cyrilzakka/clinical-trials huggingface dataset:
Second-generation Sequencing Guides the Treatment of Severe Pneumonia

Investigators plan to conduct the participants level, 1:1 randomized trial at the Central ICU and respiratory ICU of Xiangya Hospital in Changsha, China, from January 1, 2018 to December 31, 2019. Participants with initial diagnosis of severe pneumonia will be first treated with empiric therapy, after 48-72 hours, the participants's condition will be evaluated, and participants who will have been initially cured and died should be excluded.The participants who will have failed the initial treatment will be then randomly divided into two groups: the NGS group and the conventional treatment group. Bronchoalveolar lavage fluid will be taken by bedside bronchoscopy when the participants underwent nasal high-flow oxygen therapy, non-invasive ventilation, and invasive ventilation,or venous blood will be taken for examination. Participants in the NGS group will be tested for both NGS and conventional pathogens, however, the routine group will be only routinely tested. According to the pathogen results, participants with non-severe pneumonia will be excluded, and medication should be adjusted under the joint guidance of infectious and respiratory specialists. Then investigators will compare the first outcome: 28-day mortality, and secondary outcome: ICU hospitalization time, mechanical ventilation time, Hospitalization costs, antibiotic use costs, SOFA scores, CURB-65 scores, APACHE scores, and other clinical indicators.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with severe pneumonia between the ages of 18 and 85 years; the diagnosis of severe pneumonia is based on IDSA / ATS

Exclusion Criteria:

* \< 18 years old, received antibiotic treatment within 14 days before admission, suffering from severe immunosuppression, multi-drug resistance, refractory tuberculosis, end-stage renal disease or liver disease (uremia, advanced liver cancer), pregnancy. Besides, we need to rule out patients who have been improved, died, and abandoned during the initial treatment。
Study Of CP-751,871 In Combination With Exemestane In Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer

To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with a diagnosis of hormone receptor positive advanced breast cancer
* HbA1c \<5.7%

Exclusion Criteria:

* Previous treatment for advanced disease
Prophylactic Coagulation for the Prevention of Bleeding in Endoscopic Mucosal Resection of Large Sessile Colonic Polyps

The hypothesis of this study is that prophylactic coagulation therapy with coagulation forceps to visible vessels within the mucosal defect for colonic Endoscopic Mucosal Resection (EMR) will reduce the rate of delayed bleeding when compared with current established standard EMR technique.

Delayed bleeding from the site of the resection remains one of the most common complications following EMR, occurring in up to 12% of patients. The purpose of the study is to prevent such bleeding with the use of a technique known as: "coagulation therapy." This therapy involves using a small dose of heat energy that results in clotting(coagulation) of a blood vessel. It is already used widely in the stomach and we intend using this on a lower setting to blood vessels that are exposed after the resection.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to Westmead Hospital Endoscopy unit for endoscopic removal of a large sessile colonic polyp sized \>20mm
* Age \>18 years
* Able to give informed consent to involvement in trial

Exclusion Criteria:

* Pregnancy: currently pregnant or attempting to become pregnant
* Lactation: currently breastfeeding
* Taken clopidogrel within 7 days
* Taken warfarin within 5 days
* Had full therapeutic dose unfractionated heparin within 6 hours
* Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours
* Known clotting disorder
Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases

The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease.

While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established.

To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70
* histologically proven malignant melanoma with advanced inoperable soft tissue metastases
* progressive disease upon systemic first-line chemotherapy
* 2 or more bidimensionally measurable soft tisue lesions
* WHO performance status (ECOG) of 2 or more
* life expectancy of 8 weeks and more
* prior informed consent

Exclusion Criteria:

* participation in other therapy studies
* pregnancy or breast feeding
* concomitant clinically significant infection
* cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
* lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)
Validation of Kujala German

The field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used in many studies investigating patellofemoral disorders - also in german speaking patient groups. Unfortunately, we are not aware of a validated german version of the Kujala score. Other relevant knee outcome scores were already successfully translated into german language and validated by previous investigators.

