Small Cell Lung Cancer (ELEMENT)

This multicenter, observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic adenocarcinoma non-small cell lung cancer and an ECOG performance status of 0-1. Eligible participants receiving Tarceva according to the Summary of Product Characteristics and local label will be followed for the duration of their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Histologically or cytologically confirmed, locally advanced (Stage IIIb) or metastatic (Stage IV) adenocarcinoma non-small cell lung cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate hematologic, renal and liver function
* Participant initiating treatment with Tarceva according to the Summary of Product Characteristics

Exclusion Criteria:

* Any contraindications to treatment with Tarceva according to the Summary of Product Characteristics and local label
* Any other malignancies within the previous 5 years, except for in situ carcinoma of the cervix and basal and squamous cell carcinoma of the skin
* Previous systemic anti-cancer treatment with HER1/EGFR inhibitor
Exercise and Nutrition Program in Improving Physical Activity and Dietary Behavior in Non-Active, Overweight, or Obese Latinas

This pilot clinical trial studies how well an evidence-based exercise and nutrition program adapted for Latinas works in improving physical activity and dietary behavior in non-active, overweight, or obese rural Latinas. An exercise and nutrition program may reduce the risk for developing certain cancers, obesity, and chronic health conditions in Latinas who are non-active, overweight, or obese.

PRIMARY OBJECTIVES:

I. Adapt an effective evidence-based exercise and nutrition program to meet the needs of rural Latinas.

II. Implement the adapted program in a rural Latina population. III. Evaluate feasibility and potential to improve physical activity and dietary behavior of the adapted program in a rural Latina population.

OUTLINE:

Phase I: Create a community advisory board to adapt Strong Women Healthy Hearts Program (SWHHP) using feedback on the existing SWHHP from Latinas residing in the community.

Phase II: Conduct a small pilot study to assess effectiveness of the adapted program (one group pre-post design, with data collected at three time points).

INTERVENTION GROUP: Participants undergo instructor-led exercise and nutrition education classes for 60 minutes each twice a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Phase I:
* Bilingual Latina
* Live in the community
* Phase II:
* Latina
* Currently non-active (exercise two days or less per week)
* Overweight or obese (body mass index \[BMI\] of 24 or greater)

Exclusion Criteria:

* A medical condition that precludes moderate-vigorous physical activity as determined by health care provider
* Pregnancy
Determination of Ecological Awareness and Attitudes Levels of Undergraduate Physiotherapy Students in Istanbul

The natural environment, which is the living environment of all living things; Technological advances and industrialization activities are being affected more and more negatively every day. Increasing energy demand and resource consumption due to population growth lead to negative consequences on ecological balance, such as environmental pollution, climate change and loss of natural environments. Health services have also increased resource use with the advancement of technology and caused negative effects on the environment. Health services have been slow to understand their impact on the environment. The aim of the study is to determine the environmental awareness and environmental attitude levels of physiotherapy and rehabilitation department students, to popularize the field of "Environmental Physiotherapy" and to enable the training of physiotherapist candidates with high environmental awareness.

The natural environment, which is the living environment of all living things; Technological advances and industrialization activities are being affected more and more negatively every day. Increasing energy demand and resource consumption due to population growth leads to negative consequences on ecological balance, such as environmental pollution, climate change and loss of natural environments. Health services have also increased resource use with the advancement of technology and caused negative effects on the environment. Health services have been slow to understand their impact on the environment. The aim of the study is to determine the environmental awareness and environmental attitude levels of physiotherapy and rehabilitation department students, to popularize the field of "Environmental Physiotherapy" and to enable the training of physiotherapist candidates with high environmental awareness. In this descriptive study planned on physiotherapy and rehabilitation department students studying in Istanbul, participants who meet the inclusion criteria and volunteer for the study will be included. "Socio-demographic information form", "Ecological Footprint Awareness Scale", "Environmental Awareness Scale", "Environmental Attitude Scale" and 5-question survey forms prepared by the researchers will be used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* Residing in Istanbul
* Being a physiotherapy and rehabilitation undergraduate student
* Being a 2nd, 3rd or 4th grade student
* Volunteering to participate in the study

Exclusion Criteria:

* Being a first year student of physiotherapy and rehabilitation
* Refusing to participate in the study
Cap-assisted Endoscopic Sclerotherapy for Internal Hemorrhoids and Rectal Prolapse

This clinical trial aims to evaluate the efficacy and safety of long needle and short needle in the treatment of internal hemorrhoids and rectal prolapse through CAES (Cap-assisted endoscopic sclerotherapy).

