cyrilzakka/clinical-trials huggingface dataset:
Music During Pulmonary Rehabilitation for Patients With COPD

This study is aimed at determining whether listening to music during exercise will improve health-related outcomes for individuals with chronic obstructive pulmonary disease (COPD). Half of the participants will listen to music while they exercise and half will not listen to music. The study will follow participants during their pulmonary rehabilitation program and for 6 months following completion of the program.

People with chronic obstructive pulmonary disease (COPD) are encouraged to undertake exercise training as part of their treatment. However, they often find themselves limited by breathlessness and tiredness in their legs. These barriers limit how much a person may benefit from an exercise program and how well they may keep up with a recommended schedule of exercise at home. One way of reducing feelings of breathlessness and leg tiredness is by listening to music during exercise.

The impact of adding music to exercise versus exercise alone has not been explored in the setting of pulmonary rehabilitation. This study is aimed at determining the effect of listening to music during exercise sessions on exercise capacity, symptom severity, quality of life and motivation to exercise.

People with COPD will be randomly allocated to exercise plus music or exercise alone. A music therapist will aid with music selection for the exercise plus music group and the music will be loaded onto a portable device that participants will listen to with earbuds. All participants will complete assessments before starting a pulmonary rehabilitation program, at the end of the 8-10 week program and 6 months following completion of the program. They will complete walking tests, report symptom severity and complete a series of questionnaires asking about their quality of life, symptoms and keenness to exercise.

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of COPD (physician diagnosis and spirometry with FEV1/FVC ratio \<70) and smoking history of greater than 10 pack years
* Stable clinical state, with no acute exacerbations over the last 6 weeks
* Referred to pulmonary rehabilitation program

Exclusion Criteria:

* Predominant diagnosis other than COPD (asthma, bronchiectasis, interstitial lung disease)
* Co-morbidities (orthopaedic, neurological, cardiac) which might prevent safe exercise training
* Substantial hearing difficulties (inability to hear music adequately)
* Regularly uses music when exercising
Application of Laparoscopy in Gastrointestinal Injury

laparoscopy has been increasingly applied in patients with abdominal trauma , as an diagnostic and therapeutic modality. However, its clinical benefits are still under evaluation. The aim of this study is to prospectively assess the feasibility and safety of this technique in the management of traumatic gastrointestinal injury.

This prospective single arm study was undertaken in West China Hospital, Sichuan University, Chengdu, China. The institution is the largest medical center in southwest China, and also a national training center of laparoscopy. Surgeons participated in the study were well trained in gastrointestinal laparoscopy and hepatobiliary laparoscopy, and were experienced in management of abdominal trauma.

The study was approved by the institutional review committees. The participants provided written informed consent.

Patients age 18 years or older with abdominal trauma were considered eligible, regardless of the nature of trauma (blunt or penetrating), but hemodynamic stability was mandatory.

Patients meet the following criteria is prepared for laparoscopic exploration:

Evidence showed that wound penetrates the peritoneum in penetrating trauma or/and signs of peritoneal irritation or positive CT scan in those without penetration of peritoneum and patients with blunt injuries.

We defined the CT scan positive by it shows peritoneal effusion, free intraperitoneal air, fat density increase, substantive organ rupture and intestinal wall swelling and other signs of abdominal trauma.

Laparoscopic screening will be performed according to protocol. The study demands that all surgeons should complete the repair laparoscopically as much as possible when condition allow, and record reasons for conversion in detail when it is inevitable.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastrointestinal trauma
* Blood loss \< 1000ml
* Hemodynamically stable
* Vital sign is stable
* Willing to comply to the study procedure and complete the study.

Exclusion Criteria:

* Severe hemorrhage or intraperitoneal infections
* Combined with other conditions which are contraindications to laparoscopy
* Pregnant or lactating woman
* Severe immunodeficiency
* History of drug abuse
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)

The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 60 years and older (\>60yrs), untrained
* Symptomatic hypogonadism as defined by a) and b)
* a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.)
* b)Total Aging Males' symptom score above 36
* Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
* Residence in Cologne Area

Exclusion Criteria:

* Previous assignment to treatment during this study
* Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1)
* Current participation in an exercise program or within the last 6 months
* Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia
* Abnormal finding on Digital Rectal Examination (DRE)
* Prostate specific antigen (PSA) level \>4 ng/ml
* History of clinically significant post void residual urine (\> 150 ml)
* Suspicion or known history of liver tumor
* Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil
* Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants
* 32 Additional Exclusion Criteria
Prognostic of Dysfunctional Breathing in Long Covid: a Follow up Study

Dysfunctional breathing might participate to dyspnoea in long COVID-19. This study investigate the prognosis of patients diagnosed with dysfunctional breathing after SARS-CoV-2 infection in our center.