So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala score for use in German-speaking individuals with patellofemoral instability. It is hypothesized that the german version of the Kujala score shows:

* High divergent construct validity as determined by significant differences between patients and controls (hypothesis 1)
* High convergent construct validity as determined by significant correlations with other relevant scoring systems (hypothesis 2)
* High reliability (hypothesis 3)
* High responsiveness (hypothesis 4)


Eligibility Criteria:
Inclusion Criteria:

* german speaking
* MPFL-reconstruction planed

Exclusion Criteria:
The Effect of Insect Protein on Performance and Hypertrophy

Purpose: to study the effect of insect protein on performance and hypertrophy during 8 weeks of resistance training.

Hypothesis: Insect protein supplementation enhances the effect of resistance training on muscle mass and muscle strength.

Primary outcome: Muscle hypertrophy and muscle strength

Design: Two groups of healthy young men (age: 18-30 years) with resistance training experience, but no structural resistance training performed for the last 12 months. Randomized controlled intervention study +/- insect protein (placebo group ingest isocaloric carbohydrate). Both groups perform 8 weeks of progressive resistance training (4/week) aiming to induce muscle hypertrophy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy young men (age: 18-30 years) with experience in resistance training
* 2 hours of physical exercise per week or more

Exclusion Criteria:

* No structural resistance training for the last 12 months
* No injuries
* No smoking
* No ingesting of protein or creating supplementations
* No use of medicine which may influence the adaptation to strength training
A Pilot Study on Exercise After Achilles Tendon Rupture

The purpose is to study the effect of early NEuroMuscular EXercise (NEMEX) versus conventional treatment (late exercise) in patients with acute non-operative achilles tendon rupture (ATR).

There is currently no consensus on treatment for achilles tendon rupture with regard to surgical or non-surgical treatment. In addition, the optimal time to start exercise treatment after the injury, with or without surgery, is not well understood. Animal studies show positive effects of early mobilization in tendon healing. Neuromuscular exercise has shown better effects than strength exercise in people with knee injury or knee disease. There are few studies in humans focusing on exercise as treatment, without surgical intervention, after ATR.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18 - 60 years.
2. The patient should before the achilles tendon rupture have been able to walk independently without aid, walk without limping, run/jog and be able to jump on one leg
3. The patient shall be able to read, understand and to assimilate the written information about the study.

Exclusion Criteria:

1. Previous achilles tendon rupture
2. Acute achilles tendon rupture, more than 5 days.
3. Medical restrictions regarding physical exercise, not related to the achilles tendon rupture
Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder

The purpose of this study is to evaluate how effective quetiapine versus placebo is when added to an existing therapy, in reducing the symptoms of PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalised and non-hospitalised patients / Veteran or Civilian / Have had symptoms of PTSD for a minimum of 12 months prior to giving consent to the study

Exclusion Criteria:

* History of psychotic condition / quetiapine or other anti-psychotics not worked previously / Taking prohibited medications (mood stabilizers / substance abuse)
Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics and Anti-tumor Activity of HM95573

The main objective of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose of HM95573.

Besides the main objective, there are 3 other objectives as follows:

* To evaluate the anti-cancer effect of HM95573 in solid tumor patients
* To investigate the pharmacokinetic profile of HM95573 after oral administration.
* To investigate biomarkers related to the safety and efficacy of HM95573.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 20 years of age or older
* Subjects who have provided voluntary consent to participate in the study, and signed the written consent document.
* Estimated life expectancy of at least 12 weeks
* Histologically or cytologically confirmed advanced solid tumor

Exclusion Criteria:

* Symptomatic or uncontrolled central nervous system metastases
* Patients who are unable to take tablets orally or have a clinically significant gastrointestinal disorder, which may interfere with administration, metabolism and absorption of the investigational drug.
* Patients who, in the investigator's opinion, are not suitable for the study for any other reason.
Endometrial Changes in Breast Cancer Women.

This is a prospective observational multicentric study. The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

This is a prospective observational multicentric study. Patient with a history of breast cancer treated with adjuvant hormonal therapies or with no therapies, will be enrolled and followed once a year with physical exam and endovaginal ultrasound. Patients with suspected endometrial pathology will undergo hysteroscopy with endometrial biopsy or endometrial lesion resection.