Traditional endoscopic sclerotherapy for internal hemorrhoids require retroflection of the endoscope. Retroflection of the endoscope has blind areas and affects the precise operation. And, short-needle injection can easily lead to artificial ulcer and secondary bleeding. CAES is a new, minimally invasive endoscopic technique for the treatment of internal hemorrhoids and rectal prolapse. CAES was performed based on the requirement of the cap, endoscope, disposable endoscopic long injection needle, enough insufflated air and sclerosing agent. It can accurately control the injection angle, direction and depth under direct vision, and avoid iatrogenic injury caused by ectopic injection to the greatest possible extent. To investigate the effect of long needle and short needle on the outcome of CAES, participants with internal hemorrhoids and rectal prolapse were randomly assigned to a long needle group and a short needle group using a prospective, randomized, controlled study at multiple centers in China. The efficacy, adverse events and satisfaction of the two groups were observed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with internal hemorrhoids and rectal prolapse, combined with external hemorrhoids or without external hemorrhoids.
2. Patients with bowel preparation.

Exclusion Criteria:

1. History of anoscopic/endoscopic sclerotherapy.
2. Patients with acute thrombotic external hemorrhoids.
3. Patients with serious internal hemorrhoids of grade IV.
4. Patients with anal stenosis, anal fissure, fistula, fecal incontinence, ulcerative colitis, Crohn's disease.
5. Patients with acute diarrhea in the past 24 hours.
6. Hypertensive patients with uncontrolled blood pressure, patients with cerebrovascular accident and obvious bleeding tendency, pregnant women, mental disorders and decompensated cirrhosis.
Digitalization of Osteoarthritis Care

The overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. The primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

The primary aim of this study is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis. The secondary aims are to evaluate how 1) patient-related outcome measures regarding the ability of the patient to "forget" about their problematic joint after treatment, quality of life, pain-related self-efficacy, and level of physical activity and 2) care consumption, cost-effectiveness, and carbon footprint differ between the three care models in a short-term (three months) and long-term perspective (one and three years respectively). Further aims are to evaluate how patient experience of the benefits provided by the two digital care models differs and how patient experience with respect to work alliance differs between the three care models. The primary hypothesis is that patients who are randomized to an app-based care model will improve significantly more in terms of function in daily life from baseline to one year compared with patients who are randomized to a web-based model and usual care. The secondary hypothesis is that patients randomized to the app-based care model change equivalently from baseline to one year in terms of patient-reported measures, but that the app-based care model is more cost-effective compared with the other two care models at one and three years, respectively.

Eligibility Criteria:
Inclusion Criteria:

The participant:

* has given their written consent to participate in the study
* has been referred to the orthopaedic clinic at Sahlgrenska University Hospital /Mölndal for primary hip- and or knee osteoarthritis
* has a positive attitude in using digital tools
* has access to a smart phone / tablet
* has been assessed not to be in need of hip or knee surgery trough triage based on a patient reported outcome (the Osteoarthritis Guidelines Instrument)

Exclusion Criteria:

Patients:

* with secondary osteoarthritis (due to osteonecrosis)
* referred to a specific orthopaedic surgeon
* with impaired mental ability, reluctance or language difficulties that make it difficult to understand the meaning of participating in the study
* who undergo treatment, have disability or illness that according to the research group can affect the treatment or the study result
Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain

The plan " Quantitative analysis of different acupuncture needle manipulation to treat chronic shoulder pain "includes an objective observation of acupuncture operation (movement in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions. Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking medicine or Western medicine were included. Then use of distal acupoints GB34 and GB39, giving once acupuncture manipulation therapy.

Numerical rating scale (NRS) and pain pressure algometer were used to objective and quantitative assessment of the patient's pain. And shoulder pain and disability index-SPADI was used to objectively assess the functional changes of acupuncture treatment in patients with chronic shoulder pain. Massachusetts General Hospital Acupuncture Sensation Scale - MASS was used to get objectively record of de-qi when needle manipulation for the the body (acupoints) reactions. Acusensor2 was used to get objective observation reaction during needling manipulation, the sensor provided measurement parameters such as the lift and thrust, twisting, strength and torque during needle manipulation. Investigators will study and analysis associated clinical outcome with needling process, the needle manipulation by lifting-thrusting or twisting-rotating during the process of reinforce method or reducing method to study its dynamics and kinematics.

Eligibility Criteria:
Inclusion Criteria:

* (A) have agreed to participate in the trial and signed by the Chang Geng Memorial Hospital Human Body Test Committee approved the human test consent.
* (B) suffering from chronic shoulder pain (including frozen shoulder, or rotator cuff injury, or subclavian bursitis, Or biceps tendonitis or nonspecific shoulder pain).
* (C) at least six weeks before the screening period of shoulder pain, digital grading scale measurement of pain intensity of 5 points or more.