Dysfunctional breathing (DB) with or without hyperventilation syndrome (HVS) as diagnosed using cardiopulmonary exercise test (CPET) was recently demonstrated as an important physiopathological mechanism of persistent dyspnoea in long COVID patients \[1\]. DB is characterized by specific ventilation pattern on CPET accompanied by respiratory discomfort and/or dyspnea at exercise \[2\]. Most patients with DB will have undergone some sort a specific physiotherapy retraining \[3\]. However the prognostic and the predictors of persistence/resolution of DB after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are unknown.

The aim of the study is to determine the prognostic of patients diagnosed with DB after SARS-CoV-2 infection, as well as prognosis factors and predictors of persistence/resolution of DB during a prospective follow up visit.

Eligibility Criteria:
Inclusion Criteria:

* patients 14 years or more
* diagnosis of DB after SARS-CoV-2 at our long covid clinic using a combined approach of symptoms and CPET analysis in the hospitals of Sion, Martigny or Rennaz
* Inclusion between November 2020 and until the end of October 2021

Exclusion Criteria:

* Refusal to participate
* comorbidities preventing the CPET or PFT to be carried out
Effect of the Molecular Weight of Oat β-glucan on Its Ability to Lower Serum Cholesterol

The purposes of this study were:

1. To determine if a breakfast cereal containing 3g of high molecular weight oat beta-glucan fiber would lower low-density lipoprotein (LDL) - cholesterol (the "bad" cholesterol) compared to a control cereal containing wheat fiber.
2. To determine if the LDL-cholesterol-lowering effect of oat beta-glucan fiber was reduced when the molecular weight of the fiber was reduced.

The FDA allows a health claim that oat products may reduce the risk of heart disease, based on meta-analyses showing a cholesterol-lowering effect of oat beta-glucan, if the product delivers at least a 3g daily dose of oat beta-glucan. However, not all studies have demonstrated a lowering of oat products. This may be due to variable bioactivity of the beta-glucan in the oat products. The bioactivity of oat beta-glucan is believed to depend upon its viscosity in the gut. Factors influencing viscosity include the molecular weight (MW) of the beta-glucan molecule and the amount of soluble beta-glucan in the product, which, in turn determines its concentration (C) in solution. In finished food products both MW and C can be modified by beta-glucanase enzymes present in other ingredients in the food (eg. wheat flour), processing (eg. extrusion) and storage (eg. freezing of moist products such as muffins). The effect of altering the MW and solubility of beta-glucan in foods on glycemic responses has been shown, but a role for MW and C in cholesterol lowering has not been established.

To address this issue, this study was designed with 2 primary objectives:

1. An extruded oat cereal containing 3g high-molecular weight oat β-glucan daily will reduce LDL cholesterol compared to a control wheat bran cereal.
2. A significant correlation exists between LDL cholesterol and log(C×MW), where C is the amount of soluble β-glucan in the daily dose of cereal and MW is the molecular weight of the β-glucan in the cereal.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 18.5 to 40.0 kg/m\^2
* no intention to lose or gain weight
* fasting total cholesterol 5.0 to 8.0 mmol/L
* fasting LDL cholesterol 3.0 to 5.0 mmol/L
* consuming diet containing \<15% energy from saturated fat

Exclusion Criteria:

* use of any cholesterol-lowering drug, herbal or nutritional supplement
* regular consumption of oatmeal, oat bran or psyllium - containing cereals
* fasting serum triglycerides \>4.0mmol/L
* serum aspartate transaminase \>1.5 times upper limit of normal
* serum urea or creatinine \>1.8 times upper limit of normal
* presence of diabetes or fasting glucose \>6.9mmol/L
* presence or recent major surgical or medical event
* allergy to wheat or oats
* presence of condition or drug which alters digestion or absorption of foods
Pectin, Aging and Intestinal Barrier Function