The aim is to evaluate the incidence of endometrial cancer and endometrial atypical hyperplasia in patients with previous breast cancer, treated with different adjuvant therapies. The second aim is to identify ultrasonographic soft markers related with endometrial cancer or atipycal hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* Personal history of breast cancer

Exclusion Criteria:

* Personal history of other hormonal sensitive cancers
* Assumption of hormones in the previous 5 years
* Previous medical assisted reproduction technique
* Lynch syndrome or BRCA 1/2 mutations
Acute Effects of Aerobic Exercise on Motor Memory Consolidation in Older People

Scientific evidence suggests that an aerobic exercise session promotes improvements in the consolidation of motor memory in adults. In this sense, the main purpose of this study was to investigate if an aerobic training session could improve motor memory consolidation in older people.

The participants of this study were 33 subjects of both genders (M = 68 years old; SD = 4.2 years old) and were divided in two groups: a control group (N = 15; M = 67, 6 years old; SD = 4.1 years old) and an experimental group (N = 18; M = 67, 4 years old; SD = 4.4 years old). The participants performed a Soda Pop test before the aerobic training session (Baseline). The training session lasted 45 minutes and was composed of running exercises. After the training session, the motor memory consolidation was held in three different stages: Training; 1 hour after training; 24 hours after training.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* sensory abnormalities;
* mental abnormalities;
* motor abnormalities;
* other atypical health problems.
The Effect of Yoga on Sexual Function in Primiparous Pregnants

This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women.150 pregnant women will be randomized.The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group

This study was planned as a single blind randomized controlled type in order to examine the effect of yoga on sexual function in primipara pregnant women. The data of the research will be collected through the "Data Collection Form, Female Sexual Function Scale (FSFI)" and The Body Exposure During Sexual Activities Questionnaire (BESAQ), which are created by the researchers by scanning the literature. Research Volunteers who apply to SBU Haseki Training and Research Hospital Pregnancy Outpatient Clinic and meet the sample selection criteria will constitute the sample of the study. In order to determine the minimum sample size required for this study, the power analysis 80% power and α = 0.50 were calculated to include a total of 138 women with a minimum 69 sample size in each group. The intervention and control ratio is 1. However, considering the probability of loss, 150 pregnant women will be randomized. The data will be interviewed online with pregnant women and online yoga training will be held for the intervention group, and the data will be uploaded to the ISM SPSS 22.0 (Statistical Package for the Social Sciences) statistics program; Parametric (Anova and T test) and nonparametric (Mann-Whitney U Test, Kruskal Wallis, Chi Square) statistical methods will be used.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-35,

  * In primiparous pregnant women (18-26 weeks),
  * Female Sexual Function Scale (FSFI) score\> 22.7,
  * Volunteering to participate in research,
  * To speak Turkish.

Exclusion Criteria:

* Having a disability that makes it difficult for the pregnant woman to do yoga asanas,

  * have done yoga Subtraction criterion Not attending the trainings regularly,
  * Not attending at least 5 of the trainings
Social Norms, Messengers, and Processing Fluency to Increase Hypertension Medication Adherence

Medicare Advantage beneficiaries ages 65-79 and insured by Humana with at least two unique fills of hypertension medication within the 2023 calendar year and adherence level between 60 and 85% will be identified using Humana Medicare Advantage claims data. Individuals meeting these inclusion criteria will be included and, with an institutional review board approved waiver of informed consent, will be randomized to one of 6 mailed messages or control (no message). The messages will be sent by Humana and use different behavioral techniques (social norms, messenger effects, and/or processing fluency) providing their medication refill score. Humana will send a second message within 60 days of the first message noting any changes in the refill score.

The primary outcome will be the average end-of-year adherence in each arm. A secondary outcome will be the proportion of study participants with end-of-year adherence greater than or equal to 80%. The study team's hypothesis is that messages using dynamic social norms, messenger effects, and processing fluency in combination will more effectively increase average end-of-year adherence level compared to usual care.

Humana will conduct all study participant outreach and data analyses, which will be performed using routinely collected insurance claims data. Regulatory oversight is conducted using Humana's centralized institutional review board (IRB) of record. The work completed by Humana study staff is funded by Humana, Inc.