Exclusion Criteria:

* (A) shoulder fracture
* (B) intra-articular infection
* (C) stroke hemiplegia
* (D) spinal cord injury
* (E) postoperative shoulder surgery
* (F) pregnant woman,
* (G) took traditional Chinese medicine or Western medicine, less than one month before the screening period
A Study of Experimental Medication BMS-986036 Given to Healthy Participants

This is a study of experimental medication BMS-986036 given to healthy participants.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviations from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* BMI of 18 to ≤ 40 kg/m2

Exclusion Criteria:

* Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
* Any bone trauma (fracture) or bone surgery (i.e. hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Known or suspected autoimmune disorder, excluding vitiligo
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
* Any significant acute or chronic medical illness
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any major surgery within 6 weeks of study drug administration
* History of diabetes mellitus

Other protocol defined inclusion/exclusion criteria could apply
Exercise and Treatment-as-usual in Substance Use Treatment Outcomes

The research study compares the substance abuse treatment outcomes (e.g., craving, withdrawal symptoms, rates of use, abstinence) of standard intensive outpatient care, with or without an added 6-wk aerobic exercise component. In addition, certain biomarkers associated with both exercise and substance use (e.g., endocannabinoids and cortisol) will be assessed. In a rolling admissions format over the course of a year, approximately 36 treatment-seeking substance users who are currently receiving Intensive Outpatient Treatment through a local Alcohol or Other Drug Abuse agency will be randomized to either receive 6 weeks aerobic exercise training in addition to standard care or standard care with 6 weekly laboratory visits to complete questionnaires (18 per group).


Eligibility Criteria:
Inclusion Criteria:

* Intact cognitive status and ability to provide informed consent
* ability to read and write in English sufficient to provide consent and complete study questionnaires
* current diagnosis of a single or of multiple substance use disorders
* currently enrolled in an Intensive Outpatient Treatment substance use program
* desire to quit and to seek treatment for substance use
* currently sedentary, not participating in any formal/structured exercise program

Exclusion Criteria:

* a history or present diagnosis of severe depression, psychotic, or bipolar disorder
* presence of cardiac disease or any other medical condition that would make engaging in exercise unsafe
* Undergoing methadone treatment
* chronic conditions such as cancer, diabetes, kidney disease, or autoimmune disorders
* women who are pregnant or planning to become pregnant
Measurement of Hormone Levels in Patients Receiving 17-HPC for Preterm Delivery

The purpose of this study is to measure hormones in the blood known to affect the timing of delivery after a single injection of 17-P in order to help understand its mechanism of action in preventing preterm delivery.

A recent study by Meis and colleagues published in the New England Journal of Medicine in June 2003 demonstrated a 33% reduction in the rate of preterm delivery in patients with a previous history of preterm delivery who then used weekly 17-P injections in the subsequent pregnancy.

This is a milestone in the prevention of preterm delivery and is the reason you have chosen to receive treatment with 17-P.

However, how 17-P works to prevent preterm delivery is unclear. Knowledge of the mechanism of action of 17-P would help in selecting patients for treatment and may be useful in monitoring the efficacy of therapy.

Studies have suggested that the timing of delivery depends on a type of placental clock, affected by levels of corticotropin-releasing hormone (CRH) and progesterone (P).

CRH can be thought to act as an accelerator, and P as a brake. Serial injections of 17-P beginning in the second trimester of pregnancy may prevent preterm delivery by maintaining progesterone dominance, and be reflected in increased levels of progesterone and/or 17-P, or decreased levels of cortisol and/or CRH. These are the hormones that will be measured in this study.

Results of the study will be important whatever the outcome. If there is no measurable change in the hormones measured, this is important to know and investigation of other markers can be pursued. If there is a measurable change in the hormones measured, then this pilot study could serve to support a larger more definitive study, which could lead to very valuable information relating to the practical use of 17-P for the prevention of preterm delivery.

Eligibility Criteria:
Inclusion Criteria:

* Spontaneous preterm delivery in a previous pregnancy, are between 15-20 weeks gestation during the current pregnancy, and have already decided whether or not to receive 17-alphahydroxyprogesterone caproate (17-P) for the prevention of preterm delivery.

Exclusion Criteria:

* Multiple gestation
* Known fetal anomaly
* Progesterone or heparin treatment during the current pregnancy
* Seizure disorder
* Pre-existing or gestational diabetes
* Hypertension requiring medication
* Thyroid or adrenal gland disorder