The population is aging worldwide, which requires more attention to health needs and leads to a dramatic increase in health care costs. Prevention or delay of onset of disorders associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have beneficial effects on gut health parameters, i.e. intestinal barrier function, immune function and microbial composition. As intestinal barrier function may be compromised in the elderly we will investigate whether the effects of pectin on selected parameters of gut health differ between young vs. older individuals. The primary objective of this study is to investigate the effects of aging on pectin-induced changes in intestinal permeability. Furthermore, this study has seven secondary objectives. This study conforms to a randomized, double-blind and placebo-controlled design including two parallel arms.The study population consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30 kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before and after the supplementation period, several measurements will take place. The main study parameter is the change in urinary sugar excretion ratio before and after the intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined.
* Age between 18 - 40 years and 65 - 75 years.
* Body Mass Index (BMI) between 20 and 30 kg/m2. Normal BMI has been chosen because obesity is associated with an altered microbial composition and increased intestinal permeability.

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol.
* Use of proton-pump inhibitors, nonsteroidal anti-inflammatory drugs and/or vitamin supplementation, within 14 days prior to testing. Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used.
* Administration of probiotic or prebiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 90 days prior to the study
* Use of antibiotics in the 90 days prior to the study.
* Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator).
* Pregnancy, lactation.
* Excessive alcohol consumption (\>20 alcoholic consumptions per week).
* Smoking.
* Blood donation within 3 months before or after the study period.
* Self-admitted human immunodeficiency virus-positive state.
* History of side effects towards intake of prebiotic supplements.
Connective Tissue Graft Versus a Porcine-derived Membrane (Mucoderm) After Immediate Placement

Esthetic outcome of immediate implant placement in fresh extraction sockets remains one of the biggest challenges in implant dentistry. Recently a method to preserve the peri-implant tissues was introduced using provisional restoration, allogenic bone and soft tissue thickening. However, the evidence that this immediate provisialisation with soft tissue grafting using different grafting materials results in constantly high Pink Esthetic scores, especially compared to the delayed loading approach is still lacking.

The aim of this clinical trial is to assess the esthetic outcome of immediate temporization of immediately placed and loaded tapered implants in fresh extraction sockets with bone and soft tissue augmentation, using either a connective tissue graft (CTG) or a porcine-derived membrane (Mucoderm) in maxillary anterior sites.

The secondary objectives are to investigate the influence of immediate loading on the success rate of tapered implants and crestal bone levels.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females of at least 18 years of age
2. 1 implant per patient
3. Subject must have voluntarily signed the informed consent before any study related action, are willing and able to attend scheduled follow-up visits, and agree that the pseudonymized data will be collected and analyzed
4. Anterior single teeth (canines and incisors) in both jaws
5. Class I extraction socket (intact buccal wall) or Class II (1/3 of buccal wall)
6. No recession of gingival contour of tooth to be extracted
7. No periodontal bone loss of neighboring anterior teeth
8. No implants in neighboring teeth
9. Atraumatic extraction of the tooth with intact socket walls remaining

Exclusion Criteria:

1. Deep bite (severe II class)
2. Heavy smokers (more than 10 cigarettes/day)
3. Systemic disease (diabetes, osteoporosis)
4. Primary stability after implant placement not achieved
5. Pregnancy
Effect of Berberine on Hormonal and Metabolic Features in Obese Women With Polycystic Ovary Syndrome (PCOS)

Berberine has showed effective in lowering blood sugar levels in db/db mice and anti-dyslipidemia in human.Studies on the effect of berberine on metabolic and hormonal features of women with polycystic ovary syndrome (PCOS) are lacking.The objective of this study is to examine the effect of Berberine metabolic and hormonal parameters and insulin resistance in obese patients with PCOS.


Eligibility Criteria:
Inclusion Criteria

1. Age of women between 18 and 35 years.
2. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism.
3. Body mass index (BMI) equal to or greater than 23 kg/m2.
4. With no desire of children within 6 month. PCOS is defined by the modified Rotterdam criteria: oligomenorrhea or amenorrhea, together with presence of ≥12 antral follicles (≤9mm) and/or ovarian volume \>10 ml on transvaginal scanning, and/or clinical/biochemical hyperandrogenism. Oligomenorrhea is defined as an intermenstrual interval \>35 days and \<8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval \>90 days. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5.