Dr. Choudhry and his colleagues (including subaward recipients ideas42 and Tuck School of Business at Dartmouth) will provide technical and subject matter expertise related to study research design and implementation, protocol design, statistical analysis, publication (abstract, poster, manuscript) preparation and/or review, and assistance throughout the peer review process including revisions and additional analyses if necessary for this project. The work completed by study staff at Brigham and Women's Hospital, ideas42, and Tuck School of Business at Dartmouth is funded by NIA.


Eligibility Criteria:
Inclusion Criteria:

* Medicare Advantage beneficiary insured by Humana
* Between the ages of 65 and 79
* Having at least two unique fills of any class of hypertension medication within the calendar year (2023).
* Adherence level (as measured by the proportion of days covered \[PDC\] metric) between 60% and 85%

Exclusion Criteria:

* Beneficiaries in plans which, per contractual agreements, privacy policies and rules, or legal requirements, do not participate in research
Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension

The primary clinical hypothesis is that long-term exposure of evolocumab will be safe and well tolerated in subjects with clinically evident atherosclerotic cardiovascular disease (CVD).

This is a multicenter, open-label extension study designed to assess the long-term safety of evolocumab in subjects who completed the FOURIER study,which is a randomized placebo-controlled study of evolocumab in subjects with clinically evident atherosclerotic CVD on stable effective statin therapy. Eligible subjects at sites participating in FOURIER OLE who have signed the FOURIER OLE informed consent may be enrolled at the completion of FOURIER study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has provided informed consent before initiation of any study-specific activities/procedures
* Subject has completed FOURIER (Study 20110118) while still receiving assigned investigational product.

Exclusion Criteria:

* Investigational product was permanently discontinued during FOURIER for any reason, including an adverse event or serious adverse event
* Subject is currently receiving treatment in another investigational device or drug study, or ended treatment on another investigational device or drug study(ies) within less than 4 weeks. Other investigational procedures while participating in this study are excluded
* Subject is not likely to be available to complete protocol-required study visits or procedures and/or to comply with required study procedures to the best of the subject's and investigator's knowledge
* Subject has a history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
* Subject has a known sensitivity to any of the active substances or excipients (eg, sodium acetate) to be administered during dosing
* Female subject is pregnant or breastfeeding or is planning to become pregnant or planning to breastfeed during treatment with evolocumab and within 15 weeks after the end of treatment with evolocumab
* Female subjects of childbearing potential who are not willing to use an acceptable method(s) of effective birth control during treatment with evolocumab and for an additional 15 weeks after the end of treatment with evolocumab are excluded
Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of a New Ultra Low Molecular Weight Heparin (RO-14) Administered Subcutaneously Increasing Single-doses to Healthy Male Volunteers

Clinical trial to evaluate the tolerability and pharmacokinetics of a new ultra low molecular weight heparin (RO-14) administered subcutaneously increasing single-doses to healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteers: male subjects aged between 18 and 45 years
2. Body weight: 65-75 Kg
3. Not meaningful abnormalities in physical examination and in clinical history
4. Without evidence of significant organic or psychiatric illness
5. Hemogram, biochemistry and coagulation in normal values established in the reference range of the local hospital laboratory
6. Vital signs (blood pressure, heart beat rate and body temperature) and EKG within normal range
7. Healthy volunteers who are not participating in another clinical trial or have not done so in the past 2 months
8. Not give blood in the last 4 weeks.
9. Healthy male volunteers who have not received heparin in the past
10. Healthy male volunteers who have accepted to participate in the study and have signed the written informed consent

Exclusion Criteria:

1. Previous history of alcoholism, drug dependency, drug abuse or habitual psychoactive drugs consumption
2. Important consumption of exciting drinks: alcohol consumption \> 30 g/day; coffee, tea, cola \> 5 /day
3. Allergy, idiosyncrasy or hypersensitivity to medicines
4. Healthy volunteers who are receiving another medication in the past 15 days
5. Positive serology of hepatitis B, C or HIV
6. Cardiovascular, respiratory, renal, hepatic, endocrine, gastrointestinal, hematologic, psychiatric, neurological and others events
7. Mayor Surgery in the last 6 months
8. Smoking \> 10 cigarettes / day
9. Ethanol, cannabis, cocaine, amphetamine, benzodiazepine or opiate in urine
10. Healthy volunteers with a familiar history evident hemorrhagic episodes