Exclusion criteria are

1. Use of hormonal drugs or other medications including Chinese Herbal prescriptions in the past 3 months.
2. Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome
3. Patients with known sever organ dysfunction or mental illness.
A Proposed Tetra-modal Treatment Protocol for Muscle Invasive Urothelial Carcinoma of the Urinary Bladder

In Egypt, bladder cancer has been the most common cancer during the past 50 years. In 2002, Egypt's world-standardized bladder cancer incidence was 37/ 100,000, representing approximately 30,000 new cases each year.

About 25% of new diagnoses are muscle-invasive bladder cancer (MIBC), which carry a worse prognosis compared to non-muscle invasive disease.

Neoadjuvant chemotherapy (NAC) followed by radical cystectomy (RC) with bilateral pelvic lymphadenectomy is considered the standard of care for treatment of MIBC by multiple international guidelines.

However, this is associated with a significant impact on quality of life.

The effect of our proposed Tetra-modal treatment protocol for muscle invasive Urothelial carcinoma of the urinary bladder on muscle invasive bladder cancer recurrence free survival, cancer specific survival, and overall survival?

Koga developed a selective bladder-sparing protocol with a tetra modal therapy comprising maximal transurethral resection of bladder tumor, induction chemoradiation (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection, allowing the confirmation of CRT response pathologically. In the preliminary analysis of the initial cases enrolled in their protocol, none of the patients who completed the protocol with consolidative PC experienced MIBC recurrence, suggesting that consolidative PC may improve local cancer control in the preserved bladder by surgically eliminating possible cancer remnants after CRT.

Our proposed Tetra-modal treatment protocol for MIBC is supposed to eliminate the surgical difficulties of performing PC in a radiated field and hence decrease the post operative complications of PC.


Eligibility Criteria:
Inclusion Criteria:

1. Tumor size ≤ 50 % of bladder surface or multiple tumors in an area of the bladder that is ≤ 50 % of total bladder surface.
2. Tumor at least 2 cm away from bladder neck or trigone.
3. Clinically, no residual disease or minimal amounts of non-invasive disease in the original MIBC site after NAC at restaging TURBT (if done).
4. Pathologically confirmed urothelial carcinoma.

Exclusion Criteria:

1. Prescence of CIS.
2. Presence of distant metastasis.
3. Patients unfit for cisplatin-based chemotherapy.
68Ga-NYM096/177Lu-NYM096 in Metastatic CcRCC

This is a single-center, phase I study. Patients with metastatic clear cell renal cell carcinoma will be recruited in this study to (Phase A) evaluate using 68Ga-NYM096 PET/CT and to (Phase B) treat with 177Lu-NYM096.

The study will be conducted in two phases. The purpose is Phase A: to evaluate the safety, tolerability, and imaging characteristics of 68Ga-NYM096 Phase B: to evaluate the safety, tolerability, and recommended phase 2 dose of 177Lu-NYM096


Eligibility Criteria:
Inclusion Criteria:

1. Age≥18y
2. Histologically or cytologically confirmed metastatic clear cell renal cell carcinoma
3. Progression after or cannot undergo standard therapy with tyrosine kinase inhibitor (TKI) treatment or TKI combined with immune checkpoint inhibitor treatment.
4. Presence of at least 1 non-irradiated tumor lesion detected at conventional imaging (computed tomography / magnetic resonance imaging (CT/MRI)) documented within 4 weeks prior to the 68Ga-NYM096 administration which should be measurable per response evaluation criteria in solid tumors (RECIST) v1.1.
5. ECOG= 0 or 1
6. Written informed consent.
7. For Phase B: 68Ga-NYM096 should meet the imaging inclusion criteria

Exclusion Criteria:

1. Any major surgery within 12 weeks before enrollment
2. Inability to stay in the scanner bed and keep still for the duration of the scan
3. Participants who have not had resolution of clinically significant toxic effects of prior systemic cancer therapy, surgery, or radiotherapy to Grade ≤1
4. EGFR no higher than 30ml/min\*1.73m2
5. Inflammatory bowel disease
6. Phase A: TKI treatment within one week before 68Ga-NYM096 administration
7. Phase B: Participants who received any systemic antineoplastic therapy for the underlying disease and/or other investigational agents within a period which is ≤5 half-lives or ≤4 weeks (whichever is shorter).
8. Any previous CA IX-targeting treatment
9. Prior external beam radiation therapy (EBRT) to more than 25% of the bone marrow
10. Pregnant or breastfeeding